Read-across approaches: current applications and regulatory acceptance in Korea, Japan, and China. Issue 5 (4th March 2022)

• Record Type: Journal Article
• Authors: Lee, Byung-Mu; Lee, Sang Hee; Yamada, Takashi; Park, Sanghee; Wang, Ying; Kim, Kyu-Bong; Kwon, Seok
• Is Part Of: Journal of toxicology and environmental health. Volume 85:Issue 5(2022)
• Page Start: 184
• Page End: 197
• Publication Date: 2022-03-04
• Subjects: Read-across -- toxicity prediction -- alternative approaches -- computational toxicology -- regulatory acceptance; Toxicology -- Periodicals; Environmental health -- Periodicals; 615.90205
• DOI: 10.1080/15287394.2021.1992323
• Languages: English
• ISSNs: 1528-7394

Abstract

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.