Health & Chemicals

Information on Ecotoxicity Tests (CSCL-related)

The Good Laboratory Practice (GLP) Compliance Monitoring Programme of Japan for industrial chemicals for Ecotoxicity Tests

Efforts are being made to advance the global harmonization of testing methods and other procedures for evaluating the safety of chemical substances. The OECD has established the “OECD Guidelines for the Testing of Chemicals” to standardize testing methods, and the “OECD Principles of Good Laboratory Practice” to set standards that should be followed by test facilities. Under the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (This act is known as the “Chemical Substances Control Law ; CSCL”), Japanese government has adopted testing methods conforming with the OECD Guidelines for the Testing of Chemicals and has instituted a GLP Compliance Monitoring Programme for industrial chemicals based on the OECD Principles of Good Laboratory Practice.

There are seven categories of ecotoxicity tests subject to compliance confirmation under the GLP Compliance Monitoring Programme for industrial chemicals: 
  • Avian Reproduction Test (TG206)
  • Freshwater Alga and Cyanobacteria, Growth Inhibition Test (TG201)
  • Daphnia sp., Acute Immobilisation Test (TG202)
  • Fish, Acute Toxicity Testing (TG203)
  • Daphnia magna Reproduction Test (TG211)
  • Fish, Early-life Stage Toxicity Test (TG210)
  • Sediment-Water Chironomid Toxicity Test Using Spiked Sediment (TG218)

A list of GLP-related Japanese regulations for industrial chemicals

For details on regulations pertaining to the GLP Compliance Monitoring Programme for industrial chemicals, see the following documents (provisional English translations). 

Application Procedure to Receive GLP Confirmation

For information on the procedures for receiving confirmation of compliance with the GLP, refer to document A-05 above. Test facilities that wish to receive confirmation need to submit an application to the competent Director-General (in the case of ecotoxicity tests, the Director-General of the Environmental Health Department, MOE), and undergo a document review and an on-site inspection as part of the confirmation process. After the initial confirmation, test facilities need to undergo this process once every three years to renew their certificate of compliance.