GB/T 21788: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 21788-2025 | English | RFQ |
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Chemicals - Test method of bacterial reverse mutation
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GB/T 21788-2025
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| GB/T 21788-2008 | English | 229 |
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Chemicals -- Test method of combined chronic toxicity/carcinogenicity study
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GB/T 21788-2008
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Basic data | Standard ID | GB/T 21788-2025 (GB/T21788-2025) | | Description (Translated English) | Chemicals - Test method of bacterial reverse mutation | | Sector / Industry | National Standard (Recommended) | | Date of Implementation | 2025-12-01 | | Older Standard (superseded by this standard) | GB/T 21788-2008 | GB/T 21788-2008: Chemicals -- Test method of combined chronic toxicity/carcinogenicity study---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Chemicals. Test method of combined chronic toxicity/carcinogenicity study
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Chemicals chronic toxicity and carcinogenicity
Joint Test Method
Posted 2008-05-12
2008-09-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
This standard is identical with the Organisation for Economic Co-operation and Development (OECD) Chemicals testing guidelines No. 453 (1981) "chronic toxicity and carcinogenicity
Of the Joint Test "(in English).
The editorial changes made the following standards.
--- Increasing the scope;
--- A unit of measurement unity to our legal units of measurement;
--- Delete the reference section of the OECD.
This standard is managed by the National Standardization Technical Committee chemicals dangerous (SAC/TC251) and focal points.
This standard is drafted by. China Center for Disease Control and Prevention of Occupational Health and Poison Control.
Participated in the drafting of this standard. Hubei Entry-Exit Inspection and Quarantine of Liaoning.
The main drafters of this standard. Sun Jinxiu, Cui Hairong, Lin Zheng, Hu Zhong Guo Jian, Cheng Ye, Chen Jianjun, Contour.
OECD Introduction
1. OECD has released a lot of documents for chronic, carcinogenicity, toxicological or safety evaluation; of these documents, suggest that in addition to
In experimental design and operation of some differences on two aspects it is common generic. In the preparation of these guidelines by reference and cited in many countries
The draft guidelines. Plus expert efforts of many countries in the group, thanked the World Health Organization (WHO) and the International Center for Research Cancer (IARC) in addition to
An important document provides expert advice of these organizations, but also to offer.
2. Most of the life of a mammal or to detect toxic effects after exposure to a variety of life-long test was caused, including the major chronic toxicity
, Carcinogenicity and corresponding dose - response relationship.
3. This test was designed to detect and operations other general toxicity (including neural, physiological, biochemical, hematological and contact-related disease
Morphological aspects of the role of reason), it should also detect the test substance to induce tumor effect and potential carcinogenic effects.
Chemicals chronic toxicity and carcinogenicity
Joint Test Method
1 Scope
This standard specifies the scope of rodent chronic toxicity and carcinogenicity joint test, the test of basic principles, test methods, test reports.
This standard applies to chemicals of chronic toxicity and carcinogenicity joint test.
2 test basic principles
During most of the period of life of laboratory animals in a manner long-term exposure test was observed symptoms of poisoning of animals, and biochemical parameters
Standard, hematological, histopathological examination, to evaluate the chronic toxicity of the test substance; at the same time the number of animals observed tumor appears, type,
Occurrence location and time of occurrence, evaluate the carcinogenic potential of the test substance.
3 Test Method
3.1 The oral administration of the basic requirements for the test substance test
3.1.1 The test substance is a solid or liquid, etc;
3.1.2 was tested chemical identifying characteristics;
3.1.3 Purity test substance (and impurity content);
3.1.4 solubility test;
3.1.5 stability test substance (including in the manufacture of animal feed, water mixed with post-Stability);
3.1.6 Relationship hydrolysis pH value;
3.1.7 ability to form complexes;
3.1.8 Melting point/boiling point.
3.2 inhalation test the basic requirements of the test substance
3.2.1 gases, volatile material or aerosol/particulate matter;
3.2.2 was tested chemical identifying characteristics;
3.2.3 test substance purity and impurity;
3.2.4 Liquid test substances. saturated vapor pressure, boiling point;
3.2.5 aerosol/particulate test substance. particle size, shape and dispersion;
3.2.6 test substance flashpoint;
3.2.7 test was explosive.
3.3 Experimental animals and breeding environment
3.3.1 Animal Selection
Early in the relevant acute test conducted provided, subacute and subchronic toxicokinetics, information is available for the selection of an appropriate animal
(Species and strains) provide a strong basis. As discussed in mice and rats and other laboratory manual is to evaluate the carcinogenic potential of the test substance
The most widely used animals, rats and dogs most used in chronic toxicity tests.
Chronic toxicity/carcinogenicity binding evaluation tests should be used in conventional rats, but does not exclude the use of other animals. In principle, the selected animal
Species and strains of the carcinogenic effects of the test substance and should be sensitive to the toxic effects, but the spontaneous tumor background should not be too high on the carcinogenic effects
Meaningful evaluation.
3.3.2 Experimental animal breeding breeding environment, feed and water
In order to obtain meaningful test results, it must be strictly controlled breeding environment and animal management technique. In addition to strict control, the animals
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