Derivation of permitted daily exposure value for trifluoroacetic acid as an impurity in pharmaceutical products

Author:

Sanada Hisakazu1,Kikuno Tsukasa2,Kitamura Kimiyoshi2,Hashimoto Kiyohiro3,Mishima Masayuki1

Affiliation:

1. Translational Research Division, Chugai Pharmaceutical Co., Ltd.

2. Pharmaceutical Impurities Safety Assessment Research Institute (PhiAS), Co., Ltd.

3. Drug Safety Research Laboratory, Takeda Pharmaceutical Co., Ltd.

Publisher

Japanese Society of Toxicology

Subject

General Medicine

Reference11 articles.

1. Airaksinen, M.M. and Tammisto, T. (1968): Toxic actions of the metabolites of halothane: LD50 and some metabolic effects of trifluoroethanol and trifluoroacetic acid in mice and guinea pigs. Ann. Med. exp. Fenn., 46, 242-248.

2. Byun, J.Y., et al. (2013): Occupational airborne contact dermatitis caused by trifluoroacetic acid in an organic chemistry laboratory. Contact Dermatitis, 70, 63-64.

3. ECHA (European Chemical Agency) C&L Inventory. (Accessed on August 2023) Summary of Classification and Labelling. Available from https://echa.europa.eu/information-on-chemicals/cl-inventory-database/-/discli/details/47316

4. GESTIS Substance Database (Accessed on August 2023) Trifluoroacetic acid solution. Available from https://gestis-database.dguv.de/data?name=530088

5. GHS Classification Results by Ministries and Agencies Concerned. (Accessed on August 2023) Ministry of Health, Labour and Welfare/Ministry of the Environment, 2011 GHS Classification Result, Trifluoroacetic acid. https://www.nite.go.jp/chem/ghs/11-mhlw-0142.html

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