Registration Dossier
Registration Dossier
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EC number: 701-182-0 | CAS number: -
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a sub-chronic toxicity study (90 days) does not need to be conducted because the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day 'limit test' and human exposure is limited
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Data from the Episkin reconstructed human epidermis model indicated that the substance was non-irritant and non-corrosive to skin. In addition, an acute dermal application study on the read across substance aluminum, benzoate C16-18 fatty acid complexes in rats tested up to the maximum exposure of 2000 mg/kg b.w. showed no dermal toxicity. The read across substance aluminum, benzoate C16-18 fatty acid complexes was also shown to be non-sensitising in a Mouse Local Lymph Node Assay. Consequently, further studies on the potential for dermal toxicity of this substance are unlikely to provide additional information, thus the Annex IX requirement for a subchronic study is waived in accordance with Annex XI.
Data source
Materials and methods
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
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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