Registration Dossier
Registration Dossier
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EC number: 478-080-5 | CAS number: 57043-35-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Chromosome Aberration: This study is a read-across to MAES.The report describes the results of an in vitro study for the detection of structural chromosomal aberrations in cultured mammalian cells. It supplements microbial systems insofar as it identifies potential mutagens that produce chromosomal aberrations rather than gene mutations (Scott et al, 1990). The method used followed that described in the OECD Guidelines for Testing of Chemicals (1997) No. 473 "Genetic Toxicology: Chromosome Aberration Test" and Method B10 of Commission Directive 2000/32/EC. The study design also meets the requirements of the UK Department of Health Guidelines for Testing of Chemicals for Mutagenicity.
The test material induced small but statistically significant increases in the frequency of cells with chromosome aberrations in both the absence and presence of a liver enzyme metabolising system in two separate experiments. The test material was therefore considered to be weakly clastogenic to human lymphocytes in vitro.
Bacterial Reverse Mutation Assay: The Bacterial Reverse Mutation Assay (Ames Test) was performed in order to evaluate the ability of five concentrations of this test article to induce mutations in five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537, and TA102).
The average number of revertant colonies for all test article concentrations was not significantly higher than the average number of revertant colonies of the corresponding solvent control, either with or without S9 metabolic activation.
The results of this Bacterial Reverse Mutation Assay indicate that under the experimental conditions, the test article was not mutagenic for any tester strain, either with or without S9 metabolic activation.
Mouse Micronucleus Assay: The objective of this Mouse Micronucleus (MN) Assay was to evaluate the ability of four concentrations of a test article to induce cytogenetic damage (i.e., micronuclei) in mouse erythrocyte precursor cells. The study was carried out based on OECD and International Conference for Harmonisation (ICH) testing guidelines.
Under the experimental conditions of this assay, test article does not induce micronuclei in CD-1 mice.
Short description of key information:
The test material was therefore considered to be weakly clastogenic to human lymphocytes in vitro., non-mutagenic in the AMES test and negative in the Mouse Micronuclus Assay. Although the test material was found to be weakly clastogenic to human lymphocytes in vitro the overall conclusion is that the test material is not classified as regards genetic toxicity.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The test material was therefore considered to be weakly clastogenic to human lymphocytes in vitro., non-mutagenic in the AMES test and negative in the Mouse Micronuclus Assay. Although the test material was found to be weakly clastogenic to human lymphocytes in vitro the overall conclusion is that the test material is not classified as regards genetic toxicity.
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