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GB/T 21603-2008: Chemicals -- Test method of acute oral toxicity
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Chemicals -- Test method of acute oral toxicity
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GB/T 21603-2008
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Basic data | Standard ID | GB/T 21603-2008 (GB/T21603-2008) | | Description (Translated English) | Chemicals -- Test method of acute oral toxicity | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A80 | | Classification of International Standard | 13.300; 11.100 | | Word Count Estimation | 5,567 | | Date of Issue | 2008-04-01 | | Date of Implementation | 2008-09-01 | | Quoted Standard | GB/T 21605-2008 | | Adopted Standard | OECD No.401-1987, MOD | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 5, 2008 (No. 118 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 animals of chemicals acute oral toxicity test methods, test procedures and test results. This standard applies to chemicals Determination of acute oral toxicity. | GB/T 21603-2008: Chemicals -- Test method of acute oral 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 acute oral toxicity
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Chemicals acute oral toxicity test method
Posted 2008-04-01
2008-09-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Book `
Foreword
This revised standard adopts the United Nations Organisation for Economic Co-operation and Development (OECD) Chemicals Test Method No. 401 "acute oral toxicity test
Test "(1987).
This standard OECD Chemicals Test Method No. 401, the following differences.
--- To OECD Chemicals Test Method No. 401 were editorial changes;
--- Increase the preamble.
This standard is managed by the National Standardization Technical Committee chemicals dangerous (SAC/TC251) and focal points.
This standard is drafted by. Tianjin Inspection and Quarantine Institute of Science and Technology.
Participated in the drafting of this standard. Tianjin Inspection and Quarantine Institute of Science and Technology, Jiangnan University, China Chemical standardization, Tianjin Entry
Inspection and Quarantine Bureau, Chinese Center for Disease Prevention and Control of Occupational Health and Poison Control.
The main drafters. Zhang Yuan, Wangli Bing, Zhao Zhuo, Xu came, Wang Xiaobing, in Chi Rui, Li Chaoyang.
This standard was first formulated.
Chemicals acute oral toxicity test method
1 Scope
This standard specifies the chemical animal acute oral toxicity test of the test methods, test procedures and test results.
This standard applies to the determination of acute oral toxicity of chemicals.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 21605-2008 Chemical Acute inhalation toxicity testing
The Ministry of Health "toxic chemicals identified technical specifications" (2005)
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Once or several times in the 24h of experimental animals after oral administration of the test sample, animals health damage effect in the short term.
3.2
After orally once or several times within 24h oral administration of the test sample, causing the death of half of the population of experimental animals poison statistical agent
the amount. Accept the test sample per body mass (mg/kg or g/kg) is represented.
3.3
Chemical poisons represent the relationship between the dose of a particular group in the incidence of mass effect.
Test Method 4
4.1 Processing of the test sample
The test sample should be dissolved or suspended in a suitable vehicle, we recommend preferred vegetable oil or water as a solvent, may also consider the use of other excipients
(E.g., carboxymethyl cellulose, gelatin, starch, etc.) were prepared at a suspension; can not be formulated as a suspension, it may be formulated into other forms (e.g. a paste); not
The solvent can be employed in organic chemistry has significant toxicity, such as the use of toxic solvents should be single-vehicle control group was observed.
4.2 Experimental Animals
Preferred healthy adult mice (18g ~ 22g) and rats (180g ~ 220g), can also be used other sensitive animals. Sex with animals
The difference between the weight of the individual shall not exceed 20% of the average weight. Before the test animals to adapt to the 3d ~ 5d time at least in the test environment.
4.3 dose design
According to the requirements of the selected method, it should be located 4 to 5 dose groups, in principle, each animal is usually 10, male and female. Each dose group
From size to accommodate the size of toxicity and death is appropriate, usually in large groups, and a lesser amount from the pre-test animals. If the toxicity of the test sample
Low, may also limit the maximum method, which uses 20 animals (male and female), using 5000mg/kg dose, not resulting in death of the animal can be
No multiple doses of acute oral toxicity test.
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