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Key value for chemical safety assessment

Additional information

Genetic toxicity in vitro was analyzed in a study which was performed according to OECD guideline 471 (BASF, 1988). Bacteria S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 were treated with 20, 100, 500, 2500 and 5000 µg/plate 1,6-hexandediol with and without metabolic activation by a Aroclor 1254 pretreated rat liver S9 mix. As result, 1,6-hexandediol did not show mutagenic toxicity in this study using the two methods, preincubation and plate incorporation.

In another study, a mammalian cell gene mutation assay with Chinese hamster V79 cells was conducted under GLP in compliance

with OECD guideline 476 and EPA OPPTS 870.5300 (BASF, 1993). The cells were treated with 0.5, 1, 2.5 and 5 mg/ml

1,6-hexanediol for 4 and 24 hours in two trials with and without metabolic activation by Aroclor 1254 induced rat liver S9 mix.

After six to seven days in a selection culture containing thioguanine, cells were prepared and more than 50 cells were used for

evaluation of mutations in the HGPRT (hypoxanthine-guanine phosphoribosyl transferase) gene. As result, no gene mutations at the

HGPRT locus in V79 cells were reported in this mutagenicity assay and under the experimental conditions.

In addition, an in vitro mammalian chromosome aberration test could be taken into account for assessment since it was conducted

under GLP according to OECD guideline 473 and EU method B.10 (BASF, 1993). Chinese hamster V79 cells were treated with

doses of 0.3, 0.6 and 1.2 µg/ml 1,6-hexanediol with and without metabolic activation for four hours. After an expression time of 18 or 28 hours, the cells were fixed and a minimum of 100 cells were analyzed for chromosomal aberrations. As result, 1,6-Hexandiol

was found neither to be a chromosome-damaging (clastogenic) agent nor to have any aneugenic activity under in vitro conditions using V79 cells.

Short description of key information:
1,6-Hexanediol is non mutagenic in all in vitro mutagenicity tests conducted so far (OECD 471, 473, 476).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Due to the negative results in different in vitro guideline studies, no classification as mutagenic is necessary.