Registration Dossier
Registration Dossier
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EC number: 700-768-3 | CAS number: 1285610-71-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Ames test:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in a GLP compliant reverse mutation assay following OECD guideline 471 on strains Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA (BASF,40M0590/11M221, 2012). In this study, the standard plate test with concentrations of 0.33 μg - 5 500 μg/plate (salmonella strains) and 33 µg – 5500 µg/plate (E. coli) as well as the preincubation test with dose levels of 0.33 μg - 100 μg/plate (Salmonella strains) and 33 μg - 5 500 μg/plate (PIT, E. coli) were conducted, each with and without metabolic activation (liver S9 mix from induced rats). Precipitation of the test substance was found at 5 500 μg/plate with and without S9 mix. A bacteriotoxic effect was observed depending on the strain and test conditions from about 33 μg/plate onward. A biologically relevant increase in the number of his+or trp+revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
Short description of key information:
The substance was not mutagenic in the Ames test in Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537, tested both in the absence and presence of S9 mix (BASF 2012).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the present data, classification for genotoxicity is not warranted under Directive 67/548/EEC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the present data, classification for genotoxicity is not warranted under Regulation (EC) No.1272/2008.
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