GB/T 21766: Evolution and historical versions
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| GB/T 21766-2008 | English | 279 |
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Basic data | Standard ID | GB/T 21766-2025 (GB/T21766-2025) | | Description (Translated English) | Chemicals - Test method of reproduction/developmental toxicity screening | | Sector / Industry | National Standard (Recommended) | | Date of Implementation | 2025-12-01 | | Older Standard (superseded by this standard) | GB/T 21766-2008 | GB/T 21766-2008: Chemicals -- Test method of reproduction/developmental toxicity screening---This is a DRAFT version for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 reproduction/developmental toxicity screening
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Toxicity screening test methods for chemicals reproductive/developmental
Posted 2008-05-28
2008-08-01 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. 421 (1995) "reproductive/developmental toxicity
Screening Test "(in English).
The editorial changes made the following standard.
--- Increasing the scope section;
--- Change the unit of measure of legal units of measurement;
--- Delete the reference section of the OECD.
Appendix A of this standard is a normative appendix, Appendix B is an informative annex.
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.
It participated in the drafting of this standard. People's Republic of China Exit Inspection and Quarantine, Ningbo, Tianjin, Inspection and Quarantine Institute of Science and Technology.
The main drafters of this standard. Mazhong Chun, Sun Jinxiu, then Long Hao, Hou powder Xia, Chen Xiaoqing, Lin Zhenxing.
OECD Introduction
1.1990 in January, an ad hoc group of experts in London to discuss the reproductive toxicity screening methods, and reached a "preliminary reproductive toxicity
Screening test "program, which is effective for preliminary evaluation of existing substances.
2. This guide is to reach the program's London conference later, it was mentioned in October 1992, held in Tokyo reproductive toxicity screening methods
The outcome of the meeting made by experts. It builds on the original method of detecting various Member States with existing high production volume chemicals and with the positive control
Basis to explore the experience gained on the test.
3. This guide is designed to evaluate the chemical test male and female reproductive function on, such as gonadal function, mating behavior, by
Pregnancy, fetal development and childbirth, the results of the information obtained is limited. It is not an alternative, it can not be used to replace the existing methods guide
414, 415 and 416.
4. This guide can be used for possible effects of the provision of reproductive/developmental aspects, including the evaluation of the toxicological properties of chemicals or the early stages of
Concern chemicals. It can also be used as part of the initial screening test to detect a group of chemically little or no toxicological information
Goods to be determined as part of wider dose range of reproductive/developmental studies, or any other related research.
5. This test does not provide complete information on reproduction and development in all its aspects. Offer only limited means to detect prenatal exposure causes
Postpartum performance, or the postpartum period may be induced by exposure effect. Due to the relatively small number of infected animals, the toxicity endpoint selection,
Test cycle is short, so this method can not provide evidence of no effect. Thus, despite the negative results do not indicate absolute safety of reproductive and developmental
Full, but if the actual exposure levels significantly lower than observed adverse effect level (NOAEL), then this information to ensure the safety of certain
Full sex. And in the absence of data obtained from other reproductive/developmental toxicity test, positive results are useful for initial hazard assessment
It can help determine the need for and timing of additional testing.
6. This guide uses oral exposure. If another route of exposure, some modifications are needed.
Toxicity screening test methods for chemicals reproductive/developmental
1 Scope
This standard specifies the chemical to reproductive/developmental toxicity screening test scope, terms and definitions, basic test principle, test methods, test
Data and reports.
This standard applies to detect chemicals Reproductive toxicity, reproductive toxicity screening and growth.
2 Terms and definitions
The following terms and definitions apply to this standard.
2.1
Harmful effects on future generations, and (or) damage male, female (animal) physiological or reproductive functions.
2.2
Direct or indirect harmful effects on pregnancy in female animals.
2.3
Female or male reproductive function in animals or unusual ability.
2.4
It belongs to reproductive toxicity, mean offspring before birth, perinatal and after the birth of the show's structure (body defects) or functional abnormalities.
2.5
Means the amount of the amount of the test substance subjected, often mass (g, mg) or animals given per body weight of the test substance (mg/kg) is represented; e.g.
The test was incorporated into the feed were fed infected, the test substance can also be used in feed constant mass fraction (mg/kg) to represent.
2.6
Including the exposure dose, exposure frequency and duration of exposure of the general terms.
2.7
Specific cytotoxicity after administration of the test sample performance, risk assessment can be used as sufficient evidence, is expected to increase with the exposure dose
May develop severe symptoms until death.
2.8
No maximum dose and exposure-related adverse effects.
3 test basic principles
According to male and female both sexes, provided multiple dose administration of the test substance.
From the beginning of the test until the time of sacrifice, exposure of male animals at least four weeks, that is the least exposed two weeks pre-mating, mating and mating period after
Two weeks of exposure. Since the male animal mating early exposure time is short, only the size of the reproductive capacity to evaluate chemicals on male animals
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