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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 re‐evaluated triethanolamine [102‐71‐6], considering all toxicological endpoints. Available publications and unpublished study reports are described in detail. After single application, triethanolamine was not found to have any relevant irritation potential for the skin or mucous membranes. The systemic toxicity of triethanolamine via all routes of exposure is low. A 28‐day inhalation study in rats with aerosol exposure revealed a LOAEC of 20 mg/m3 for inflammation of the larynx, the most sensitive toxicological end point. A benchmark calculation for focal laryngeal inflammation yielded a BMDL of 14.8 mg/m3 for male rats and 14.1 mg/m3 for female rats and the maximum concentration at the work place (MAK value) is set at 5 mg/m3 which also provides protection from systemic effects caused by triethanolamine. Since the critical effect is local, Peak Limitation Category I is designated, with an excursion factor of 4 because the effects on the larynx were observed only after prolonged exposure to 20 mg/m3 and triethanolamine had, if at all, a very low acute irritative potency. There are no conclusive studies on developmental toxicity available. Triethanolamine is therefore classified in Pregnancy Risk Group D. Triethanolamine is not genotoxic in vitro or in vivo; there is no evidence of germ cell mutagenicity. Oral and dermal studies in rats and mice yielded no evidence of a carcinogenic potential. Skin contact is not expected to contribute significantly to systemic toxicity. The sensitizing potency of triethanolamine is only very slight. Triethanolamine has therefore not been designated with “Sh” or “Sa” (for substances which cause sensitization of the skin or airways).
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