Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The Ames test (King_2003) performed according to OCED 471 was rated with RL=1 (reliable without restrictions) and used as a key study. The results indicate that the test substance under the experimental conditions described, is not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA 102 in the presence and absence of a metabolising system.

The in-vitro mammalian chromosome aberration test (Kunz_2006) performed according to OCED 473 was rated with RL=1 (reliable without restrictions) and used as a key study. The test item did not induce structural chromosomal aberrations. Therefore, SymWhite 377 is considered to be non-clastogenic in the chromosome aberration test when tested up to the highest evaluable or cytotoxic concentrations.

The in-vitro mammalian cell gene mutation assay (Wollny_2008) performed according to OCED 476 was rated with RL=1 (reliable without restrictions) and used as a key study. The test item did not induce mutations in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence and presence of metabolic activation. Therefore, SymWhite 377 is considered to be non-mutagenic in this mouse lymphoma assay.


Short description of key information:
In-vitro studies:
Ames test (OECD 471) - K_King_2003: negative
Chromosome aberration test (OECD 473) - K_Kunz_2006: negative
Mammalian cell gene mutation assay (OECD 476) - K_Wollny_2008: negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All available reliable studies showed no genetic toxicity for SymWhite 377. Thus, no classification is required according to Regulation 1272/2008 and subsequent regulations.