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GB/T 21758-2008: Chemicals -- Test method of two-generation reproduction toxicity study
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 21758-2008 | English | 214 |
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Chemicals -- Test method of two-generation reproduction toxicity study
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GB/T 21758-2008
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Basic data | Standard ID | GB/T 21758-2008 (GB/T21758-2008) | | Description (Translated English) | Chemicals -- Test method of two-generation reproduction toxicity study | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A80 | | Classification of International Standard | 13.300; 11.100 | | Word Count Estimation | 11,129 | | Date of Issue | 2008-05-12 | | Date of Implementation | 2008-09-01 | | Adopted Standard | OECD No.416-2001, IDT | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 7, 2008 (No. 120 overall) | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This standard specifies the two-generation reproduction toxicity test chemicals range, test the basic principles, test methods, test data and reports. This standard applies to reproductive toxicity testing of chemicals. | GB/T 21758-2008: Chemicals -- Test method of two-generation reproduction toxicity 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 two-generation reproduction toxicity study
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Chemical generation reproduction toxicity 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. 416 (2001), "two-generation reproduction toxicity test
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.
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. Ningbo Entry-Exit Inspection and Quarantine of Guangdong.
The main drafters of this standard. Sun Jinxiu, Chen Xiaoqing, Ma Zhongchun, then Long Hao, Lin Zhenxing, Xuchong Hui, Cheng Shujun.
OECD Introduction
1. June 1995, reproductive and developmental toxicity OECD Working Group held a discussion meeting in Copenhagen, called for the existing OECD Health
Reproductive and developmental toxicity test guidelines are updated, the development of new developmental toxicity end points are not in the original guide. The Working Group recommended that the United States should be based on
And Germany, two-generation reproduction toxicity test proposed amendments. Working Group reached agreement on all major amendments of this guide.
2. It provides general information on the test sample of the entire male and female reproductive function and behavior of animals, reproductive system effects. such as sexual
Gland function, estrous cycle, mating behavior, conception, pregnancy, childbirth, breast-feeding, weaning and progeny growth and development, but also to provide newborn
Illness, death, developmental toxicity and achieved preliminary information before and after birth, provide a reference for the next toxicity tests. In addition to research F1 progeny
To confirm mating situation. Determined after mating, females should be placed in a separate cage production or delivery cage rearing; can also be a small group housed in groups, in
Before delivery 1d or 2d moved childbirth cage monoculture. When approaching childbirth, pregnant rats should provide a suitable pad nest material.
3.1.3 Animal Preparation
Select in young, healthy, and had not received other animal tests. Adapt to the laboratory environment before the test at least 5d. Test animals
It shall indicate the species, strain, source, sex, weight, and (or) weeks. It should clear kinship of animals used in order to avoid compatriots prior to testing
mating. Animals should be randomly divided into control and treatment groups (recommended weight-randomized). Cage placement should be avoided if possible
Depending on placement and impact tests. Each animal must have a single unique tag. Parental (P) animals should be at the beginning of exposure
Ago. Progeny F1, the animals selected for weaning and mating before completion. All selected F1 progeny of animals, to record and preserve their nest
Other information sources. When the pups need to weigh or an inspection, shall be marked only after birth sign as early as possible.
Parental (P) animals should be weaned after 5 weeks to 9 weeks of exposure. All experimental animals should be as close as possible weight and weeks of age.
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