Polyethylenglykole (PEG) (mittlere Molmasse 200–600) [MAK Value Documentation in German language, 2019]

Abstract

Abstract The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re-evaluated polyethylene glycols (PEGs) (average molar mass 200?600) [25322-68-3] considering all toxicological endpoints. In 13-week studies in rats, the NOAEC for aerosols of PEG 200 and PEG 400 was the highest concentration tested of 1000 mg/m3. Taking into account the increased respiratory volume at the workplace (see List of MAK and BAT Values, Sections I b and I c), the extrapolation of data in animals to humans and the preferred value approach, the maximum concentration at the workplace (MAK value) has now been lowered to 200 mg/m3 for the inhalable fraction. PEG 300 is composed of PEG 200 and PEG 400. PEG 600 is composed of 50% PEG 400. Therefore, the MAK value also applies to PEG 300 and PEG 600. In a chronic study at 2000 mg PEG 400/kg body weight and day, the body weight gain in rats was diminished. Therefore, the critical effect of PEGs is expected to be systemic and PEGs are classified in Peak Limitation Category II. As the half-life is between 2 and 4 hours, the excursion factor of 2 is confirmed. Because formation of a mist is possible, exposure should be minimized for reasons of occupational safety and hygiene. Several studies in rats, mice and rabbits with PEG 200 and PEG 400 show that the margins between the NOAECs for developmental toxicity scaled to a concentration at the workplace and the MAK value of 200 mg/m3 are sufficient. Therefore, damage to the embryo or foetus is unlikely when the MAK value is not exceeded and PEGs remain classified in Pregnancy Risk Group C. PEGs are not genotoxic and are not suspected to be carcinogenic. According to skin absorption models, PEGs are not taken up via the skin in toxicologically relevant amounts. A large number of studies in humans show that PEGs are not skin sensitizers, however, it cannot be excluded that autoxidation products of PEG might induce a low number of positive reactions. There are no data on respiratory sensitization.