Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

 Genetic toxicity was assessed in an Ames test, which was conducted in compliance with OECD guideline 471 (BASF, 1992). Bacteria strains Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 were treated with pentane-1,2-diol at concentrations of 20, 100, 500, 2500, 5000 ug/plate with and without metabolic activation by a Aroclor 1254 pretreated rat liver S9 mix. As result, no mutagenic activity was observed.

The same result was found in another study, which was also conducted according to OECD guideline 471 (Grötsch, 1992). Thereby, Salmonella typhimurium strains

TA1535, TA1537, TA1538, TA98 and TA100 were tested with and without metabolic activation by a S9-homogenate. Since a significant toxicity of the test compound was detected at 200 µl/l/plate in a first trial, concentrations of 0.24 - 150 µl/plate were tested in the second trial.


In addition a mammalian cell gene mutation assay was conducted under GLP in compliance with OECD guideline 476 (RCC CCR, 2008). Mouse lymphoma L5178Y cells (TK+/-) were treated with 65, 131, 261, 522, 1044 µg/mL 1,2 pentandiol. The dose range was up to 10 mM (1040 µg/ml). No substantial and reproducible dose dependent increase of the mutation frequency was observed in the main experiments with and without metabolic activation. Positive and negative controls gave the expected results.

An in vitro mammalian chromosome aberration test was conducted under GLP according to OECD guideline 473 and EU method B.10 (RCC CCR, 2008). The human lyphocytes were treated with 340, 594, and 1040 µg/ml 1,2 pantane diol for 4 hours with and without metabolic activation by rat liver S9 mix. The dose range was up to 10 mM (1040 µg/ml). In a second experiment cells were incubated for 22 or 46 h without metabolic activation. In both experiments, in the absence and presence of S9 mix, no biologically relevant increase in the number of cells carrying structural chromosome aberrations was observed. The aberration rates of the cells after treatment with the test item were close to the range of the solvent control values (0.5 – 2.0 % aberrant cells, excluding gaps) and within the range of laboratory´s historical control data: 0.0 - 4.0 % aberrant cells, excluding gaps. Negative and positive controls gave the expected results and were valid.

Short description of key information:
1,2 pentanediol is non mutagenic in the Ames test (OECD 471) and the mouse lymphoma test (L5178Y TK +/-; OECD476). No clastogenicity was found in a chromosomal aberration test (OECD 473).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

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