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Safety data sheet

according to Regulation (EU) 453/2010, amending
Regulation (EC) 1907/2006
Printing date: 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

* 1 Identification of the substance/mixture and of the company/undertaking

· Product identifier
Ethyl Methyl Ketoxime
2-butanone oxime
· Trade name: MEKO: Methyl Ethyl Ketoxime
· CAS Number:
96-29-7
· EC number:
202-496-6
· Registration number 01-2119539477-28-0002
· Relevant identified uses of the substance or mixture
· Sector of Use
SU3 Industrial uses: Uses of substances as such or in preparations at industrial sites
SU21 Consumer uses: Private households / general public / consumers
SU22 Professional uses: Public domain (administration, education, entertainment,
services, craftsmen)
· Application of the substance / the preparation
Intermediate
Coating compound/ Surface coating/ paint
Application of paints
Curing agent for silicon rubber
Blocking agent for polyurethane
View uses described in the exposure scenarios attached to the safety data sheet.
· Details of the supplier of the safety data sheet
UBE Chemical Europe, S.A.
Polígono El Serrallo s/n
12100 Grao de Castellón (Spain)
Tel: +34 964 73 80 00
[email protected]

Commercial office:
UBE Chemical Europe, S.A
CARDENAL MARCELO SPINOLA, 2
28016 MADRID, SPAIN
Tel:+ 34 915 972 069
· Emergency telephone number:
Telephone in Spain: 704.1000.87
European Phone: +44.1235.239.670

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008

GHS08 health hazard

Carc. 2 H351 Suspected of causing cancer.

(Contd. on page 2)
GB

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Safety data sheet
according to Regulation (EU) 453/2010, amending
Regulation (EC) 1907/2006
Printing date: 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

GHS05 corrosion

Eye Dam. 1 H318 Causes serious eye damage.

GHS07

Acute Tox. 4 H312 Harmful in contact with skin.

Skin Sens. 1 H317 May cause an allergic skin reaction.
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC
Xn; Harmful
R21-40: Harmful in contact with skin. Limited evidence of a carcinogenic effect.

Xi; Irritant
R41: Risk of serious damage to eyes.

Xi; Sensitising
R43: May cause sensitisation by skin contact.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008
The substance is classified and labelled according to the CLP regulation.
· Hazard pictograms

GHS05 GHS07 GHS08

· Signal word Danger

· Hazard statements
H312 Harmful in contact with skin.
H318 Causes serious eye damage.
H317 May cause an allergic skin reaction.
H351 Suspected of causing cancer.
· Precautionary statements
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P281 Use personal protective equipment as required.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing.
P310 Immediately call a POISON CENTER or doctor/physician.
P321 Specific treatment (see on this label).
P322 Specific measures (see on this label).
P312 Call a POISON CENTER or doctor/physician if you feel unwell.
P405 Store locked up.
(Contd. on page 3)
GB

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Safety data sheet
according to Regulation (EU) 453/2010, amending
Regulation (EC) 1907/2006
Printing date: 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

P501 Dispose of contents/container in accordance with local/regional/national/

international regulations.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Substances
· CAS No. Description
96-29-7 2-butanone oxime
· EC number: 202-496-6

4 First aid measures

· Description of first aid measures
· General information:
Seek medical treatment.
Take affected persons out into the fresh air.
Immediately remove any clothing soiled by the product.
Personal protection for the First Aider.
· After inhalation:
Supply fresh air.
If not breathing, give artificial respiration.
Call a doctor immediately.
· After skin contact:
Wash contaminated skin with water.
Remove contaminated clothing
Seek medical treatment.
Wash clothing before reuse. Properly clean shoes before reuse
· After eye contact:
Immediately flush exposed area with copious amounts of water for at least 15 minutes.
Seek medical treatment.
· After swallowing:
Wash inside the mouth thoroughly with water. (only if the person is conscious)
Allow water to be drunk
Do not induce vomiting; call for medical help immediately.
· Information for doctor:
· Most important symptoms and effects, both acute and delayed
Methaemoglobinaemia
Strong irritant to eyes, skin and respiratory tract.
· Indication of any immediate medical attention and special treatment needed
No specific treatment information is available. Symptomatic treatment is advisable
GB
(Contd. on page 4)

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Safety data sheet
according to Regulation (EU) 453/2010, amending
Regulation (EC) 1907/2006
Printing date: 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
Dry chemical
Carbon dioxide
Foam
Alcohol resistant foam
· For safety reasons unsuitable extinguishing agents: Not known
· Special hazards arising from the substance or mixture
In case of fire, the following can be released:
Carbon monoxide (CO)
Nitrogen oxides (NOx)
Formation of toxic gases is possible during heating or in case of fire.
· Advice for firefighters
· Protective equipment:
Wear self-contained respiratory protective device.
Wear fully protective suit.

6 Accidental release measures

· Personal precautions, protective equipment and emergency procedures
keep away from sources of ignition
Ensure adequate ventilation
Avoid breathing dust/fume/vapours.
Isolate hazard area
Remove persons from danger area.
Use personal protective equipment as indicated in paragraph 8
· Environmental precautions: Prevent the material from spreading into the environment.
· Methods and material for containment and cleaning up:
Absorb with non-combustible material (eg. sand)
Dispose contaminated material as waste according to item 13.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for disposal information.

7 Handling and storage

· Handling:
· Precautions for safe handling
Ensure good ventilation/exhaustion at the workplace.
Keep away from heat and open flames.
Avoid contact with eyes, skin and clothing.
Do not eat, drink, smoke or sniff while working.
Wash hands before breaks and at the end of work.
Keep away from foodstuffs, beverages and feed.
· Information about fire - and explosion protection: keep away from sources of ignition
(Contd. on page 5)
GB

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Safety data sheet
according to Regulation (EU) 453/2010, amending
Regulation (EC) 1907/2006
Printing date: 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

· Conditions for safe storage, including any incompatibilities

· Storage:
· Requirements to be met by storerooms and receptacles:
Store in a cool location.
Store in a dry place with low humidity.
Store receptacle in a well ventilated area.
Suitable material for receptacles and pipes: Stainless steel.
Unsuitable material for receptacle: glass or ceramic.
· Information about storage in one common storage facility:
Store away from oxidizing agents.
· Further information about storage conditions:
Store in cool, dry conditions in well sealed receptacles.
Keep container tightly sealed.
· Specific end use(s)
A chemical safety assessment has been carried out for this substance and Exposures
Scenarios are attached.

8 Exposure controls/personal protection

· Additional information about design of technical facilities:
Mechanical ventilation at the point of escape of steam or fog.
· Control parameters
· Ingredients with limit values that require monitoring at the workplace: Not required.
· DNEL (workers)
Dermal DNEL (Acute/short term exposure–systemic effects) 2.5 mg/kg bw/day (-)
DNEL (Long-term exposure – systemic effects) 1.3 mg/kg bw/day (-)
Inhalative DNEL (Long-term exposure – local effects) 3.33 mg/m3 (-)
DNEL (Long-term exposure – systemic effects) 9 mg/m3 (-)
· DNEL (general population)
Dermal DNEL (Systemic effects acute/short term exposure) 1.5 mg/kg bw/d (-)
DNEL (Systemic effects-Long-term exposure) 0.78 mg/Kg bw/day (-)
Inhalative DNEL (Local effects-Long-term exposure) 2 mg/m³ (-)
DNEL (Systemic effects-Long-term exposure) 2.7 mg/m³ (-)
· PNECs
PNEC (STP) 177 mg/L (-)
PNEC (intermittent release) 0.118 mg/L (-)
PNEC(fresh water) 0.256 mg/L (-)
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
Avoid breathing dust/fume/vapours.
In accordance with Directive 89/686/EEC on personal protective equipment
· Respiratory protection:
Under conditions of frequent use or heavy exposure, respiratory protection is needed
Filter P3
(Contd. on page 6)
GB

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Safety data sheet
according to Regulation (EU) 453/2010, amending
Regulation (EC) 1907/2006
Printing date: 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

· Protection of hands:

Protective gloves

The glove material has to be impermeable and resistant to the product/ the substance/ the
preparation.
· Material of gloves
Nitrile rubber, NBR
Recommended thickness of the material: 0.4 mm
· Eye protection:
Face protection

Tightly sealed goggles

· Skin and body protection:

Personal protective equipment for the body should be selected based on the task being
performed and the risks involved and should be approved by a specialist before handling
this product. Apron, boots and full protection suit made from a suitable plastic (e.g. Viton).

9 Physical and chemical properties

· Information on basic physical and chemical properties
· General Information
· Appearance:
Form: Fluid
Colour: Yellowish
· Odour: Characteristic
· Odour threshold: Not determined.
· pH-value (114 g/l) at 20 °C: 6.5
· Change in condition
Melting point/Melting range: -29.5 °C
Boiling point/Boiling range: >152 °C
· Flash point: 62 °C ((closed cup))
· Flammability (solid, gaseous): Product is not flammable.
· Ignition temperature 345 °C
· Decomposition temperature: Not determined.
· Self-igniting: 314-317ºC
· Danger of explosion: Product does not present an explosion hazard.
· Explosion limits:
Lower: 1.9 Vol %
Upper: 12.3 Vol %
(Contd. on page 7)
GB

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Safety data sheet
according to Regulation (EU) 453/2010, amending
Regulation (EC) 1907/2006
Printing date: 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

· Oxidizing properties No oxidising properties

· Vapour pressure at 20 °C: 10.7 hPa
· Density:
Relative density at 20 °C 0.92 g/cm³
Vapour density 3 ((air=1))
Evaporation rate Not determined.
· Solubility in / Miscibility with
water at 25 °C: 100 g/l
· Partition coefficient (n-octanol/water) at
25 °C: 0.63 log POW
· Viscosity:
Dynamic at 20 °C: 15 mPas
· Other information Dissociation constant:pK = 12.45 at 25 °C
Soluble in alcohol and ether.

10 Stability and reactivity

· Reactivity
MEKO does not contain groups that indicate potential reactivity with water or pyrophoric
properties
· Chemical stability Stable at environment temperature.
· Thermal decomposition / conditions to be avoided: Stable at environment temperature.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid
Avoid heat, flames, sparks and other sources of ignition.
Containers may rupture or explode if they are exposed to high temperatures.
· Incompatible materials:
Strong acids
Oxidizing materials
Alkaline agents.
· Hazardous decomposition products:
Nitrogen oxides
Carbon monoxide

11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values relevant for classification:
Oral LD50 2326 mg/kg (rat) ((OECD401))
Dermal LD50 1000 mg/kg (rabbit) ((OECD402))
Inhalative LC50/4 h 13.2 mg/l (rat) ((estimated))
· Primary irritant effect:
· on the skin: Slightly irritating (PDII=ca. 1.5)
(Contd. on page 8)
GB

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Safety data sheet
according to Regulation (EU) 453/2010, amending
Regulation (EC) 1907/2006
Printing date: 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

· on the eye:
Corrosive (Corneal opacity, iritis, conjunctival hyperaemia and necrosis were observed 24,
48, and 72 hours post exposure)
· Sensitization: Skin sensitizing (Guinea pig maximization test)
· Other information (about experimental toxicology):
Aspiration hazard: No data available from the supplier.
· Repeated dose toxicity
Hematopoietic system abnormality was observed over 25mg/kg/day (oral-rat, 13weeks).
· CMR effects (carcinogenity, mutagenicity and toxicity for reproduction)
In vitro mammalian cell gene mutation: Negative
Ames test: Negative
DNA damage and repair: Negative
In vivo gene mutation: Negative
In vivo chromosome aberration: Negative
NOAEC: 270 mg/m3
Two-generation reproductive toxicity: NOAEL 200 mg/kg/day (oral)
Developmental toxicity: NOAEL 24 mg/kg/day
Carc. 2

12 Ecological information
· Toxicity
· Aquatic toxicity:
EC 50(72h) 11.8 mg/l (algae) ((OECD201))
EC50 (48 h) 201 mg/l (daphnia magna) ((OECD202))
LC50 (96 h) >100 mg/l (Oryzias latipes) ((OECD209))
NOEC (14d) 50 mg/L (Oryzias latipes) ((OECD204))
NOEC(21d) 100 mg/L (daphnia magna) ((OECD211))
· Persistence and degradability Degree of biodegradation = 14.5 % (21d)
· Behaviour in environmental systems:
· Bioaccumulative potential BCF values in fish (Cyprinus carpio): 0.5 to 5.8
· Mobility in soil It is not likely to adsorb to soil
· Additional ecological information:
· General notes:
Water hazard class 1 (German Regulation) (Assessment by list): slightly hazardous for water
Do not allow undiluted product or large quantities of it to reach ground water, water course or
sewage system.
· Results of PBT and vPvB assessment
· PBT:
The substance does not fulfil the PBT criteria (not PBT) and not the vPvB criteria (not
vPvB).
· vPvB:
The substance does not fulfil the PBT criteria (not PBT) and not the vPvB criteria (not
vPvB).
· Other adverse effects No further relevant information available.
GB
(Contd. on page 9)

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Safety data sheet
according to Regulation (EU) 453/2010, amending
Regulation (EC) 1907/2006
Printing date: 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

13 Disposal considerations
· Waste treatment methods
· Recommendation
Chemical residues generally count as special waste
Disposal must be made according to official regulations.
Do not allow product to reach sewage system or any water course.
· Uncleaned packaging:
· Recommendation:
Packaging may contain residues of the product and should be treated accordingly.
Disposal must be made according to official regulations.

14 Transport information
· UN-Number
· ADR T he substance is not classi f i ed under
transport regulations
· ADN, IMDG, IATA None
· UN proper shipping name T he substance is not classi f i ed under
transport regulations
· ADR, ADN, IMDG, IATA None
· Transport hazard class(es) T he substance is not classi f i ed under
transport regulations
· ADR
· Class None
T he substance is not classi f i ed under
transport regulations
· ADN/R Class: None
· Packing group T he substance is not classi f i ed under
transport regulations
· ADR, IMDG, IATA None
· Environmental hazards:
· Marine pollutant: No
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of
MARPOL73/78 and the IBC Code Not applicable.
· UN "Model Regulation": -

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or
mixture
· Labelling according to Regulation (EC) No 1272/2008 GHS label elements
(Contd. on page 10)
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Safety data sheet
according to Regulation (EU) 453/2010, amending
Regulation (EC) 1907/2006
Printing date: 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

· Chemical safety assessment

A chemical safety assessment has been carried out for this substance and Exposures
Scenarios are attached.
· National regulations:
Class Share in %
I 100.0
· Chemical safety assessment: A Chemical Safety Assessment has been carried out.

* 16 Other information
This information is based on our present knowledge. However, this shall not constitute a
guarantee for any specific product features and shall not establish a legally valid contractual
relationship.
· Training hints Workers need to have an specific training to handle the substance.
· Department issuing MSDS: Corporate Social Responsibility- Product Liability
· Abbreviations and acronyms:
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations
Concerning the International Transport of Dangerous Goods by Rail)
ICAO: International Civil Aviation Organization
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the
International Carriage of Dangerous Goods by Road)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
EINECS: European Inventory of Existing Commercial Chemical Substances
CAS: Chemical Abstracts Service (division of the American Chemical Society)
DNEL: Derived No-Effect Level (REACH)
PNEC: Predicted No-Effect Concentration (REACH)
LC50: Lethal concentration, 50 percent
LD50: Lethal dose, 50 percent
· * Data compared to the previous version altered.
Annex: Amendments to the exposure scenarios.
GB

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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

EXPOSURE ASSESSMENT
Exposure to MEKO is described for five exposure scenarios. The division is based on life cycle stage. In each
exposure scenario, different process categories associated with different levels of exposure are presented. The
worker exposure assessment is based modelled exposure estimates based on ECETOC TRA (version 2.0) for
workers (industrial and professional) exposure assessment (ECETOC, 2009), the consumer exposure assessment
tool CONSEXPO4.1 (RIVM 2006) and EUSES (version 2.1) for environmental emission assessment (EUSES,
2008). For the risk assessment, it is considered that if the highest exposure estimate within an exposure scenario
is safe, the other processes within the scenario are also safe.

General information
Overview

Overview of exposure scenarios

Table 1. Overview of exposure scenarios (ES)

ES number Exposure scenario name
1 Intermediate use of MEKO
2 Formulation of liquid paints containing MEKO
3 Industrial application of paints containing MEKO
4 Professional application of paints containing MEKO
5 Consumer application of coatings
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
Table 2. Short description of all Identified Uses with their use descriptors and life cycle stage

Life Cycle Stage(s) covered

by the IU

End Use

Service Life (for article)

Sector Environme
Product Process Article
of ntal Release
Short description of Identified Use Categor Category Category
use Category
y (PC) (Proc) (AC)
(SU) (ERC)

Manufacture
Number (IU)

Formulation

Professional

Consumer
Industrial
ES
Intermediate use of MEKO
1
SU3,
1 Receipt and storage of raw materials: raw material storage X PROC1
SU9
Manufacturing equipment cleaning: enclosed off-line in SU3,
1 X PROC2
workplace SU9
Receipt and storage of raw materials: packaged goods delivery
Blending/dissolving/dispersion: mixing, milling, dispersing,
SU3,
1 completion X PROC3 ERC1 /
SU9
Waste management: solvent recovery using condensation or CEPE
adsorption/ desorption processes SPERC1
Blending/dissolving/dispersion: mixing, milling, dispersing,
completion -(additions) SU3,
1 X PROC5
Manufacturing equipment cleaning: open in situ in workplace SU9
Manufacturing equipment cleaning: open off-line in workplace
Filtering and filling: filtering or sieving and filling – enclosed SU3,
1 X PROC8a
non-dedicated lines SU9
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

Life Cycle Stage(s) covered

by the IU

End Use

Service Life (for article)

Sector Environme
Product Process Article
of ntal Release
Short description of Identified Use Categor Category Category
use Category
y (PC) (Proc) (AC)
(SU) (ERC)

Manufacture
Number (IU)

Formulation

Professional

Consumer
Industrial
Receipt and storage of raw materials: bulk raw material delivery
Raw material assembly and charging: raw material dispensing
of liquids manually from bulk storage or packaged goods
SU3,
1 Waste management: transfer of process wastes to storage X PROC8b
SU9
containers: off-line in workplace
Manufacturing equipment maintenance: cleaning manufacturing
equipment for maintenance purposes
Filtering and filling: filtering or sieving and filling – enclosed SU3,
1 X PROC9
dedicated lines SU9
ES
Formulation of liquid paints containing MEKO
2
SU3,
2 Receipt and storage of raw materials: raw material storage X PROC1
SU10
Manufacturing equipment cleaning: enclosed off-line in SU3,
2 X PROC2 ERC2 /
workplace SU10
CEPE
Receipt and storage of raw materials: packaged goods delivery
SPERC
Blending/dissolving/dispersion: mixing, milling, dispersing,
SU3, 1 and 2
2 completion X PROC3
SU10
Waste management: solvent recovery using condensation or
adsorption/ desorption processes
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

Life Cycle Stage(s) covered

by the IU

End Use

Service Life (for article)

Sector Environme
Product Process Article
of ntal Release
Short description of Identified Use Categor Category Category
use Category
y (PC) (Proc) (AC)
(SU) (ERC)

Manufacture
Number (IU)

Formulation

Professional

Consumer
Industrial
Blending/dissolving/dispersion: mixing, milling, dispersing,
completion -(additions)
SU3,
2 Manufacturing equipment cleaning: open in situ in workplace X PROC5
SU10
Manufacturing equipment cleaning: open off-line in workplace
Laboratory use: R&D laboratory
Filtering and filling: filtering or sieving and filling – enclosed SU3,
2 X PROC8a
non-dedicated lines SU10
Receipt and storage of raw materials: bulk raw material delivery
Raw material assembly and charging: raw material dispensing
of liquids manually from bulk storage or packaged goods
SU3,
2 Waste management: transfer of process wastes to storage X PROC8b
SU10
containers: off-line in workplace
Manufacturing equipment maintenance: cleaning manufacturing
equipment for maintenance purposes
Filtering and filling: filtering or sieving and filling – enclosed SU3,
2 X PROC9
dedicated lines SU10
ES
Industrial application of paints containing MEKO
3
Loading of application equipment and preparation of material
3 X SU3 PROC1
for application: liquid products - fully enclosed
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

Life Cycle Stage(s) covered

by the IU

End Use

Service Life (for article)

Sector Environme
Product Process Article
of ntal Release
Short description of Identified Use Categor Category Category
use Category
y (PC) (Proc) (AC)
(SU) (ERC)

Manufacture
Number (IU)

Formulation

Professional

Consumer
Industrial
Preparation of material for application and loading of
3 application equipment: liquid products. X SU3 PROC2
film formation (force drying (50 - 100°C)/stoving (>100°C))
Equipment cleaning: enclosed in situ – indoor. ERC4 /
Product delivery/storage. CEPE
3 X SU3 PROC3
Waste management: storage of waste prior to removal for off- SPERC
site management 16a
3 Film formation: airdrying X SU3 PROC4
Laboratory use: QC laboratory,
3 Equipment cleaning: open off-line - indoor X SU3 PROC5
Preparation of material for application liquid products
3 Application: on-line manual spray application X SU3 PROC7
3 Loading of application equipment-liquid products X SU3 PROC8a
Preparation of material for application: liquid coatings - transfer
of material from one container to another.
3 X SU3 PROC8b
Loading of application equipment liquid products.
Product delivery/storage bulk product delivery.
 Pag 16/76
Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

Life Cycle Stage(s) covered

by the IU

End Use

Service Life (for article)

Sector Environme
Product Process Article
of ntal Release
Short description of Identified Use Categor Category Category
use Category
y (PC) (Proc) (AC)
(SU) (ERC)

Manufacture
Number (IU)

Formulation

Professional

Consumer
Industrial
Application: on-line application by roller, spreader, flow coating
or printing- large scale (open equipment) [e.g. metal packaging,
3 X SU3 PROC10
coil coating, automotive OEM, flexible packaging, newspapers,
wall coverings]
3 Application: on-line application by dipping X SU3 PROC13
ES
Professional application of paints containing MEKO
4
Loading of application equipment-closed, continuous.
4 X SU22 PROC2
Equipment cleaning- open in situ.
Product delivery/storage, including packaged product delivery
and product storage.
4 Preparation of material for application-closed, continuous. X SU22 PROC3 ERC8a,8d /
Waste management: storage of waste prior to removal for off- CEPE
site management. SPERC
4 Film formation-airdrying X SU22 PROC4 11, 13
Loading of application equipment, and preparation of material
for application-batch, indoor.
4 X SU22 PROC5
Equipment cleaning -open in situ.
Laboratory use (QC laboratory)
 Pag 17/76
Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

Life Cycle Stage(s) covered

by the IU

End Use

Service Life (for article)

Sector Environme
Product Process Article
of ntal Release
Short description of Identified Use Categor Category Category
use Category
y (PC) (Proc) (AC)
(SU) (ERC)

Manufacture
Number (IU)

Formulation

Professional

Consumer
Industrial
Product delivery/storage: bulk product delivery.
Preparation of material for application.
Transfer of material from one container to another - indoor, and
loading of application equipment.
4 X SU22 PROC8a
Transfer of material from one container to another: waste
management,
Transfer of process wastes to storage containers: off-line inside
and outside.
Application: manual brush, roller, spreader application of
4 X SU22 PROC10
coatings
Application: coatings from aerosol dispensers manual spray
4 X SU22 PROC11
Application of coatings: manual spray application of coatings
4 Application: hand - paints, pastels, pigment powders X SU22 PROC19
ES
Consumer application of coatings
5
5 Consumer application high solid paint PC9a X SU21
ERC8a,8d /
5 Consumer application waterborne wall paint PC9a X SU21
CEPE
5 Consumer application waterborne paint PC9a X SU21
SPERC
5 Consumer application of paint by pneumatic spraying PC9a X SU21
11, 13
5 Consumer application of paint by spraycan PC9a X SU21
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

Life Cycle Stage(s) covered

by the IU

End Use

Service Life (for article)

Sector Environme
Product Process Article
of ntal Release
Short description of Identified Use Categor Category Category
use Category
y (PC) (Proc) (AC)
(SU) (ERC)

Manufacture
Number (IU)

Formulation

Professional

Consumer
Industrial
5 Consumer application of floor coating PC9a X SU21
5 Consumer application of artist paint PC9a X SU21
 Pag 19/76
Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
The following information has been used for the exposure assessments:
Substance MEKO
CAS no. 96-29-7
Vapour Pressure 1.07E+03 Pa at 20 ºC
TRA volatility range Medium volatility
Biodegradability Inherently biodegradable, fulfilling criteria
Henry's Law Constant 1.32 Pa/m3/mol at 25 ºC
Molecular Weight 87.12 g/mol
Melting Point -29.5 ºC
Boiling Point >152 ºC
Water solubility 1.00E+05 at 25 ºC
Log Kow 0.63
Log Koc 0.5 L/kg

Environmental emission assessment using EUSES

Emission estimates were all based on the EUSES v2.1 model (2008) in which default values have been used
from EUSES 2.1 (2008) and Tables 16-23 and 16-24 from Reach Guidance R.16 (ECHA, 2010), unless
otherwise indicated in this document. When default values differed between Tables 16-23 and 16-24 from
Reach Guidance R.16 (ECHA, 2010) and EUSES 2.1 (2008) the default values from Tables 16-23 and 16-24
were taken into account.

MEKO is not produced in the EU; the imported volume is 10,000 tonnes/year. The uses and life-cycle stages
that were considered in the current emission assessment are listed in Table 3.

Table 3 Life-cycle stages, ERCs and volumes.

ES Life-cycle stage ERC SpERC Maximum quantity
(tones/year)
1 Use as intermediate ERC1 CEPE1 2,000
2 Manufacturing liquid paints ERC2 CEPE1, CEPE2 8,000
3 Industrial application of coatings ERC4 CEPE16a 1,600
4a Professional application of coatings (Indoor) ERC8a CEPE11 1,600
4b Professional application of coatings (Outdoor) ERC8d CEPE13 1,600
5a Consumer application of coatings (Indoor) ERC8a CEPE10 1,600
5b Consumer application of coatings (Outdoor) ERC8d CEPE11 1,600
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

Exposure Scenario 1: Intermediate use of MEKO

Exposure scenario

Section 1 Exposure Scenario Title

Title Intermediate use of MEKO; CAS: 96-29-7
Use Descriptor Sector of Use: SU3, SU9
Process Categories: PROC1, PROC2, PROC3, PROC5, PROC8a,
PROC8b, PROC9
Environmental Release Categories: ERC1
Specific Environmental Release Categories: CEPE1
Processes, tasks, activities covered Use MEKO as an intermediate. Includes recycling/ recovery, material
transfers, storage, maintenance and loading (including marine
vessel/barge, road/rail car and bulk container), sampling and
associated laboratory activities
Section 2 Operational conditions and risk management measures
Field for additional statements to explain scenario if required.
Section 2.1 Control of worker exposure
Product characteristics
Physical form of product Liquid, vapour pressure 0.5 - 10 kPa [OC4].
Concentration of substance in product Covers percentage substance in the product up to 100 % (unless
stated differently) [G13].
Amounts used Not applicable
Frequency and duration of use Covers daily exposures up to 8 hours (unless stated differently) [G2]
Human factors not influenced by risk Not applicable
management
Other Operational Conditions affecting Assumes a good basic standard of occupational hygiene is
worker exposure implemented [G1].
Assumes use at not more than 20°C above ambient temperature,
unless stated differently [G15].
Contributing Scenarios Risk Management Measures
Note: list RMM standard phrases according to the control hierarchy
indicated in the ECHA template: 1. Technical measures to prevent
release, 2. Technical measures to prevent dispersion, 3.
Organisational measures, 4. Personal protection.
General exposures (closed systems) No specific measures identified [EI18].
[CS15]. Initial factory fill of equipment
[CS75]. Storage [CS67]. Receipt and
storage of raw materials: raw material
storage (PROC1 - Use in closed
process, no likelihood of exposure)
Drum/batch transfers [CS8]. Initial Use drum pumps [E53].Avoid carrying out operation for more than 1
factory fill of equipment [CS75]. hour [OC11]. Wear suitable gloves tested to EN374 [PPE15].*;
Storage [CS67]. Receipt and storage of Use suitable eye protection [PPE26]*.
raw materials: packaged goods delivery
(PROC3 - Use in closed batch process
(synthesis or formulation))
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Drum/batch transfers [CS8]. Dedicated Avoid carrying out operation for more than 15 minutes [OC10]
facility [CS81]. Initial factory fill of Wear a respirator conforming to EN140 with Type A filter or better.
equipment [CS75]. Storage [CS67]. [PPE22]. Avoid all skin contact with product, clean up
Receipt and storage of raw materials: contamination/spills as soon as they occur. Wear gloves (tested to
bulk raw material delivery (PROC8b - EN374) if hand contamination likely, wash off any skin
Transfer of chemicals from/to vessels/ contamination immediately. Provide basic employee training to
large containers at dedicated facilities) prevent / minimise exposures and to report any skin problems that
may develop [E3]. Use suitable eye protection [PPE26]*
General exposures (closed systems) No specific measures identified [EI18].
[CS15]. Raw material assembly and
charging: raw material dispensing of
liquids via pipeline from bulk storage
(PROC1 - Use in closed process, no
likelihood of exposure)
Drum/batch transfers [CS8]. Dedicated Provide extract ventilation to points where emissions occur [E54].
facility [CS81]. Raw material assembly Avoid all skin contact with product, clean up contamination/spills as
and charging: raw material dispensing soon as they occur. Wear gloves (tested to EN374) if hand
of liquids manually from bulk storage contamination likely, wash off any skin contamination immediately.
or packaged goods (PROC8b -Transfer Provide basic employee training to prevent / minimise exposures and
of chemicals from/to vessels/ large to report any skin problems that may develop [E3].
containers at dedicated facilities) Wear a respirator conforming to EN140 with Type A filter or better.
[PPE22]. Use suitable eye protection [PPE26]*
General exposures (closed systems) Provide extract ventilation to points where emissions occur [E54].
[CS15]. Continuous process [CS54]. Avoid all skin contact with product, clean up contamination/spills as
With sample collection [CS56]. soon as they occur. Wear gloves (tested to EN374) if hand
Blending/dissolving/dispersion: mixing, contamination likely, wash off any skin contamination immediately.
milling, dispersing, completion Provide basic employee training to prevent / minimise exposures and
(PROC2 - Use in closed, continuous to report any skin problems that may develop [E3].
process with occasional controlled Wear a respirator conforming to EN140 with Type A filter or better.
exposure ) [PPE22]. Use suitable eye protection [PPE26]*

General exposures (closed systems) Provide extract ventilation to points where emissions occur [E54].
[CS15]. Use in contained batch Wear a respirator conforming to EN140 with Type A filter or better.
processes [CS37]. With sample [PPE22]. Avoid all skin contact with product, clean up
collection [CS56]. Use in contained contamination/spills as soon as they occur. Wear gloves (tested to
batch processes [CS37]. EN374) if hand contamination likely, wash off any skin
Blending/dissolving/dispersion: mixing, contamination immediately. Provide basic employee training to
milling, dispersing, completion prevent / minimise exposures and to report any skin problems that
(PROC3 - Use in closed batch process may develop [E3]. Use suitable eye protection [PPE26]*
(synthesis or formulation))
Mixing operations (open systems) Provide extract ventilation to points where emissions occur [E54].
[CS30]. Batch process [CS55]. (open Wear chemically resistant gloves (tested to EN374) in combination
systems) [CS108]. with intensive management supervision controls [PPE18].*
Blending/dissolving/dispersion: mixing, Wear a respirator conforming to EN140 with Type A filter or better.
milling, dispersing, completion - [PPE22]. Use suitable eye protection [PPE26]*.
(additions) (PROC5 - Mixing or
blending in batch processes (multistage
and/or significant contact))
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
Drum/batch transfers [CS8]. Limit the substance content in the product to 1% [OC16].
Transfer from/pouring from containers Provide extract ventilation to points where emissions occur [E54].
[CS22]. Drum and small package filling Avoid all skin contact with product, clean up contamination/spills as
[CS6]. Filtering and filling: filtering or soon as they occur. Wear gloves (tested to EN374) if hand
sieving and filling – enclosed dedicated contamination likely, wash off any skin contamination immediately.
lines Provide basic employee training to prevent / minimise exposures and
Max concentration 1% (PROC9 - to report any skin problems that may develop [E3].
Transfer of chemicals into small
containers (dedicated filling line))
Manual [CS34]. Transfer from/pouring Limit the substance content in the product to 1% [OC16].
from containers [CS22]. Non-dedicated Provide extract ventilation to points where emissions occur [E54].
facility [CS82]. Filtering and filling: Wear suitable gloves tested to EN374 [PPE15]*.
filtering or sieving and filling – Wear a respirator conforming to EN140 with Type A filter or better.
enclosed non-dedicated lines [PPE22]
Max concentration 1% (PROC8a -
Transfer of chemicals from/to vessels/
large containers at non dedicated
facilities)
Mixing operations (open systems) Provide extract ventilation to points where emissions occur [E54].
[CS30]. Equipment cleaning and Wear chemically resistant gloves (tested to EN374) in combination
maintenance [CS39]. Batch process with intensive management supervision controls [PPE18]. Wear a
[CS55]. Manufacturing equipment respirator conforming to EN140 with Type A filter or better.
cleaning: open in situ in workplace [PPE22]. Use suitable eye protection [PPE26].*
(PROC5 - Mixing or blending in batch
processes (multistage and/or significant
contact))
Mixing operations (open systems) Provide extract ventilation to points where emissions occur [E54].
[CS30]. Equipment cleaning and Wear chemically resistant gloves (tested to EN374) in combination
maintenance [CS39]. Batch process with intensive management supervision controls [PPE18].
[CS55]. Manufacturing equipment Wear a respirator conforming to EN140 with Type A filter or better.
cleaning: open off-line in workplace [PPE22]. Use suitable eye protection [PPE26].*
(PROC5 - Mixing or blending in batch
processes (multistage and/or significant
contact))
General exposures (closed systems) Provide extract ventilation to points where emissions occur [E54].
[CS15]. Equipment cleaning and Avoid all skin contact with product, clean up contamination/spills as
maintenance [CS39]. Continuous soon as they occur. Wear gloves (tested to EN374) if hand
process [CS54]. Manufacturing contamination likely, wash off any skin contamination immediately.
equipment cleaning: enclosed off-line Provide basic employee training to prevent / minimise exposures and
in workplace (PROC2 - Use in closed, to report any skin problems that may develop [E3].
continuous process with occasional Wear a respirator conforming to EN140 with Type A filter or better.
controlled exposure) [PPE22]. Use suitable eye protection [PPE26]*
Drum/batch transfers [CS8]. Disposal Limit the substance content in the product to 1% [OC16].Provide
of wastes [CS28]. Dedicated facility extract ventilation to points where emissions occur [E54].
[CS81]. Waste management: transfer of
process wastes to storage containers:
off-line in workplace
Max concentration 1% (PROC8b -
Transfer of chemicals from/to vessels/
large containers at dedicated facilities)
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
Drum/batch transfers [CS8]. Disposal Ensure operation is undertaken outdoors [E69]. Avoid carrying out
of wastes [CS28]. Dedicated facility operation for more than 1 hour [OC11]
[CS81]. Waste management: transfer of
recovered solvent into bulk storage
tanks or IBCs
Max concentration 0.8% (PROC8b -
Transfer of chemicals from/to vessels/
large containers at dedicated facilities)
Use in contained batch processes Limit the substance content in the product to 1% [OC16].Ensure
[CS37]. Disposal of wastes [CS28]. operation is undertaken outdoors [E69]. Wear suitable gloves tested
Waste management: solvent recovery to EN374 [PPE15].
using condensation or adsorption/ Wear a respirator conforming to EN140 with Type A filter or better.
desorption processes [PPE22]
Max concentration 1% (PROC3 - Use
in closed batch process (synthesis or
formulation))
Drum/batch transfers [CS8]. Limit the substance content in the product to 1% [OC16].Provide
Dedicated facility [CS81]. Equipment extract ventilation to points where emissions occur [E54].
cleaning and maintenance [CS39].
Manufacturing equipment maintenance:
cleaning manufacturing equipment for
maintenance purposes
Max concentration 1% (PROC8b -
Transfer of chemicals from/to vessels/
large containers at dedicated facilities)
Section 2.2 Control of environmental exposure
Product characteristics Substance is a unique structure [PrC1].
Non-hydrophobic [PrC4b].
Inherently biodegradable, fulfilling criteria [PrC5d].
Operational conditions Indoor/Outdoor use [OOC3].
Amounts used
Fraction of EU tonnage used in region 1
[A1]:
Regional use tonnage (tonnes/year) 2.00E+03
[A2]:
Fraction of Regional tonnage used 1
locally [A3]:
Maximum daily site tonnage (kg/day) 8.89E+03
[A4]:
Annual site tonnage (tonnes/year) [A5]: 2.00E+03
Frequency and duration of use
Type of release Continuous release [FD2].
Emission Days (days/year) [FD4]: 225
Environmental factors not influenced by risk management
Local freshwater dilution factor [EF1]: 10
Local marine water dilution factor Not applicable, no emissions to marine water
[EF2]:
Receiving surface water flow is 18000 m3/d [EF3].
Other Operational Conditions of use Use in open/closed systems.
affecting environmental exposure Either wet or dry processes.
Release fraction to air from process 3.60E-02
(initial release prior to RMM) [OOC4]:
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Release fraction to wastewater from 0.00E+00
process (initial release prior to RMM)
[OOC5]:
Release fraction to soil from process 0.00E+00
(initial release prior to RMM) [OOC6]:
Risk Management Measures Off-gasses are treated by:
Reduction and cleaning of air emissions - Air filtration, and/or
Reduction and cleaning of air emissions - Membrane Separation,
and/or
Reduction and cleaning of air emissions - Thermal oxidation, and/or
Reduction and cleaning of air emissions - Catalytic oxidation, and/or
Reduction and cleaning of air emissions - Adsorption, and/or
Reduction and cleaning of air emissions - Biological treatment,
and/or
Reduction and cleaning of air emissions - Condensation
Technical conditions and measures at Common practices vary across sites thus conservative process release
process level (source) to prevent estimates used [TCS1].
release
Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil
Air: Treat air emission to provide a typical removal efficiency of (%)
[TCR7]: 98
Wastewater: Wastewater emission controls are not applicable as there is no direct
release to wastewater [TCR3].
Soil: Soil emission controls are not applicable as there is no direct release
to soil [TCR4].
Organisation measures to Prevent environmental discharge consistent with regulatory
prevent/limit release from site requirements [OMS2].
Conditions and measures related to Not applicable as there is no release to wastewater [STP1].
municipal sewage treatment plant
Conditions and measures related to This substance is consumed during use and no waste of the substance
external treatment of waste for is generated [ETW5].
disposal
Conditions and measures related to This substance is consumed during use and no waste of the substance
external recovery of waste is generated [ERW3].
Other environmental control None
measures additional to above
* When exposure is likely

Exposure estimation

Worker exposure

Acute/Short term exposure

MEKO is classified for acute dermal toxicity (Xn, R21 / Acute Tox. 4; H312: Harmful in contact with skin).
However, dermal exposure is expressed as amount (per kg bw) per day which implies that acute dermal
exposure (peaks; in mg/kg bw/day) will not be higher than a calculated total exposure per day (chronic; in
mg/kg bw/day). As the long-term dermal DNEL is lower compared to the acute dermal DNEL, the risk
characterisation for long-term dermal exposure will also cover the risks after acute dermal exposure.

Long-term exposure

The worker exposure estimates for the activities associated with the use of MEKO as an intermediate have been
assessed using ECETOC TRAv2 with some modifications.
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
The modifications include:
- Adjusted efficacy values for gloves as adopted by CEFIC.
- Linear correction for concentration of the substance (0.8%) instead of the broad default TRA categories.
- Use of drum pumps results in an 80% lower exposure, as adopted by CEFIC.

Table ES.1 contains the tables used to model the worker exposures. These tables contain all the operating
conditions, and when applicable the efficiencies of the exposure modifiers including Respiration protection
equipment (RPE) or other personal protection equipment (PPE) and Local exhaust ventilation (LEV).
Qualitative human exposure assessment

MEKO is classified for skin sensitisation (R43 / Skin Sens. 1; H317: May cause an allergic skin reaction) and
serious damage to the eyes (Xi, R41 / Eye Damage 1; H318: Causes serious eye damage). According to the
guidance on information requirements and chemical safety assessment (part E), such effects need a qualitative
risk assessment rather than a quantitative assessment. The qualitative assessment has been addressed by
assessing the likelihood and/or frequency of exposure for each PROC.

Skin exposure
Likelihood/frequency of exposure is considered to be very low for PROC 1 as these closed processes have no
likelihood of exposure.
Likelihood/frequency of exposure is considered to be very low for PROC2, PROC3, PROC 3, PROC8b and
PROC9 due to generally closed processes with only occasional potential dermal contact. Actual exposure will
be further reduced due the application of gloves and basis employee training.
For the contributing scenarios with <1% of MEKO (PROC3, PROC8a, PROC8b and PROC9) skin sensitisation
is not expected as this percentage is below the DSD and EU-CLP classification limit for skin sensitisation.
Likelihood/frequency of exposure for PROC5 is considered to be low. Potential exposure due to skin contact
during mixing operation at open systems may be relatively high. Actual exposure will be low due to stringent
use of protective gloves in combination with specific activity training and intensive management supervision.

Ocular exposure
Exposure to the eyes can occur in two ways: direct from the air (splashes, aerosols, dust) or indirect via hand-
eye contact.
The likelihood/frequency of hand-eye contact is considered to be very low for all contributing scenarios due to
the fact that the likelihood of actual hand exposure is at most low and workers have been trained to prevent
exposure.
The intensity of exposure is considered to be very low for the contributing scenarios with <1% of MEKO
(PROC3, PROC8a, PROC8b and PROC9) as shown by the low concentrations in air (maximum 0.5 ppm for
PROC9-transfer of chemicals into small containers (dedicated filling line)).
Likelihood/frequency of exposure via direct contact with concentrations in the air is considered to be very low
for PROC 1 as these closed processes have no likelihood of exposure.
Likelihood/frequency of exposure via direct contact with concentrations in the air is considered to be low for
PROC2, PROC3, PROC8b and PROC9 due to generally closed processes with only occasional potential contact.
Exposure will be further reduced due to the use of suitable eye-protection equipment.
Potential exposure may be higher during mixing operation at open systems (PROC5) due to initial higher
concentrations in the air. Actual exposure will be low due to the use of extract ventilation to reduce the
concentration in the air and due to the use of suitable eye-protection equipment.

Summary of the worker exposure for all contributing scenarios is presented in Table.
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Safety data sheet
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Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
Table 4. Exposure levels after assessment of safe use for ES1 Intermediate use of MEKO, using the
ECETOC TRA v2 model
ES1: Intermediate use of MEKO
Exposure Scenario
Predicted Predicted Dermal
Contributing Scenarios Inhalation Exposure (mg/kg
Exposure in ppm bw/d)
General exposures (closed systems) [CS15]. Initial factory fill of
equipment [CS75]. Storage [CS67]. Receipt and storage of raw
0.01 (=0.04 mg/m3) 0.34
materials: raw material storage (PROC1 - Use in closed process,
no likelihood of exposure)
Drum/batch transfers [CS8]. Initial factory fill of equipment
[CS75].
Storage [CS67]. Receipt and storage of raw materials: packaged 0.7 (=2.49 mg/m3) 0.03
goods delivery (PROC3 - Use in closed batch process (synthesis
or formulation))
Drum/batch transfers [CS8]. Dedicated facility [CS81]. Initial
factory fill of equipment [CS75]. Storage [CS67]. Receipt and
storage of raw materials: bulk raw material delivery (PROC8b - 0.35 (=1.25 mg/m3) 0.69
Transfer of chemicals from/to vessels/ large containers at
dedicated facilities)
General exposures (closed systems) [CS15]. Raw material
assembly and charging: raw material dispensing of liquids via
0.01 (=0.04 mg/m3) 0.34
pipeline from bulk storage (PROC1 - Use in closed process, no
likelihood of exposure)
Drum/batch transfers [CS8]. Dedicated facility [CS81]. Raw
material assembly and charging: raw material dispensing of
liquids manually from bulk storage or packaged goods (PROC8b 0.15 (=0.53 mg/m3) 0.69
- Transfer of chemicals from/to vessels/ large containers at
dedicated facilities)
General exposures (closed systems) [CS15]. Continuous process
[CS54]. With sample collection [CS56].
Blending/dissolving/dispersion: mixing, milling, dispersing, 0.1 (=0.36 mg/m3) 0.14
completion (PROC2 - Use in closed, continuous process with
occasional controlled exposure)
General exposures (closed systems) [CS15]. Use in contained
batch processes [CS37]. With sample collection [CS56]. Use in
contained batch processes [CS37].
0.25 (=0.89 mg/m3) 0.03
Blending/dissolving/dispersion: mixing, milling, dispersing,
completion (PROC3 - Use in closed batch process (synthesis or
formulation))
Mixing operations (open systems) [CS30]. Batch process [CS55]
(open systems) [CS108]. Blending/dissolving/dispersion: mixing,
milling, dispersing, completion - (additions) (PROC5 - Mixing 0.5 (=1.78 mg/m3) 0.27
or blending in batch processes (multistage and/or significant
contact))
Drum/batch transfers [CS8]. Transfer from/pouring from
containers [CS22]. Drum and small package filling [CS6].
Filtering and filling: filtering or sieving and filling – enclosed
0.5 (=1.78 mg/m3) 0.07
dedicated lines
Max concentration 1% (PROC9 -Transfer of chemicals into
small containers (dedicated filling line))
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according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
ES1: Intermediate use of MEKO
Exposure Scenario
Predicted Predicted Dermal
Contributing Scenarios Inhalation Exposure (mg/kg
Exposure in ppm bw/d)
Manual [CS34]. Transfer from/pouring from containers [CS22].
Non-dedicated facility [CS82]. Filtering and filling: filtering or
sieving and filling – enclosed non-dedicated lines 0.05 (=0.18 mg/m3) 0.27
Max concentration 1% (PROC8a -Transfer of chemicals from/to
vessels/ large containers at non dedicated facilities)

Mixing operations (open systems) [CS30]. Equipment cleaning

and maintenance [CS39]. Batch process [CS55]. Manufacturing
equipment cleaning: open in situ in workplace (PROC5 -Mixing 0.5 (=1.78 mg/m3) 0.27
or blending in batch processes (multistage and/or significant
contact))
Mixing operations (open systems) [CS30]. Equipment cleaning
and maintenance [CS39]. Batch process [CS55]. Manufacturing
equipment cleaning: open off-line in workplace (PROC5 - 0.5 (=1.78 mg/m3) 0.27
Mixing or blending in batch processes (multistage and/or
significant contact))
General exposures (closed systems) [CS15]. Equipment cleaning
and maintenance [CS39]. Continuous process [CS54].
Manufacturing equipment cleaning: enclosed off-line in 0.1 (=0.36 mg/m3) 0.14
workplace (PROC2 - Use in closed, continuous process with
occasional controlled exposure )
Drum/batch transfers [CS8]. Disposal of wastes [CS28].
Dedicated facility [CS81]. Waste management: transfer of
process wastes to storage containers: off-line in workplace 0.15 (=0.53 mg/m3) 0.69
Max concentration 1% (PROC8b - Transfer of chemicals from/to
vessels/ large containers at dedicated facilities)
Drum/batch transfers [CS8]. Disposal of wastes [CS28].
Dedicated facility [CS81]. Waste management: transfer of
0.056 (=0.20
recovered solvent into bulk storage tanks or IBCs 0.05
mg/m3)
Max concentration 0.8% (PROC8b -Transfer of chemicals
from/to vessels/ large containers at dedicated facilities)
Use in contained batch processes [CS37]. Disposal of wastes
[CS28]. Waste management: solvent recovery using
0.175 (=0.62
condensation or adsorption/ desorption processes 0.03
mg/m3)
Max concentration 1% (PROC3 - Use in closed batch process
(synthesis or formulation))
Drum/batch transfers [CS8]. Dedicated facility [CS81].
Equipment cleaning and maintenance [CS39]. Manufacturing
equipment maintenance: cleaning manufacturing equipment for
0.15 (=0.53 mg/m3) 0.69
maintenance purposes
Max concentration 1% (PROC8b -Transfer of chemicals from/to
vessels/ large containers at dedicated facilities)

Consumer exposure

Not applicable.
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Indirect exposure of humans via the environment

The assessment of exposure via the oral route is not considered relevant during normal use of MEKO. The
human intake of MEKO from indirect exposure via inhalation from intermediate use is presented in Table 5.

Table 5. Local concentrations for exposure of humans via the environment

Human intake media Exposure concentrations Justification
Air (mg/m3) 0.055 EUSES calculation

Environmental exposure

Environmental releases

The use volume of MEKO as an intermediate is 2,000 tonnes/year. The fraction of EU tonnage used in region
and the fraction of the regional tonnage used locally are set to 1

In the assessment the CEPE1 SpERC was used as it is assumed that the release to the environment from the use
of MEKO as an intermediate is similar as the release from formulation. The default emission to air of 0.036
from the CEPE1 SpERC is used in the assessment as the vapour pressure of MEKO at 25 ºC is higher than
1,000 Pa. The default emission factors to waste water and soil from the CEPE1 SpERC are both zero. The
number of emission days is set to 225 and the fraction of regional tonnage used locally is set to 1 by default.

The releases to the environment that are taken into account for the exposure estimation are listed in Table6.

Table 6. Summary of the releases to the environment

Compartments Release Release for Justification
from point total
source regional
(kg/d) (local exposure
exposure estimation
estimation) (kg/d)
Waste water 0 84.2 See above
Surface water 0 21 EUSES calculation
Air 320 7.01E+03 See above
Soil (direct releases only) 0 4.38 Table R16.23 (Reach Guidance R.16 [ECHA, 2010])

Exposure concentration in sewage treatment plants (STP)

There is no emission to waste water, an exposure estimation for the sewage treatment plant is therefore not
necessary.

Exposure concentration in aquatic pelagic compartment

The exposure estimation for marine water is not justified as the substance is not expected to be released to the
marine environment under normal conditions of use. The local concentration and Predicted Exposure
Concentration (PEC) in freshwater that are taken into account for risk characterisation are listed in Table7.
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Table 7. Predicted Exposure Concentrations (PEC) in aquatic compartment
Compartments Local PEC Justification
concentration (local+regional)
Freshwater (in mg/l) 0 7.27E-04 EUSES calculation

Exposure concentration in sediments

No release to sediment is anticipated during normal use of MEKO. In addition, MEKO has an estimated log Koc
of 0.56 indicating minimal if any adsorption to soil or sediment. An exposure estimation for the benthic
compartment is therefore not necessary.

Exposure concentrations in soil and groundwater

No release to soil is anticipated during normal use of MEKO. In addition, MEKO has an estimated log Koc of
0.56 indicating minimal if any adsorption to soil or sediment. An exposure estimation for the terrestrial
compartment is therefore not necessary.

Atmospheric compartment

The local concentrations and Predicted Exposure Concentration (PEC) in air that are taken into account for risk
characterisation are listed in Table 818.

Table 81. Predicted Exposure Concentrations (PEC) in air

Compartments Local PEC Justification
concentration (local+regional)
During emission (mg/m3) 0.089 n.c. EUSES calculation
Annual average (mg/m3) 0.055 0.055 EUSES calculation
2
Annual deposition (mg/m /d) 0.079 n.c. EUSES calculation
n.c. - not calculated in EUSES

Exposure concentration relevant for the food chain (secondary poisoning)

Exposure assessment through secondary poisoning is not necessary for MEKO. Taking into account the
measured log Kow of MEKO of 0.63 and the low observed bioaccumulation of MEKO in fish (ranging from 0.5
to 5.8), it is not expected that MEKO would biocaccumulate in a high extent. Furthermore, MEKO is not
classified as R48, R60, R61, R62, R63 and/or R64. Therefore MEKO does not pose a risk as a result of
secondary poisoning via the aquatic food web.
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Table ES1: Intermediate use of MEKO; Characterising the Risk - Chemical Safety Assessment - Evaluation of Safe Use
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Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
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Exposure Scenario 2: Formulation of liquid paints containing MEKO
Exposure scenario

Section 1 Exposure Scenario Title

Title Formulation of liquid paints containing MEKO; CAS: 96-29-7
Use Descriptor Sector of Use: SU3, SU10
Process Categories: PROC1, PROC2, PROC3, PROC5, PROC8a,
PROC8b, PROC9
Environmental Release Categories: ERC2
Specific Environmental Release Categories: CEPE1, CEPE2
Processes, tasks, activities covered Formulation, packing and re-packing of MEKO and its mixtures in
batch or continuous operations, including storage, materials transfers,
mixing, compression, extrusion, large and small scale packing,
sampling, maintenance and associated laboratory activities
Section 2 Operational conditions and risk management measures
Field for additional statements to explain scenario if required.
Section 2.1 Control of worker exposure
Product characteristics
Physical form of product Liquid, vapour pressure 0.5 - 10 kPa [OC4].
Concentration of substance in product Covers percentage substance in the product up to 100 % (unless
stated differently) [G13].
Amounts used Not applicable
Frequency and duration of use Covers daily exposures up to 8 hours (unless stated differently) [G2]

Human factors not influenced by risk Not applicable

management
Other Operational Conditions affecting Assumes a good basic standard of occupational hygiene is
worker exposure implemented [G1].
Assumes use at not more than 20°C above ambient temperature,
unless stated differently [G15].
Contributing Scenarios Risk Management Measures
Note: list RMM standard phrases according to the control hierarchy
indicated in the ECHA template: 1. Technical measures to prevent
release, 2. Technical measures to prevent dispersion, 3.
Organisational measures, 4. Personal protection.
General exposures (closed systems) No specific measures identified [EI18].
[CS15]. Initial factory fill of equipment
[CS75]. Storage [CS67]. Receipt and
storage of raw materials: raw material
storage (PROC1 - Use in closed
process, no likelihood of exposure)
Drum/batch transfers [CS8]. Initial Use drum pumps [E53].
factory fill of equipment [CS75]. Avoid carrying out operation for more than 1 hour [OC11]
Storage [CS67]. Receipt and storage of Wear chemically resistant gloves (tested to EN374) in combination
raw materials: packaged goods delivery with ‘basic’ employee training [PPE16].*
(PROC3 - Use in closed batch process Use suitable eye protection [PPE26].*
(synthesis or formulation))
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Drum/batch transfers [CS8]. Dedicated Avoid carrying out operation for more than 15 minutes [OC10]
facility [CS81]. Initial factory fill of Avoid all skin contact with product, clean up contamination/spills as
equipment [CS75]. Storage [CS67]. soon as they occur. Wear gloves (tested to EN374) if hand
Receipt and storage of raw materials: contamination likely, wash off any skin contamination immediately.
bulk raw material delivery (PROC8b - Provide basic employee training to prevent / minimise exposures and
Transfer of chemicals from/to vessels/ to report any skin problems that may develop [E3].
large containers at dedicated facilities) Wear a respirator conforming to EN140 with Type A filter or better.
[PPE22];
Use suitable eye protection [PPE26].*
General exposures (closed systems) No specific measures identified [EI18].
[CS15]. Raw material assembly and
charging: raw material dispensing of
liquids via pipeline from bulk storage
(PROC1 - Use in closed process, no
likelihood of exposure)
Drum/batch transfers [CS8]. Dedicated Provide extract ventilation to points where emissions occur [E54].
facility [CS81]. Raw material assembly Avoid all skin contact with product, clean up contamination/spills as
and charging: raw material dispensing soon as they occur. Wear gloves (tested to EN374) if hand
of liquids manually from bulk storage contamination likely, wash off any skin contamination immediately.
or packaged goods (PROC8b -Transfer Provide basic employee training to prevent / minimise exposures and
of chemicals from/to vessels/ large to report any skin problems that may develop [E3].
containers at dedicated facilities) Wear a respirator conforming to EN140 with Type A filter or better.
[PPE22]. Use suitable eye protection [PPE26].*
General exposures (closed systems) Provide extract ventilation to points where emissions occur [E54].
[CS15]. Continuous process [CS54]. Avoid all skin contact with product, clean up contamination/spills as
With sample collection [CS56]. soon as they occur. Wear gloves (tested to EN374) if hand
Blending/dissolving/dispersion: mixing, contamination likely, wash off any skin contamination immediately.
milling, dispersing, completion Provide basic employee training to prevent / minimise exposures and
(PROC2 - Use in closed, continuous to report any skin problems that may develop [E3].
process with occasional controlled Wear a respirator conforming to EN140 with Type A filter or better.
exposure) [PPE22]. Use suitable eye protection [PPE26].*
General exposures (closed systems) Provide extract ventilation to points where emissions occur [E54].
[CS15]. Use in contained batch Wear a respirator conforming to EN140 with Type A filter or better.
processes [CS37]. With sample [PPE22]. Use suitable eye protection [PPE26].* Avoid all skin
collection [CS56]. Use in contained contact with product, clean up contamination/spills as soon as they
batch processes [CS37]. occur. Wear gloves (tested to EN374) if hand contamination likely,
Blending/dissolving/dispersion: mixing, wash off any skin contamination immediately. Provide basic
milling, dispersing, completion employee training to prevent / minimise exposures and to report any
(PROC3 - Use in closed batch process skin problems that may develop [E3].
(synthesis or formulation))
Mixing operations (open systems) Provide extract ventilation to points where emissions occur [E54].
[CS30]. Batch process [CS55]. Wear chemically resistant gloves (tested to EN374) in combination
(open systems) [CS108]. with intensive management supervision controls [PPE18].* ;
Blending/dissolving/dispersion: mixing, Wear a respirator conforming to EN140 with Type A filter or better.
milling, dispersing, completion [PPE22];
(additions) (PROC5 - Mixing or Use suitable eye protection [PPE26].*
blending in batch processes (multistage
and/or significant contact))
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Drum/batch transfers [CS8]. Limit the substance content in the product to 1% [OC16].
Transfer from/pouring from containers Provide extract ventilation to points where emissions occur [E54].
[CS22]. Drum and small package filling Avoid all skin contact with product, clean up contamination/spills as
[CS6]. Filtering and filling: filtering or soon as they occur. Wear gloves (tested to EN374) if hand
sieving and filling – enclosed dedicated contamination likely, wash off any skin contamination immediately.
lines Provide basic employee training to prevent / minimise exposures and
Max concentration 0.8% (PROC9 - to report any skin problems that may develop [E3].
Transfer of chemicals into small
containers (dedicated filling line))
Manual [CS34]. Limit the substance content in the product to 1% [OC16].
Transfer from/pouring from containers Provide extract ventilation to points where emissions occur [E54].
[CS22]. Non-dedicated facility [CS82]. Wear suitable gloves tested to EN374 [PPE15].*
Filtering and filling: filtering or sieving Wear a respirator conforming to EN140 with Type A filter or better.
and filling – enclosed non-dedicated [PPE22].
lines
Max concentration 0.8% (PROC8a -
Transfer of chemicals from/to vessels/
large containers at non dedicated
facilities)
Mixing operations (open systems) Provide extract ventilation to points where emissions occur [E54].
[CS30]. Equipment cleaning and Wear chemically resistant gloves (tested to EN374) in combination
maintenance [CS39]. with intensive management supervision controls [PPE18].*
Batch process [CS55]. Manufacturing Wear a respirator conforming to EN140 with Type A filter or better.
equipment cleaning: open in situ in [PPE22].
workplace (PROC5 - Mixing or Use suitable eye protection [PPE26].*
blending in batch processes (multistage
and/or significant contact))
Mixing operations (open systems) Provide extract ventilation to points where emissions occur [E54].
[CS30]. Equipment cleaning and Wear chemically resistant gloves (tested to EN374) in combination
maintenance [CS39]. with intensive management supervision controls [PPE18].*
Batch process [CS55]. Manufacturing Wear a respirator conforming to EN140 with Type A filter or better.
equipment cleaning: open off-line in [PPE22].
workplace (PROC5 - Mixing or Use suitable eye protection [PPE26].*
blending in batch processes (multistage
and/or significant contact))
General exposures (closed systems) Provide extract ventilation to points where emissions occur [E54].
[CS15]. Equipment cleaning and Avoid all skin contact with product, clean up contamination/spills as
maintenance [CS39]. soon as they occur. Wear gloves (tested to EN374) if hand
Continuous process [CS54]. contamination likely, wash off any skin contamination immediately.
Manufacturing equipment cleaning: Provide basic employee training to prevent / minimise exposures and
enclosed off-line in workplace to report any skin problems that may develop [E3].
(PROC2 - Use in closed, continuous Wear a respirator conforming to EN140 with Type A filter or better.
process with occasional controlled [PPE22]. Use suitable eye protection [PPE26].*
exposure )
Drum/batch transfers [CS8]. Disposal Limit the substance content in the product to 1% [OC16].
of wastes [CS28]. Dedicated facility Provide extract ventilation to points where emissions occur [E54].
[CS81]. Waste management: transfer of
process wastes to storage containers:
off-line in workplace
Max concentration 0.8% (PROC8b -
Transfer of chemicals from/to vessels/
large containers at dedicated facilities)
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Drum/batch transfers [CS8]. Disposal Ensure operation is undertaken outdoors [E69].
of wastes [CS28]. Avoid carrying out operation for more than 1 hour [OC11]
Dedicated facility [CS81]. Waste
management: transfer of recovered
solvent into bulk storage tanks or IBCs
Max concentration 0.8% (PROC8b -
Transfer of chemicals from/to vessels/
large containers at dedicated facilities)
Use in contained batch processes Limit the substance content in the product to 1% [OC16].
[CS37]. Disposal of wastes [CS28]. Ensure operation is undertaken outdoors [E69]. Wear suitable gloves
Waste management: solvent recovery tested to EN374 [PPE15].
using condensation or adsorption/ Wear a respirator conforming to EN140 with Type A filter or better.
desorption processes [PPE22]
Max concentration 0.8% (PROC3 -
Use in closed batch process (synthesis
or formulation))
Drum/batch transfers [CS8]. Limit the substance content in the product to 1% [OC16].
Dedicated facility [CS81]. Equipment Provide extract ventilation to points where emissions occur [E54].
cleaning and maintenance [CS39].
Manufacturing equipment maintenance:
cleaning manufacturing equipment for
maintenance purposes (PROC8b -
Transfer of chemicals from/to vessels/
large containers at dedicated facilities)
Section 2.2 Control of environmental exposure
Product characteristics Substance is a unique structure [PrC1].
Non-hydrophobic [PrC4b].
Inherently biodegradable, fulfilling criteria [PrC5d].
Operational conditions Indoor/Outdoor use [OOC3].
Amounts used
Fraction of EU tonnage used in region 1
[A1]:
Regional use tonnage (tonnes/year) 8.00E+03
[A2]:
Fraction of Regional tonnage used 1
locally [A3]:
Maximum daily site tonnage (kg/day) 3.56E+04
[A4]:
Annual site tonnage (tonnes/year) [A5]: 8.00E+03
Frequency and duration of use
Type of release Continuous release [FD2].
Emission Days (days/year) [FD4]: 225
Environmental factors not influenced by risk management
Local freshwater dilution factor [EF1]: 10
Local marine water dilution factor Not applicable, no emissions to marine water
[EF2]:
Receiving surface water flow is 18000 m3/d [EF3].
Other Operational Conditions of use Use in open/closed systems.
affecting environmental exposure Either wet or dry processes.
Release fraction to air from process 3.60E-02
(initial release prior to RMM) [OOC4]:
Release fraction to wastewater from 0.00E+00
process (initial release prior to RMM)
[OOC5]:
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Release fraction to soil from process 0.00E+00
(initial release prior to RMM) [OOC6]:
Risk Management Measures Off gasses are treated by:
Reduction and cleaning of air emissions - Air filtration, and/or
Reduction and cleaning of air emissions - Membrane Separation,
and/or
Reduction and cleaning of air emissions - Thermal oxidation, and/or
Reduction and cleaning of air emissions - Catalytic oxidation, and/or
Reduction and cleaning of air emissions - Adsorption, and/or
Reduction and cleaning of air emissions - Biological treatment,
and/or
Reduction and cleaning of air emissions - Condensation
Technical conditions and measures at Common practices vary across sites thus conservative process release
process level (source) to prevent estimates used [TCS1].
release
Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil
Air: Treat air emission to provide a typical removal efficiency of (%)
[TCR7]: 98
Wastewater: Wastewater emission controls are not applicable as there is no direct
release to wastewater [TCR3].
Soil: Soil emission controls are not applicable as there is no direct release
to soil [TCR4].
Organisation measures to Prevent environmental discharge consistent with regulatory
prevent/limit release from site requirements [OMS2].
Conditions and measures related to Not applicable as there is no release to wastewater [STP1].
municipal sewage treatment plant
Conditions and measures related to External treatment and disposal of waste should comply with
external treatment of waste for applicable local and/or national regulations [ETW3].
disposal
Conditions and measures related to External recovery and recycling of waste should comply with
external recovery of waste applicable local and/or national regulations [ERW1].
Other environmental control None
measures additional to above
* When exposure is likely

Exposure estimation

Worker exposure

Acute/Short term exposure

MEKO is classified for acute dermal toxicity (Xn, R21 / Acute Tox. 4; H312: Harmful in contact with skin).
However, dermal exposure is expressed as amount (per kg bw) per day which implies that acute dermal
exposure (peaks; in mg/kg bw/day) will not be higher than a calculated total exposure per day (chronic; in
mg/kg bw/day). As the long-term dermal DNEL is lower compared to the acute dermal DNEL, the risk
characterisation for long-term dermal exposure will also cover the risks after acute dermal exposure.

Long-term exposure

The worker exposure estimates for the activities associated with the use of MEKO as an intermediate have been
assessed using ECETOC TRAv2 with some modifications.
The modifications include:
- Adjusted efficacy values for gloves as adopted by CEFIC.
- Linear correction for concentration of the substance (0.8%) instead of the broad default TRA categories.
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- Use of drum pumps results in an 80% lower exposure, as adopted by CEFIC.

Table ES.2 contains the tables used to model the worker exposures. These tables contain all the operating
conditions, and when applicable the efficiencies of the exposure modifiers including Respiration protection
equipment (RPE) or other personal protection equipment (PPE) and Local exhaust ventilation (LEV).

Qualitative human exposure assessment

MEKO is classified for skin sensitisation (R43 / Skin Sens. 1; H317: May cause an allergic skin reaction) and
serious damage to the eyes (Xi, R41 / Eye Damage 1; H318: Causes serious eye damage). According to the
guidance on information requirements and chemical safety assessment (part E), such effects need a qualitative
risk assessment rather than a quantitative assessment. The qualitative assessment has been addressed by
assessing the likelihood and/or frequency of exposure for each PROC.

Skin exposure
Likelihood/frequency of exposure is considered to be very low for PROC 1 as these closed processes have no
likelihood of exposure.
Likelihood/frequency of exposure is considered to be very low for the PROC2, PROC3, PROC5, PROC8b and
PROC9 due to generally closed processes with only occasional potential dermal contact. Actual exposure will
be further reduced due the application of gloves and basis employee training.
For the contributing scenarios with <1% of MEKO (PROC3, PROC8a, PROC8b and PROC9) skin sensitisation
is not expected as this percentage is below the DSD and EU-CLP classification limit for skin sensitisation.
Likelihood/frequency of exposure for PROC5 is considered to be low. Potential exposure due to skin contact
during mixing operation at open systems may be relatively high. Actual exposure will be low due to stringent
use of protective gloves in combination with specific activity training and intensive management supervision.

Ocular exposure
Exposure to the eyes can occur in two ways: direct from the air (splashes, aerosols, dust) or indirect via hand-
eye contact.
The likelihood/frequency of hand-eye contact is considered to be very low for all contributing scenarios due to
the fact that the likelihood of actual hand exposure is at most low and workers have been trained to prevent
exposure.
The intensity of exposure is considered to be very low for the contributing scenarios with <1% of MEKO
(PROC3, PROC8a, PROC8b and PROC9) as shown by the low concentrations in air (maximum 0.5 ppm for
PROC9-transfer of chemicals into small containers (dedicated filling line)).
Likelihood/frequency of exposure via direct contact with concentrations in the air is considered to be very low
for PROC 1 as these closed processes have no likelihood of exposure.
Summary of the worker exposure for all contributing scenarios is presented in Table9.

Table 9. Exposure levels after assessment of safe use for ES2 Formulation of liquid paints containing
MEKO, using the ECETOC TRA v2 model
ES2: Formulation of liquid paints
Exposure Scenario containing MEKO

Predicted Predicted Dermal

Contributing Scenarios Inhalation Exposure (mg/kg
Exposure in ppm bw/d)
General exposures (closed systems) [CS15]. Initial factory fill of
equipment [CS75]. Storage [CS67]. Receipt and storage of raw
0.01 (=0.04 mg/m3) 0.34
materials: raw material storage (PROC1 - Use in closed process,
no likelihood of exposure)
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ES2: Formulation of liquid paints
Exposure Scenario containing MEKO

Predicted Predicted Dermal

Contributing Scenarios Inhalation Exposure (mg/kg
Exposure in ppm bw/d)
Drum/batch transfers [CS8]. Initial factory fill of equipment
[CS75]. Storage [CS67]. Receipt and storage of raw materials:
0.7 (=2.49 mg/m3) 0.03
packaged goods delivery (PROC3 - Use in closed batch process
(synthesis or formulation))
Drum/batch transfers [CS8]. Dedicated facility [CS81]. Initial
factory fill of equipment [CS75]. Storage [CS67]. Receipt and
storage of raw materials: bulk raw material delivery (PROC8b - 0.35 (=1.25 mg/m3) 0.69
Transfer of chemicals from/to vessels/ large containers at
dedicated facilities)
General exposures (closed systems) [CS15]. Raw material
assembly and charging: raw material dispensing of liquids via
0.01 (=0.04 mg/m3) 0.34
pipeline from bulk storage (PROC1 - Use in closed process, no
likelihood of exposure)
Drum/batch transfers [CS8]. Dedicated facility [CS81]. Raw
material assembly and charging: raw material dispensing of
liquids manually from bulk storage or packaged goods (PROC8b 0.15 (=0.53 mg/m3) 0.69
- Transfer of chemicals from/to vessels/ large containers at
dedicated facilities)
General exposures (closed systems) [CS15]. Continuous process
[CS54]. With sample collection [CS56].
Blending/dissolving/dispersion: mixing, milling, dispersing, 0.1 (=0.36 mg/m3) 0.14
completion (PROC2 - Use in closed, continuous process with
occasional controlled exposure )
General exposures (closed systems) [CS15]. Use in contained
batch processes [CS37]. With sample collection [CS56]. Use in
contained batch processes [CS37].
0.25 (=0.89 mg/m3) 0.03
Blending/dissolving/dispersion: mixing, milling, dispersing,
completion (PROC3 - Use in closed batch process (synthesis or
formulation))
Mixing operations (open systems) [CS30]. Batch process [CS55]
(open systems) [CS108]. Blending/dissolving/dispersion: mixing,
milling, dispersing, completion (additions) (PROC5 - Mixing or 0.5 (=1.78 mg/m3) 0.27
blending in batch processes (multistage and/or significant
contact))
Drum/batch transfers [CS8]. Transfer from/pouring from
containers [CS22]. Drum and small package filling [CS6].
Filtering and filling: filtering or sieving and filling – enclosed
0.5 (=1.78 mg/m3) 0.07
dedicated lines
Max concentration 0.8% (PROC9 - Transfer of chemicals into
small containers (dedicated filling line))
Manual [CS34]. Transfer from/pouring from containers [CS22].
Non-dedicated facility [CS82]. Filtering and filling: filtering or
sieving and filling – enclosed non-dedicated lines 0.05 (=0.18 mg/m3) 0.27
Max concentration 0.8% (PROC8a - Transfer of chemicals
from/to vessels/ large containers at non dedicated facilities)
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ES2: Formulation of liquid paints
Exposure Scenario containing MEKO

Predicted Predicted Dermal

Contributing Scenarios Inhalation Exposure (mg/kg
Exposure in ppm bw/d)
Mixing operations (open systems) [CS30]. Equipment cleaning
and maintenance [CS39]. Batch process [CS55]. Manufacturing
equipment cleaning: open in situ in workplace (PROC5 -Mixing 0.5 (=1.78 mg/m3) 0.27
or blending in batch processes (multistage and/or significant
contact))
Mixing operations (open systems) [CS30]. Equipment cleaning
and maintenance [CS39]. Batch process [CS55]. Manufacturing
equipment cleaning: open off-line in workplace (PROC5 - 0.5 (=1.78 mg/m3) 0.27
Mixing or blending in batch processes (multistage and/or
significant contact))
General exposures (closed systems) [CS15]. Equipment cleaning
and maintenance [CS39]. Continuous process [CS54].
Manufacturing equipment cleaning: enclosed off-line in 0.1 (=0.36 mg/m3) 0.14
workplace (PROC2 - Use in closed, continuous process with
occasional controlled exposure )
Drum/batch transfers [CS8]. Disposal of wastes [CS28].
Dedicated facility [CS81]. Waste management: transfer of
process wastes to storage containers: off-line in workplace 0.15 (=0.53 mg/m3) 0.69
Max concentration 0.8% (PROC8b - Transfer of chemicals
from/to vessels/ large containers at dedicated facilities)
Drum/batch transfers [CS8]. Disposal of wastes [CS28].
Dedicated facility [CS81]. Waste management: transfer of
0.056 (=0.20
recovered solvent into bulk storage tanks or IBCs 0.05
mg/m3)
Max concentration 0.8% (PROC8b - Transfer of chemicals
from/to vessels/large containers at dedicated facilities)
Use in contained batch processes [CS37]. Disposal of wastes
[CS28]. Waste management: solvent recovery using
0.175 (=0.62
condensation or adsorption/ desorption processes 0.03
mg/m3)
Max concentration 0.8% (PROC3 - Use in closed batch process
(synthesis or formulation))
Drum/batch transfers [CS8]. Dedicated facility [CS81].
Equipment cleaning and maintenance [CS39]. Manufacturing
equipment maintenance: cleaning manufacturing equipment for 0.15 (=0.53 mg/m3) 0.69
maintenance purposes (PROC8b - Transfer of chemicals from/to
vessels/ large containers at dedicated facilities)

Consumer exposure

Not applicable.

Indirect exposure of humans via the environment

The assessment of exposure via the oral route is not considered relevant during normal use of MEKO. The
human intake of MEKO from indirect exposure from manufacturing of liquid paints is presented in Table 10.
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Table 10. Local concentrations for exposure of humans via the environment
Human intake media Exposure concentrations Justification
Air (mg/m3) 0.219 EUSES calculation

Environmental exposure

Environmental releases

The use volume of MEKO for manufacturing of liquid paints is 8,000 tonnes/year. The fraction of EU tonnage
used in region and the fraction of the regional tonnage used locally are set to 1 (see Section 9.0.2).
In the assessment the CEPE1 SpERC was used as it was not known whether MEKO is formulated in small or
large scale industries. The default emission to air of 0.036 from the CEPE1 SpERC is used in the assessment as
the vapour pressure of MEKO at 25 ºC is higher than 1,000 Pa. The default emission factors to waste water and
soil from the CEPE1 SpERC are both zero. The number of emission days is set to 225 and the fraction of
regional tonnage used locally is set to 1 by default.
The releases to the environment that are taken into account for the exposure estimation are listed in Table10.

Table11. Summary of the releases to the environment

Compartments Release Release for Justification
from point total
source regional
(kg/d) (local exposure
exposure estimation
estimation) (kg/d)
Waste water 0 84.2 See above
Surface water 0 21 EUSES calculation
Air 1.28E+03 7.01E+03 See above
Soil (direct releases only) 0 4.38 Table R16.23 (Reach Guidance R.16 [ECHA, 2010])

Exposure concentration in sewage treatment plants (STP)

There is no emission to waste water, an exposure estimation for the sewage treatment plant is therefore not
necessary.

Exposure concentration in aquatic pelagic compartment

The exposure estimation for marine water is not justified as the substance is not expected to be released to the
marine environment under normal conditions of use. The local concentration and Predicted Exposure
Concentration (PEC) in freshwater that are taken into account for risk characterisation are listed in Table12.

Table 12. Predicted Exposure Concentrations (PEC) in aquatic compartment

Compartments Local PEC Justification
concentration (local+regional)
Freshwater (in mg/l) 0 7.27E-04 EUSES calculation

Exposure concentration in sediments

No release to sediment is anticipated during normal use of MEKO. In addition, MEKO has an estimated log Koc
of 0.56 indicating minimal if any adsorption to soil or sediment. An exposure estimation for the benthic
compartment is therefore not necessary.
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Exposure concentrations in soil and groundwater

No release to soil is anticipated during normal use of MEKO. In addition, MEKO has an estimated log Koc of
0.56 indicating minimal if any adsorption to soil or sediment. An exposure estimation for the terrestrial
compartment is therefore not necessary.

Atmospheric compartment

The local concentrations and Predicted Exposure Concentration (PEC) in air that are taken into account for risk
characterisation are listed in Table13.

Table 13. Predicted Exposure Concentration (PEC) in air

Compartments Local PEC Justification
concentration (local+regional)
During emission (mg/m3) 0.356 n.c. EUSES calculation
3
Annual average (mg/m ) 0.219 0.219 EUSES calculation
2
Annual deposition (mg/m /d) 0.316 n.c. EUSES calculation
n.c. - not calculated in EUSES

Exposure concentration relevant for the food chain (secondary poisoning)

Exposure assessment through secondary poisoning is not necessary for MEKO. Taking into account the
measured log Kow of MEKO of 0.63 and the low observed bioaccumulation of MEKO in fish (ranging from 0.5
to 5.8), it is not expected that MEKO would biocaccumulate in a high extent. Furthermore, MEKO is not
classified as R48, R60, R61, R62, R63 and/or R64. Therefore MEKO does not pose a risk as a result of
secondary poisoning via the aquatic food web.
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Table ES2: Formulation of liquid paints containing MEKO; Characterising the Risk - Chemical Safety Assessment - Evaluation of Safe Use
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Exposure Scenario 3: Industrial applications of paints containing
MEKO
Exposure scenario

Section 1 Exposure Scenario Title

Title Industrial applications of paints containing MEKO;CAS: 96-29-7
Use Descriptor Sector of Use: SU3
Process Categories: PROC1, PROC2, PROC3, PROC5, PROC8a,
PROC8b, PROC9
Environmental Release Categories: ERC4
Specific Environmental Release Categories: CEPE16a
Processes, tasks, activities covered Formulation, packing and re-packing of MEKO and its mixtures in
batch or continuous operations, including storage, materials transfers,
mixing, compression, extrusion, large and small scale packing,
sampling, maintenance and associated laboratory activities
Section 2 Operational conditions and risk management measures
Field for additional statements to explain scenario if required.
Section 2.1 Control of worker exposure
Product characteristics
Physical form of product Liquid, vapour pressure 0.5 - 10 kPa [OC4].
Concentration of substance in product Covers percentage substance in the product up to 100 % (unless
stated differently) [G13].
Amounts used Not applicable
Frequency and duration of use Covers daily exposures up to 8 hours (unless stated differently) [G2]

Human factors not influenced by risk Not applicable

management
Other Operational Conditions affecting Assumes a good basic standard of occupational hygiene is
worker exposure implemented [G1].
Assumes use at not more than 20°C above ambient temperature,
unless stated differently [G15].
Contributing Scenarios Risk Management Measures
Note: list RMM standard phrases according to the control hierarchy
indicated in the ECHA template: 1. Technical measures to prevent
release, 2. Technical measures to prevent dispersion, 3.
Organisational measures, 4. Personal protection.
Batch process [CS55]. Initial factory No specific measures identified [EI18].
fill of equipment [CS75]. Storage
[CS67]. Product delivery/product
storage (PROC3 - Use in closed batch
process (synthesis or formulation))
Material transfers [CS3]. Ensure operation is undertaken outdoors [E69].
Dedicated facility [CS81]. Initial
factory fill of equipment [CS75].
Storage [CS67]. Product
delivery/storage bulk product delivery
(PROC8b -Transfer of chemicals
from/to vessels/ large containers at
dedicated facilities)
General exposures (closed systems) No specific measures identified [EI18].
[CS15]. Bulk closed loading [CS500].
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(closed systems) [CS107]. Loading of
application equipment liquid coatings -
fully enclosed (PROC1 - Use in closed
process, no likelihood of exposure)
Continuous process [CS54]. Bulk No specific measures identified [EI18].
closed loading [CS500]. Loading of
application equipment liquid products
(PROC2 - Use in closed, continuous
process with occasional controlled
exposure )
Material transfers [CS3]. Non- Ensure operation is undertaken outdoors [E69].
dedicated facility [CS82]. Bulk open
loading [CS504]. Batch process
[CS55]. Loading of application
equipment liquid products (PROC8a -
Transfer of chemicals from/to vessels/
large containers at non dedicated
facilities)
Material transfers [CS3]. Dedicated No specific measures identified [EI18].
facility [CS81]. Bulk closed loading
[CS500]. Batch process [CS55].
Loading of application equipment
liquid products (PROC8b - Transfer of
chemicals from/to vessels/ large
containers at dedicated facilities)
General exposures (closed systems) No specific measures identified [EI18].
[CS15]. Filling /preparation of
equipment from drums or containers.
[CS45] (closed systems) [CS107].
Preparation of material for application
liquid products - fully enclosed
(PROC1 - Use in closed process, no
likelihood of exposure)
Continuous process [CS54]. Filling / No specific measures identified [EI18].
preparation of equipment from drums
or containers [CS45]. Preparation of
material for application liquid products
(PROC2 - Use in closed, continuous
process with occasional controlled
exposure )
Mixing operations (open systems) No specific measures identified [EI18].
[CS30]. Filling /preparation of
equipment from drums or containers.
[CS45]. Batch process [CS55].
Preparation of material for application
liquid products (PROC5 - Mixing or
blending in batch processes (multistage
and/or significant contact))
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Material transfers [CS3]. Dedicated No specific measures identified [EI18].
facility [CS81]. Filling / preparation of
equipment from drums or containers
[CS45]. Preparation of material for
application liquid coatings - transfer of
material from one container to another
(PROC8b -Transfer of chemicals
from/to vessels/ large containers at
dedicated facilities)
Spraying/fogging by manual Provide extract ventilation to points where emissions occur [E54].
application [CS24] (open systems)
[CS108]. Application on-line manual
spray application (PROC7 - Industrial
spraying)
Roller, spreader, flow application No specific measures identified [EI18].
[CS98]. Application on-line application
by roller, spreader, flow coating or
printing- large scale (open equipment)
[e.g. metal packaging, coil coating,
automotive OEM, flexible packaging,
newspapers, wall coverings] (PROC10
- Roller application or brushing)
Dipping, immersion and pouring [CS4]. No specific measures identified [EI18].
application on-line application by
dipping (PROC13 - Treatment of
articles by dipping and pouring)
Use in contained batch processes No specific measures identified [EI18].
[CS37]. Equipment cleaning and
maintenance [CS39]. Equipment
cleaning enclosed in situ - indoor
(PROC3 - Use in closed batch process
(synthesis or formulation))
Mixing operations (open systems) No specific measures identified [EI18].
[CS30]. Equipment cleaning and
maintenance [CS39]. Equipment
cleaning open off-line - indoor
(PROC5 - Mixing or blending in batch
processes (multistage and/or significant
contact))
Continuous process [CS54]. Film No specific measures identified [EI18].
formation - force drying (50 - 100°C).
Stoving (>100°C). UV/EB radiation
curing [CS94]. Film formation
force drying (50 - 100°C)/stoving
(>100°C) (PROC2 - Use in closed,
continuous process with occasional
controlled exposure)
Batch process [CS55]. Film formation - No specific measures identified [EI18].
air drying [CS95]. Film formation
air drying (PROC4 - Use in batch and
other process (synthesis) where
opportunity for exposure arises )
Disposal of wastes [CS28]. Storage Ensure operation is undertaken outdoors [E69].
[CS67]. Waste management storage of
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waste prior to removal for off-site
management (PROC3 - Use in closed
batch process (synthesis or
formulation))
Laboratory activities [CS36]. No specific measures identified [EI18].
Laboratory use QC laboratory (PROC5
- Mixing or blending in batch processes
(multistage and/or significant contact))
Section 2.2 Control of environmental exposure
Product characteristics Substance is a unique structure [PrC1].
Non-hydrophobic [PrC4b].
Inherently biodegradable, fulfilling criteria [PrC5d].
Operational conditions Indoor/Outdoor use [OOC3].
Amounts used
Fraction of EU tonnage used in region 1
[A1]:
Regional use tonnage (tonnes/year) 1.60E+03
[A2]:
Fraction of Regional tonnage used 0.05
locally [A3]:
Maximum daily site tonnage (kg/day) 3.64E+02
[A4]:
Annual site tonnage (tonnes/year) [A5]: 8.00E+01
Frequency and duration of use
Type of release Continuous release [FD2].
Emission Days (days/year) [FD4]: 220
Environmental factors not influenced by risk management
Local freshwater dilution factor [EF1]: 10
Local marine water dilution factor Not applicable, no emissions to marine water
[EF2]:
Receiving surface water flow is 18000 m3/d [EF3].
Other Operational Conditions of use Use in open/closed systems.
affecting environmental exposure Either wet or dry processes.
Release fraction to air from process 9.80E-01
(initial release prior to RMM) [OOC4]:
Release fraction to wastewater from 2.00E-02
process (initial release prior to RMM)
[OOC5]:
Release fraction to soil from process 0.00E+00
(initial release prior to RMM) [OOC6]:
Risk Management Measures
Technical conditions and measures at Common practices vary across sites thus conservative process release
process level (source) to prevent estimates used [TCS1].
release
Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil
Air: No air emission controls required; required removal efficiency is 0%
[TCR5].
Wastewater: If discharging to domestic sewage treatment plant, no onsite
wastewater treatment required [TCR9].
Soil: Soil emission controls are not applicable as there is no direct release
to soil [TCR4].
Organisation measures to Prevent environmental discharge consistent with regulatory
prevent/limit release from site requirements [OMS2].
Conditions and measures related to Estimated substance removal from wastewater via domestic sewage
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municipal sewage treatment plant treatment (%) [STP3]: 41.4
Assumed domestic sewage treatment plant flow (m3/d) [STP5]: 2000
Conditions and measures related to External treatment and disposal of waste should comply with
external treatment of waste for applicable local and/or national regulations [ETW3].
disposal
Conditions and measures related to External recovery and recycling of waste should comply with
external recovery of waste applicable local and/or national regulations [ERW1].
Other environmental control None
measures additional to above
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Exposure estimation

Worker exposure

Acute/Short term exposure

MEKO is classified for acute dermal toxicity (Xn, R21 / Acute Tox. 4; H312: Harmful in contact with skin).
However, dermal exposure is expressed as amount (per kg bw) per day which implies that acute dermal
exposure (peaks; in mg/kg bw/day) will not be higher than a calculated total exposure per day (chronic; in
mg/kg bw/day). As the long-term dermal DNEL is lower compared to the acute dermal DNEL, the risk
characterisation for long-term dermal exposure will also cover the risks after acute dermal exposure.

Long-term exposure

The worker exposure estimates for the activities associated with the industrial application of paint containing
MEKO have been assessed using ECETOC TRAv2 with some modifications.
The modifications include:
- linear correction for concentration of the substance (0.8%) instead of the broad default TRA categories.

Table ES.3 contains the tables used to model the worker exposures. These tables contain all the operating
conditions, and when applicable the efficiencies of the exposure modifiers including Respiration protection
equipment (RPE) or other personal protection equipment (PPE) and Local exhaust ventilation (LEV).
Qualitative human exposure assessment

MEKO is classified for skin sensitisation (R43 / Skin Sens. 1; H317: May cause an allergic skin reaction) and
serious damage to the eyes (Xi, R41 / Eye Damage 1; H318: Causes serious eye damage). According to the
guidance on information requirements and chemical safety assessment (part E), such effects need a qualitative
risk assessment rather than a quantitative assessment. However, all contributing scenarios describe activities
with <1% of MEKO which is below the DSD and EU-CLP classification limit for these effects.

Summary of the worker exposure for all contributing scenarios is presented in Table14.

Table14. Exposure levels after assessment of safe use for ES3 Industrial application of paints containing
MEKO, using the ECETOC TRA v2 model
ES3:
Exposure Scenario Industrial applications of paints
containing MEKO
Predicted Predicted Dermal
Contributing Scenarios Inhalation Exposure (mg/kg
Exposure in ppm bw/d)
Batch process [CS55]. Initial factory fill of equipment [CS75].
Storage [CS67]. Product delivery/storage product storage
0.2 (=0.71 mg/m3) 0.003
(PROC3 - Use in closed batch process (synthesis or
formulation))
Material transfers [CS3]. Dedicated facility [CS81]. Initial
factory fill of equipment [CS75]. Storage [CS67]. Product
delivery/storage bulk product delivery (PROC8b -Transfer of 0.28 (=1.00 mg/m3) 0.05
chemicals from/to vessels/ large containers at dedicated
facilities)
General exposures (closed systems) [CS15]. Bulk closed loading
[CS500] (closed systems) [CS107]. Loading of application 0.00008 (=0.00
0.00
equipment liquid coatings - fully enclosed (PROC1 - Use in mg/m3)
closed process, no likelihood of exposure)
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ES3:
Exposure Scenario Industrial applications of paints
containing MEKO
Predicted Predicted Dermal
Contributing Scenarios Inhalation Exposure (mg/kg
Exposure in ppm bw/d)
Continuous process [CS54]. Bulk closed loading [CS500].
Loading of application equipment liquid products (PROC2 - Use
0.08 (=0.28 mg/m3) 0.01
in closed, continuous process with occasional controlled
exposure)
Material transfers [CS3]. Non-dedicated facility [CS82]. Bulk
open loading [CS504]. Batch process [CS55]. Loading of
application equipment liquid products (PROC8a - Transfer of 0.28 (=1.00 mg/m3) 0.11
chemicals from/to vessels/ large containers at non dedicated
facilities)
Material transfers [CS3]. Dedicated facility [CS81]. Bulk closed
loading [CS500]. Batch process [CS55]. Loading of application
0.4 (=1.42 mg/m3) 0.05
equipment liquid products (PROC8b - Transfer of chemicals
from/to vessels/ large containers at dedicated facilities)
General exposures (closed systems) [CS15]. Filling /preparation
of equipment from drums or containers [CS45] (closed systems)
0.00008 (=0.00
[CS107]. Preparation of material for application liquid products 0.003
mg/m3)
- fully enclosed (PROC1 - Use in closed process, no likelihood
of exposure)
Continuous process [CS54]. Filling / preparation of equipment
from drums or containers [CS45]. Preparation of material for
0.08 (=0.28 mg/m3) 0.01
application- liquid products (PROC2 - Use in closed, continuous
process with occasional controlled exposure)
Mixing operations (open systems) [CS30]. Filling /preparation
of equipment from drums or containers [CS45]. Batch process
[CS55]. Preparation of material for application liquid products 0.4 (=1.42 mg/m3) 0.11
(PROC5 - Mixing or blending in batch processes (multistage
and/or significant contact))
Material transfers [CS3]. Dedicated facility [CS81]. Filling /
preparation of equipment from drums or containers [CS45].
Preparation of material for application liquid coatings - transfer
0.4 (=1.42 mg/m3) 0.05
of material from one container to another (PROC8b - Transfer
of chemicals from/to vessels/ large containers at dedicated
facilities)
Spraying/fogging by manual application [CS24]. (open systems)
[CS108]. Application on-line manual spray application (PROC7 0.1 (=0.36 mg/m3) 0.34
-Industrial spraying)
Roller, spreader, flow application [CS98]. Application
on-line application by roller, spreader, flow coating or printing -
large scale (open equipment) [e.g. metal packaging, coil coating, 0.4 (=1.42 mg/m3) 0.22
automotive OEM, flexible packaging, newspapers, wall
coverings] (PROC10 - Roller application or brushing)
Dipping, immersion and pouring [CS4]. Application on-line
application by dipping (PROC13 - Treatment of articles by 0.4 (=1.42 mg/m3) 0.11
dipping and pouring)
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ES3:
Exposure Scenario Industrial applications of paints
containing MEKO
Predicted Predicted Dermal
Contributing Scenarios Inhalation Exposure (mg/kg
Exposure in ppm bw/d)
Use in contained batch processes [CS37]. Equipment cleaning
and maintenance [CS39]. Equipment cleaning enclosed in situ -
0.2 (=0.71 mg/m3) 0.00
indoor (PROC3 - Use in closed batch process (synthesis or
formulation))
Mixing operations (open systems) [CS30]. Equipment cleaning
and maintenance [CS39]. Equipment cleaning open off-line -
0.4 (=1.42 mg/m3) 0.11
indoor (PROC5 - Mixing or blending in batch processes
(multistage and/or significant contact))
Continuous process [CS54]. Film formation - force drying (50 -
100°C). Stoving (>100°C). UV/EB radiation curing [CS94].
Film formation force drying (50 - 100°C)/stoving (>100°C) 0.08 (=0.28 mg/m3) 0.01
(PROC2 - Use in closed, continuous process with occasional
controlled exposure)
Batch process [CS55]. Film formation - air drying [CS95]. Film
formation air drying (PROC4 - Use in batch and other process 0.16 (=0.57 mg/m3) 0.05
(synthesis) where opportunity for exposure arises)

Disposal of wastes [CS28]. Storage [CS67]. Waste management

storage of waste prior to removal for off-site management
0.14 (=0.50 mg/m3) 0.003
(PROC3 - Use in closed batch process (synthesis or
formulation))

Laboratory activities [CS36]. Laboratory use QC laboratory

(PROC5 - Mixing or blending in batch processes (multistage 0.4 (=1.42 mg/m3) 0.11
and/or significant contact))

Consumer exposure

Not applicable.

Indirect exposure of humans via the environment

The assessment of exposure via the oral route is not considered relevant during normal use of MEKO. The
human intake of MEKO from indirect exposure from industrial application of coatings is presented in Table15.

Table 15. Local concentrations for exposure of humans via the environment
Human intake media Exposure concentrations Justification
Air (mg/m3) 0.060 EUSES calculation

Environmental exposure

Environmental releases

The use volume of MEKO in industrial application of coatings is 1,600 tonnes/year. The fraction of EU tonnage
used in region and the fraction of the regional tonnage used locally are set to 1 (see Section 9.0.2).
In the assessment the CEPE16a SpERC was used. The default emission to air of 0.98 from the CEPE16a SpERC
is used in the assessment. The default emission factor to waste water from the CEPE16a SpERC is 0.02. The
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default emission factor to soil from the CEPE1 SpERC is zero. The number of emission days is set to 220 by
default. The fraction of regional tonnage used locally is set to 0.05 as with the resulting maximum use tonnage
of 80 tonnes/year of MEKO industrial settings safe use could be demonstrated. As a maximum of 0.8% of
MEKO is used in paints this equals a total tonnage of 10,000 tonnes of MEKO containing paint used per year. It
was confirmed by CEPE that no more than 7,000 tonnes of MEKO containing paint is used per year (personal
communication).

The releases to the environment that are taken into account for the exposure estimation are listed in Table 16.
Table 16. Summary of the releases to the environment
Compartments Release Release for Justification
from point total
source regional
(kg/d) (local exposure
exposure estimation
estimation) (kg/d)
Waste water 7.27 84.2 See above
Surface water 0 21 EUSES calculation
Air 356 7.01E+03 See above
Soil (direct releases only) 0 4.38 Table R16.23 (Reach Guidance R.16 [ECHA, 2010])

Exposure concentration in sewage treatment plants (STP)

The Predicted Exposure Concentrations (PECs) in the sewage treatment plant that are taken into account for risk
characterisation are listed in Table17.

Table17. Predicted Exposure Concentrations (PEC) in sewage

Compartments Value Justification
Concentration in sewage (PECSTP)(in mg/l) 2.13 EUSES calculation
Concentration in sewage sludge (in mg/kg bw) 0.57 EUSES calculation

Exposure concentration in aquatic pelagic compartment

The exposure estimation for marine water is not justified as the substance is not expected to be released to the
marine environment under normal conditions of use. The local concentration and Predicted Exposure
Concentration (PEC) in freshwater that are taken into account for risk characterisation are listed in Table 1818.

Table 18. Predicted Exposure Concentrations (PEC) in aquatic compartment

Compartments Local PEC Justification
concentration (local+regional)
Freshwater (in mg/l) 0.213 0.214 EUSES calculation

Exposure concentration in sediments

No release to sediment is anticipated during normal use of MEKO. In addition, MEKO has an estimated log Koc
of 0.56 indicating minimal if any adsorption to soil or sediment. An exposure estimation for the benthic
compartment is therefore not necessary.
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Exposure concentrations in soil and groundwater

No release to soil is anticipated during normal use of MEKO. In addition, MEKO has an estimated log Koc of
0.56 indicating minimal if any adsorption to soil or sediment. An exposure estimation for the terrestrial
compartment is therefore not necessary.

Atmospheric compartment

The local concentrations and Predicted Exposure Concentration (PEC) in air that are taken into account for risk
characterisation are listed in
Table19.

Table 19. Predicted Exposure Concentration (PEC) in air

Compartments Local PEC Justification
concentration (local+regional)
During emission (mg/m3) 0.099 n.c. EUSES calculation
3
Annual average (mg/m ) 0.060 0.060 EUSES calculation
2
Annual deposition (mg/m /d) 0.086 n.c. EUSES calculation
n.c. - not calculated in EUSES

Exposure concentration relevant for the food chain (secondary poisoning)

Exposure assessment through secondary poisoning is not necessary for MEKO. Taking into account the
measured log Kow of MEKO of 0.63 and the low observed bioaccumulation of MEKO in fish (ranging from 0.5
to 5.8), it is not expected that MEKO would biocaccumulate in a high extent. Furthermore, MEKO is not
classified as R48, R60, R61, R62, R63 and/or R64. Therefore MEKO does not pose a risk as a result of
secondary poisoning via the aquatic food web.
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Table ES3: Industrial applications of paints containing MEKO; Characterising the Risk - Chemical Safety Assessment - Evaluation of Safe Use
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Exposure scenario 4: Professional application of paints containing
MEKO
Exposure scenario

Section 1 Exposure Scenario Title

Title Professional application of paints containing MEKO;
CAS: 96-29-7
Use Descriptor Sector of Use: SU22
Process Categories: PROC1, PROC2, PROC3, PROC5, PROC8a,
PROC8b, PROC9
Environmental Release Categories: ERC8a, ERC8d
Specific Environmental Release Categories: CEPE11, CEPE13
Processes, tasks, activities covered Formulation, packing and re-packing of MEKO and its mixtures in
batch or continuous operations, including storage, materials transfers,
mixing, compression, extrusion, large and small scale packing,
sampling, maintenance and associated laboratory activities
Section 2 Operational conditions and risk management measures
Field for additional statements to explain scenario if required.
Section 2.1 Control of worker exposure
Product characteristics
Physical form of product Liquid, vapour pressure 0.5 - 10 kPa [OC4].
Concentration of substance in product Covers percentage substance in the product up to 100 % (unless
stated differently) [G13].
Amounts used Not applicable
Frequency and duration of use Covers daily exposures up to 8 hours (unless stated differently) [G2]

Human factors not influenced by risk Not applicable

management
Other Operational Conditions affecting Assumes a good basic standard of occupational hygiene is
worker exposure implemented [G1].
Assumes use at not more than 20°C above ambient temperature,
unless stated differently [G15].
Contributing Scenarios Risk Management Measures
Note: list RMM standard phrases according to the control hierarchy
indicated in the ECHA template: 1. Technical measures to prevent
release, 2. Technical measures to prevent dispersion, 3.
Organisational measures, 4. Personal protection.
Initial factory fill of equipment [CS75]. Ensure operation is undertaken outdoors [E69].
Storage [CS67]. Product
delivery/storage packaged product
delivery product storage (PROC3 - Use
in closed batch process (synthesis or
formulation))
Initial factory fill of equipment [CS75]. No specific measures identified [EI18].
Bulk open unloading [CS505]. Product
delivery/product storage (PROC3 - Use
in closed batch process (synthesis or
formulation))
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Material transfers [CS3]. Ensure operation is undertaken outdoors [E69]. Wear suitable gloves
Non-dedicated facility [CS82]. Filling / tested to EN374 [PPE15].
preparation of equipment from drums
or containers. [CS45]. Product
delivery/storage bulk product delivery
preparation of material for application
transfer of material from one container
to another (PROC8a - Transfer of
chemicals from/to vessels/ large
containers at non dedicated facilities)
Batch process [CS55]. Filling / Wear suitable gloves tested to EN374 [PPE15].
preparation of equipment from drums
or containers [CS45]. Preparation of
material for application closed,
continuous (PROC3 - Use in closed
batch process (synthesis or
formulation))
Mixing operations (open systems) Wear suitable gloves tested to EN374 [PPE15].
[CS30]. Filling /preparation of
equipment from drums or containers
[CS45]. Preparation of material for
application batch, indoor (PROC5 -
Mixing or blending in batch processes
(multistage and/or significant contact))
Material transfers [CS3]. No specific measures identified [EI18].
Non-dedicated facility [CS82]. Bulk
closed loading [CS500]. Preparation of
material for application transfer of
material from one container to another -
indoor (PROC8a - Transfer of
chemicals from/to vessels/ large
containers at non dedicated facilities)
Continuous process [CS54]. Bulk open No specific measures identified [EI18].
loading [CS504]. Batch process
[CS55]. Loading of application
equipment closed, continuous (PROC2
- Use in closed, continuous process
with occasional controlled exposure)
Mixing operations (open systems) No specific measures identified [EI18].
[CS30]. Bulk open loading [CS504].
Loading of application equipment
(PROC5 - Mixing or blending in batch
processes (multistage and/or significant
contact))
Material transfers [CS3]. Non- No specific measures identified [EI18].
dedicated facility [CS82]. Loading of
application equipment - transfer of
material from one container to another
(PROC8a - Transfer of chemicals
from/to vessels/ large containers at non
dedicated facilities)
Rolling, Brushing [CS51]. Application Wear suitable gloves tested to EN374 [PPE15].
manual brush, roller, spreader
application of coatings (PROC10 -
Roller application or brushing )
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Spraying/fogging by manual Provide extract ventilation to points where emissions occur [E54].
application [CS24]. Manual [CS34]. Wear suitable gloves tested to EN374 [PPE15].
application coatings from aerosol
dispensers manual spray application of
coatings (PROC11 - Non industrial
spraying)
Spraying [CS10]. Manual [CS34]. Ensure operation is undertaken outdoors [E69].
application manual spray application of
coatings (PROC11 - Non industrial
spraying)
Mixing operations (open systems) Wear chemically resistant gloves (tested to EN374) in combination
[CS30]. Equipment cleaning and with ‘basic’ employee training [PPE16].
maintenance [CS39]. Application hand Wear a respirator conforming to EN140 with Type A filter or better.
- paints, pastels, pigment powders [PPE22]
(PROC19 - Hand-mixing with intimate
contact (only PPE available)
Mixing operations (open systems) No specific measures identified [EI18].
[CS30]. Film formation - force drying
(50 - 100°C). Stoving (>100°C).
UV/EB radiation curing [CS94].
Equipment cleaning open in situ
(PROC5 - Mixing or blending in batch
processes (multistage and/or significant
contact))
Continuous process [CS54]. Film No specific measures identified [EI18].
formation - air drying [CS95].
Equipment cleaning open in situ
(PROC2 - Use in closed, continuous
process with occasional controlled
exposure)
Batch process [CS55]. Disposal of No specific measures identified [EI18].
wastes [CS28]. Film formation air
drying (PROC4 - Use in batch and
other process (synthesis) where
opportunity for exposure arises)
Storage [CS67]. Disposal of wastes Ensure operation is undertaken outdoors [E69].
[CS28]. Waste management storage of
waste prior to removal for off-site
management (PROC3 - Use in closed
batch process (synthesis or
formulation))
Material transfers [CS3]. Non- No specific measures identified [EI18].
dedicated facility [CS82]. Waste
management transfer of process wastes
to storage containers: off-line inside
outside (PROC8a - Transfer of
chemicals from/to vessels/ large
containers at non dedicated facilities)
Laboratory activities [CS36]. No specific measures identified [EI18].
Laboratory use QC laboratory (PROC5
- Mixing or blending in batch processes
(multistage and/or significant contact))
Section 2.2 Control of environmental exposure
Product characteristics Substance is a unique structure [PrC1].
Non-hydrophobic [PrC4b].
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Inherently biodegradable, fulfilling criteria [PrC5d].
Contributing scenario - Professional application of coatings (Indoor)
Operational conditions Indoor use [OOC2].
Amounts used
Maximum daily site tonnage (kg/day) 8.77E+00
[A4]:
Frequency and duration of use
Type of release Dispersive use [FD3].
Emission Days (days/year) [FD4]: 365
Environmental factors not influenced by risk management
Local freshwater dilution factor [EF1]: 10
Local marine water dilution factor Not applicable, no emissions to marine water
[EF2]:
Receiving surface water flow is 18000 m3/d [EF3].
Other Operational Conditions of use affecting environmental exposure
Release fraction to air from wide 9.90E-01
dispersive use (regional only) [OOC7]:
Release fraction to wastewater from 1.00E-02
wide dispersive use [OOC8]:
Release fraction to soil from wide 0.00E+00
dispersive use (regional only) [OOC9]:
Measures to reduce or limit discharges, air emissions and releases to soil
Air: No air emission controls required; required removal efficiency is 0%
[TCR5].
Soil: Soil emission controls are not applicable as there is no direct release
to soil [TCR4].
Conditions and measures related to Estimated substance removal from wastewater via domestic sewage
municipal sewage treatment plant treatment (%) [STP3]: 41.4
Assumed domestic sewage treatment plant flow (m3/d) [STP5]: 2000
Conditions and measures related to External treatment and disposal of waste should comply with
external treatment of waste for applicable local and/or national regulations [ETW3].
disposal
Conditions and measures related to External recovery and recycling of waste should comply with
external recovery of waste applicable local and/or national regulations [ERW1].
Other environmental control None
measures additional to above
Contributing scenario - Professional application of coatings (Outdoor)
Operational conditions Outdoor use [OOC1].
Amounts used
Maximum daily site tonnage (kg/day) 8.77E+00
[A4]:
Frequency and duration of use
Type of release Dispersive use [FD3].
Emission Days (days/year) [FD4]: 365
Environmental factors not influenced by risk management
Local freshwater dilution factor [EF1]: 10
Local marine water dilution factor Not applicable, no emissions to marine water
[EF2]:
Receiving surface water flow is 18000 m3/d [EF3].
Other Operational Conditions of use affecting environmental exposure
Release fraction to air from wide 9.85E-01
dispersive use (regional only) [OOC7]:
Release fraction to wastewater from 1.00E-02
wide dispersive use [OOC8]:
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Release fraction to soil from wide 5.00E-03
dispersive use (regional only) [OOC9]:
Measures to reduce or limit discharges, air emissions and releases to soil
Air: No air emission controls required; required removal efficiency is 0%
[TCR5].
Soil: Soil emission controls are not applicable as there is no direct release
to soil [TCR4].
Conditions and measures related to Estimated substance removal from wastewater via domestic sewage
municipal sewage treatment plant treatment (%) [STP3]: 41.4
Assumed domestic sewage treatment plant flow (m3/d) [STP5]: 2000
Conditions and measures related to External treatment and disposal of waste should comply with
external treatment of waste for applicable local and/or national regulations [ETW3].
disposal
Conditions and measures related to External recovery and recycling of waste should comply with
external recovery of waste applicable local and/or national regulations [ERW1].
Other environmental control None
measures additional to above

Exposure estimation

Worker exposure

Acute/Short term exposure

MEKO is classified for acute dermal toxicity (Xn, R21 / Acute Tox. 4; H312: Harmful in contact with skin).
However, dermal exposure is expressed as amount (per kg bw) per day which implies that acute dermal
exposure (peaks; in mg/kg bw/day) will not be higher than a calculated total exposure per day (chronic; in
mg/kg bw/day). As the long-term dermal DNEL is lower compared to the acute dermal DNEL, the risk
characterisation for long-term dermal exposure will also cover the risks after acute dermal exposure.

Long term exposure

The worker exposure estimates for the activities associated with the professional application of paint containing
MEKO have been assessed using ECETOC TRAv2 with some modifications.
The modifications include:
- adjusted efficacy values for gloves as adopted by CEFIC.
- linear correction for concentration of the substance (0.8%) instead of the broad default TRA categories.

Table ES.4 contains the tables used to model the worker exposures. These tables contain all the operating
conditions, and when applicable the efficiencies of the exposure modifiers including Respiration protection
equipment (RPE) or other personal protection equipment (PPE) and Local exhaust ventilation (LEV).
Qualitative human exposure assessment

MEKO is classified for skin sensitisation (R43 / Skin Sens. 1; H317: May cause an allergic skin reaction) and
serious damage to the eyes (Xi, R41 / Eye Damage 1; H318: Causes serious eye damage). According to the
guidance on information requirements and chemical safety assessment (part E), such effects need a qualitative
risk assessment rather than a quantitative assessment. However, all contributing scenarios describe activities
with <1% of MEKO which is below the DSD and EU-CLP classification limit for these effects.

Summary of the worker exposure for all contributing scenarios is presented in Table20.
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Version / revision nº: 5
Table 20. Exposure levels after assessment of safe use for ES4 Professional application of paints
containing MEKO, using the ECETOC TRA v2 model
ES4:
Exposure Scenario Professional application of paints
containing MEKO
Predicted Predicted Dermal
Contributing Scenarios Inhalation Exposure (mg/kg
Exposure in ppm bw/d)
Initial factory fill of equipment [CS75]. Storage [CS67]. Product
delivery/storage packaged product delivery product storage
0.14 (=0.50 mg/m3) 0.003
(PROC3 - Use in closed batch process (synthesis or
formulation))

Initial factory fill of equipment [CS75]. Bulk open unloading

[CS505]. Product delivery/storage product storage (PROC3 - 0.2 (=0.71 mg/m3) 0.003
Use in closed batch process (synthesis or formulation))
Material transfers [CS3]. Non-dedicated facility [CS82]. Filling /
preparation of equipment from drums or containers [CS45].
Product delivery/storage bulk product delivery preparation of
0.56 (=1.99 mg/m3) 0.11
material for application transfer of material from one container
to another (PROC8a - Transfer of chemicals from/to
vessels/large containers at non dedicated facilities)
Batch process [CS55]. Filling / preparation of equipment from
drums or containers. [CS45]. Preparation of material for
0.2 (=0.71 mg/m3) 0.003
application closed, continuous (PROC3 - Use in closed batch
process (synthesis or formulation))
Mixing operations (open systems) [CS30]. Filling /preparation
of equipment from drums or containers. [CS45]. Preparation of
material for application batch, indoor (PROC5 - Mixing or 0.8 (=2.85 mg/m3) 0.11
blending in batch processes (multistage and/or significant
contact))
Material transfers [CS3]. Non-dedicated facility [CS82]. Bulk
closed loading [CS500]. Preparation of material for application
transfer of material from one container to another - indoor 0.8 (=2.85 mg/m3) 0.11
(PROC8a - Transfer of chemicals from/to vessels/large
containers at non dedicated facilities)
Continuous process [CS54]. Bulk open loading [CS504]. Batch
process [CS55]. Loading of application equipment closed,
0.16 (=0.57 mg/m3) 0.01
continuous (PROC2 - Use in closed, continuous process with
occasional controlled exposure)
Mixing operations (open systems) [CS30]. Bulk open loading
[CS504]. Loading of application equipment (PROC5 - Mixing or
0.8 (=2.85 mg/m3) 0.11
blending in batch processes (multistage and/or significant
contact))
Material transfers [CS3]. Non-dedicated facility [CS82].
Loading of application equipment - transfer of material from one
0.8 (=2.85 mg/m3) 0.11
container to another (PROC8a - Transfer of chemicals from/to
vessels/ large containers at non dedicated facilities)

Rolling, Brushing [CS51]. Application manual brush, roller,

spreader application of coatings (PROC10 - Roller application 0.8 (=2.85 mg/m3) 0.04
or brushing )
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Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
ES4:
Exposure Scenario Professional application of paints
containing MEKO
Predicted Predicted Dermal
Contributing Scenarios Inhalation Exposure (mg/kg
Exposure in ppm bw/d)
Spraying/fogging by manual application [CS24]. Manual
[CS34]. application coatings from aerosol dispensers manual
0.4 (=1.42 mg/m3) 0.17
spray application of coatings (PROC11 - Non industrial
spraying)

Spraying [CS10]. Manual [CS34]. Application manual spray

0.28 (=1.00 mg/m3) 0.86
application of coatings (PROC11 - Non industrial spraying)

Mixing operations (open systems) [CS30]. Equipment cleaning

and maintenance [CS39]. Application hand - paints, pastels,
0.8 (=2.85 mg/m3) 0.11
pigment powders (PROC19 - Hand-mixing with intimate contact
(only PPE available)
Mixing operations (open systems) [CS30]. Film formation -
force drying (50 - 100°C). Stoving (>100°C). UV/EB radiation
curing [CS94]equipment cleaning open in situ (PROC5 - Mixing 0.8 (=2.85 mg/m3) 0.11
or blending in batch processes (multistage and/or significant
contact))
Continuous process [CS54]. Film formation - air drying [CS95].
Equipment cleaning open in situ (PROC2 - Use in closed, 0.16 (=0.57 mg/m3) 0.01
continuous process with occasional controlled exposure)

Batch process [CS55]. Disposal of wastes [CS28]. Film

formation air drying (PROC4 - Use in batch and other process 0.4 (=1.42 mg/m3) 0.05
(synthesis) where opportunity for exposure arises)

Storage [CS67]. Disposal of wastes [CS28]. Waste management

storage of waste prior to removal for off-site management
0.14 (=0.50 mg/m3) 0.003
(PROC3 - Use in closed batch process (synthesis or
formulation))
Material transfers [CS3]. Non-dedicated facility [CS82]. Waste
management transfer of process wastes to storage containers:
0.8 (=2.85 mg/m3) 0.11
off-line inside outside (PROC8a - Transfer of chemicals from/to
vessels/ large containers at non dedicated facilities)

Laboratory activities [CS36]. Laboratory use QC laboratory

(PROC5 - Mixing or blending in batch processes (multistage 0.8 (=2.85 mg/m3) 0.11
and/or significant contact))

Consumer exposure

Not applicable.

Indirect exposure of humans via the environment

The assessment of exposure via the oral route is not considered relevant during normal use of MEKO. The
human intake of MEKO from indirect exposure from professional application of coatings is presented in
Table21.
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Table 21. Local concentrations for exposure of humans via the environment
Human intake media Exposure concentrations Justification
Professional application of coatings (indoor)
Air (mg/m3) 1.43E-04 EUSES calculation
Professional application of coatings (outdoor)
Air (mg/m3) 1.43E-04 EUSES calculation

Environmental exposure

Environmental releases

The use volume of MEKO in professional application of coatings is 3,200 tonnes/year. It assumed that half of
this use volume is used indoors and the other half is used outdoors. The fraction of EU tonnage used in region
and the fraction of the regional tonnage used locally are set to 1 (see Section 9.0.2).

Professional application of coatings (indoor)

In the assessment the CEPE11 SpERC was used for indoor applications. The default emission to air of 0.99
from the CEPE11 SpERC is used in the assessment. The default emission factor to waste water from the
CEPE10 SpERC is 0.01. The default emission factor to soil from the CEPE11 SpERC is zero. The number of
emission days is set to 365 and the fraction of regional tonnage used locally is set to 0.002 by default.

Professional application of coatings (outdoor)

In the assessment the CEPE13 SpERC was used for outdoor applications. The default emission to air of 0.985
from the CEPE13 SpERC is used in the assessment. The default emission factor to waste water from the
CEPE13 SpERC is 0.01. The default emission factor to soil from the CEPE13 SpERC is 0.005. The number of
emission days is set to 365 and the fraction of regional tonnage used locally is set to 0.002 by default.

The releases to the environment that are taken into account for the exposure estimation are listed in Table22.

Table 22. Summary of the releases to the environment

Compartments Release Release for Justification
from point total
source regional
(kg/d) (local exposure
exposure estimation
estimation) (kg/d)
Professional application of coatings (indoor)
Waste water 8.77E-03 84.2 See above
Surface water 0 21 EUSES calculation
Air 0 7.01E+03 See above
Soil (direct releases only) 0 4.38 Table R16.23 (Reach Guidance R.16 [ECHA, 2010])
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Compartments Release Release for Justification
from point total
source regional
(kg/d) (local exposure
exposure estimation
estimation) (kg/d)
Professional application of coatings (outdoor)
Waste water 8.77E-03 84.2 See above
Surface water 0 21 EUSES calculation
Air 0 7.01E+03 See above
Soil (direct releases only) 0 4.38 Table R16.23 (Reach Guidance R.16 [ECHA, 2010])

Exposure concentration in sewage treatment plants (STP)

The Predicted Exposure Concentrations (PEC) in the sewage treatment plant that are taken into account for risk
characterisation are listed in Table23.

Table 23. Predicted Exposure Concentrations (PEC) in sewage

Compartments Value Justification
Professional application of coatings (indoor)
Concentration in sewage (PECSTP)(in mg/l) 2.57E-03 EUSES calculation
Concentration in sewage sludge (in mg/kg dw) 6.88E-04 EUSES calculation
Professional application of coatings (outdoor)
Concentration in sewage (PECSTP)(in mg/l) 2.57E-03 EUSES calculation
Concentration in sewage sludge (in mg/kg dw) 6.88E-04 EUSES calculation

Exposure concentration in aquatic pelagic compartment

The exposure estimation for marine water is not justified as the substance is not expected to be released to the
marine environment under normal conditions of use. The local concentration and Predicted Exposure
Concentration (PEC) in freshwater that are taken into account for risk characterisation are listed in Table24.

Table 24. Predicted Exposure Concentrations (PEC) in aquatic compartment

Compartments Local PEC Justification
concentration (local+regional)
Professional application of coatings (indoor)
Freshwater (in mg/l) 2.57E-04 9.84E-04 EUSES calculation
Professional application of coatings (outdoor)
Freshwater (in mg/l) 2.57E-04 9.84E-04 EUSES calculation

Exposure concentration in sediments

No release to sediment is anticipated during normal use of MEKO. In addition, MEKO has an estimated log Koc
of 0.56 indicating minimal if any adsorption to soil or sediment. An exposure estimation for the terrestrial
compartment is therefore not necessary.
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Exposure concentrations in soil and groundwater

No release to soil is anticipated during normal use of MEKO. In addition, MEKO has an estimated log Koc of
0.56 indicating minimal if any adsorption to soil or sediment. An exposure estimation for the terrestrial
compartment is therefore not necessary.

Atmospheric compartment

The local concentrations and Predicted Exposure Concentration (PEC) in air that are taken into account for risk
characterisation are listed in Table25.

Table 25. Predicted Exposure Concentration (PEC) in air

Compartments Local PEC Justification
concentration (local+regional)
Professional application of coatings (indoor)
During emission (mg/m3) 1.91E-08 n.c. EUSES calculation
3
Annual average (mg/m ) 1.91E-08 1.43E-04 EUSES calculation
2
Annual deposition (mg/m /d) 2.74E-08 n.c. EUSES calculation
Professional application of coatings (outdoor)
During emission (mg/m3) 1.91E-08 n.c. EUSES calculation
3
Annual average (mg/m ) 1.91E-08 1.43E-04 EUSES calculation
Annual deposition (mg/m2/d) 2.74E-08 n.c. EUSES calculation
n.c. - not calculated in EUSES

Exposure concentration relevant for the food chain (secondary poisoning)

Exposure assessment through secondary poisoning is not necessary for MEKO. Taking into account the
measured log Kow of MEKO of 0.63 and the low observed bioaccumulation of MEKO in fish (ranging from 0.5
to 5.8), it is not expected that MEKO would biocaccumulate in a high extent. Furthermore, MEKO is not
classified as R48, R60, R61, R62, R63 and/or R64. Therefore MEKO does not pose a risk as a result of
secondary poisoning via the aquatic food web.
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Table ES.4: Professional application of paints containing MEKO; Characterising the Risk - Chemical Safety Assessment- Evaluation of Safe Use
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Table 1: Mapping Uses in the Supply Chain Table 2: Characterising the Risk - Chemical Safety Assessment - Evaluation of Safe Use

Typical Mapped
Generic Exposure Scenario Contributing Scenarios Operating Typical Mapped RMMs Inhalatory exposure Dermal exposure Risk Characterization
Conditions Use Descriptor
TRA Predicted TRA Dermal extra Predicted Dermal
Dermal exposure exposure exposure Exposure
Life Cycle Stage / TRA Predicted Dilution Extra Predicted
TRA LEV : TRA TRA Free text - comment (mg/kg/d) - no LEV TRA modifier: Free text - comment (mg/kg/d) -
LEV Process Category [scroll Exposure - ventilation TRA RPE exposure Exposure - RCR RCR RCR
Short Title Area of Title supporting phrase [optional] CS further specification [free text] [free text] [free text] (Yes/No] (ppm) -
efficiency
effectiveness
concentration duration
factor modifier:
to clarify additional
(ppm) - modifiers reduction concentration PPE factor [optional] to clarify additional modified
list] (%) factor factor modifier (inhalation) factor factor modifier (dermal) (inhalation) (dermal) (all routes)
Application no modifiers (%) [optional] modified

Professional Professional - SU22 Initial factory fill of equipment product delivery/storage Daily; 4 -8 hour; 225 Outdoor No 3 - Use in closed batch 25 30 >4 hours 0.008 linear correction 0.14 0.34 0.008 linear correction 0.00 0.15 0.002 0.15
application of [CS75] packaged product delivery days per annum; process (synthesis or for concentration for concentration
product storage concentration 0.8% formulation) of substance of substance
paints containing
(0.8%) instead of (0.8%) instead of
MEKO
default TRA default TRA
parameter. parameter.
Professional - SU22 Initial factory fill of equipment Storage [CS67]. product delivery/storage Daily; 4 -8 hour; 225 No 3 - Use in closed batch 25 >4 hours 0.008 linear correction 0.20 0.34 0.008 linear correction 0.00 0.21 0.002 0.22
[CS75] product storage days per annum; process (synthesis or for concentration for concentration
concentration 0.8% formulation) of substance of substance
(0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Material transfers [CS3]. ; Bulk open unloading [CS505]. product delivery/storage Daily; 4 -8 hour; 225 Outdoor No 8a -Transfer of chemicals 100 30 >4 hours 0.008 linear correction 0.56 13.71 0.008 linear correction 0.11 0.60 0.08 0.68
Non-dedicated facility [CS82] bulk product delivery days per annum; from/to vessels/ large for concentration for concentration
preparation of material for application concentration 0.8% containers at non dedicated of substance of substance
facilities (0.8%) instead of (0.8%) instead of
transfer of material from one container to
default TRA default TRA
another
parameter. parameter.

Professional - SU22 Batch process [CS55]. Filling / preparation of equipment from drums or preparation of material for application Daily; 4closed,
-8 hour;continuous
225 No 3 - Use in closed batch 25 >4 hours 0.008 linear correction 0.20 0.34 0.008 linear correction 0.00 0.21 0.00 0.22
containers. [CS45]. days per annum; process (synthesis or for concentration for concentration
concentration 0.8% formulation) of substance of substance
(0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Mixing operations (open Filling / preparation of equipment from drums or preparation of material for application Daily; 4 -8 hour;
batch, 225 indoor/outdoor
indoor No 5 -Mixing or blending in 100 >4 hours 0.008 linear correction 0.80 13.71 0.008 linear correction 0.11 0.86 0.08 0.94
systems) [CS30]. containers. [CS45]. days per annum; batch processes for concentration for concentration
concentration 0.8% (multistage and/or of substance of substance
significant contact) (0.8%) instead of (0.8%) instead of
Professional - SU22 Material transfers [CS3]. ; Filling / preparation of equipment from drums or preparation of material for application Daily; 4 -8 transfer
hour; 225of material from one container
No to8a -Transfer
another of chemicals
- indoor 100 >4 hours 0.008 default
linear TRA
correction 0.80 13.71 0.008 default
linear TRA
correction 0.11 0.86 0.08 0.94
Non-dedicated facility [CS82] containers. [CS45]. days per annum; from/to vessels/ large for concentration for concentration
concentration 0.8% containers at non dedicated of substance of substance
facilities (0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.

Professional - SU22 Continuous process [CS54]. Bulk closed loading [CS500]. loading of application equipment Daily;closed,
4 -8 hour; 225
continuous No 2 - Use in closed, 20 >4 hours 0.008 linear correction 0.16 1.37 0.008 linear correction 0.01 0.17 0.01 0.18
days per annum; continuous process with for concentration for concentration
concentration 0.8% occasional controlled of substance of substance
exposure (0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Mixing operations (open Bulk open loading [CS504].; loading of application equipment Daily; 4 -8 hour; 225 indoor/outdoor No 5 -Mixing or blending in 100 >4 hours 0.008 linear correction 0.80 13.71 0.008 linear correction 0.11 0.86 0.08 0.94
systems) [CS30]. Batch process [CS55]. days per annum; batch processes for concentration for concentration
concentration 0.8% (multistage and/or of substance of substance
significant contact) (0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Material transfers [CS3]. ; Bulk open loading [CS504]. loading of application eequipment - Daily; 4 -8 hour; 225 indoor/outdoor No 8a -Transfer of chemicals 100 >4 hours 0.008 linear correction 0.80 13.71 0.008 linear correction 0.11 0.86 0.08 0.94
Non-dedicated facility [CS82] transfer of material from one container to days per annum; from/to vessels/ large for concentration for concentration
another concentration 0.8% containers at non dedicated of substance of substance
facilities (0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Rolling, Brushing [CS51]. application Daily; 4 -8 hour; 225 indoor/outdoor No 10 - Roller application or 100 >4 hours 0.008 linear correction 0.80 27.43 gloves 0.008 linear correction 0.04 0.86 0.03 0.89
manual brush, roller, spreader application days per annum; brushing for concentration for concentration
of coatings concentration 0.8% of substance of substance
(0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Spraying/fogging by manual application Daily; 4 -8 hour; 225 Yes 11 - Non industrial spraying 500 90 >4 hours 0.008 linear correction 0.40 107.14 gloves 0.008 linear correction 0.17 0.43 0.13 0.56
application [CS24]. coatings from aerosol dispensers days per annum; for concentration for concentration
manual spray application of coatings concentration 0.8% of substance of substance
(0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Spraying [CS10]. Manual [CS34]. application Daily; 4 -8 hour; 225 Outdoor No 11 - Non industrial spraying 500 30 >4 hours half 0.008 linear correction 0.28 107.14 0.008 linear correction 0.86 0.30 0.66 0.96
manual spray application of coatings days per annum; mask for concentration for concentration
concentration 0.8% of substance of substance
(0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Mixing operations (open Manual [CS34]. application Daily; 4 -8 hour; 225 Yes 19 - Hand-mixing with 100 >4 hours 0.008 linear correction 0.80 141.43 gloves-basic 0.008 linear correction 0.11 0.86 0.09 0.94
systems) [CS30]. hand - paints, pastels, pigment powders days per annum; intimate contact (only PPE for concentration training for concentration
concentration 0.8% available of substance of substance
(0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Mixing operations (open Equipment cleaning and maintenance [CS39]. equipment cleaning Daily; 4 -8 hour; 225 indoor/outdoor No 5 -Mixing or blending in 100 >4 hours 0.008 linear correction 0.80 13.71 0.008 linear correction 0.11 0.86 0.08 0.94
systems) [CS30]. open in situ days per annum; batch processes for concentration for concentration
concentration 0.8% (multistage and/or of substance of substance
significant contact) (0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Continuous process [CS54]. Film formation - force drying (50 - 100°C). Stoving equipment cleaning Daily; 4 -8 hour; 225 indoor/outdoor No 2 - Use in closed, 20 >4 hours 0.008 linear correction 0.16 1.37 0.008 linear correction 0.01 0.17 0.01 0.18
(>100°C). UV/EB radiation curing [CS94] open in situ days per annum; continuous process with for concentration for concentration
concentration 0.8% occasional controlled of substance of substance
exposure (0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Batch process [CS55]. Film formation - air drying [CS95] film formation Daily; 4 -8 hour; 225 indoor/outdoor No 4 - Use in batch and other 50 >4 hours 0.008 linear correction 0.40 6.86 0.008 linear correction 0.05 0.43 0.04 0.47
airdrying days per annum; process (synthesis) where for concentration for concentration
concentration 0.8% opportunity for exposure of substance of substance
arises (0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Storage [CS67]. Disposal of wastes [CS28]. waste management Daily; 4 -8 hour; 225 Outdoor No 3 - Use in closed batch 25 30 >4 hours 0.008 linear correction 0.14 0.34 0.008 linear correction 0.00 0.15 0.00 0.15
storage of waste prior to removal for off-site days per annum; process (synthesis or for concentration for concentration
management concentration 0.8% formulation) of substance of substance
(0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Material transfers [CS3]. ; Disposal of wastes [CS28]. waste management Daily; 4 -8 hour; 225 indoor/outdoor No 8a -Transfer of chemicals 100 >4 hours 0.008 linear correction 0.80 13.71 0.008 linear correction 0.11 0.86 0.08 0.94
Non-dedicated facility [CS82] transfer of process wastes to storage days per annum; from/to vessels/ large for concentration for concentration
containers: off-line insideoutside concentration 0.8% containers at non dedicated of substance of substance
facilities (0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
Professional - SU22 Laboratory activities [CS36]. laboratory use Daily; 4 -8 hour; 225 No 5 -Mixing or blending in 100 >4 hours 0.008 linear correction 0.80 13.71 0.008 linear correction 0.11 0.86 0.08 0.94
QC laboratory days per annum; batch processes for concentration for concentration
concentration 0.8% (multistage and/or of substance of substance
significant contact) (0.8%) instead of (0.8%) instead of
default TRA default TRA
parameter. parameter.
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
Exposure scenario 5: Consumer application of coatings
Exposure scenario

Section 1 Exposure Scenario Title

Title Consumer application of coatings; CAS: 96-29-7
Use Descriptor Sector of Use: SU21
Product Category PC9a
Environmental Release Categories: ERC8a, ERC8d
Specific Environmental Release Categories: CEPE11, CEPE13
Processes, tasks, activities covered Preparation of material for application and transfer of material from
one container to another incl. loading of application equipment,
manual spray application and application of aerosol dispensers,
brush and roller application, hand application - artist paints, pastels,
air drying and equipment clean-up.
Section 2 Operational conditions and risk management measures
Field for additional statements to explain scenario if required.
Section 2.1 Control of worker exposure
Physical form of product Liquid
Vapour pressure (Pa) 1000 Pa
Molecular weight 87.12
Concentration of substance in product Unless otherwise stated, covers concentrations up to 0.8%
[ConsOC1]
Amounts used Unless otherwise stated, for each use event covers use amounts up
to 3.75 kg. [ConsOC2]
Frequency and duration of use Unless otherwise stated, covers use up to 1 times/day of use
[ConsOC4];
Unless otherwise stated, covers exposure up to 132min/event
[ConsOC14]
Human factors not influenced by risk Unless otherwise stated, bodyweight 60 kg and Inhalation rate up to
management 32.9 m3/day;
Unless otherwise stated, covers skin contact area up to 860cm2
[ConsOC5]

Other Operational Conditions affecting Assumes use at ambient temperatures [ConsOC15];

worker exposure Unless otherwise stated, covers use in room size of 1 m3.
Unless otherwise stated, assumes use with typical ventilation
[ConsOC8].
Unless otherwise stated, covers use with a release area up to 15 m2.
Product Categories
PC9a (Coatings and Paints, thinners, OC Material transfers[CS3]; Mixing operations (open
paint removers) MEKO used in high systems)[CS30]
solid paint - Covers exposure up to 5 min/event [ConsOC14];
- For each use event covers use amounts up to
162.5 g [ConsOC2];
- Covers use in room size of 20 m3 [ConsOC11].
RMM No specific measures identified
OC Rolling, Brushing [CS51]
- For each use event covers use amounts up to
162.5 g [ConsOC2];
- Covers use in room size of 20 m3 [ConsOC11];
- Covers use with a release area up to 1.5 m2.
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Version / revision nº: 5
RMM Avoid using when windows closed [ConsRMM8]

PC9a (Coatings and Paints, thinners, OC Material transfers[CS3]; Mixing operations (open
paint removers) MEKO used in used in systems)[CS30]
water born wall paints - Covers exposure up to 5 min/event [ConsOC14];
- Covers use with a release area up to 0.95 m2.
RMM No specific measures identified
OC Rolling, Brushing [CS51]
- Covers exposure up to 66 min/event
[ConsOC14];
- For each use event covers use amounts up to
2.03 kg [ConsOC2];
- Covers use in room size of 20 m3 [ConsOC11].
RMM - Avoid using at a product concentration greater
than 0.4% [ConsRMM1];
- Avoid using when windows closed
[ConsRMM8];
- Avoid using in room with closed doors
[ConsRMM7].
PC9a (Coatings and Paints, thinners, OC Rolling, Brushing [CS51]
paint removers) MEKO used in water - Covers exposure up to 66 min/event
born paints [ConsOC14];
- For each use event covers use amounts up to
285g [ConsOC2];
- Covers use in room size of 20 m3 [ConsOC11];
- Covers use with a release area up to 1.94 m2.
RMM No specific measures identified
PC9a (Coatings and Paints, thinners, OC Spraying[CS10]
paint removers) application of MEKO - Covers exposure up to 25 min/event
containing paint by pneumatic spraying [ConsOC14];
- Covers spray duration up to 13.3 minutes/event
RMM - Avoid using in rooms smaller than a garage -
room volume of at least 34 m3 [ConsRMM11];
- Spray away from person
PC9a (Coatings and Paints, thinners, OC Spraying[CS10]
paint removers) application of MEKO - - Covers exposure up to 20 min/event
containing paint by spray can - [ConsOC14]; Covers spray duration up to 15
min/event.
RMM - Avoid using in rooms smaller than a garage -
room volume of at least 34 m3 [ConsRMM11];
- Spray away from person
PC9a (Coatings and Paints, thinners, OC Rolling, Brushing [CS51]
paint removers) MEKO used in artist - - Covers exposure up to 120 min/event
paint - For each use event covers use amounts up to 100
g. [ConsOC2]
- Covers use in room size of 20 m3 [ConsOC11].
- Covers use with a release area up to 1.36 m2.
RMM - Avoid using at a product concentration greater
than 0.95% [ConsRMM1]
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according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
PC9a (Coatings and Paints, thinners, OC Material transfers[CS3]; Mixing operations (open
paint removers) MEKO used in systems)[CS30]
coatings e.g. floor coatings - Covers use up to 3 times/day of use [ConsOC4];
- Covers exposure up to 1.33 min/event
[ConsOC14];
- For each use event covers use amounts up to 1
kg [ConsOC2];
- Covers use in room size of 34 m3 [ConsOC11].
RMM - Avoid using at a product concentration greater
than 0.35% [ConsRMM1];
- Avoid using when windows closed
[ConsRMM8];
- Avoid using in room with closed doors
[ConsRMM7].
OC Spreading
- Covers exposure up to 60 min/event
[ConsOC14];
- For each use event covers use amounts up to 3
kg [ConsOC2];
- Covers use in room size of 34 m3 [ConsOC11].
- covers skin contact area up to 108cm2 (hand
palm) [ConsOC5]
RMM - Avoid using at a product concentration greater
than 0.35% [ConsRMM1];
- Avoid using when windows closed
[ConsRMM8];
- Avoid using in room with closed doors
[ConsRMM7].
Section 2.2 Control of environmental exposure
Product characteristics Substance is a unique structure [PrC1].
Non-hydrophobic [PrC4b].
Inherently biodegradable, fulfilling criteria [PrC5d].
Contributing scenario - Consumer application of coatings (Indoor)
Operational conditions Indoor use [OOC2].
Amounts used
Maximum daily site tonnage (kg/day) 8.77E+00
[A4]:
Frequency and duration of use
Type of release Dispersive use [FD3].
Emission Days (days/year) [FD4]: 365
Environmental factors not influenced by risk management
Local freshwater dilution factor [EF1]: 10
Local marine water dilution factor Not applicable, no emissions to marine water
[EF2]:
Receiving surface water flow is 18000 m3/d [EF3].
Other Operational Conditions of use affecting environmental exposure
Release fraction to air from wide 9.90E-01
dispersive use (regional only) [OOC7]:
Release fraction to wastewater from 1.00E-02
wide dispersive use [OOC8]:
Release fraction to soil from wide 0.00E+00
dispersive use (regional only) [OOC9]:
Measures to reduce or limit discharges, air emissions and releases to soil
Air: No air emission controls required; required removal efficiency is 0%
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Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
[TCR5].
Soil: Soil emission controls are not applicable as there is no direct release
to soil [TCR4].
Conditions and measures related to Estimated substance removal from wastewater via domestic sewage
municipal sewage treatment plant treatment (%) [STP3]: 41.4
Assumed domestic sewage treatment plant flow (m3/d) [STP5]: 2000
Conditions and measures related to External treatment and disposal of waste should comply with
external treatment of waste for applicable local and/or national regulations [ETW3].
disposal
Conditions and measures related to External recovery and recycling of waste should comply with
external recovery of waste applicable local and/or national regulations [ERW1].
Other environmental control None
measures additional to above
Contributing scenario - Consumer application of coatings (Outdoor)
Operational conditions Outdoor use [OOC1].
Amounts used
Maximum daily site tonnage (kg/day) 8.77E+00
[A4]:
Frequency and duration of use
Type of release Dispersive use [FD3].
Emission Days (days/year) [FD4]: 365
Environmental factors not influenced by risk management
Local freshwater dilution factor [EF1]: 10
Local marine water dilution factor Not applicable, no emissions to marine water
[EF2]:
Receiving surface water flow is 18000 m3/d [EF3].
Other Operational Conditions of use affecting environmental exposure
Release fraction to air from wide 9.85E-01
dispersive use (regional only) [OOC7]:
Release fraction to wastewater from 1.00E-02
wide dispersive use [OOC8]:
Release fraction to soil from wide 5.00E-03
dispersive use (regional only) [OOC9]:
Measures to reduce or limit discharges, air emissions and releases to soil
Air: No air emission controls required; required removal efficiency is 0%
[TCR5].
Soil: Soil emission controls are not applicable as there is no direct release
to soil [TCR4].
Conditions and measures related to Estimated substance removal from wastewater via domestic sewage
municipal sewage treatment plant treatment (%) [STP3]: 41.4
Assumed domestic sewage treatment plant flow (m3/d) [STP5]: 2000
Conditions and measures related to External treatment and disposal of waste should comply with
external treatment of waste for applicable local and/or national regulations [ETW3].
disposal
Conditions and measures related to External recovery and recycling of waste should comply with
external recovery of waste applicable local and/or national regulations [ERW1].
Other environmental control None
measures additional to above

Exposure estimation

Worker exposure

Not applicable.
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5

Consumer exposure

Acute/Short term exposure

MEKO is classified for acute dermal toxicity (Xn, R21 / Acute Tox. 4; H312: Harmful in contact with skin).
However, dermal exposure is expressed as amount (per kg bw) per day which implies that acute dermal
exposure (peaks; in mg/kg bw/day) will not be higher than a calculated total exposure per day (chronic; in
mg/kg bw/day). As the long-term dermal DNEL is lower compared to the acute dermal DNEL, the risk
characterisation for long-term dermal exposure will also cover the risks after acute dermal exposure.

Long term exposure

MEKO is used in various paints and coatings. This ES relates to the consumer use of paints and coatings.
The Consumer exposure estimates for the activities associated with the application of various paints and
coatings containing MEKO have been assessed using ConsExpo 4.1.
The contributing scenarios describe reasonable worst-case but representative scenarios based on the exposure
potential. The following scenarios have been chosen for consumer exposure:
- MEKO used in high solid paint, was chosen because of the larger dermal exposure potential.
- MEKO used in used in water born wall paints and floor coatings, was chosen because of the larger
inhalation exposure potential due to the large surface area and longer exposure duration.
- MEKO used in artist paint and in water born (trim) paints was chosen because of the commonly higher
percentage of MEKO in the product
- MEKO containing paint by pneumatic spraying and by spray were chosen because of the larger inhalation
potential via aerosol formation and/or vapours.

ConsExpo 4.1 does contain various default scenarios for this product type, but some additions and iterations
were required in order to have exposure scenarios describing all relevant routes and to demonstrate safe use.
The input parameters are based on information from the ConsExpo fact sheets and expert judgments. General
considerations regarding the input values are described below. Appendix B.5 contains an overview of the full
assessment with all the operating conditions and risk management measures. In line with REACH guidance
R15, only those Risk Management Measures (RMMs) should be applied for consumer products which can be
controlled by the manufacturer of the product. The so called product integrated RMMs. These address technical
measures developed during the design phase and that are applied during the manufacturing, assembling and
finishing operations of a product before its use by consumers. Paragraph 9.5.1 contains the Exposure Scenarios.

Exposure via the oral route is considered to be not relevant for consumers due to the nature of the product.1

Bodyweight
Bodyweight is an input parameter important for estimating dermal exposure in mg/kg bw/day.
ConsExpo has as default bodyweight 65 kg, which is the average bodyweight for men (70 kg) and women (60
kg). A bodyweight of 60 kg is assumed as a reasonable worst case value which is in accordance with Example
R.15-1 of the REACH guidance.

Percentage
According to internal industrial knowledge 0.3% of MEKO is general and 0.8% is considered reasonable worst
case. The exposure assessment was initiated with the reasonable worst case percentage (0.8%) but iterations
towards lower concentrations were required for some scenarios in order to demonstrate safe use. The iteration

1
Inline with RIVM report 320104008, ConsExpo Paint Products Fact Sheet-To assess the risks for the consumer.
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Safety data sheet
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Version / revision nº: 5
resulted in Risk Management Measures of maximum 0.4% or 0.35% of MEKO in the product for some
scenarios.

Exposure duration
Exposure duration is based on defaults from ConsExpo, internal industrial knowledge (CEPE) or expert
judgement.

Product amount
Product amounts are based on defaults from ConsExpo, internal industrial knowledge (CEPE) or expert
judgement.

Room volume and ventilation rate

Product amounts are based on defaults from ConsExpo or expert judgement.

Skin contact area

The exposed area is based on defaults from ConsExpo.

The frequency of exposure

The frequency of exposure is set at once a day, which is considered worst case.

The exercise level

With respect to the exercise level relevant for the inhalation rate, light exercise was selected as a reasonable
worst case.

Summary of the consumer exposure for all contributing scenarios is presented in Table26.

Table 26. Exposure levels after assessment of safe use for ES5 Consumer applications of coatings
containing MEKO, using the ECETOC TRA v2 model
ES5: Consumer applications of coatings
Exposure Scenario containing MEKO

Predicted Inhalation Predicted Dermal

Contributing Scenarios
Exposure (mg/m3) Exposure (mg/kg bw/d)
PC9a (Coatings and Paints, Material transfers and 0.102 0.007
thinners, paint removers) Mixing operations (open
MEKO used in high solid systems)
paint Rolling, Brushing 0.874 0.368
PC9a (Coatings and Paints, Material transfers and 0.005 0.003
thinners, paint removers) Mixing operations (open
MEKO used in used in systems)
water born wall paints Rolling, Brushing 1.620 0.120
PC9a (Coatings and Paints, Rolling, Brushing 0.983 0.222
thinners, paint removers)
MEKO used in water born
paints
PC9a (Coatings and Paints, Spraying 0.001 0.195
thinners, paint removers)
application of MEKO
containing paint by
pneumatic spraying
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Safety data sheet
according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
ES5: Consumer applications of coatings
Exposure Scenario containing MEKO

Predicted Inhalation Predicted Dermal

Contributing Scenarios
Exposure (mg/m3) Exposure (mg/kg bw/d)
PC9a (Coatings and Paints, Spraying 0.042 0.200
thinners, paint removers)
application of MEKO
containing paint by spray
can
PC9a (Coatings and Paints, Rolling, Brushing 1.360 0.222
thinners, paint removers)
MEKO used in artist paint
PC9a (Coatings and Paints, Material transfers and 0.219 <0.001
thinners, paint removers) Mixing operations (open
MEKO used in coatings e.g. systems)
floor coatings Spreading 1.620 0.015

Qualitative human exposure assessment

MEKO is classified for skin sensitisation (R43 / Skin Sens. 1; H317: May cause an allergic skin reaction) and
serious damage to the eyes (Xi, R41 / Eye Damage 1; H318: Causes serious eye damage). According to the
guidance on information requirements and chemical safety assessment (part E), such effects need a qualitative
risk assessment rather than a quantitative assessment. However, all consumer products contain <1% of MEKO
which is below the DSD and EU-CLP classification limit for these effects.

Indirect exposure of humans via the environment

See Exposure Scenario 4 for exposure estimations.

Environmental exposure

See Exposure Scenario 4 for exposure estimations.

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Overall exposure (combined for all relevant emission/release sources)

Human health (combined for all exposure routes)

Combined exposure for human health is addressed in section below.

Environmental emission assessment (combined for all emission/release routes)

It is not expected that a combination of emission sources would lead to an environmental risk

Environmental emission assessment - regional exposure concentrations

Environmental releases

The total regional release to the environment that is taken into account for the exposure estimation is listed in
Table27.

Table 27. Summary of the releases to the environment

Compartments Total release for Justification
regional exposure
estimation (kg/d)
Waste water 84.2 EUSES calculation
Surface water 21 EUSES calculation
Air 7.01E+03 EUSES calculation
Soil (direct releases only) 4.38 Table R16.23 (Reach Guidance R.16 [ECHA, 2010])

Regional exposure concentrations in the environment

The exposure estimation for marine water is not justified as the substance is not expected to be released to the
marine environment under normal conditions of use. No release to sediment and soil is anticipated during
normal use of MEKO. In addition, MEKO has an estimated log Koc of 0.56 indicating minimal if any
adsorption to soil or sediment. An exposure estimation for the benthic and terrestrial compartment is therefore
not necessary.

The regional Predicted Exposure Concentrations (PECs) in the environment are listed in Table 228.

Table 28. Regional concentrations in the environment

Compartments Predicted regional Exposure Explanation / source of
Concentrations measured data
Freshwater (mg/l) 7.27E-04 EUSES calculation

Regional indirect exposure of humans via the environment

The assessment of exposure via the oral route is not considered relevant during normal use of MEKO. The
regional human intake of MEKO from indirect exposure is presented in Table 28. The estimations are results of
EUSES v2.1 (2008) calculations.
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according to Regulation (EU) 453/2010, amending Regulation (EC) 1907/2006
Printing date 16.10.2013 Date of compilation / revision: 16.10.2013
Version / revision nº: 5
Table 29. Local concentrations for exposure of humans via the environment
Human intake media Exposure concentrations Justification
Air (mg/m3) 1.43E-04 EUSES calculation