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Key value for chemical safety assessment

Additional information

In a key in vitro genetic toxicity study the mutagenicity of n-hexane was examined (Dunnick, 1991; Klimisch score =1). Four strains of S. typhimurium were exposed to concentrations of test substance up to 1,000 ug/plate both with and without metabolic activation. The test substance was negative for mutagenicity both in the presence and absence of metabolic activation.

In another key in vitro genetic toxicity study the mutagenicity of n-hexane to mouse lymphoma cells was examined (Draus, 1982; Klimisch score =2). Mouse lymphoma L5178Y cells were exposed to concentrations of up to 500 ug/plate of test substance both with and without metabolic activation. A two-fold or greater increase in the number of mutations as compared to negative controls was seen at two treatment concentrations in the absence of metabolic activation. No significant increase in the number of mutations was seen in the presence of metabolic activation. Concentrations of test substance of 350 ug/plate or more were cytotoxic. The test substance is considered a weak mutagen in the absence of metabolic activation.

In a third key in vitro genetic toxicity study the mutagenicity of the test substance C6 aliphatics, high n-hexane to mouse lymphoma cells was determined (API, 1981; Klimisch score =1) . Mouse lymphoma L5178Y cells were exposed to concentrations of up to 200 µ g/plate of test substance both with and without metabolic activation. Under the conditions of this study, the test substance was not considered mutagenic with or without activation.

In a key in vivo genetic toxicity study the effect of inhalation exposure of n-hexane in a dominant lethal mutagenic assay was examined (API, 1980; Klimisch score =1). Groups of 3 male mice were exposed to 0, 100 and 400 ppm of test substance vapor for 6 hrs/day for 5 days for eight weeks. The test substance did not induce dominant lethal mutations in mice at the two tested dose levles. The sensitivity of the assay was confirmed by the significant induction of dominant lethal mutations in the positive control treated with TEM.


Short description of key information:
Three in vitro genetic toxicity (Dunnick, 1991; Klimisch score =1, Draus, 1982; Klimisch score =2 and API, 1981; Klimisch score =1) and one genetic toxicity in vivo study (API, 1980; Klimisch score =1) were identified for n-hexane.

The test substance was not mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

n-Hexane is not classified for genetic toxicity.