GB/T 15670.27-2017Toxicological test methods for pesticides registration - Part 27: Carcinogenicity study (English PDF)

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 27 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 GB/T 15670-1995 compared with the cancer test part of 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,

7.2.3 and Chapter 8); - modified the requirements for the test substance (see 6.1.1,.1995 edition 17.5.1); - modified the requirements for laboratory animals (see 6.2.2,.1995, 17.3.3). 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 27. carcinogenic tests

1 Scope

GB/T 15670.27-2017 is the Chinese national standard on toxicological test methods for pesticides registration - part 27: carcinogenicity study, in the field of agriculture. The /T suffix marks it as a recommended standard: it is not compulsory by itself, but it becomes binding as soon as a contract, a tender or a customer specification calls it up - which in practice is how most foreign buyers meet it. It was issued on 12 July 2017 by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China, and has been in force since 1 February 2018. Classification: ICS 65.100, CCS B17. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the issuing body are taken from there. The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.

This part of GB/T 15670 specifies the basic principles, methods and requirements for carcinogenic trials. This section applies to carcinogenic tests 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 Chemical carcinogenesis Chemical substances cause tumor incidence and/or type of increase, the effect of shortening latency.

3.2 Chemical carcinogen chemicalcarcinogen Can make the body produce tumors, tumor incidence or tumor latency shortened chemical substances.

4 Purpose of the test

Through a certain way to give experimental animals of different doses of the test substance to observe the animals in the near life time tumor occurrence, To assess the chemical carcinogenic effects of long-term exposure to the test substance on animals.

5 Test Overview

The test substance was repeatedly administered orally, transdermally or via respiratory tract for most of the normal life cycle of the experimental animal. The number of tumors, type, place of occurrence, time of occurrence, and by histopathological examination to clarify whether the test substance is carcinogenic.

6 Test method

6.1 Test substance Before starting this test, you should be aware of the various materials available to the subject. Including the trade name and other names of the test substance (including CAS ), Physical, chemical, structural, molecular and relative molecular mass, storage methods, analytical methods and chemical stability of the test substance.