Press Release
January 24, 2025
- Health & Chemicals
Adoption of OECD Test Method for Endocrine Disrupting Effects to Invertebrates (Japan's Contribution to the Development of International Standard Test Methods)
1. Short-term Juvenile Hormone Activity Screening Assay using Daphnia magna (JHASA), developed in the program of the Ministry of the Environment (MOE) Japan on endocrine disrupting effects of chemical substances (currently "EXTEND2022"), and then discussed as a Japan-led project at the OECD, was adopted as an international standard test method: OECD Test Guideline No. 253.
2. In Japan, the National Institute for Environmental Studies (NIES) serves as center of excellence in the development of methods for testing and assessment of biological effects of chemical substances. The institute has developed JHASA and led studies at the OECD.
3. In order to evaluate endocrine disrupting effects of chemical substances on organisms in the environment, MOE Japan will continue testing and assessment under EXTEND2022 while utilizing these test methods. At the same time, the development of unfinished test methods and contribution to the establishment of standard test methods by the OECD will be promoted.
* Link to published OECD Test Method
https://www.oecd.org/en/publications/2024/06/test-no-253-short-term-juvenile-hormone-jh-activity-screening-assay-in-daphnia-magna_f857f4ce.html
2. In Japan, the National Institute for Environmental Studies (NIES) serves as center of excellence in the development of methods for testing and assessment of biological effects of chemical substances. The institute has developed JHASA and led studies at the OECD.
3. In order to evaluate endocrine disrupting effects of chemical substances on organisms in the environment, MOE Japan will continue testing and assessment under EXTEND2022 while utilizing these test methods. At the same time, the development of unfinished test methods and contribution to the establishment of standard test methods by the OECD will be promoted.
* Link to published OECD Test Method
https://www.oecd.org/en/publications/2024/06/test-no-253-short-term-juvenile-hormone-jh-activity-screening-assay-in-daphnia-magna_f857f4ce.html
1. Background to the development of test methods
(Ministry of the Environment's programs leading up to EXTEND2022)
In order to understand the effects of endocrine disruption of chemical substances on the environment, the program of the Ministry of the Environment (MOE) Japan (currently "Further Actions on Endocrine Disrupting Effects of Chemical Substances - EXTEND2022 -") has established the test system utilizing internationally standardized test methods, under which testing and assessment are being conducted. In addition, Japan has been taking the lead in developing and revising test methods in this field at the OECD, by developing unestablished methods in the program of MOE Japan and proposing them to the OECD as new projects.
(OECD Test Guidelines)
The OECD Test Guidelines are internationally agreed test methods for use in assessing the safety of chemicals and their mixtures. The test data obtained in accordance with these methods can be accepted in other countries if the conditions are met (mutual acceptance of data (MAD) for chemical safety), accordingly they are regarded as international standard test methods.
In addition, the OECD has been developing Guidance Documents on test methods that are not premised on MAD but have been agreed upon by member countries.
In addition, the OECD has been developing Guidance Documents on test methods that are not premised on MAD but have been agreed upon by member countries.
(Contribution of the National Institute for Environmental Studies)
In Japan, the National Institute for Environmental Studies (NIES) plays a central role in the development of testing and assessment methods for the biological effects of chemical substances and has been responsible for development of many of the test methods for endocrine disruption under the MOE’s programs.
2. Details of the formulation of the test method
○ Short-term Juvenile Hormone Activity Screening Assay using Daphnia magna (JHASA) (OECD Test Guideline No. 253）
While Annex 7 of Daphnia magna Reproduction Test (OECD Test Guideline No. 211) for detecting substances with juvenile hormone activity is assigned as a "Tier 2 in vivo test" in EXTEND2022, appropriate Tier 1 in vivo assay for screening this activity has not been established.
Scientists at NIES have developed a screening test method to be used as a Tier 1 in vivo assay for juvenile hormone activity of chemical substances under this program. This was accepted as a Japan-led project under the OECD Test Guidelines Programme in 2016 and international validation studies were conducted under the leadership of the institute. The Test Guidelines and its validation report were adopted at the OECD meeting in April 2024 and released thereafter.
Scientists at NIES have developed a screening test method to be used as a Tier 1 in vivo assay for juvenile hormone activity of chemical substances under this program. This was accepted as a Japan-led project under the OECD Test Guidelines Programme in 2016 and international validation studies were conducted under the leadership of the institute. The Test Guidelines and its validation report were adopted at the OECD meeting in April 2024 and released thereafter.
3. Next Actions
Short-term Juvenile Hormone Activity Screening Assay using Daphnia magna (JHASA) is assigned as one of the "Tier 1 in vivo assay" in EXTEND2022, and we will consider conducting tests for substances with potential juvenile hormone activities.
Efforts to develop the test methods required under the EXTEND2022 framework will be continued with the cooperation of NIES, aiming at adoption at the OECD. These efforts will contribute to the establishment of standard test methods by the OECD.
Efforts to develop the test methods required under the EXTEND2022 framework will be continued with the cooperation of NIES, aiming at adoption at the OECD. These efforts will contribute to the establishment of standard test methods by the OECD.
4. Related Links
(1) Published OECD Test Method and Validation Report
Test Guideline No. 253: Short-term Juvenile Hormone Activity Screening Assay using Daphnia magna (JHASA)
https://www.oecd.org/en/publications/2024/06/test-no-253-short-term-juvenile-hormone-jh-activity-screening-assay-in-daphnia-magna_f857f4ce.html
Series on Testing and Assessment No. 395: Validation of the Short-term Juvenile Hormone Activity Screening Assay using Daphnia magna (JHASA).
https://www.oecd.org/en/publications/validation-of-the-short-term-juvenile-hormone-activity-screening-assay-using-daphnia-magna-jhasa_7b633310-en.html
https://www.oecd.org/en/publications/2024/06/test-no-253-short-term-juvenile-hormone-jh-activity-screening-assay-in-daphnia-magna_f857f4ce.html
Series on Testing and Assessment No. 395: Validation of the Short-term Juvenile Hormone Activity Screening Assay using Daphnia magna (JHASA).
https://www.oecd.org/en/publications/validation-of-the-short-term-juvenile-hormone-activity-screening-assay-using-daphnia-magna-jhasa_7b633310-en.html
(2) Overview of OECD Test Methods [in Japanese]
(3) Press release from the National Institute for Environmental Studies [in Japanese]
Contact
Chemical Safety Division, Environmental Health Department, Ministry’s Secretariat, Ministry of the Environment
- Representative number
- +81-(0)3-3581-3351
- Direct number
- +81-(0)3-5521-8261
- Senior Assistant for Chemical Safety Policy Planning
- HASEGAWA Takahiro
- Deputy Director
- YAMAZAKI Kunihiko