045 ESDS 045 P 04 08 Neeliglow Solvent Yellow 172 Superior Quality
045 ESDS 045 P 04 08 Neeliglow Solvent Yellow 172 Superior Quality
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COMMISSION REGULATION (EU) No 2015/830 of 1 June 2015 amending Annex II
of Regulation (EU) No 453/2010
Issue date 05/12/2018 Date of Revision: 15/06/2019 Due Date of Revision: 14/06/2022
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COMMISSION REGULATION (EU) No 2015/830 of 1 June 2015 amending Annex II
of Regulation (EU) No 453/2010
Issue date 05/12/2018 Date of Revision: 15/06/2019 Due Date of Revision: 14/06/2022
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COMMISSION REGULATION (EU) No 2015/830 of 1 June 2015 amending Annex II
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Issue date 05/12/2018 Date of Revision: 15/06/2019 Due Date of Revision: 14/06/2022
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Issue date 05/12/2018 Date of Revision: 15/06/2019 Due Date of Revision: 14/06/2022
- DERMAL Exposure
Systemic Effects Long-term : (DNEL) 5 mg/kg bw/day repeated dose toxicity
- EYE Exposure : Low hazard (no threshold derived)
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COMMISSION REGULATION (EU) No 2015/830 of 1 June 2015 amending Annex II
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Issue date 05/12/2018 Date of Revision: 15/06/2019 Due Date of Revision: 14/06/2022
Boots
· Change in condition
Melting point/Melting range: 298 - 303 °C
IN
(Contd. on page 7)
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COMMISSION REGULATION (EU) No 2015/830 of 1 June 2015 amending Annex II
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COMMISSION REGULATION (EU) No 2015/830 of 1 June 2015 amending Annex II
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Issue date 05/12/2018 Date of Revision: 15/06/2019 Due Date of Revision: 14/06/2022
the corneas. Concurrent negative and positive controls were run using physiological saline
and 20 % imidazole solution in physiological saline, respectively. The test material did not
induce ocular irritation through both endpoints (opacity and permeability), resulting in a mean
in vitro irritancy score of -0.1 after 240 minutes of treatment. The negative control responses
for opacity and permeability were less than the upper limits of the laboratory historical range
indicating that the negative control did not induce irritancy on the corneas. The mean in vitro
irritancy score of the positive control was 103 and within two standard deviations of the
current historical positive control mean. It was therefore concluded that the test conditions
were adequate and that the test system functioned properly.
Conclusions: Under the conditions of this study, as the test material induced an IVIS ≤ 3, no
classification is required for eye irritation or serious eye damage.
· Respiratory or skin sensitisation
Skin sensitisation: in vivo (LLNA)
Guideline: OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Method: Test material concentrations selected for the main study were based on the results
of a pre-screen test. In the main study, three experimental groups of five female CBA/J mice
were treated with test material concentrations of 10, 25 or 50 % w/w on three consecutive
days, by open application on the ears. Five vehicle control animals were similarly treated, but
with the vehicle alone (N,N-Dimethyl formamide). Three days after the last exposure, all
animals were injected with 3H-methyl thymidine and after five hours the draining (auricular)
lymph nodes were excised and pooled for each animal. After precipitating the DNA of the
lymph node cells, radioactivity measurements were performed. The activity was expressed
as the number of disintegrations per minute (DPM) and a stimulation index (SI) was
subsequently calculated for each group.
Conclusions: Under the conditions of this study, the test material was not considered to be a
skin sensitiser.
· Repeated dose toxicity
Short-term repeated dose toxicity: oral
Guideline: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the
Reproduction / Developmental Toxicity Screening Test)
Method : The test material was administered by daily oral gavage to male and female Wistar
Han rats at dose levels of 100, 300 and 750 mg/kg/day (10 rats/sex/dose level). Concurrent
controls (10 rats/sex) received the vehicle, water for injection, alone. Formulations were
analysed once during the study to assess accuracy and homogeneity. Males were treated for
30 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females that
delivered were treated for at least 51 days, i.e. during 2 weeks prior to mating, during mating,
during pregnancy, and during 13 days of lactation. Females which failed to deliver healthy
offspring were treated for at least 41 days.
Conclusions: No Observed Adverse Effect Level (NOAEL) of the test material is at least 750
mg/kg/day.
· CMR effects (carcinogenity, mutagenicity and toxicity for reproduction)
· Germ cell mutagenicity
In vitro gene mutation study in bacteria
Guideline: OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Method: The test material was tested in the Salmonella typhimurium reverse mutation assay
with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA98 and
TA100) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain
(Contd. on page 9)
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COMMISSION REGULATION (EU) No 2015/830 of 1 June 2015 amending Annex II
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Issue date 05/12/2018 Date of Revision: 15/06/2019 Due Date of Revision: 14/06/2022
of Escherichia coli (WP2uvrA). The test was performed in two independent experiments in
the presence and absence of S9-mix (rat liver S9-mix induced by Aroclor 1254). In the dose
range finding test, the test material was tested up to concentrations of 5000 µg/plate in the
absence and presence of S9-mix in the strains TA100 and WP2uvrA. The test material was
tested up to or beyond a precipitating dose level. The bacterial background lawn was not
reduced at any of the concentrations tested and no biologically relevant decrease in the
number of revertants was observed. Results of this dose range finding test were reported as
part of the first mutation assay. Based on the results of the dose range finding test, the test
material was tested in the first mutation assay at a concentration range of 5.4 to 1600 µg/
plate in the absence and presence of 5 % (v/v) S9-mix in the tester strains TA1535, TA1537
and TA98. The test material was precipitated on the plates at concentrations of 512 and
1600 µg/plate. The bacterial background lawn was not reduced at any of the concentrations
tested and no biologically relevant decrease in the number of revertants was observed.
Conclusions: It is concluded that the test material is mutagenic in the Salmonella
typhimurium reverse mutation assay and not mutagenic in the Escherichia coli reverse
mutation assay.
· Carcinogenicity Based on available data, the classification criteria are not met.
· Reproductive toxicity
Screening for reproductive / developmental toxicity
Guideline: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the
Reproduction / Developmental Toxicity Screening Test)
Method : The test material was administered by daily oral gavage to male and female Wistar
Han rats at dose levels of 100, 300 and 750 mg/kg/day (10 rats/sex/dose level). Concurrent
controls (10 rats/sex) received the vehicle, water for injection, alone. Formulations were
analysed once during the study to assess accuracy and homogeneity. Males were treated for
30 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females that
delivered were treated for at least 51 days, i.e. during 2 weeks prior to mating, during mating,
during pregnancy, and during 13 days of lactation. Females which failed to deliver healthy
offspring were treated for at least 41 days.
Conclusions: No Observed Adverse Effect Level (NOAEL) of the test material is at least 750
mg/kg/day for parental, reproduction and developmental toxicity.
· STOT-single exposure Based on available data, the classification criteria are not met.
· STOT-repeated exposure Based on available data, the classification criteria are not met.
· Aspiration hazard Based on available data, the classification criteria are not met.
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COMMISSION REGULATION (EU) No 2015/830 of 1 June 2015 amending Annex II
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Issue date 05/12/2018 Date of Revision: 15/06/2019 Due Date of Revision: 14/06/2022
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COMMISSION REGULATION (EU) No 2015/830 of 1 June 2015 amending Annex II
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Issue date 05/12/2018 Date of Revision: 15/06/2019 Due Date of Revision: 14/06/2022
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 Harmonised 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
PBT: Persistent, Bioaccumulative and Toxic
SVHC: Substances of Very High Concern
vPvB: very Persistent and very Bioaccumulative
· Sources
• REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL on classification, labelling and packaging of substances and mixtures, amending
and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No
1907/2006
•http://echa.europa.eu/information-on-chemicals/cl-inventory-database/-/cl-inventory/view-
notification-summary/84809
· * Data compared to the previous version altered.
•Section 1: Identification of the substance/mixture and of the company/undertaking
•Section 2: Hazard Identification
•Section 3: Composition/information on ingredients
•Section 4: First-aid measures.
•Section 5: Fire-fighting measures
•Section 6: Accidental Release measures
•Section 7: Handling and storage.
•Section 8: Exposure Controls/Personal protection.
•Section 9: Physical and Chemical properties.
•Section 10: Stability and Reactivity
•Section 11: Toxicological Information.
•Section 12: Ecological Information.
•Section 13: Disposal consideration
•Section 14: Transport information
•Section 15: Regulatory information
•Section 16: Other information
IN