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www.ChineseStandard.net Database: 189760 (18 Oct 2025)

GB/T 21750-2025 English PDF

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GB/T 21750-2025: Chemicals - Test method of toxicokinetics studies
Status: Valid

GB/T 21750: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB/T 21750-2025	English	359	Add to Cart	4 days [Need to translate]	Chemicals - Test method of toxicokinetics studies	Valid	GB/T 21750-2025
GB/T 21750-2008	English	134	Add to Cart	3 days [Need to translate]	Chemicals -- Test method of toxicokinetic studies	Valid	GB/T 21750-2008

Basic data

Standard ID	GB/T 21750-2025 (GB/T21750-2025)
Description (Translated English)	Chemicals - Test method of toxicokinetics studies
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	A80
Classification of International Standard	13.300
Word Count Estimation	18,188
Date of Issue	2025-08-29
Date of Implementation	2025-12-01
Older Standard (superseded by this standard)	GB/T 21750-2008
Issuing agency(ies)	State Administration for Market Regulation, National Standardization Administration

GB/T 21750-2025: Chemicals - Test method of toxicokinetics studies

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT21750-2025
ICS 13.300 CCSA80 National Standard of the People's Republic of China Replaces GB/T 21750-2008 Toxicokinetic test methods for chemicals Released on August 29, 2025 Implementation on December 1, 2025 State Administration for Market Regulation The National Standardization Administration issued

Preface

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document replaces GB/T 21750-2008 "Toxicokinetic Test Methods for Chemicals" and is consistent with GB/T 21750-2008. In addition to structural adjustments and editorial changes, the main technical changes are as follows. a) Added “Abbreviations” (see Chapter 4); b) The content of “Basic Principles of Testing” has been modified (see Chapter 5, Chapter 4 of the.2008 edition); c) The content of "Test Methods" has been changed (see Chapter 6, Chapter 5 of the.2008 edition), and the content of "Preliminary Tests" and "Experimental Animals" has been added. Content (see 6.1, 6.2); d) Added “Clinical Observation” content (see 6.4); e) Added the content of “Supplementary methods” (see 6.5); f) The content of “Test Data and Report” has been modified (see Chapter 7, Chapter 6 of the.2008 edition). Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed and coordinated by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251). This document was drafted by. Institute of Occupational Health and Poison Control, Chinese Center for Disease Control and Prevention, Capital Medical University, Liaoning Provincial Center for Disease Control and Prevention Control Center. The main drafters of this document are. Li Bin, Chen Xiao, Niu Piye, Xiao Jingwei, Zhang Yi, Bian Hongying, Li Xiaoran, Hong Xiujuan, and Ning Lili. The previous versions of this document and the documents it replaces are as follows. ---First published in.2008 as GB/T 21750-2008; ---This is the first revision.

introduction

Toxicokinetic (TK) studies of chemical substances are aimed at obtaining a comprehensive understanding of their absorption, distribution, biotransformation (i.e. metabolism) and excretion. To provide information to help relate the concentration or dose to the observed toxicity and to help understand the mechanism of toxicity. Animals are exposed systemically to a test substance and reveal which molecules are circulating (parent substance/metabolites) to aid understanding of toxicology studies. The essential TK parameters determined from these studies will also provide information on the potential accumulation of the test substance in tissues and/or organs and the potential for the test substance to accumulate in the tissues and/or organs as a result of exposure to the test substance. information on the potential of substances to induce biotransformation. TK data assist in assessing the adequacy and relevance of animal toxicity data for extrapolation to human hazard and/or risk assessment. In addition, toxicokinetic studies can be used to determine the dose level (linear and nonlinear kinetics), the effect of the toxicity pathway, the bioavailability, and the Some types of TK data can be used to assess physiologically based toxicokinetics. Development of the (PBTK) model. Important uses of metabolite/TK data include indicating possible toxicity and mode of action and their relationship to dose level and route of exposure. In addition, metabolic data can provide information that helps to assess the toxicological significance of exposure to exogenous metabolites of the test substance. Adequate toxicokinetic data will help support further acceptance and application of quantitative structure-activity relationships, analogies, or grouping approaches. Application in Material Safety Assessment. Kinetic data can also be used to assess the toxicological relevance of other studies (e.g., in vivo/in vitro). Unless otherwise specified, this document is primarily applicable to oral exposure routes. Toxicokinetic test methods for chemicals

1 Scope

This document establishes the basic principles of chemical toxicokinetic testing, describes the test methods, and specifies the test data and reporting requirements. Announcement content. This document applies to toxicokinetic studies of chemicals.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB 14925 Laboratory Animal Environment and Facilities

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Toxicokinetics The science of studying the absorption, distribution, metabolism and excretion of a test substance in the body over time. 3.2 Atrioventricular compartment A structure or biochemical unit of an organism, tissue, or cell that is separate from other parts. 3.3 absorption The process by which the test substance or its metabolites enter the body or tissues. 3.4 distribution The process of transporting the test substance that enters the systemic circulation to the body's distributable fluids, tissues, and organs. 3.5 metabolism The process (usually enzymatic) by which a test substance is chemically converted into a different chemical substance in the body. Note. Metabolism is also called biotransformation. 3.6 excretion The process of transporting the test substance and (or) metabolites out of the body. 3.7 half-life t1/2

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