Registration Dossier
Registration Dossier
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EC number: 617-745-8 | CAS number: 856976-65-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The test item was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. The strains tested were TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA in a dose range of 16.72 - 4180 µg/plate (SPT) and 3.344 µg - 2 090 µg/plate (PIT) under Standard plate test (SPT) and under preincubation test conditions (PIT). The test was conducted with and without metabolic activation. Precipitation of the test substance was found from about 500 µg/plate onward. A weak bacteriotoxic effect was observed under all test conditions. An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system. According to the results of the present study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions.
Justification for selection of genetic toxicity endpoint
GLP study according to guidelines.
Short description of key information:
The test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. Based on the result of the Ames-Test the substance is not considered to be classified under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the result of the Ames-Test the substance is not considered to be classified under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation No 605/2014.
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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