Registration Dossier
Registration Dossier
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EC number: 932-121-8 | CAS number: 1147459-12-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
There are indications from a single rabbit exposed topically that severe irritant reactions are elicited in dermis. The degree of reaction observed in one rabbit - grade 4 erythema and oedema with possible indications of corrosive lesions in the skin - precludes assessment of ocular reactions in vivo. From an ethical and animal welfare point no investigation of eye irritation is warranted. The requirement for an ocular irritation test is waived on the basis that GHS classification H314 takes account of the severe dermal reactions involved with corrosive effects and addresses the likely ocular damage/serious reaction that may occur, without requiring in vivo confirmation. Since AA coco DMAPA is classified as corrosive, no eye study is needed.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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