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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Genetic toxicity of 1,5-pentanediol in vitro was analyzed in a study performed according to OECD guideline 471 and EU method B.13/14 (BASF, 1992). Bacteria S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 were treated with concentrations of 20, 100, 500, 2500 and 5000 ug/plate with and without metabolic activation by Aroclor 1254 pretreated rat liver S9 mix. With both used methods, the plate incorporation and the preincubation methods, no genetic toxicity was found.


 


The substance 1,5-Pentanediol was assessed for its potential to induce gene mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus in Chinese hamster ovary (CHO) cells in vitro.  The negative controls gave mutant frequencies within the range expected for the CHO cell line. Both positive control substances, ethyl methanesulfonate (EMS) and 7,12-dimethylbenz[a]-anthracene (DMBA), led to the expected statistically significant increase in the frequencies of forward mutations. In this study, in all experiments in the absence and the presence of metabolic activation no relevant cytotoxicity (relative survival below 20%) was observed up to the highest applied test substance concentration. The test substance did not cause any biologically relevant increase in the mutant frequencies both without S9 mix and after the addition of a metabolizing system in all experiments performed independently of each other. Thus, the test substance 1,5-Pentanediol is not mutagenic in the HPRT locus assay under in vitro conditions in CHO cells in the absence and the presence of metabolic activation.


 


According to the results an in vitro micronucleus assay, the test substance 1,5-Pentanediol did not lead to a increase in the number of micronucleated cells either without S9 mix or after the addition of a metabolizing system in two experiments performed independently of each other. The frequencies of micronuclei after test substance treatment were within the range of the concurrent negative control values at both exposure times and within the range of the 95% control limit of our historical negative control data. The increase in the frequencies of micronuclei induced by the positive control substances MMC, Colchicine and CPA clearly demonstrated the sensitivity of the test system and/or the metabolic activity of the S9 mix employed. The values were compatible the range of the historical positive control data and, thus, fulfilled the acceptance criteria of this study.

Justification for classification or non-classification

Due to the negative results in several studies performed according to OECD guideline, no classification is required with respect to genetic toxicity according to Regulation 1272/2008 (CLP).