TY - JOUR
KW - Acute systemic toxicity
KW - animal alternatives
KW - hazard classification and risk assessment
KW - lethality testing
KW - Regulatory toxicology
AU - Judy Strickland
AU - Esther Haugabrooks
AU - David G. Allen
AU - Luciene B. Balottin
AU - Yoko Hirabayashi
AU - Nicole C. Kleinstreuer
AU - Hajime Kojima
AU - Claudio Nishizawa
AU - Pilar Prieto
AU - Deborah E. Ratzlaff
AU - Jayoung Jeong
AU - JinHee Lee
AU - Ying Yang
AU - Pinpin Lin
AU - Kristie Sullivan
AU - Warren Casey
AB - Chemical regulatory authorities around the world require systemic toxicity data from acute exposures via the oral, dermal, and inhalation routes for human health risk assessment. To identify opportunities for regulatory uses of non-animal replacements for these tests, we reviewed acute systemic toxicity testing requirements for jurisdictions that participate in the International Cooperation on Alternative Test Methods (ICATM): Brazil, Canada, China, the European Union, Japan, South Korea, Taiwan, and the USA. The chemical sectors included in our review of each jurisdiction were cosmetics, consumer products, industrial chemicals, pharmaceuticals, medical devices, and pesticides. We found acute systemic toxicity data were most often required for hazard assessment, classification, and labeling, and to a lesser extent quantitative risk assessment. Where animal methods were required, animal reduction methods were typically recommended. For many jurisdictions and chemical sectors, non-animal alternatives are not accepted, but several jurisdictions provide guidance to support the use of test waivers to reduce animal use for specific applications. An understanding of international regulatory requirements for acute systemic toxicity testing will inform ICATM’s strategy for the development, acceptance, and implementation of non-animal alternatives to assess the health hazards and risks associated with acute toxicity.
BT - Critical Reviews in Toxicology
DA - 2023-08-30
DO - 10.1080/10408444.2023.2240852
IS - 0
N2 - Chemical regulatory authorities around the world require systemic toxicity data from acute exposures via the oral, dermal, and inhalation routes for human health risk assessment. To identify opportunities for regulatory uses of non-animal replacements for these tests, we reviewed acute systemic toxicity testing requirements for jurisdictions that participate in the International Cooperation on Alternative Test Methods (ICATM): Brazil, Canada, China, the European Union, Japan, South Korea, Taiwan, and the USA. The chemical sectors included in our review of each jurisdiction were cosmetics, consumer products, industrial chemicals, pharmaceuticals, medical devices, and pesticides. We found acute systemic toxicity data were most often required for hazard assessment, classification, and labeling, and to a lesser extent quantitative risk assessment. Where animal methods were required, animal reduction methods were typically recommended. For many jurisdictions and chemical sectors, non-animal alternatives are not accepted, but several jurisdictions provide guidance to support the use of test waivers to reduce animal use for specific applications. An understanding of international regulatory requirements for acute systemic toxicity testing will inform ICATM’s strategy for the development, acceptance, and implementation of non-animal alternatives to assess the health hazards and risks associated with acute toxicity.
PY - 2023
SP - 1
EP - 27
T2 - Critical Reviews in Toxicology
TI - International regulatory uses of acute systemic toxicity data and integration of new approach methodologies
UR - https://doi.org/10.1080/10408444.2023.2240852
VL - 0
Y2 - 2023-09-13
SN - 1040-8444
ER -