Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Justification for selection of genetic toxicity endpoint
Justification for use of the results obtained with the read-across source substance WS405777 for classification of WS406663 is provided in the “Validity Assessment Report for the read-across approach” attached in IUCLID Section 13.

Short description of key information:
Three in vitro tests were performed with the read-across source substance WS405777:

AMES TEST: (according to OECD 471):
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100, and E. coli WP2 uvrA (pKM101) , all negative without and with metabolic activation.

IN VITRO MAMMALIAN CHROMOSOME ABERRATION TEST (according to OECD 473):
exposure of human lymphocytes for 3 hours and 20 hours without or 3h with metabolic activation:
- all tested concentrations negative.

IN VITRO MAMMALIAN CELL GENE MUTATION TEST: (according to OECD 476):
3 hours exposure without and with metabolic activation and 24 hours exposure without metabolic activation: all negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the negative results attained in the three in vitro genotoxicity tests the read-across source substance WS405777 is considered not to be genotoxic and does not warrant any classification regarding mutagenicity according to European classification rules [REGULATION (EC) 1272/2008].

The same conclusion of non-classification for mutagenicity can be drawn for the read-across target substance WS406663 based on the close chemical similarity between the two substances (see IUCLID Section 13 „Validity Assessment Report“ for the read-across approach).