Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The mutagenic/genotoxic potential of 2,2,4-trimethyl-1,3-pentanediol has been characterized in well-conducted in vitro bacterial (AMES) and mammalian cell (mouse lymphoma) mutagenicity assays and an in vitro chromosomal aberration assay. All 3 studies were conducted according to current OECD Guidelines and are considered to be key studies.

In a bacterial reverse gene mutation assay conducted according to OECD Guideline 471, there was no increase in cytotoxicity or mutation frequency in any strain of Salmonella typhimurium or Escherichia coli at concentrations up to 5000 µg/plate in the presence or absence of metabolic activation. 

In a mammalian mutagenicity assay conducted according to OECD Guideline 476 using an L5178Y mouse lymphoma cell line, there were no increases in the mutation frequency at the thymidine kinase locus, either with or without metaboic activation.

In an in vitro chromosome aberration assay conducted according to OECD Guideline 472, there was no increase in chromosome aberrations or polyploidy in Chinese Hamster Ovary cells tested at concentrations up to 1500 µg/mL in the presence and absence of metabolic activation, even at concentrations that caused cytotoxicity. In all studies, vehicle, negative and positive controls induced the appropriate responses.

Endpoint Conclusion:

Justification for classification or non-classification

Although no in vitro or in vivo germ cell mutagenicity/genotoxicity studies were available for review, the total weight-of-the-evidence from 3 independent in vitro studies indicates that 2,2,4-trimethyl-1,3-pentanediol is not expected to induce heritable mutations in the germ cells of humans and is not classified for mutagenicity/genotoxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). 2,2,4-Trimethyl-1,3-pentanediol is not classified for mutagenicity/genotoxicity according to Annex I of Directive 67/548/EEC.