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Toxicological information

Carcinogenicity

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Description of key information

Based on results of the analogue n-butyl acrylate, isobutyl acrylate is not anticipated to be carcinogenic in rats via inhalation at doses up to 135 ppm (0.773 mg/L/day) and in mice by dermal exposure at approx. 8 mg/kg bw.

Key value for chemical safety assessment

Additional information

No adequate animal data are available and no epidemiological studies or case reports investigating the carcinogenicity of isobutyl acrylate were identified. However, data from the structural analogue n-butyl acrylate are available.

In a 2-year inhalation study, Sprague-Dawley rats were exposed by whole body exposure 6 hours per day, 5 days a week to 0, 15, 45 or 135 ppm (corresponding to approx. 0, 0.086, 0.258, 0.773 mg/L/day) n-butyl acrylate. During the first 13 weeks of the study, the concentrations were lower: 0, 5, 15 or 45 ppm. The post observation period was 6 months. Results of the clinical, clinico-chemical, haematological, ophthalmological, gross pathological and histopathological examinations are described in section7.5, Repeated dose toxicity. n-Butyl acrylate showed no carcinogenic effect up to the highest concentration tested of 135 ppm (0.773 mg/L/day) (BASF AG 1985).

In addition, a lifetime dermal carcinogenesis study was conducted in mice (BASF AG 1982). The dermal carcinogenic potential of n-butyl acrylate was assessed by applying 25 µL of a 1% (v/v) dilution in acetone (corresponding to approx. 8 mg/kg bw) to the backs of 40 male C3H/HeJ mice. A negative control group receiving acetone was dosed simultaneously. Both applications were performed three times a week throughout the lifetime of the animals. No biologically significant skin tumours were observed in the group tested with acetone or in the n-butyl acrylate group. No signs of skin irritation were observed in this study. No significant difference in mortality rate was observed between the treated group and the acetone control group. n-Butyl acrylate was not carcinogenic when applied to the skin of C3H/HeJ mice throughout their lifetime.

IARC-Evaluation: n-Butyl acrylate is not classifiable as to its carcinogenicity to humans (Group 3).

Conclusion

Based on results of the analogue n-butyl acrylate, isobutyl acrylate is not anticipated to be carcinogenic in rats via inhalation at doses up to 135 ppm (0.773 mg/L/day) and in mice by dermal exposure at approx. 8 mg/kg bw.

Justification for classification or non-classification

EU classification according to Annex VI of Directive 67/548/EEC: no classification required

GHS classification (GHS UN rev.3, 2009): no classification required