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Standard to be satisfied by test facilities, etc. conducting toxicity investigation

Chapter 1 General Provisions (Article 1 - Article 2)

In Japanese

(Application)

Article 1 This notification shall apply to test facilities, etc. in which mutagenicity studies or carcinogenicity studies are carried out in the toxicity investigations as provided by Paragraph 1, Article 57-3 of Industrial Safety and Health Law (Law No. 57, 1972, hereinafter called the "Law").

Of the toxicity investigations as provided by Paragraph 1, Article 57-3 of the Law, the standard to be satisfied by test facilities, etc. in which studies other than mutagenicity studies or carcinogenicity studies are carried out shall conform to the provisions as set forth by Director-General, Labour Standards Bureau, Ministry of Health, Labour, and Welfare.

(Definition)

Article 2 As used in this notification, the following terms shall be defined as set forth in the relevant items.

"Study sponsor, etc." means a person who entrusts test facilities, etc. with a study to be performed (hereinafter simply called the "study") or a person who submits the study results to Minister of Health, Labour, and Welfare.

"Master schedule sheet" means a document that states for all tests conducted in the test facilities, etc. throughout the year, the test system, kind of studies, date when the study begins, state of study progress , name of the study director, and state of final report preparation , for each of the test substances, etc.

"Test system" means a system of measurement apparatus for physical and chemical data and systems of microorganisms, cultured cells, and animals used in the study.

"Specimens" mean those collected from the test system for examination or analysis.

"Raw data" mean original observation results, etc. such as worksheets, laboratory notes, memoranda, recording charts, magnetic tapes obtained with respect to the study and those necessary for reconstruction and evaluation of the study concerned.

"Test substance" means a chemical substance submitted for the study.

"Control substance" means a chemical substance used for investigating the standard conditions of the test system.