GB/T 21759: Evolution and historical versions
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Chemicals - Test method of chronic toxicity
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| GB/T 21759-2008 | English | 174 |
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Basic data | Standard ID | GB/T 21759-2025 (GB/T21759-2025) | | Description (Translated English) | Chemicals - Test method of chronic toxicity | | Sector / Industry | National Standard (Recommended) | | Date of Implementation | 2025-12-01 | | Older Standard (superseded by this standard) | GB/T 21759-2008 | GB/T 21759-2008: Chemicals -- Test method of chronic toxicity---This is a DRAFT version for illustration, not a final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 chronic toxicity
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Chronic toxicity testing of chemicals
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 Test Method No. 452 (1981) "chronic toxicity test"
(In English).
This standard made the following editorial changes.
--- Press text format GB/T 1.1-2000 made editorial changes;
--- Increase "OECD Introduction" section, the OECD Chemical Test Method No. 452 in the test purposes included "OECD cited
Yan ";
--- To increase the "scope" chapter;
--- Remove the OECD Chemical Test Method No. "References" section 452.
This standard is managed by the National Standardization Technical Committee chemicals dangerous (SAC/TC251) and focal points.
This standard is drafted by. SZCIQ.
Participated in the drafting of this standard. Shanghai CIQ.
The main drafters of this standard. Li Ying, Liu Li, Yu Shuyuan, Chen Xiangyang, Sun Xiaoying, Liuxian Jie, Zhang Ya, Wu Jingwu, Liu Yuhong, Chen Xiang,
Jiang Wei.
OECD Introduction
Introduction
Essential information chronic oral toxicity test
--- Solid or liquid test substance;
--- Chemical properties of the test substance;
--- Test substance purity and impurity;
--- Solubility;
--- Stability, including stability in the feed or water;
--- Hydrolysis pH value under certain circumstances;
--- Ability to form complexes;
--- Melting point/boiling point.
Chronic toxicity test of essential information
--- Gases, volatile material or aerosol/particulate test substance;
--- Chemical properties of the test substance;
--- Test substance purity and impurity;
--- Liquids. vapor pressure, boiling point;
--- Aerosol/particle. particle size, shape and dispersion;
---Flash point;
--- Explosive.
Test purposes
Objective chronic toxicity tests on the substance reflects the impact of a prolonged and repeated exposure to mammalian species produced. In addition to tumor-like
Neuropathy, chronic toxicity test period remains controversial. Under the experimental conditions, the long incubation period or cumulative effect may not
Obviously, such as carcinogenic effects and shorten the life of the non-specific effects. In addition, in accordance with the guidelines to get the number of major chronic toxicity
It is, and can show a dose-response relationship. In theory, experimental design and implementation should take into account the major toxicity including neurological, physiological, biochemical, blood
Detection and exposure associated with morphological (pathology) affected.
Chronic toxicity testing of chemicals
1 Scope
This standard specifies the chemical chronic toxicity test range, test methods, data and reports.
This standard applies to chemicals chronic toxicity tests.
Test Method 2
2.1 Characteristics of the test substance and the test mixture
Before you begin toxicology, you should understand the characteristics of the test substance. Chemical properties and structure information can sometimes be used based on structure-activity Off
Analysis system, to indicate the possible biological or toxicological activity. Physical and chemical properties of the test substance for the exposure route selection, experimental design, by
Material handling and storage of the test provides an important basis.
Before any toxicity studies begin, we must understand the composition of the test substance, including major impurities.
Before chronic toxicity test must also understand the relevant physical and chemical properties of the test substance, including the stability of the test substance.
Established at the beginning of the test substance should be preceded by long-term studies (including the possible case of major impurity) in the vehicle and the qualitative and biological materials
Quantitative analysis.
2.2 Experimental Animals
2.2.1 Selection of animal species
In principle, the chronic toxicity test is recommended to use two types of rodent and non-rodent mammals.
Clear genetic background should be used, usually, have no ability to resist disease and birth defects in animals. Rodents generally used
Rats; non-rodent generally used dogs or primates, because of their larger individuals, for clinical and biochemical assays, and dogs or primates
It was also relatively easy to obtain. But the international use of such animals have many restrictions. If only rodent data, the data extrapolation
When reduced sensitivity to people.
Such a case can not be used in the usual manner. Although the proposal is a result from chronic effects in rodents and non-rodents,
But long-term experimental animal species should be chosen according to the actual situation and the results of previous experiments. In some cases, the use of a single genus of animals
That can evaluate chemical risks to provide sufficient data.
2.2.2 Experimental animal sex and initial weeks
Male and female both sexes should be used.
Test applications young, healthy animals. Rodents should adapt to the environment and the rapid growth period after weaning started experimenting.
2.2.3 Test of scale
Use a sufficient number of animals to ensure that each group has a detailed biological studies sufficient to meet the end of the test animals. Particularly important
To use a random selection process is a reasonable allocation of the animal test group and control group.
As with rodents, each dose group and control groups in each sex should be at least 20 each, non-rodent animals of each sex to the
Less all four. Considering the way there will be deaths, the number should be increased accordingly.
2.2.4 animal feeding and management, food, water
In order to ensure highly reliable test results, strict control and appropriate animal management methods of environmental conditions are important prerequisites.
Animals equipment should also be effective monitoring to avoid accidents.
Factors animal room conditions, disease, medication, diet, air, impurities in the water, litter, and other major animal care facility able to move
The results were a huge impact.
If the rodent breeding or feeding in the absence of specific pathogens in the environment, which will help to concurrent sexually transmitted diseases or parasites
control. Long-term litter used in the experiment should be disinfected. Animal breeding room should be quiet, well-ventilated, can control the lighting, temperature and humidity. move
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