Abstract
The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated the maximum concentration at the workplace (MAK value) of tert‐butyl acetate, considering all toxicity endpoints. Available unpublished study reports and publications are described in detail. The critical effects of tert‐butyl acetate are irritation and systemic effects on the liver and kidneys, in addition neurotoxic effects in rats and mice. The subchronic NOAEC in mice is 100 ml/m3 based on transient acute neurotoxic symptoms which can be used to calculate a MAK value of 50 ml/m3. This value also provides protection from irritation. As the critical effect is systemic, Peak Limitation Category II is assigned. The default excursion factor of 2 is set as no half‐life in blood is known, and it is not clear whether the clinical effects were caused by the substance itself or a metabolite. Damage to the embryo and foetus is unlikely if the MAK value for tert‐butyl acetate is observed taking into consideration the data for the metabolite tert‐butyl alcohol. Therefore tert‐butyl acetate has been classified in Pregnancy Risk Group C. Skin contact is not expected to contribute significantly to systemic toxicity. tert‐Butyl acetate is not genotoxic and carcinogenicity data are missing. Sensitization is not expected from the limited data.
Hartwig, A