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NAMs and acute systemic toxicity


The paper:

International Regulatory Uses of Acute Systemic Toxicity Data and Integration of New Approach Methodologies.


Critical Reviews in Toxicology 2023, 0 (0), 1–27. https://doi.org/10.1080/10408444.2023.2240852.


The paper discusses the global regulatory requirements for assessing the systemic toxicity of chemicals through various exposure routes (oral, dermal, and inhalation) for human health risk assessment. It focuses on the efforts of the International Cooperation on Alternative Test Methods (ICATM) to identify opportunities for using non-animal replacements for these tests.


In our training you will find detailed descriptions of the in silico approaches available for acute systemic toxicity and how to use them in a regulatory context.


The study covers several countries participating in ICATM, including Brazil, Canada, China, the European Union, Japan, South Korea, Taiwan, and the USA. The review includes various chemical sectors such as cosmetics, consumer products, industrial chemicals, pharmaceuticals, medical devices, and pesticides.


The primary findings are that most jurisdictions require acute systemic toxicity data mainly for hazard assessment, classification, labelling purposes, and occasionally for quantitative risk assessment. In cases where animal testing methods are necessary, efforts to reduce animal use are recommended. However, non-animal alternatives are not widely accepted in many jurisdictions and chemical sectors. Some jurisdictions do offer guidance on test waivers to minimize animal testing for specific applications. This international understanding of regulatory requirements for acute systemic toxicity testing is vital for ICATM's efforts to develop, gain acceptance, and implement non-animal alternatives for assessing health hazards and risks related to acute toxicity.

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