Registration Dossier
Registration Dossier
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EC number: 604-269-0 | CAS number: 14205-46-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The mutagenic potential of the test item 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.No evidence of mutagenic activity was seen in the treated cultures with and without S9 -mix. Thus, the test item can be considered as non- mutagenic in the Ames Test.
In a bone marrow micronucleus test performed according to OECD TG 474, 3 ml/kg bw test substance was given per gavage to 5 males and 5 female mice per group. The animals were sacrificed 24, 48, and 72 hours after treatment. General toxicity and bone marrow toxicity became obvious. No indication of a clastogenic effect of the test item was found under the conditions of this test.
Short description of key information:
Gene mutation in vitro (bacterial reverse mutation assay, GLP): negative in the Salmonella typhimurium strains TA 1535, TA 1537, TA 100 and TA 98 with and without S9 mix
In vivo bone marrow micronucleus assay in mice: negative
Chromosome aberration in vitro (Chinese hamster V79 cells, GLP, OECD TG 473, EU Method B.10, OPPTS 870.5375): negative with and without S9 mix
[Bayer AG, Report No. PH-34432, 2006-04-27]
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 and Regulation (EC) No. 1272/2008 (CLP) is not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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