Derivation of the permitted daily exposure value for p-tert-butylphenol as an impurity in pharmaceutical products

Author:

Ohnishi Yasuyuki1,Sanada Hisakazu2,Mishima Masayuki2,Hashimoto Kiyohiro3

Affiliation:

1. Discovery Research Laboratory, Nippon Chemiphar Co., Ltd.

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

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

Publisher

Japanese Society of Toxicology

Subject

General Medicine

Reference15 articles.

1. EU Risk Assessment Report (2008): European Union Risk Assessment Report, P-tert-Butylphenol (CAS No. 98-54-4, EINCS No. 202-679-0), European Comminutes.

2. Freitag, D., Geyer, H., Kraus, A., Viswanathan, R., Kotzias, D., Attar, A., Klein, W. and Korte, F. (1982): Ecotoxicological profile analysis. VII. Screening chemicals for their environmental behavior by comparative evaluation. Ecotoxicol. Environ. Saf., 6, 60-81.

3. Gellin, G.A., Maibach, H.I., Misiaszek, M.H. and Ring, M. (1979): Detection of environmental depigmenting substances. Contact Dermatitis, 5, 201-213.

4. Hirose, M., Fukushima, S., Kurata, Y., Tsuda, H., Tatematsu, M. and Ito, N. (1988): Modification of N-methyl-N'-nitro-N-nitrosoguanidine-induced forestomach and glandular stomach carcinogenesis by phenolic antioxidants in rats. Cancer Res., 48, 5310-5315.

5. IARC. (2003): IARC Working Group on Predictive Value of Rodent Forestomach and Gastric Neuroendocrine Tumors in Evaluating Carcinogenic Risks to Humans, 2003 Lyon World Health Organization, International Agency on Research for Cancer, IARC Technical Publication No. 39.

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