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Toxicological test methods for pesticides registration -- Part 28: Combined chronic toxicity/carcinogenicity study
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Basic data Standard ID | GB/T 15670.28-2017 (GB/T15670.28-2017) | Description (Translated English) | Toxicological test methods for pesticides registration -- Part 28: Combined chronic toxicity/carcinogenicity study | Sector / Industry | National Standard (Recommended) | Classification of Chinese Standard | B17 | Classification of International Standard | 65.100 | Word Count Estimation | 10,167 | Date of Issue | 2017-07-12 | Date of Implementation | 2018-02-01 | Regulation (derived from) | s Republic of China | 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 |
GB/T 15670.28-2017: Toxicological test methods for pesticides registration -- Part 28: Combined chronic toxicity/carcinogenicity 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.
Toxicological test methods for pesticides registration - Part 28. Combined croat/carcinogenicity study
ICS 65.100
B17
National Standards of People's Republic of China
Part of the replacement GB/T 15670-1995
Pesticide registration toxicology test method
Part 28. Chronic toxicity and carcinogenesis trials
Part 28. Combinedchronicticity/carcinogenicitystudy
2017-07-12 released
2018-02-01 Implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People 's Republic of China
China National Standardization Management Committee released
Foreword
GB/T 15670 "Pesticide registration toxicology test method" is divided into the following parts.
- Part 1. General;
- Part 2. Acute oral toxicity test;
- Part 3. Sequential method of acute oral toxicity test;
- Part 4. Acute oral toxicity test probability unit method;
- Part 5. Acute percutaneous toxicity test;
- Part 6. Acute inhalation toxicity test;
- Part 7. Skin irritation/corrosivity test;
- Part 8. Acute eye irritation/corrosivity test;
- Part 9. Skin allergy (sensitization) test;
- Part 10. Short-term repeated oral exposure (28 days) toxicity test;
- Part 11. Short term repeated percutaneous exposure (28 days) toxicity test;
- Part 12. Short-term repeated inhalation exposure (28 days) toxicity test;
- Part 13. Subchronic toxicity test;
- Part 14. Bacterial response mutations;
- Part 15. Micronucleus test of mammalian bone marrow polychromatic erythrocytes;
- Part 16. Chromosome aberration test of mammalian bone marrow cells in vivo;
- Part 17. Chromosome aberration of spermatogonia/spermatocytes in mammals;
- Part 18. Sexual lethal test of rodents;
- Part 19. In vitro mammalian cell chromosome aberration test;
- Part 20. In vitro mammalian cell gene mutation test;
Part 21. Systemic DNA synthesis (UDS) test for mammalian hepatocytes in vivo;
- Part 22. DNA damage and repair/programmed DNA synthesis in mammalian cells in vitro;
- Part 23. Teratogenic tests;
- Part 24. Two generations of reproductive toxicity tests;
- Part 25. Acute delayed neurotoxicity test;
- Part 26. Chronic toxicity test;
- Part 27. Cancer test;
- Part 28. Chronic toxicity and carcinogenesis trials;
- Part 29. Metabolic and toxic kinetic tests.
This part is part 28 of GB/T 15670.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part of the part of GB/T 15670-1995 "pesticide registration toxicology test method".
This part of the chronic toxicity and GB/T 15670-1995 compared with the main part of the test compared with the main changes are as follows.
--- modify and adjust the overall structure and layout format;
- Added some chapters (see Chapter 1, Chapter 2, Chapter 3, Chapter 5, 6.2.3, 6.5.3, Chapters 7 and 8);
- modified the requirements for the test substance (see 6.1.1,.1995 edition 19.5.1);
- modified the requirements for laboratory animals (see 6.2.2,.1995 edition 19.3.2).
This section is made by the Ministry of Agriculture of the People's Republic of China.
This part is headed by the Department of Agriculture and Plant Management of the People's Republic of China.
This part of the drafting unit. Ministry of Agriculture Pesticide Testing Institute.
The main drafters of this part. Wang Jie, Tao Chuanjiang, Li Zenggang, Song Hongyu, Zhang Liying, Qu ็ ็.
This part of the previous version of the standard to replace the release of the situation.
--- GB/T 15670-1995.
Pesticide registration toxicology test method
Part 28. Chronic toxicity and carcinogenesis trials
1 Scope
This part of GB/T 15670 specifies the basic principles, methods and requirements for chronic toxicity and carcinogenesis trials.
This section applies to chronic toxicity and carcinogenesis trials for pesticide registration.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
Laboratory Animal Environment and Facilities
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Chronic toxicity chronictoxicity
The health effects of the animals are repeatedly exposed to the test substance for most of the normal life cycle.
3.2
No adverse effects on dose levels observed Noobservedadverseeffectlevel; NOAEL
Under the prescribed test conditions, the test substance of the harmful effect associated with the exposure was not observed by the existing technical means and the detection index
High dose or concentration.
3.3
Observed at the lowest dose level of harmful effects lowestobservedadverseeffectlevel; LOAEL
Under the prescribed test conditions, the lowest dose of the test substance, which is detrimental to the exposure, was observed using the prior art and the assay
Amount or concentration.
3.4
Target organ
A substance that causes a significant toxic effect in the body.
3.5
Chemical carcinogenesis
Chemical substances cause tumor incidence and/or type of increase, the effect of shortening latency.
3.6
Chemical carcinogen chemicalcarcinogen
Can make the body produce tumors, tumor incidence or tumor latency shortened chemical substances.
4 Purpose of the test
In most of the animal's life cycle, the test substance is repeatedly given to the experimental animals, while observing the chronic toxicity of experimental animals and
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