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Key value for chemical safety assessment

Additional information

In vitro Studies

Ames test :

n-heptanol-1 was negative for mutagenicity in a standard bacterial mutagenicity test with and without metabolic activation (Haddouk, 2000). This study followed OECD test guideline 471. Five strains of bacteriaSalmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to five dose-levels of the test item (three plates/dose level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored. N- heptanol did not induce mutagenicity in Salmonella bacterial strains with or without metabolic activation.The positive controls responded as expected. 

Mouse Lymphoma assay

n-heptanol-1 was negative in a in vivo mammalian cells (mouse lymphoma assay) (Sarlang, 2011). The test was performed under OECD 476 guideline. Under the experimental conditions of this study, the test item, n-heptanol, did not show any mutagenic activity in the mouse lymphoma assay, in the presence or absence of a rat metabolizing system.

Mammalian Chromosome Aberration test

n-Heptanol-1 was negative in a in vitro mammalian chromosome aberration test (Griffon, 2000). The study was performed according to OECD 473 guideline. The test substance n-heptanol was tested in two independent experiments, both with and without a metabolic activation system, the S9 mix, prepared from a liver microsomal fraction (S9 fraction) of rats induced with Aroclor 1254.

No significant increase in the frequency of cells with structural chromosomal aberrations was noted at both harvest times, with and without S9 mix. Under these experimental conditions, the test substance, n-heptanol (batch No. 9803005; purity 99.85%) does not induce chromosome aberrations in cultured human lymphocytes.

Short description of key information:
n-heptanol-1 was found to be negative in the in vitro gene mutations assays on bacteria (Ames test) and mammalian cells (mouse lymphoma assay and chromosome aberration test), both in the presence and absence of metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

None of the available test results in vitro showed that substance treatment induced mutagenic effects. The susbtance should not be classified for genotoxicity according to EU Directive 67/584/EEC and EU regulation (EC) No 1272/2008 (CLP).