1. Read-across approaches: current applications and regulatory acceptance in Korea, Japan, and China.
- Author
-
Lee, Byung-Mu, Lee, Sang Hee, Yamada, Takashi, Park, Sanghee, Wang, Ying, Kim, Kyu-Bong, and Kwon, Seok
- Subjects
- *
GOVERNMENT agencies , *RECORDING & registration - Abstract
The aim of this paper was to investigate the current status of read-across approaches in the Republic of Korea, Japan, and China in terms of applications and regulatory acceptance. In the Republic of Korea, over the last 6 years, approximately 8% of safety data records used for chemical registrations were based upon read-across, and a guideline published on the use of read-across results in 2017. In Japan, read-across is generally accepted for screening hazard classification of toxicological endpoints according to the Chemical Substances Control Law (CSCL). In China, read-across data, along with data from other animal alternatives are accepted as a data source for chemical registrations, but could be only considered when testing is not technically feasible. At present, read-across is not widely used for chemical registrations and regulatory acceptance of read-across may differ among countries in Asia. With consideration of the advantages and limitations of read-across, it is expected that read-across may soon gradually be employed in Asian countries. Thus, regulatory agencies need to prepare for this progression. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF