Registration Dossier
Registration Dossier
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EC number: 608-591-2 | CAS number: 31221-06-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Diazobarbitursäure was initially investigated according to OECD TG 471 using the Salmonella/microsome plate incorporation methodology and Salmonella typhimurium TA1535, TA100, TA1537, TA98 and TA102. The test item was dissolved in DMSO, in doses of up to and including 5000 µg/plate. In all of the Salmonella typhimurium strains in test a biologically relevant increase in the mutant count compared to the corresponding negative control was found. Due to these results Diazobarbitursäure has to be regarded as mutagenic in the Salmonella/Microsome test.
In the available HPRT test in mamalian V79 cells of the Chinese hamster which was performed according to OECD TG 476 and GLP, concentrations up to 1600 µg/mL were used. No substantial and reproducible dose dependent increase in the mutation frequency was observed in both main experiments, therefore, Diazobatrbiturc acid is considered to be non-mutagenic in this HPRT assay.
Overall, there are two studies available investigating point mutations. The Ames test in bacteria yielded a positive result, whereas the HPRT test using somatic mammalian cell sytem, was negative. Both test are performed according to the respective guideline under GLP conditions and are evaluated with Klimisch score 1. Based on the negative data in the mamalian cell assay (HPRT) it can be concluded that mutagenicity of the test item is unlikely.
Short description of key information:
There are two studies available investigating point mutations. The Ames test in bacteria yielded a positive result, whereas the HPRT test using somatic mamalian cells was negative. Overall, based on the available data, mutagenicity of the test item is unlikely.
Endpoint Conclusion:
Justification for classification or non-classification
Overall, there are two studies available investigating point mutations. The Ames test in bacteria yielded a positive result, whereas the HPRT test using somatic mammalian cell sytem, was negative. Both test are performed according to the respective guideline under GLP conditions and are evaluated with Klimisch score 1. Based on the negative data in the mamalian cell assay (HPRT) it can be concluded that mutagenicity of the test item is unlikely.
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