Isopropyl acetate

Endpoint summary

Additional information

Isopropyl acetate was not mutagenic in a standard Ames assay (TA97, TA98, TA 100, TA 1535 and TA 1537) when tested to a maximum concentration of 10 mg/plate in the presence and absence of metabolic activation (Zeiger, et al., 1992). Zimmermann et al (1989) reported that isopropyl acetate was a weak inducer of chomosomal malsegregation in Saccharomyces cerevesiae, and potentiated this effect when administered in combination with a potent inducer, propionitrile. Similar results have been reported in this assay for many aprotic polar solvents. The relevance of these findings to human health are not understood.

The frequency of chromosome aberrations was evaluated in Chinese Hamster Ovary cells exposed to ethyl acetate (a substance very similar to isopropyl acetate) at concentrations up to 1500 ug/ml in a well reported study that was similar to guideline. Results were negative with and without metabolic activation up to the highest dose tested of 15mg/ml.

An in vivo mouse micronucleus test was conducted with the in vivo hydrolysis product, isopropanol, by intraperitoneal injection (Kapp, et al., 1993). Isopropyl alcohol was injected once to male and female ICR mice (17 per sex per dose) at doses up to 2,500 mg/kg bw body weight. The incidence of mortality was 0, 0, and 15 % among animals treated with isopropyl alcohol at doses of 350, 1173, and 2500 mg/kg bw. Bone marrow cells were collected from treated mice (5/sex/dose) at 24, 48, and 72 hours after treatment. Isopropyl alcohol did not produce an increase in the incidence of micronuclei at any dose level. There was no effect on the P/N ratio in among mice treated with isopropyl alcohol.

Isopropanol was not mutagenic in the Chinese Hamster Ovary HGPRT locus gene mutation assay in vitro (with and without energy-supplmented S-9 mix) at sub-cytotoxic concentrations up to 5.0 mg/ml.

The evidence from data generated on isopropyl acetate itself, close structural analogues such as ethyl acetate and on the rapidly produced in vivo metabolite isopropanol indicate that isopropyl acetate is very unlikely to exhibit genotoxic or mutagenic properties.

Short description of key information:
Isopropyl acetate is not mutagenic in the Ames assay. Like many aprotic polar solvents, isopropyl acetate has been reported to be a weak inducer of chromosomal malsegregation in Saccharomyces cerevesiae. The relevance of this finding to human health assessment is unclear.

The in vivo hydrolysis product, isopropanol, was negative in an in vivo mouse micronucleus study.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available experimental data, no classification is appropriate.