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GB/T 21771-2008: Chemicals -- Test method of combined repeated dose toxicity study with the reproduction/developmental toxicity screening
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 21771-2008 | English | 274 |
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Chemicals -- Test method of combined repeated dose toxicity study with the reproduction/developmental toxicity screening
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GB/T 21771-2008
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Basic data | Standard ID | GB/T 21771-2008 (GB/T21771-2008) | | Description (Translated English) | Chemicals -- Test method of combined repeated dose toxicity study with the reproduction/developmental toxicity screening | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A80 | | Classification of International Standard | 13.300; 11.100 | | Word Count Estimation | 14,130 | | Date of Issue | 2008-05-12 | | Date of Implementation | 2008-09-01 | | Adopted Standard | OECD No.422-1996, 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 repeated dose toxicity of chemicals combined reproductive/developmental toxicity screening test for growth and scope, terms and definitions, test basic principles, test methods, test data and reports. This standard is applicable to the detection of chemicals repeated dose toxicity and teratogenicity, reproduction and growth toxicity screening. This standard can also be used as teratogenicity test, two-generation reproduction toxicity generation and the pre-test. | GB/T 21771-2008: Chemicals -- Test method of combined repeated dose toxicity study with the reproduction/developmental toxicity screening
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Chemicals. Test method of combined repeated dose toxicity study with the reproduction/developmental toxicity screening
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Chemicals combined repeated dose toxicity reproductive/developmental
Toxicity Screening 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. 422 (1996), "repeat-dose toxicity together
And reproductive/developmental toxicity screening test "(in English).
The editorial changes made the following standards.
--- Increasing the scope section;
--- Change the unit of measure of legal units of measurement;
--- Deleted the reference section of the OECD.
The Standard Appendix A, Appendix B normative appendix.
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. Beijing Center for Disease Control and Prevention, Shenzhen CIQ, Shanghai Entry-Exit Inspection and
Quarantine Bureau.
The main drafters of this standard. Xiao Mu group, Deng Ying, Ai Wei Wu, Zhaochao Ying, Sun Jinxiu, Lin Zheng, Li Ying, Qiu Lu.
OECD Introduction
1.1990 January reproductive toxicity screening methods specially convened meeting of experts in London to discuss and reach a relevant subacute
Reproductive toxicity merger/developmental toxicity screening test programs can be effectively applied to existing preliminary evaluation of chemicals.
2. The screening test program on reproductive toxicity screening method in October 1992, held in Tokyo designated (appoint) the outcome of the Expert Meeting,
London Conference also agreed an updated version of the draft. The program reproductive/developmental toxicity screening is based on the Member States to use part of the original
The method of existing large number of tests and exploratory test for positive control chemicals have been produced chemicals carried accumulated experience base
On basis. Subacute toxicity portion of the content and guidelines for 407 (and is now being updated proposal) is consistent.
3. In the course of toxicity characteristics of chemicals for evaluation usually after acute oral toxicity test is then performed oral subacute
Toxicity test, the test can provide health damage effects may occur after a relatively limited time repeated administration of the test sample. in
When the test has not yet ratified were 90d (such as yield does not exceed the standard to be done to test the 90d time), this test can provide multiple administration of the test sample
The basic toxicity information is also available as a pre-test of long-term tests.
4. Because reproductive/developmental toxicity screening test for merger, this study also provides preliminary test sample of male and female animals born
Colonization (gonadal function, mating behavior, pregnancy, and fetal rat pups's development) may affect the data. This test can also be dangerous
Early evaluation (as an early evaluation of chemicals or on chemicals toxicity), or can be targeted to specific types of chemicals
Detection. This test can not provide all the information on reproductive and developmental aspects. It must be pointed out that the test detected before birth exposure to lead
Or performance may be due to exposure to possible damage caused after birth action to provide limited evidence after the birth. Among other reasons, because the test
End test and selective test duration is relatively short, this method can not be obtained without reproductive/developmental toxicity definitive conclusion. although
However, to obtain a negative result does not mean that the test substance in reproductive and developmental absolute security, such as chemicals, much lower than the actual exposure was not observed
Dose of harmful effects (NOAEL), then negative results can be eliminated reproductive/developmental toxicity some doubts.
5. This guide will be emphasized as indicators of neurotoxicity endpoint detection, but also stressed the need for experimental animals very careful clinical
Observe in order to obtain as much information. The method should identify neurotoxic chemicals may be present for future conduct in this regard
In-depth study. In addition, the test can also provide some basic indications of immunotoxicity.
6. In the absence of other systemic toxicity, reproductive/developmental toxicity, neurotoxicity and immunotoxicity studies when the positive results of the initial risk
Harm (risk of) the comments and do other tests must be made as to whether or how long the test period is useful. The positive results of preliminary
Provide the basis for hazard assessment and may provide the basis for judging the need for additional test or tests to determine cycle. Test results can be used
One part of the provision of information on the evaluation of the toxicity of capital; the "toxicity screening database" (SIDS ScreeningInformationDataSet)
Material with little or no existing chemicals particularly useful, this test can also be used to replace the subacute toxicity test and reproductive/developmental toxicity screening test
These two independent experiments. In addition, the test may also be a long-term reproductive/developmental toxicity test dose range selection, or for other related
Happening.
7. Generally believed that pregnant and non-pregnant animals sensitive to chemicals is different. Because this test is generally only observed toxicity,
And observed reproductive/developmental toxicity, therefore, determine dosage levels than were subacute toxicity and reproductive/developmental toxicity screening test more complex
miscellaneous. Furthermore, since in the study of serum biochemical tests and histological examination was not carried out simultaneously, so the explanation of general systemic toxicity
Subacute toxicity test conducted independently than difficult. Because of these technical difficulties, to carry out this test requires respect toxicity test
Experience. On the other hand, this test can not only save the animals, for the distinction between the test sample and following the direct damage to the reproductive/developmental system
Indirect damage occurs in other system damage, providing a better way.
8. This test is longer than the exposure time of traditional 28d repeated exposure test, but the ratios are subacute toxicity and reproductive/developmental
Toxicity screening tests save animals.
9. Exposure pathways of the program is administered orally, such as the use of other exposure mode, should make appropriate adjustments.
Chemicals combined repeated dose toxicity reproductive/developmental
Toxicity Screening Test Method
1 Scope
This standard specifies the chemical combined repeated dose toxicity reproductive/developmental toxicity screening test the extent of growth, the terms and definitions, test group
The principles, test methods, test data and reports.
This standard is applicable to the detection of chemicals repeated dose toxicity and teratogenicity, reproduction and growth toxicity screening.
This standard can be used as teratogenicity test, pre-test generation and two-generation reproduction toxicity.
2 Terms and definitions
The following terms and definitions apply to this standard.
2.1
Harmful effects on future generations, and (or) damage male, female (animal) physiological or reproductive functions.
2.2
Direct or indirect harmful effects on pregnancy in female animals.
2.3
Female or male reproductive function in animals or unusual ability.
2.4
It belongs to reproductive toxicity, mean offspring before birth, perinatal and after the birth of the show's structure (body defects) or functional abnormalities.
2.5
Suffered amount of test substance, the amount often mass (g, mg) or animals given per body weight of the test substance (mg/kg) is represented; such will be subject to
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.
2.6
Including the exposure dose, exposure frequency and duration of exposure of the general terms.
2.7
Specific cytotoxicity after administration of the test sample performance, risk assessment can be used as sufficient evidence, is expected to increase with the exposure dose
May develop severe symptoms until death.
2.8
No maximum dose and exposure-related adverse effects.
3 test basic principles
At least four weeks should be located more than 3.1 dose group tested was dosed designed an array of male female animals exposed, exposure of male animals
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