Read-across approaches: current applications and regulatory acceptance in Korea, Japan, and China

J Toxicol Environ Health A. 2022 Mar 4;85(5):184-197. doi: 10.1080/15287394.2021.1992323. Epub 2021 Oct 20.

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.

Keywords: Read-across; alternative approaches; computational toxicology; regulatory acceptance; toxicity prediction.

MeSH terms

  • Chemical Safety
  • China
  • Hazardous Substances / toxicity*
  • Japan
  • Republic of Korea
  • Risk Assessment / methods*
  • Toxicology / legislation & jurisprudence
  • Toxicology / methods*

Substances

  • Hazardous Substances