N-Butyl-1,2-benzisothiazolin-3-one

MAK Value Documentation – Translation of the German version from 2021

  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-butyl-1,2-benzisothiazolin-3-one [4299-07-4] to derive an occupational exposure limit value (maximum concentration at the workplace, MAK value) considering all toxicological end points. The critical effect is the corrosive action of N-butyl-1,2-benzisothiazolin-3-one on the skin of rabbits. This strong irritant effect was also observed in oral repeated dose studies in rats (stomach ulcers) and dogs (vomiting). As a repeated inhalation study is not available, a MAK value cannot be derived. N-Butyl-1,2-benzisothiazolin-3-one did not lead to developmental toxicity in rats up to an oral dose of 300 mg/kg body weight and day; this dose was toxic to the dams (stomach ulcers). Germ cell mutagenicity tests are not available. An in vitro mouse lymphoma test with N-butyl-1,2-benzisothiazolin-3-one was negative. A positive chromosomal aberration test in human lymphocytes was not confirmed in vivo by the results of a mouse micronucleus test. A carcinogenicity study has not been performed with N-butyl-1,2-benzisothiazolin-3-one. Skin contact is not expected to contribute significantly to systemic toxicity. Animal studies on sensitizing effects yielded positive and negative results. As the limited human data show clinically relevant skin sensitization, N-butyl-1,2-benzisothiazolin-3-one is designated with “Sh”. There are no data for sensitizing effects on the respiratory tract.

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