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SN/T 2181-2008: One-generation reproduction toxicity study
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| SN/T 2181-2008 | English | 169 |
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One-generation reproduction toxicity study
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SN/T 2181-2008
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Basic data | Standard ID | SN/T 2181-2008 (SN/T2181-2008) | | Description (Translated English) | One-generation reproduction toxicity study | | Sector / Industry | Commodity Inspection Standard (Recommended) | | Classification of Chinese Standard | C70 | | Classification of International Standard | 13.300 | | Word Count Estimation | 6,640 | | Date of Issue | 2008-09-04 | | Date of Implementation | 2009-03-16 | | Quoted Standard | GB 14924.1; GB 14925 | | Adopted Standard | OECD NO.415-1983, MOD | | Issuing agency(ies) | General Administration of Customs | | Summary | This standard specifies the generation reproduction toxicity test animals terminology and definitions, test animals, dose levels, test procedures, evaluation of results, test reports and test results interpretation. This standard applies to reproductive toxicity testing of chemicals. | SN/T 2181-2008: One-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.
One-generation reproduction toxicity study
Exit inspection and quarantine industry standard book People's Republic of China
Generation reproductive toxicity study
Posted 2008-09-04
2009-03-16 implementation
People's Republic of China
The State Administration of Quality Supervision, Inspection and Quarantine released
Foreword
This revised standard adopts the United Nations Organisation for Economic Co-operation and Development (OECD) Chemicals Test Method No. 415 "generation reproduction toxicity test
Test "(1983).
This standard OECD Chemicals Test Method No. 415 compared with the following differences.
--- To OECD Chemicals Test Method No. 415 were editorial changes;
--- Increased the preamble;
--- Increasing the exposure time and procedures rats;
--- Increasing the breeding index is calculated.
This standard was proposed by the State Administration of Quality Supervision Inspection and Quarantine of People's Republic of China.
This standard by the National Certification and Accreditation Administration Committee.
This standard is drafted by. People's Republic of China Tianjin Exit Inspection and Quarantine.
Participated in the drafting of this standard. the Chemical Institute of Standardization, Jiangnan University, Tianjin Academy of Inspection and Quarantine.
The main drafters. Zhang Yuan, Lu Gang, Zhao Zhuo, in Chi Rui, Zhou Lei, Li Xue Yang.
This standard is the first release of the entry-exit inspection and quarantine industry standards.
Generation reproductive toxicity study
1 Scope
This standard specifies the generation reproductive toxicity test animal terms and definitions, test animals, dose levels, test procedures, the results of the evaluation, test
Inspection reports and interpretation of test results.
This standard applies to the detection of chemicals reproductive toxicity.
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 14924.1 animal feed common quality standards
GB 14925 Laboratory Animal Facilities and Environment
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Female or reduce damage caused by the chemicals in male reproductive function or fertility, such as the decline in reproductive rates; or cause non progeny
Hereditary adverse effects, such as growth and developmental toxicity, including teratogenic effects of damage to health and the breast-feeding period.
4 test animals
4.1 species and strain selection
Preferred healthy adult rats or mice. The most commonly used weaning, seven weeks to 8 weeks, at least through 5d adaptation of animals to be complicated
Reproductive toxicity test. Female animals must not have been produced Aberdeen.
4.2 the number of animals
Males and females usually in a ratio of 1 or 1.2 mated. The number of animals mating should ensure that each dose group and control group
Access to about 20 pregnant rats.
4.3 rearing environment
Experimental animal husbandry and environmental facilities shall comply with the requirements of GB 14924.1 and GB 14925's. The test animals using free diet.
When pregnant rats approaching childbirth, childbirth should be caged in a cage, the cage in place when needed build nest litter.
5 dose levels
The experiment included at least three dose groups and a control group. The highest dose should enable the parent animals significant toxicity, but does not cause movement
Was dead; intermediate doses can cause mild toxicity; low dose should not induce any toxic effects in animals and their offspring. If that sample
Less toxic products, the dose of 1000mg/kg, the reproductive process has not produced any toxic effects, you can use a limited test, that test
Test does not need to set up additional dose group. If the pre-test to the effect of high doses of significant maternal toxicity, but had no effect on fertility, can also be used
High-dose pilot study conducted limited tests.
6 Test procedure
6.1 and control group
Before the exposure dose animals were randomly divided into two groups. If the test sample using a vehicle control group should be used excipients
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