Registration Dossier
Registration Dossier
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EC number: 236-007-2 | CAS number: 13093-17-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Genetic toxicity in vitro:
Bacterial reverse mutation assay:
Thompson (2013) performed an Ames (preliminary toxicity test, plate incorporation assay and preincubation method) test with S typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA in the presence and absence metabolic activation (10% S9 -mix).
Following test concentrations were applied in triplicate:
Preliminary toxicity test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate (cerium tetranitrate as active ingredient)
Mutation test - experiment 1:
15, 50, 150, 500, 1500, 5000 µg/plate (cerium tetranitrate as active ingredient)
Mutation test - experiment 2:
5, 15, 50, 150, 500, 1500, 5000 µg/plate (cerium tetranitrate as active ingredient)
Solvent control, negative control and positive controls were run in triplicate. Solvent, negative and positive controls were valid. The test item caused a visible reduction in the growth of the bacterial background lawns of TA100, TA1537 and WP2uvrA at 5000 µg/plate
in both the absence and presence of S9-mix and in both experiments. Weakened bacterial backgrond lawns were also noted for TA98 at 5000 µg/plate in the absence of S9 -mix employing pre-incubation methodology only. These results were not considered indicative of sufficient toxicity to prevent the test item being tested up to 5000 µg/plate. No precipitation was observed on the plates at any of the doses tested in the presence or absence of metabolic activation in both experiments.No significant increase in the frequency of revertant colonies was recorded for any bacterial strains, with any dose of the test item either with or without metabolic activation or exposure method. It was concluded, therefore, that cerium tetranitrate was not mutagenic under the conditions of the test.
Short description of key information:
Genetic toxicity in vitro:
In an Ames test according to OECD Guideline 471, EU Method B.13/14 and EPA OPPTS 870.5100 (Thompson, 2013), cerium tetranitrate proved to be negative for mutagenicity with and without metabolic activation.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
On the basis of the available information and according to the criteria of the DSD and CLP Regulation, cerium tetranitrate should not be classified for mutagenicity.
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