Registration Dossier
Registration Dossier
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EC number: 208-655-6 | CAS number: 537-01-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test of skin sensitisation in guinea pigs was carried out according to O.E.C.D. guideline No. 406, Directive 67/548/EEC, Annex V, test method B6 and in compliance with Good Laboratory Practices. Fifteen female Dunkin/Hartley guinea-pigs were included in this study. Ten animals were used for the test article and 5 for the control, respectively. Induction was carried out in 2 phases: - Phase 1: Day 1, animals were injected by the intradermal route with Cerium carbonate (25 % w/w in purified water) +/- Freund Complete Adjuvant or with the vehicle; - Phase 2: a 48 hours topical occlusive application was performed Day 8 with Cerium carbonate at 50 % w/w in purified water or the vehicle. The control and test animals were challenged topically 2 weeks after the topical induction application with Cerium carbonate at 25 % w/w in purified water for 24 hours. The challenge sites were evaluated 24 and 48 hours after removal of the patches. The reactions were graded for erythema and oedema according to a numerical scale. No clinical signs and no deaths, related to treatment, were noted during the study. No cutaneous reactions were observed after challenge application.
From the results obtained, Cerium carbonate is not classified as a skin sensitiser according to Annex VI of the Directive 67/548/EEC.
Migrated from Short description of key information:
Based on the results of the only available (and reliable) study, the test substance is not considered as skin sensitiser.
Justification for classification or non-classification
Based on the results of a study performed according to OECD test guideline 406, dicerium tricarbonate does not need to be classified as skin sensitising according to Annex VI of the Directive 67/548/EEC and UN/EU GHS classification system.
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