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GB/T 15670.17-2017Toxicological test methods for pesticides registration—Part 17: Mammalian spermatogonial/spermatocyte chromosome aberration test (English PDF)

农药登记毒理学试验方法 第17部分:哺乳动物精原细胞/精母细胞染色体畸变试验

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

July 12, 2017

Implementation date

February 1, 2018

Scope

GB/T 15670.17-2017 is the English-translated version of 农药登记毒理学试验方法 第17部分:哺乳动物精原细胞/精母细胞染色体畸变试验.

GB/T 15670.17-2017 is the part of the Chinese toxicological test methods for pesticide registration that covers the mammalian spermatogonial and spermatocyte chromosome aberration test.

It sets the basic principles, methods and requirements of the test, whose purpose is to detect chromosome aberrations caused by a test substance in mammalian germ cells and so assess whether it may cause genetic mutations in germ cells.

It defines chromatid-type and chromosome-type aberrations, gaps, polyploidy and chromosome structural aberrations, and deals with the test animals, dose levels and grouping, exposure and the operating procedure, with animal facilities referred to GB 14925.

Laboratories that generate toxicology data for pesticide registration use it. It is one of 29 parts of GB/T 15670 and partly replaces GB/T 15670-1995. It was issued on 12 July 2017 and has applied since 1 February 2018.

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Document preview — GB/T 15670.17-2017

National Standard of the People's Republic of China

ICS
65.100
Classification
B 17
Replacing
GB/T 15670-1995

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Test purposes

Foreword

GB/T 15670 "pesticide registration toxicology test method" is divided into the following sections.

--- Part 1. General principles;

--- Part 2. Acute oral toxicity test Horn's method;

--- Part 3. Acute oral toxicity test sequential method;

--- Part 4. Acute oral toxicity test probability unit method;

--- Part 5. Acute dermal toxicity test;

--- Part 6. Acute inhalation toxicity test;

--- Part 7. Skin irritation/corrosivity test;

--- Part 8. Acute eye irritation/corrosiveness test;

--- Part 9. Skin allergy (sensitization) test;

--- Part 10. Short-term repeated oral toxicity (28 days) toxicity test;

--- Part 11. Short-term repeated transdermal (28 days) toxicity test;

--- Part 12. Short-term repeated inhalation exposure (28 days) toxicity test;

--- Part 13. Subchronic toxicity test;

--- Part 14. bacterial recovery mutation test;

--- Part 15. In vivo mammalian bone marrow polychromatic erythrocyte micronucleus test;

--- Part 16. In vivo mammalian bone marrow cell chromosome aberration test;

--- Part 17. Mammalian spermatogonial/spermatocyte chromosome aberration test;

--- Part 18. Rodent dominant lethality test;

--- Part 19. In vitro mammalian chromosome aberration test;

--- Part 20. In vitro mammalian cell gene mutation test;

--- Part 21. In vivo mammalian hepatocyte extracellular DNA synthesis (UDS) test;

--- Part 22. DNA damage and repair in vitro mammalian cells/DNA synthesis test outside the program;

--- Part 23. Teratogenicity test;

--- Part 24. Two generations of reproductive toxicity test;

--- Part 25. Acute delayed neurotoxicity test;

--- Part 26. Chronic toxicity test;

--- Part 27. Carcinogenicity test;

--- Part 28. Chronic toxicity and carcinogenicity combined test;

--- Part 29. Metabolism and toxicokinetic tests.

This section GB/T 15670 Part 17.

This section drafted in accordance with GB/T 1.1-2009 given rules.

Part of this section instead of GB/T 15670-1995 "pesticide registration toxicology test methods."

This section GB/T 15670-1995 mouse testicular spermatozoon chromosome aberration test section compared to the main changes are as follows.

--- Modify the test name of this section;

--- Modify and adjust the standard of the overall structure and layout format;

--- Added some chapters (see Chapter 1, Chapter 2, Chapter 3, Chapter 4, Chapter 5, Chapter 7.1 and Chapter 9);

--- Revised animal requirements (see 7.2, 1995 edition 14.6.2);

--- Modify the dosage and grouping requirements (see 7.3, 1995 edition 14.6.3);

--- Modify the method of exposure (see 7.1.4.1, 1995 edition 14.6.4);

--- Modify the operating procedures (see 7.4, 1995 version 14.6.5).

1 Scope

GB/T 15670 provisions of this part of the mammalian spermatogonial/spermatocyte chromosome aberration test the basic principles, methods and Claim.

This section applies to mammalian registration of pesticides spermatogonia/spermatocyte chromosome aberration test.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB 14925 laboratory animal environment and facilities

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Chromatid-type aberration

Chromosomal structural damage, manifested as chromatid fragmentation or chromatid fragmentation and reorganization of the injury.

3.2 Chromosome-type aberration

Chromosomal structural damage is manifested by a change in cleavage or cleavage at the same site of both chromatids.

3.3 Gap

Chromosomes and chromatids have lesion lengths less than the width of one chromatid, the smallest misordered arrangement of chromatids.

3.4 Polyploid

The number of chromosomes in mammalian cells is normally diploid, and the number of chromosomes increases exponentially with the action of chemical mutagens such as triple Body, tetraploid and so on.

3.5 Chromosomal structure aberration

Microscopic observation of the cell division metaphase structural changes, such as chromosomal deletion, chromosomal exchange and internal exchange.

4 Test purposes

Detection of test substances caused by mammalian germ cell chromosome aberration effect to evaluate the test substance causes germ cell genetic mutations may […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

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Editions of GB/T 15670.17

EditionTitleRevisionStatus
GB/T 15670.17-2017Toxicological test methods for pesticides registration—Part 17: Mammalian spermatogonial/spermatocyte chromosome aberration testcurrent editionCurrent
GB/T 15670-1995Toxicological test methods for pesticides registration—Part 17: Mammalian spermatogonial/spermatocyte chromosome aberration testprevious editionSuperseded

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