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GB/T 21804-2008 English PDF

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GB/T 21804-2008: Chemicals -- Test method of acute oral toxicity-fixed dosed procedure
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
GB/T 21804-2008329 Add to Cart 3 days Chemicals -- Test method of acute oral toxicity-fixed dosed procedure Valid

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Basic data

Standard ID: GB/T 21804-2008 (GB/T21804-2008)
Description (Translated English): Chemicals -- Test method of acute oral toxicity-fixed dosed procedure
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: A80
Classification of International Standard: 13.300; 11.100
Word Count Estimation: 14,180
Date of Issue: 2008-05-12
Date of Implementation: 2008-09-01
Adopted Standard: OECD No.420-2001, 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 chemical fixed dose acute oral toxicity test scope, terms and definitions, test basic principles, test methods, test data and reports. This standard applies to the chemical determination of acute oral toxicity.

GB/T 21804-2008: Chemicals -- Test method of acute oral toxicity-fixed dosed procedure

---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-fixed dosed procedure ICS 13.300; 11.100 A80 National Standards of People's Republic of China Chemicals Acute oral toxicity fixed dose test method Posted.2008-05-12 2008-09-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China China National Standardization Administration released

Foreword

This standard is the same as adopted by the Organization for Economic Cooperation and Development (OECD) Guide to the Testing of Chemicals NO. 420 (2001) "Acute oral toxicity. Fixed dose method "(in English) This standard made the following editorial changes. --- Increased range of parts; --- Added foreword and OECD introduction part; --- Unit of measurement into China's legal unit of measurement; --- Delete OECD reference section. This standard Appendix A, Appendix B and Appendix C are normative appendix. This standard by the National Standardization Technical Committee of hazardous chemicals management (SAC/TC251) and focal point. This standard is drafted by. Tianjin Inspection and Quarantine Science and Technology Institute. The main drafters of this standard. Wang Libing, Zhang Yuan, Yu Zhi Rui, Li Xue Yang, Zhao Zhuo, Wang Hua. OECD Introduction 1. OECD Guidelines for Testing of Chemicals Revise periodically as scientific advances and standards of practice operate. The earliest OECD 420 released in July.1992 as OECD 401 (a routine acute oral toxicity test) of the first option. Based on multiple times Experts meeting suggested that this standard should be revised for the following reasons. 1) LD50 value instead of the recommended threshold in.1992 as a There is broad agreement on the criteria for the classification of substances and 2) that the results of trials of single-sex animals (usually female) are credible. 2. The traditional method of acute oral toxicity is animal death as the end point of toxicity. 1984 British Toxicology Society (BTS) under Fixed dose method proposed a new acute toxicity test method. This method can avoid the death of animals as the end point of toxicity, but the observation A significant number of toxic reactions occurred at different fixed doses. This method is validated by in vivo validation experiments in the UK and around the world 1992 was adopted by the Board as a test guide. Next, the statistics of the fixed dose method were evaluated using a mathematical model through a series of experiments significance. In vivo experiments and model studies have demonstrated that the method is reproducible and allows animals to be conserved as compared to traditional methods Less painful; this method is as toxic as other acute toxicity methods (Methods 42 and 425). 3. A guide to acute oral toxicity provides guidance on how to choose the most appropriate test method for a particular experimental purpose Guide, this guidance also provides the implementation and interpretation of the 420. 4. The principle of fixed dose method, formal test selected only moderate toxicity dose, do not choose lethal dose, do not choose to corrosion or strict Severe irritation caused or known to produce significant pain or pain dose. If you find dying animals or animals obvious pain Pain or severe pain, he/she is sacrificed on the basis of humanitarian principles and, at the time the result is explained, the animals are sacrificed in conjunction with the test The same explanation for animals. The guide contains a section on how to determine the imminent death and suffering of an animal and whether it should be executed The standard of these animals. 5. This method is used to provide information on the harmful properties of a substance so that the substance can be classified according to the GHS for acute toxicity to the chemical Standard classification classification. 6. Before the test, it is necessary to collect all relevant information about the test substance. Including the standard classification of substances and chemical structure; physical and chemical properties; Results of various in vitro and in vivo toxicological tests on this substance; toxicity data of substances structurally similar to this substance and their intended use. This information is information that must be collected for a type of trial that protects human health and helps select the right starting dose. Chemicals Acute oral toxicity fixed dose test method

1 Scope

This standard specifies the chemical acute oral toxicity fixed dose test scope, terms and definitions, basic principles of testing, test methods, test Test data and reports. This standard applies to the determination of acute oral toxicity of chemicals.

2 Terms and definitions

The following terms and definitions apply to this standard. 2.1 The test substance in 24 hours to the test animals once or more oral toxicity when the harmful effects. 2.2 No animals died within 48 h, while death occurred within the 14-day observation period. 2.3 The amount of test substance received, often in the quality (g, mg) or animal body weight given by the amount of the test substance (mg/kg) to represent; as will be subject When the test substance is mixed into the feed for exposure to the virus, the constant concentration (mg/kg) of the test substance in the feed may also be used. 2.4 A clear indication of the toxic effect that occurs after administration of the test sample is sufficient evidence of risk assessment and is expected to increase with dose Can develop into serious symptoms of poisoning until death. 2.5 Is a component of the physical and chemical properties of the United Nations Dangerous Goods Regulations and part of the International Labor Organization in the area of human health and the environment of the Organization for Economic Co-operation and Development (OECD) The ILO's link on the transport of hazardous materials is coordinated with the Inter-Agency Program for the Management of Chemical Ecosystems (IOMC). 2.6 If it is predicted that the animal will die or die during the next dose to be observed. Rodents near death State of the performance of convulsions, lying on the side, lying and trembling.
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