Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

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 and 21 hours exposure without metabolic activation, and 3 hours exposure with metabolic activation (at 2% and 5% S9 fraction in final medium): all tested concentrations negative.

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
In the Ames test relevant cytotoxicity was not evident when testing up to 5000 µg/plate. In the in vitro chromsome aberration test and the in vitro mouse lymphoma cell gene mutation test, cytotoxicity was evident.

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 WS400123 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].