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GB/T 21752-2008: Chemicals -- Test method of repeated dose 28-day oral toxicity study in rodents
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| GB/T 21752-2008 | English | 299 |
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Chemicals -- Test method of repeated dose 28-day oral toxicity study in rodents
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GB/T 21752-2008
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Basic data | Standard ID | GB/T 21752-2008 (GB/T21752-2008) | | Description (Translated English) | Chemicals -- Test method of repeated dose 28-day 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 | 13,113 | | Date of Issue | 2008-05-12 | | Date of Implementation | 2008-09-01 | | Adopted Standard | OECD No.407-2005, IDT | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 7 of 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 rodents 28d repeated dose oral toxicity test scope, terms and definitions, test basic principles, test methods, test data and reports. This standard is applicable to the detection of chemicals 28d repeated dose oral toxicity test. | GB/T 21752-2008: Chemicals -- Test method of repeated dose 28-day 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 28-day oral toxicity study in rodents
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Chemicals rodents 28 days repeated dose oral
Toxicity Test Methods
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. 407 (2005), "28 days rodent
Repeated dose oral toxicity test "(in English).
The editorial changes made the following standard.
--- Increasing the scope section;
--- Change the unit of measure of legal units of measurement;
--- Delete the reference section of the OECD.
Appendix A of this standard is an informative annex.
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. Guangdong Entry-Exit Inspection and Quarantine Shenzhen.
The main drafters of this standard. Xuchong Hui, Hou Fenxia, \u200b\u200bXie Jianjun, Liu Li.
OECD Introduction
1. 1998, OECD has launched a high priority activities, namely, revision of existing guidelines established for screening and detection of latent
The new guide endocrine disruptors. One of the tasks is to revise rodents 28 days repeated dose oral toxicity test (OECD
TG407), in which the test was added for the detection of endocrine activity evaluation. These new indicators in order to verify the increase in the inner
Correlation and secreted operability, internationally conducted extensive validation study. Use some estrogen, anti-estrogen
All data will be active secretion weight of evidence analysis after classification. When you want to develop endocrine active chemicals (chemical classification) related
When management decisions should be based on the results of the above analysis by the heavy weight of evidence, rather than relying solely on the results obtained in the TG.
14. The TG407 is to test based on the observed toxic effects, including endocrine effects, possible to detect the test substance
Harmful effects. That is, according to the results of the test substance may TG407 hazard identification and hazard assessment. Comments related to endocrine
The measurement results can be found in the price index "OECD conceptual framework for endocrine disrupting chemicals Measurement and Evaluation" (Appendix A).
15. As we all know, all operations involving animals should comply with local animal protection standards; animal protection and at below said
Management requirements are minimum requirements, local animal protection standards should be higher than this requirement. Another OECD study on "humane treatment of animals," the
specification.
Chemicals rodents 28 days repeated dose oral
Toxicity Test Methods
1 Scope
This standard specifies the rodent 28d repeat dose oral toxicity test by the scope, terms and definitions, basic principles of the test, the test side
Method, test data and reports.
This standard applies to detect chemicals 28d repeated dose oral toxicity test.
2 Terms and definitions
The following terms and definitions apply to this standard.
2.1
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 the feed of a constant concentration (mg/kg) to represent.
2.2
Including the exposure dose, exposure frequency and duration of exposure of the general terms.
2.3
After exposure the test substance there is a clear manifestation of toxicity is entirely possible for hazard evaluation test was conducted according to these toxic manifestations, but also in
Exposure dose increases are expected to be severe toxicity manifestations, and even cause death of the animal.
2.4
No cause can observe any changes in indicators of the highest dose.
2.5
No maximum dose and exposure-related adverse effects.
2.6
A chemical could play a mammalian estrogen (such as. estradiol β17) the ability of the same effect.
2.7
A chemical can play with mammals androgens (such as. testosterone) the ability of the same effect.
2.8
A chemical can play with thyroid hormone in mammals (eg. T3) the ability of the same effect.
2.9
A chemical inhibits mammalian estrogen (such as. estradiol β17) acting ability.
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