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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The in vitro Ames test, the in vitro chromosome aberration test in Chinese hamster lung fibroblasts (CHL/IU cells) 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 probably 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):
6 hours and 24 hours exposure without metabolic activation, and 6 hours exposure with metabolic activation (at 5% S9 fraction in final culture 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 and in the in vitro mouse lymphoma cell gene mutation test, relevant cytotoxicity was not evident when testing up to precipitating concentrations or the highest concentration with acceptably low fluctuation in osmolality. In the in vitro chromosome aberration test, cytotoxicity was evident, but confined to the top dose of 5000 µg/mL and therefore toxicologically not relevant.

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 ADK STAB FP-800 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].