Registration Dossier
Registration Dossier
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EC number: 609-765-0 | CAS number: 39987-85-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The mutagenic potential of the test substance ZK 9340 (M-DOC) was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in the presence and absence of S9 mix according to OECD TG 471 (Reimann and Görke, 1996a). Evidence of mutagenic activity was not seen up to the maximum recommended dose level of 5000 µg/plate. No substantial increases in revertant colony numbers of any of the five tester strains were observed at any dose level in the presence and absence of metabolic activation. Therefore, the test substance was considered to be non-mutagenic in the Salmonella typhimurium reverse mutation assay.
In addition, the mutagenic potential of the test substance ZK 9340 (M-DOC) was evaluated in the modified Ames test (preincubation method) with the S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in the presence and absence of S9 mix according to OECD TG 471(Reimann and Görke, 1996b).Evidence of mutagenic activity was not seen up to the maximum recommended dose level of 5000 µg/plate. No substantial increases in revertant colony numbers of any of the five tester strains were observed at any dose level in the presence and absence of metabolic activation. Therefore, the test substance was considered to be non-mutagenic in the Ames Salmonella/microsome test using the preincubation modification, when tested up to cytotoxic and precipitating dose levels.
Under consideration of the molecular structure similarity of M-DOC and M-DOCA the results on genetic toxicity in vitro of M-DOC has been accepted for M-DOCA (read-across approach).
Justification for selection of genetic toxicity endpoint
No study was selected, since both Ames tests with ZK 9340 (M-DOC) were negativ.
Short description of key information:
Gene mutation (bacterial reverse mutation assay / Ames test): negative with and without metabolic activation [Reimann and Görke 1996a+b]
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required.
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