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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 2‐phenoxyethanol [122‐99‐6], considering all toxicity endpoints. Available publications and study reports are described in detail. In a 14‐day inhalation study with rats, critical effects of 2‐phenoxyethanol were hyperplasia, degeneration and metaplasia of the respiratory epithelium in the nasal cavity beginning at 246 mg/m3. The NOAEC was 48.2 mg/m3 (8.4 ml/m3). Since 2014, the Commission uses an empirical approach to set maximum concentrations at the workplace (MAK values) for substances with critical effects on the upper respiratory tract or the eyes. Based on this approach, a MAK value of 1 ml/m3 has been derived. The assignment to Peak Limitation Category I, because local effects are critical, and the excursion factor of 2 have been confirmed. No developmental toxicity was detected in rats (oral) or rabbits (dermal) up to doses of 1000 or 600 mg/kg body weight and day, resp. In an oral two‐generation study in mice, the NOAEL for foetotoxicity was about 400 mg/kg body weight and day. The differences between the NOAEL for rats, mice and rabbits scaled to an inhalation concentration at the workplace and the MAK value are considered so large that damage to the embryo or foetus is unlikely when the MAK value is observed. Therefore, classification in Pregnancy Risk Group C is confirmed. 2‐Phenoxyethanol is not regarded to be genotoxic or carcinogenic. Sensitization is not expected based on results of animal studies and experience in humans. Skin contact is not expected to contribute significantly to the systemic toxicity.
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