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GB/T 21763-2008: Chemicals -- Test method of repeated dose oral toxicity study in rodents
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 21763-2008 | English | 209 |
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Chemicals -- Test method of repeated dose oral toxicity study in rodents
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GB/T 21763-2008
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Basic data | Standard ID | GB/T 21763-2008 (GB/T21763-2008) | | Description (Translated English) | Chemicals -- Test method of repeated dose oral toxicity study in rodents | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A80 | | Classification of International Standard | 13.300; 11.100 | | Word Count Estimation | 9,959 | | Date of Issue | 2008-05-12 | | Date of Implementation | 2008-09-01 | | Adopted Standard | OECD No.408-1998, 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 rodent subchronic oral toxicity test scope, terms and definitions, test basic principles, test methods, test data and reports. This standard applies to chemicals sub-chronic oral toxicity test. | GB/T 21763-2008: Chemicals -- Test method of repeated dose oral toxicity study in rodents---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 repeated dose oral toxicity study in rodents
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Chemicals rodent subchronic oral toxicity
experiment 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. 408 (1998), "rodents slow
Of oral toxicity 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 Guangdong.
The main drafters of this standard. Sun Jinxiu, Guo Jian, Chao-lin, Cui Hairong, Ye Cheng, Cengxian Dong, Wang Zhenhua, Cheng Shujun.
OECD Introduction
1. OECD guidance documents will be combined with scientific progress and make periodic revisions, the original 408 was adopted in 1981 making. The revision
Changes is to obtain more information from the test animal studies.
2. The revision is mainly held 408 OECD expert consultation in Rome in November 1995 on sub-chronic and chronic toxicity test
Based on the findings of the inspection revised.
3. Determine certain longer period ranging from after weaning, sexual maturity and growth as the year of the oral test is repeated exposure to poisonous animals
Effects toxicity, target organ and the possible cumulative toxicity, but also get the estimated value has no adverse effect level, and for the design of chronic toxicity test
Experimental design (dose selection, sensitive animals and outcome measures), as well as the development of the human body safe level of exposure to provide important reference material.
Chemicals rodent subchronic oral toxicity
experiment method
1 Scope
This standard specifies the scope of rodent subchronic oral toxicity test, the terms and definitions, basic test principle, test methods, test
Data and reports.
This standard applies to chemicals sub-chronic oral toxicity test.
2 Terms and definitions
The following terms and definitions apply to this standard.
2.1
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.
2.2
Including the exposure dose, exposure frequency and duration of exposure of the general terms.
2.3
No means the highest dose and exposure-related adverse effects.
3 test basic principles
The test substance daily with different doses of orally administered several experimental animal groups a dose. Continuous exposure 90d, during exposure to close
Cut animals were observed toxicity. During the test of death and the end of the test surviving animals to be sacrificed for gross autopsy.
Test Method 4
4.1 Experimental animals and breeding environment
4.1.1 Animal Selection
Preferred rats, mice can also be used. Usually you should use common strains and healthy young adult animals. Female animals should not become pregnant or production
Aberdeen had, after weaning to rat age appropriate, not more than 9 weeks of age. Differences in animal weight at the start of the test shall not exceed the average weight of the same sex
20%. If the test is a test of long-term pre-pre-test, the two tests should use the same strain, the same source animals.
4.1.2 Feeding Conditions
Experimental animal room temperature should be 22 ℃ ± 3 ℃. Relative humidity should be 30% to 70%, 50% to 60% for the best. Artificial light
When should next 12h, 12h dark. Fed with routine laboratory feed, water is not limited to, the test substance mixed with the feed when feeding. Animals can be a single
Caged by sex or a small group of animals raised, the number of animals per cage to keep the group does not interfere with the observation of the animals is appropriate.
4.1.3 Number and Sex
Each dose group to use at least 20 animals (10 male and female each); if designed to regularly sacrificed animals still need to increase the number of animals. according to
Or to test existing data homologs, such as the need to set up five additional male and a female as an additional control group, high dose group at a dose of dye
Poison, after the cessation of exposure the animals were sacrificed temporarily to see if there is delayed toxicity and reversibility of toxic effects, the length of time it
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