Registration Dossier
Registration Dossier
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EC number: 295-714-4 | CAS number: 92128-22-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The mutagenic potential of the test substance was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471 (Herbold, 1995). Evidence of mutagenic activity was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed. Based on this test, the test substance was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.
In another test on point mutagenic effects the test substance was investigated at the hypoxanthine-guanine phosphoribosyl transferase locus (HPRT test) in Chinese hamster V79 cells according to OECD TG 476 (Entian, 2009). Without and with S9 mix the test substance induced decreases in survival to treatment and decreases in relative population growth. These results revealed a significant concentration-related cytotoxicity. Without and with S9 mix there was no biologically relevant increase in mutant frequency above that of the negative controls. Based on these results, the test substance was considered to be non-mutagenic in the V79/HPRT Forward Mutation Assay, both with and without metabolic activation.
The clastogenic potential of the test substance was evaluated in a chromosome aberration test on Chinese hamster V79 cells in the presence and absence of S9 mix according to OECD TG 473 (Thum, 2009). Without S9 mix cytotoxic effects were observed at 6 µg/ml and above after 4 hours treatment and at 2 µg/ml and above after 18 hours treatment. With S9 mix cytotoxic effects were observed at 22 µg/ml and above. Precipitation in the medium did not occur. None of the cultures treated with the test substance in the absence and in the presence of S9 mix showed biologically relevant increased numbers of aberrant metaphases. Based on this test, the test substance was considered not to be clastogenic for mammalian cells in vitro.
Justification for selection of genetic toxicity endpoint
No study was selected, since all three in vitro studies were negative.
Short description of key information:
The substance was clearly negative in three in vitro studies with and without metabolic activation.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Genetic toxicity (in vitro)
Not classified under Annex I of Directive 67/548/EEC. According to Annex I of Regulation (EC) No 1272/2008 no classification is required for genetic toxicity.
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