GB/T 15670.24-2017Toxicological test methods for pesticides registration—Part 24: Two-generation reproduction toxicity 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 24 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 with the two generations of breeding test compared to the main changes are as follows.

- to modify and adjust the overall structure of the standard and the format of the arrangement;

- Added part of the chapter (see Chapter 1, Chapter 2, Chapter 3, Chapter 5, 6.1, 6.2.3 and Chapter 8);

- modified the requirements for laboratory animals (see 6.2, 16.4 of 1995);

- modified dose and grouped content (see 6.3, 16.5 of 1995);

- modified the contents of the observation indicators (see 6.4.4, 1995 edition 16.11).

This part of the People's Republic of China Ministry of Agriculture made and centralized.

1 Scope

This part of GB/T 15670 specifies the basic principles, methods and requirements for the two generations of reproductive toxicity tests.

This section applies to two generations of reproductive toxicity 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 document. 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.

4 Purpose of the test

Used to detect the impact of the test substance on female and male animal reproductive function, such as gonadal function, estrous cycle, mating behavior, pregnancy, childbirth, Breastfeeding and weaning and the growth and development of offspring. And may provide information on the developmental toxicity of the test substance, such as birth defects, death and abnormalities Shape and so on.

5 Test Overview

The male and female animals were divided into several dose groups, in order to evaluate the effect of the test substance on the sperm production, the exposure period is the parent male animal (P) to Less covering a complete sperm formation cycle (mice about 56 days, rats about 70 days). The parental female (P) animal has at least two complete hairs Love cycle. Thereafter, the mating animals (P) were given the test substance, and the female parent continued to administer the test substance until the F1 generation of weaning during pregnancy. F1 break After the milk, the test substance was continuously administered from the offspring of F1, adolescence, mating, generation F2 of the offspring until the F2 generation weaned to evaluate the test Two generations of reproductive toxicity effects.