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Key value for chemical safety assessment

Additional information

In vitro studies:

Tert-butylamine was tested for mutagenicity using the Salmonella/microsome preincubation assay using the standard protocol approved by the National Toxicology Program. Tert-butylamine was tested at doses of 0, 33, 100, 333, 1000, 1666 and 3333 ug/plate in 4 Salmonella typhimurium strains (TA1535, TA1537, TA98, and TA100) in the presence and absence of rat or hamster liver S-9. Tert-butylamine was negative in these tests and the highest ineffective dose tested in any Salmonella typhimurium strain was 1000 mg/plate (Zeiger et al. 1987; Val. 2). A further study (TA1538, TA1537, TA1535, TA98, and TA100) validated these negative results in the Ames test (Monsanto 1977; Val. 4).


In vivo studies:

No in vivo studies available

Short description of key information:
In vitro studies:
Ames-Test: negative (NTP standard protocol )

In vivo studies: No in vivo studies available

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Two Ames-tests, with or without metabolic activation through S9 -mix failed to provide any evidence for a mutagenic effect of tert-butylamine.