Registration Dossier
Registration Dossier
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EC number: 204-155-7 | CAS number: 116-75-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The absence of point mutation-inducing activities was demonstrated by the negative outcome in a Bacterial Reverse Mutation Test and an In Vitro Mammalian Cell Mutation Assay. The absence of chromosome aberration-inducing activities was demonstrated by the negative outcome in an In Vitro Mammalian Chromosome Aberration Test. In conclusion testing of the test substance revealed no evidence of mutagenic activity in bacteria and mammalian or human cells. Therefore the test itrem is not considered to be mutagenic.
Justification for selection of genetic toxicity endpoint
Due to the variety of possible genotoxic effects, selection of a single refernce in order to cover genetic toxicity is not sufficient. Therefore a battery of three in vitro studies was assessed:
KEY_471_2003_RCC_774500 Ames / KEY_476_2013_Harlan_1489102_HPRT / KEY_473_2013_Harlan_1489101_CALY
Short description of key information:
KEY_471_2003_RCC_774500 Ames
In this Bacterial Reverse Mutation Test (AMES-Test) with and without metabolic activation, the test substance did not induce genmutations in the genom of the tester strains used. Therefore the test item is considered to be non-mutagenic in this Salmonella and Escherichia coli Reverse Mutation Assay.
KEY_476_2013_Harlan_1489102_HPRT
In this In Vitro Mammalian Cell Mutation Assay (HPRT-Test), with and without metabolic activation, the test substance did not induce an increase of the mutation frequency. Therfore the test substance is considered to be non-mutagenic in this In Vitro Mammalian Cell Mutation Assay.
KEY_473_2013_Harlan_1489101_CALY
In this In Vitro Mammalian Chromosome Aberration Test (CA-Test), with and without metabolic activation, the test substance did not induce an increase of the number of structural chromosome aberrations or numerical aberrations. In conclusion, it can be stated that the test substance is considered not to be clastogenic or aneugenic in this Chromosom Aberration Test in Human Lymphpcytes In Vitro.
In conclusion, it can be stated that the test substance did not induce point or genmutations, chromosome mutations (structural aberrations) or genomic mutations (numerical aberrations) in this battery of in vitro genetic toxicity tests.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The test substance did not reveal any mutagenic effects in the bacterial reverse mutation assay, in the in vitro gene mutation study in mammalian cells, and in the human lymphocytes chromosome aberration test.
Since these findings do not meet the criteria for classification with respect to Mutagenicity or Germ Cell Mutagenicity according to the rules laid down in Directive 67/548EEC and in Regulation (EC) No 1272/2008, classification is not warrantable.
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