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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‐tert‐octylphenol to derive a maximum concentration at the workplace (MAK value), considering all toxicity endpoints with the exception of developmental toxicity. Available unpublished study reports and publications are described in detail. 4‐tert‐Octylphenol is an endocrine‐active substance that might impair fertility. Despite appropriate investigations, no such effects and no influence on fertility were seen in a two‐generation feeding study in rats after doses of up to 250 mg/kg bw. In this study and in a 90‐day study, the most sensitive effect is delayed body weight development with NOAEL and LOAEL of 15 and 20 mg/kg bw and day, respectively. In a Draize test, 4‐tert‐octylphenol is a severe eye irritant. Because there are no inhalation studies investigating possibly irritating effects on the airways, bisphenol A, which is also a strong eye irritant, is used as a read‐across and a MAK value of 0.5 ml 4‐tert‐octylphenol/m3 (4 mg/m3) is thus established. The dose taken up at this concentration is clearly below the equipotent dose for 4‐tert‐octylphenol calculated from the human LOAEL for ethinylestradiol and 17β‐estradiol. Since the critical effect of 4‐tert‐octylphenol is local, Peak Limitation Category I is assigned. In analogy to bisphenol A, an excursion factor of 1 has been set. The substance is not genotoxic. Skin contact is not expected to lead to systemic toxicity or contact sensitization.
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