Registration Dossier
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EC number: 203-685-6 | CAS number: 109-59-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The mutagenicity of 2-isopropoxyethanol was examined in a guideline Ames study using Salmonella typhimurium strains, TA98, TA100, TA1535 and TA1537, and in an Escherichia coli strain, WP2uvrA, at concentrations up to 5,000 μg/plate with or without an exogenous metabolic activation system. The substance did not show any mutagenic activity in any bacterial strain with or without metabolic activation.
In a guideline cytogenicity study Chinese Hamster Lung/IU cells were continuously treated with 2-isopropoxyethanol for 24 hours at concentrations of 263, 525 and 1050 μg/ml without metabolic activation. In another assay, the CHL/IU cells were briefly (6 hours) treated with 2 -isopropoxyethanol in the presence or absence of metabolic activation system at concentrations of 263, 525 and 1050 μg/ml. No increase in clastogenicity (structural chromosome aberration) or polyploidy was observed in either study.
There are no studies available on the mammalian cell gene mutation potential of isopropoxyethanol. Studies are available on two structurally similar substances: In an in vitro mammalian cell gene mutation assay, chinese hamster ovary cells (CHO-K1-BH4-D1) were exposed to 2 -butoxyethanol, a close analogue of isopropoxyethanol, up to concentrations of 1% (v/v), with or without an S-9 metabolic activating system from Arochlor 1254 induced rat liver. Doses were selected based on low cytotoxicity to CHO cells in a preliminary study. No treatment-related effects were seen, either in the presence or absence of a metabolic activating system. This result can be considered representative of the mutagenic properties of isopropoxyethanol. In a reliable guideline mammalian cell gene mutation study using mouse lymphoma 5178Y cells, ethylene glycol n-propoxy ether was negative when tested up to the limit dose concentration when tested with and without metabolic activation. In a gene mutation study, null responses were obtained at the gpt locus in CHO-AS52 cells exposed to either 2 -butoxyethanol at concentrations up to 0.9 mg/ml or its metabolite butoxyacetaldehyde at concentrations up to 0.065 % (v/v), the highest doses which did not cause cytotoxicity at a sufficient level to prohibit its evaluation for mutagenicity.
Short description of key information:
Bacterial mutation: negative
Cytotoxicity: negative
Mammalian cell gene mutation: negative, based on structural analogues.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The substance has no mutagenic properties and classification is therefore not warranted.
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