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Key value for chemical safety assessment

Additional information

Bacterial Reverse Gene Mutation Assay (Ames Test)

Strains TA 98, TA 100, TA 1535 and TA 1537 of Salmonella typhimurium and WP2 uvrA of Escherichia coli were exposed to Zorgol 8 (100 %, a.k.a. 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues) in ethanol at concentrations of 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate (pre-experiment/experiment I) and 1, 3, 10, 33, 100, 333, 1000 and 2500 µg/plate (experiment II) in the presence and absence of mammalian metabolic activation (co-incubation). Zorgol 8 was tested up to cytotoxic concentrations of 5000 µg/plate. The positive controls induced the appropriate responses in all strains included in the test. There was no evidence of induced mutant colonies over background.

Mammalian Cell Gene Mutation Test (HPRT Assay)

CHO KI Chinese hamster ovary cells were exposed to 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues (≥98 %) in DMSO (1 % v/v) for 5 hours at concentrations ranging from 6.25 to 500 µg/mL with mammalian metabolic activation (S9 mix), for 5 hours at concentrations ranging from 2.5 to 100 µg/mL without S9 mix and for 24 hours at concentrations ranging from 1.25 to 100 µg/mL without S9 mix. 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues was tested up to cytotoxic concentrations covering a range from the maximum to little or no toxicity. The positive controls induced the appropriate response in this assay. There was no evidence of induced mutant colonies over background.

Mammalian Chromosome Aberration Test (CA Assay)

V79 cell cultures were exposed to 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues in 1 % DMSO at (i) 0.76, 2.29, 6.86, 20.58, and 61.73 µg/mL (without S9 mix), 2.29, 6.86, 20.58, 61.73 and 185.18 µg/mL (with S9 mix) with 3 hours treatment and 20 hours harvest and at (ii) 0.25, 0.76, 6.86 and 20.58 µg/mL (without S9 mix) with 20 hours treatment and 28 hours harvest as well as at (iii) 2.29, 6.86, 20.58, 61.73 and 185.18 µg/mL (with S9 mix) with 3 hours treatment and 28 hours harvest. The results of a pretest on cytotoxicity were used as basis for dose level selection. v was tested up to cytotoxic concentrations covering a range from the maximum to little or no toxicity with and without metabolic activation. Positive controls induced the appropriate responses. Aneulpoidy was not observed. There was no evidence of chromosome aberration induced over background.


Short description of key information:
1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues showed no genotoxic effects in vitro in the bacterial reverse mutation assay (Ames test), the mammalian cell gene mutation test (HPRT assay) and the mammalian chromosome aberration test (CA assay) and is therefore considered to have no mutagenic potential.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on negative findings in three different guideline compliant in vitro genotoxicity assays, 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. Residues is not subject to classification and labelling as mutagenic according to Directive 67/548/EEC and Regulation 1272/2008/EC.