Registration Dossier
Registration Dossier
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EC number: 208-655-6 | CAS number: 537-01-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In a reverse gene mutation assay in bacteria (Wollny HE, 2006) classified at validity 1 according to Klimisch scoring system, strains TA1535, 1537, 98, 100 and 102 of S. typhimurium were exposed to cerium carbonate, (65.62 % a. i.), at concentrations of 3 to 5000 µg/plate in the presence and absence of mammalian metabolic activation. Cerium carbonate was tested up to precipitating concentrations. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background in any strains in the absence and presence of metabolic activation. Therefore, dicerium tricarbonate is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
In a mammalian cell cytogenetics assay (chromosome aberration assay) (Schulz, 2006) classified at validity 1 according to Klimisch scoring system, primary lymphocyte cultures were exposed to Cerium carbonate (65.62% of purity), in distilled water, at concentrations of 45.6 - 7020 µg/mL or 87.0 - 2500 µg/mL with and without metabolic activation. Cerium carbonate was tested up to precipitating concentrations. Positive controls induced the appropriate response. There was no evidence of chromosome aberration induced over background in the presence or the absence of metabolic activation. Therefore, dicerium tricarbonate is considered to be non-clastogenic in this chromosome aberration test when tested up to precipitating concentrations.
In a mammalian cell gene mutation assay (HPRT locus) (Wollny, 2006) classified at validity 1 according to Klimisch scoring system, Chinese hamster V79 cells cultured in vitro were exposed to Cerium carbonate, in deionised water, at concentrations of 143.8 to 2300 µg/mL in the presence and absence of mammalian metabolic activation. Cerium carbonate was tested up to insoluble concentrations. The positive controls induced the appropriate response. There was no evidence of induced mutant colonies over background in the presence or the absence of metabolic activation. Therefore, dicerium tricarbonate is considered to be non-mutagenic in this HPRT assay.
Short description of key information:
Reverse gene mutation assay in bacteria (Ames test): negative
Chromosomal aberration in vitro: negative
Mammalian cell gene mutation assay (HPRT locus) in vitro: negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on results of three genetic toxicity tests in vitro, the substance does not need to be classified according to GHS (Regulation (EU) 1272/2008) and also does not need to be classified according to DSD (67/548/EEC).
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