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Key value for chemical safety assessment

Additional information

Short description of key information:
Benzyltrimethylammonium chloride was examined in two Ames tests, an in vitro chromosomal aberration study using Chinese Hamster lung fibroblasts (V79), and in vitro CHO/HPRTassay as well as an in vivo chromosomal aberration study, i.e., mouse micronucleus study following dosing of mice for 13 weeks.
Benzyltrimethylammonium chloride was not mutagenic in Salmonella typhimurium strains TA97, TA98, TA100, and TA1535, with or without S9 metabolic activation enzymes. The test material, Benzyltrimethylammonium chloride, did not induce gene mutations in the S. typhimurium TA98, Ta100, TA1535 and TA1537 and E. coli WP2 strains. The ability of benzyltrimethylammoniumchloride to cause chromosome aberrations was examined using Chinese hamster lung cells. This chemical slightly increased incidences of structural chromosomal aberrations with an exogeneous metabolic activation system. Clear reproducibility was obtained the confirmation study. Benzyltrimethylammonium chloride (BTMAC) was negative in the In Vitro Mammalian Cell Forward Gene Mutation (CHO/HPRT) Assay with Duplicate Cultures under the conditions, and according to the criteria, of the test protocol. Significant increases in the frequency of micronucleated normochromatic erythrocytes were found in the peripheral blood of male and female mice administered benzyltrimethylammonium chloride by gavage for 13 weeks

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

Meets critera for classification as Category 2.