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Key value for chemical safety assessment

Additional information

The bacterial reverse mutation assay / Ames test (Thompson_2008) performed according to OCED 471 was rated with RL=1 (reliable without restrictions) and used as a key study. The study had a negative result. The results indicate that SymMollient® S under the experimental conditions described (concentration range in the main test: experiment I: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate and experiment II: 50, 150, 500, 150 and 5000 µg/plate), is not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA 102 in the presence and absence of a metabolizing system.

The mammalian cell gene mutation assay (Hall_2010) performed according to OECD 476 was rated with RL=1 (reliable without restrictions) and used as a key study. The study had a negative result. The results indicate that SymMollient® S under the experimental conditions described did not induce mutation at the hprt locus in Chinese hamster lung fibroblasts (V79). These conditions included treatments up to a maximum concentration of ca. 10 mM (3915.0 µg/mL) in two independent experiments in the absence and presence of a rat liver metabolic activation system (S9 mix).

The in-vitro mammalian chromosome aberration test (Bohnenberger_2010) performed according to OCED 473 was rated with RL=1 (reliable without restrictions) and used as a key study. The study had a negative result. The test item SymMollient® S did not induce structural chromosomal aberrations in human lymphocytes. Therefore, SymMollient® S is considered to be non-clastogenic in the chromosome aberration test when tested up to the highest concentration of 10 mM (3915.0 µg/mL) with and without metabolic activation (S9 mix).


Short description of key information:
In-vitro studies:
Bacterial reverse mutation assay / Ames test (OECD 471) - k_Thompson_2008: negative
Mammalian cell gene mutation assay (OECD 476) - k_Hall_2010: negative
Mammalian chromosome aberration test (OECD 473) - k_Bohnenberger_2010: negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All available reliable studies showed no genetic toxicity for SymMollient® S. Thus, no classification is required for the time being according to Regulation 1272/2008 and subsequent regulations.