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Administrative data

Key value for chemical safety assessment

Additional information

There is no mutagenicity data available on the substance 2 -butoxyethyl acetate. In view of the rapid hydrolysis of this substance to the parent glycol ether 2 -butoxyethanol under physiological conditions, the mutagenic potential of 2 -butoxyethyl acetate in vivo is likely to be similar to that of 2 -butoxyethanol. A summary of the key data for the latter, that are presented as summaries in this chapter, is presented here:

In vitro

Reliable studies indicate that 2 -butoxyethanol (2BE) is not mutagenic in bacteria.

In a reliable in vitro mammalian cell gene mutation assay, chinese hamster ovary cells (CHO-K1-BH4-D1) were exposed to 2 -butoxyethanol 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.

No evidence for chromosomal aberration induction was found in a mammalian cell culture study with 2 -butoxyethanol.

The balance of evidence suggests that mutagenicity is not an important property of 2 -butoxyethanol

In vivo

There is no evidence for micronucleus induction in bone marrow cells or interaction with DNA in several organs of rats. The possibility of non-disjunction occurring and not being detected in these assays appears to be remote, because the main metabolite of 2 -butoxyethanol (2BE), butoxyacetic acid (BAA), produced no evidence of aneugenicity in vitro. BAA is rapidly formed in vivo and is by far the most prevalent blood metabolite of 2BE, so exposure of possible target cells to either 2BE or the intermediate transient metabolite butoxyacetaldehyde at high concentrations is brief.

The clear balance of evidence suggests that 2 -butoxyethanol does not pose a significant mutagenic potential in vivo.


Short description of key information:
Key data for read across substance:

IN VITRO
Bacterial mutagenicity
- negative (with and without metabolic activation.) TA97, TA98, TA100, TA1535, TA1537, WP2uvrA.

Chromosome abberation
- negative (with and without metabolic activation) CHO cells

Gene mutation, mammalian cells
- negative (without metabolic activation) AS52 cells grt locus. (BAL tested separately and negative)

Sister chromatid exchange
- negative (with and without metabolic activation) CHO cells

IN VIVO
Negative (Micronucleus test, F344 rat)
Negative (Micronucleus test, B6C3F1 mouse)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

There is no clear evidence of mutagenicity for the in vivo hydrolysis product of 2 -butoxyethyl acetate, namely 2 -butoxyethanol. In particular, the in vivo data is clearly negative from a number of studies. 2 -butoxyethyl acetate is therefore unlikely to present a biologically relevant genotoxic potential and therefore classification is not warranted.