N-(2-Hydroxyethyl)piperidine

MAK Value Documentation – Translation of the German version from 2022

  Andrea Hartwig¹ (Chair of the Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Deutsche Forschungsgemeinschaft)
  MAK Commission<sup>2

1</sup> Institute of Applied Biosciences, Department of Food Chemistry and Toxicology, Karlsruhe Institute of Technology (KIT), Adenauerring 20a, Building 50.41, 76131 Karlsruhe, Germany
² Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Deutsche Forschungsgemeinschaft, Kennedyallee 40, 53175 Bonn, Germany

Abstract

The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) summarized and evaluated the data for N-(2-hydroxyethyl)piperidine [3040-44-6] to derive an occupational exposure limit value (maximum concentration at the workplace, MAK value), considering all toxicological end points. Relevant studies were identified from a literature search and also unpublished study reports were used. There are no data for human exposure and no inhalation studies in animals. N-(2-Hydroxyethyl)piperidine is a strong skin irritant and is therefore suspected of causing irritation in the upper respiratory tract when inhaled. A 9-week gavage study in female rats carried out according to OECD Test Guideline 422 established a NOAEL for N-(2-hydroxyethyl)piperidine of 75 mg/kg body weight and day, which corresponds to a concentration in workplace air of 23 mg/m³. This value seems excessive because of the severe irritation induced by N-(2-hydroxyethyl)piperidine. Therefore, an analogy is drawn between this substance and 2-diethylaminoethanol, another tertiary amine with similar chemical properties. A maximum concentration at the workplace (MAK value) of 2 ml/m³ was derived for 2-diethylaminoethanol on the basis of the NOAEC of 11 ml/m³ established in a 13-week inhalation study in rats. By analogy, the MAK value for N-(2-hydroxyethyl)piperidine has been set at 2 ml/m³. As the critical effect is local, the substance has been assigned to Peak Limitation Category I. As there are no data in humans, an excursion factor of 1 has been set and, in analogy to other aliphatic amines with the same MAK value, a momentary value of 5 ml/m³. The only available developmental toxicity study is a screening study in rats carried out according to OECD Test Guideline 422. Therefore, N-(2-hydroxyethyl)piperidine has been assigned to Pregnancy Risk Group D. There are no studies on carcinogenicity and on genotoxicity in vivo. N-(2-Hydroxyethyl)piperidine is not genotoxic in vitro and the structural properties indicate no potential hazard. According to skin absorption models, N-(2-hydroxyethyl)piperidine is not expected to be taken up via the skin in toxicologically relevant amounts. Animal studies and in vitro tests show a skin sensitizing potential for N-(2-hydroxyethyl)piperidine, which is therefore designated with “Sh”. There are no data for respiratory tract sensitization.

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