Registration Dossier
Registration Dossier
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EC number: 271-176-6 | CAS number: 68516-73-4
Endpoint summary
Administrative data
Description of key information
oral:
subacute (screening): NOAEL = 1000 mg/kg bw/day (OECD 422)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A GLP-compliant investigation of the toxicological effects resulting from repeated oral-gavage administration to rats was performed following OECD guideline 422 without deviations with with the test substance (Pigment Yellow 155, BASF, 2013). Pigment Yellow 155 was administered in water as vehicle at dosages of 100, 300, and 1000 mg/kg body weight/day, and controls received the vehicle only. Pigment Yellow 155 was administered to male rats for 41 days and to female rats for 52 days including time prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post-partum. Treatment with the test item up and including 1000 mg/kg bw/day did not reveal any clinical signs or histological findings and did not affect reproduction. All dose-treated males and females had dose-related yellow discolored feces during the treatment period. This finding is considered to be a typical effect resulting from oral administration of a yellow dyestuff and not adverse. Based on these results a general NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg body weight/day.
Justification for classification or non-classification
Classification, Labelling, and
Packaging Regulation (EC) No 1272/2008
The available experimental test
data are reliable and suitable for classification purposes under
Regulation (EC) No 1272/2008. Based on available data on repeated dose
toxicity, the test item is not classified according to Regulation (EC)
No 1272/2008 (CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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