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1000
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Abstract/Summary
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The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has evaluated 4‐methyl‐1,3‐dioxolan‐2‐one [108‐32‐7; 51260‐39‐0; 16606‐55‐6] considering all toxicological endpoints. Available publications and unpublished study reports are described in detail. The critical effect of 4‐methyl‐1,3‐dioxolan‐2‐one is eye irritation. Rats did not show systemic effects in a 13‐week inhalation study with whole‐body exposure to aerosols of 4‐methyl‐1,3‐dioxolan‐2‐one up to the highest concentration tested of 1000 mg/m3. At 100 mg/m3, swollen periocular tissue is observed in male animals. This finding is substantiated by the results of the acute eye irritation studies. Due to the weak effects, a NAEC of 50 mg/m3 (12 ml/m3) is extrapolated. At this concentration, the substance can occur as a vapour; the maximum concentration at the workplace (MAK value) is therefore set in ml/m3. By applying the usual extrapolation steps, a MAK value of 2 ml/m3 is derived. Since the critical effect of 4‐methyl‐1,3‐dioxolan‐2‐one is local, Peak Limitation Category I is designated. An excursion factor of 1 is set as the critical effect concentration is twice as high as the extrapolated NAEC. There is an adequate margin between the NOAEC for developmental toxicity and the MAK value. Therefore, damage to the embryo or foetus is unlikely when the MAK value is not exceeded and 4‐methyl‐1,3‐dioxolan‐2‐one is assigned to Pregnancy Risk Group C. 4‐Methyl‐1,3‐dioxolan‐2‐one is not genotoxic and the local tumour incidence was not increased in a chronic dermal study in male mice. Skin contact is not expected to contribute significantly to systemic toxicity. Limited data show no sensitization.
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