2‐Chlorethanol

MAK-Begründung, Nachtrag

  Andrea Hartwig¹ (Vorsitz der Ständigen Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Deutsche Forschungsgemeinschaft)
  MAK Commission<sup>2

1</sup> Institut für Angewandte Biowissenschaften, Abteilung Lebensmittelchemie und Toxikologie, Karlsruher Institut für Technologie (KIT), Adenauerring 20a, Geb. 50.41, 76131 Karlsruhe, Deutschland
² Ständige Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Deutsche Forschungsgemeinschaft, Kennedyallee 40, 53175 Bonn, Deutschland

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated 2‐chloroethanol [107‐07‐3], considering all toxicological endpoints. Available publications are described in detail. The critical effect is high systemic toxicity with a steep dose‐response relationship. The NOAELs are 45, 15, and 45 mg/kg body weight and day in rats, dogs, and monkeys, respectively, after oral administration, and 100 and about 200 mg/kg body weight and day in rats and mice, respectively, after dermal administration. Taking both oral and dermal studies in animals into consideration, a MAK value of 2 ml/m³ is derived, which also protects from irritation. As the critical effect is systemic, Peak Limitation Category II is confirmed. The excursion factor of 1 is retained because of the steep dose‐response relationship. The NOAELs for developmental toxicity are 50 and 227 mg/kg body weight and day for mice after gavage or drinking water administration, respectively, and 60 and 36 mg/kg body weight and day for mice and rabbits, respectively, after intravenous administration. The margins between the calculated concentrations at the workplace without effects and the MAK value are sufficiently high. Therefore, damage to the embryo or foetus is unlikely when the MAK value is not exceeded and the classification of 2‐chloroethanol in Pregnancy Risk Group C is retained. 2‐Chloroethanol is not regarded as genotoxic in vivo. The substance was not carcinogenic in dermal carcinogenicity studies in mice and rats. The substance is not a contact sensitizer in humans and mice. The low dermal LD₅₀ values, the estimated dermal absorption of 25% and the reports of poisoning incidents at the workplace after dermal exposure point to a significant contribution of skin contact to systemic toxicity. Therefore, the designation with an “H” is retained.

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