Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

An Ames mutagenicity test was conducted in Salmonella strains TA 1535, TA 1537, TA 98 and TA 100 on the glycol ethers heavies substance at plate incorporation levels up to 5000 µg/plate. The test material was negative either with or without metabolic activation. A mammalian cell gene mutation assay with TPM in Chinese hamster ovary cells at concentrations up to 2063 µg/mL was negative either with or without metabolic activation. An in vitro test with DPM for chromosomal aberrations in rat liver (RL4) cells up to concentrations of 5000 µg/mL was negative either with or without metabolic activation.

Methanol, the degradation product of sodium methanolate, is generally negative in mutagenicity assays. It was negative when tested in a mammalian cell mutagenicity assay with Chinese hamster V79 cells at concentrations up to 63.3 mg/mL. It was also negative in an in vitro assay for chromosomal aberrations in Chinese hamster V79 cells at a concentration of 50 µL/mL. An in vivo mouse micronucleus assay with methanol was negative in male mice dosed by gavage up to 8410 mg/kg bw.


Short description of key information:
An in vitro Ames mutagenicity test performed with the glycol ethers heavies substance, and read-across studies on the dipropylene glycol monomethyl and tripropylene monomethyl ethers and methanol are available. In addition, an in vivo mouse micronucleus test with methanol is also available. All studies on the material and its read-across surrogates indicate the substance is non-mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the lack of genotoxic potential for the glycol ethers heavies mixture, it would not be rated as a mutagen under either the EU DSD classification system (EU Directive 67/548/EEC) or the EU CLP classification system (EU Regulation 1272/2008).