DL-hexane-1,2-diol

Endpoint summary

Additional information

in vitro

1,2-Hexanediol was found negative for inducing gene mutations in three in vitro studies (Ames tests according to OECD 471, Mammalian Chromosome Aberration test according to OECD 473 and Mammalian Cells Gene Mutation test according to OECD 476), all conducted in the presence and absence of metabolic activation. The Ames test studied five mutant strains of Salmonella typhimurium (TA1535, TA1537, TA 1538, TA98, and TA100) with and without liver homogenate (S9) as well as E. coli WP2 and E. coli WP2 uvr A pKM101 with and without liver homogenate (S9) in test concentrations up to 5000 µg per plate. No increase in revertant colony numbers of any of the tester strains was observed following treatment with 1,2-hexanediol at any dose level, neither in the presence nor absence of metabolic activation (S9 mix).

In conclusion, this result indicates that test article was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA 1538, TA98, and TA100 or to E. coli WP2 (pKM101) in the absence and presence of a metabolic system.

 

The second in vitro study was performed to evaluate the potential to induce structural chromosomal aberrations in Chinese Hamster Ovary (CHO) cells in the absence and the presence of metabolic activation according to OECD guideline 473. The test article was applied up to 1180 µg/mL. In the assay 1,2-hexanediol was found not to induce structural chromosome aberrations in the absence or presence of microsomal activation in Chinese Hamster Ovary cells. Therefore, the test article was shown to be non-clastogenic in this chromosomal aberration mutagenicity test when tested up to maximum concentrations.

 

The third in vitro study was performed to investigate the potential of 1,2-hexanediol to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster according to OECD guideline 476.The test article was applied up to 1182 µg/ml in the pre-test and in the two main tests (maximum concentration of 10 µM. No substantial and reproducible dose dependent increase of the mutation frequency was observed in either of the main experiments. Thus, the test item did not induce gene mutation effects at the HPRT locus in V79 cells.

In vivo

As all available in vitro tests were negative, in vivo data are not required.

Justification for selection of genetic toxicity endpoint
All three available key in vitro tests contribute to the final assessment for the substance being considered negative inducing gene mutations.

Short description of key information:
Based on the available data, 1,2-hexanediol was found negative inducing gene mutagenicity under the experimental conditions of four in vitro tests .

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

1,2-Hexanediol does not have to be classified for mutagenicity according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) because it did not reveal any mutagenic effect in the bacterial reverse mutation assay in the presence or absence of metabolic activation, in the mammalian cell gene (HPRT) mutation test in V79 cells or in an in vitro chromosomal aberration test.