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Key value for chemical safety assessment

Additional information

In a bacterial reverse mutation (Ames) assay using the S. typhimurium strains TA 1535, TA 1537, TA1538, TA 98 and TA 100 plus the E coli strain WP2 uvrA, no mutagenic activity was observed either with our without metabolic activation up to the maximum tested dose of 10mg/plate.

Brake Fluid DOT 4, a mixture primarily of borated and unborated triethylene glycol methyl ether, was tested for potential to cause chromosomal aberrations (CA) in cultured Chinese hamster ovary cells (CHO), at concentrations up to 5000 micrograms/mL, in the presence or absence of S9 mix. No treatment-related increase in incidence of chromosomal aberrations was observed with the test substance. Positive controls benzo(a)pyrene, and methylmethanesulfonate showed significantly increased CA formation.

In a GLP and guideline (TSCA) CHO / HGPRT gene mutation assay, TGME tested at concentrations up to 5000 ug/ml did not produce evidence of mutation with or without exogenous metabolic activation by rat liver S-9.

In a guideline and GLP study in vivo study, TGME did not increase the frequency of micronucleated polychromatic erythrocytes in the bone marrow of mice treated by a single gavage dose up to 5000 mg/kg/day. The percentage of PCEs in bone marrow was also not reduced by TGME treatment.


Short description of key information:
Ames studies: 4 negative studies available
Cytogenicity study: 1 negative study available
In vitro mammalian cell gene mutation study: 1 negative study available
In vivo cytogenicity (mouse micronucleus) study: negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

There is no indication of mutagenic potential. Classification is not required.