Registration Dossier
Registration Dossier
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EC number: 604-612-4 | CAS number: 147900-93-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The in vitro Ames test, the in vitro chromosome aberration test in human lymphocytes and the in vitro mutation test with mouse lymphoma L5178Y cells were chosen as key studies for genetic toxicity, as they represent different aspects of genetic toxicity.
Short description of key information:
IN VITRO AMES TEST: (according to OECD 471 of 1997):
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100, and E. coli WP2 uvr A, all negative without and with metabolic activation.
IN VITRO MAMMALIAN CHROMOSOME ABERRATION TEST (according to OECD 473 of 1997):
3 hours or 21 hours exposure without metabolic activation:
- all tested concentrations negative.
3 hours exposure with metabolic activation (at 2% S9 fraction in final medium):
- At the intermediate test concentrations of WS400151 an increase in chromosome aberrations or in polyploidy was observed, which was biologically not significant All other test concentrations and assays with metabolic activation (at 2% or 5% S9 fraction) were negative regarding chromosome aberrations and regarding polyploidy.
IN VITRO MAMMALIAN CELL GENE MUTATION TEST: (according to OECD 476 of 1997):
3 hours exposure without and with metabolic activation and 24 hours exposure without metabolic activation: all negative.
CYTOTOXICITY
Relevant cytotoxicity was evident in the Ames test in all tested strains (except S. typhimurium TA 100) without and/or with metabolic activation, and in the in vitro mouse lymphoma cell gene mutation and chromsome aberration tests in all experiments both without and with metabolic activation.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the negative results attained in all in vitro genotoxicity studies WS400151 is considered not to be genotoxic and does not warrant any classification regarding mutagenicity according to European classification rules [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008].
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