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Acute Inhalation Toxicity - Technical Guidelines for Acute Toxic Class (ATC) Method (Draft for Comments)
Local Title:
急性吸入毒性试验-急性毒性分类法技术指导原则(征求意见稿)
Country/Region:
Chinese Mainland
Competent Authority:
National Institutes for Food and Drug Control
Type:
Regulation
Status:
Draft
Release Date:
2023-02-23
Implementation Date:
/
Document
Language Source Title Access
ZH
Official Acute Inhalation Toxicity - Technical Guidelines for Acute Toxic Class (ATC) Method (Draft for Comments)
ZH
Official Drafting Instruction for Acute Inhalation Toxicity - Technical Guidelines for Acute Toxic Class (ATC) Method (Draft for Comments)
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Acute Inhalation Toxicity - Technical Guidelines for Acute Toxic Class (ATC) Method (Draft for Comments)
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Summary

On February 23, 2023, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation on six technical guidelines for in vitro testing, determination for sun protection factor (SPF) and waterproof performance, as well as acute inhalation toxicity testing. This Guidelines is one of the six technical guidelines.

The method in this Guidelines is applicable to the toxicity classification, research and safety assessment of cosmetic ingredients (ingredients with a single component and a clear structure) that may have inhalation exposure risks. It does not apply to poorly soluble isomers, fibers, nanomaterials, etc.

The main contents of the Guidelines include the formulation background, legal basis, applicable scope, basic principles, preparation and quality control of the test substance, experimental animals selection, exposure conditions control, test groups setting, observation and detection indicators, principles for judging results, references, terminology explanations and an appendix. The appendix introduces a specific test method that can be referred to.

Notes: ATC Method is to use a small number of animals to participate a step-by-step acute inhalation toxicity test on a series of test substances with fixed concentration, so as to provide information on the inhalation toxicity characteristics of the test substance, and determine the acute inhalation toxicity of the substances and their classification.