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GB/T 15670.20-2017Toxicological test methods for pesticides registration—Part 20: In vitro mammalian cell gene mutation test (English PDF)

农药登记毒理学试验方法 第20部分:体外哺乳动物细胞基因突变试验

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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 15670.20-2017 is the English-translated version of 农药登记毒理学试验方法 第20部分:体外哺乳动物细胞基因突变试验.

GB/T 15670.20-2017 is Part 20 of the Chinese series of toxicological test methods for pesticide registration, and it covers the in vitro mammalian cell gene mutation test.

It sets out the basic principles, methods and requirements of the test, which exposes mammalian cells cultured in vitro to the test substance to detect gene mutations, including base-pair substitutions, frameshift mutations and deletions, and so assess whether the substance can cause mutation.

Its terms define forward mutation, base-pair substitution mutagens, frameshift mutagens, phenotypic expression time and mutant frequency. It refers to Part 14 of the series, the bacterial reverse mutation test, and is used when test data are prepared for the registration of pesticides. It was issued on 12 July 2017 and has applied since 1 February 2018.

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Document preview — GB/T 15670.20-2017

National Standard of the People's Republic of China

ICS
65.100
Classification
B 17

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 20.

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

1 Scope

This section GB/T 15670 specifies the basic principles, methods and requirements of in vitro mammalian cell gene mutation tests.

This section applies to the registration of pesticides in vitro mammalian cell gene mutation 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/T 15670.14-2017 Pesticide registration Toxicological test methods Part 14: Bacterial back mutation test

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Forward mutation

Wild-type gene after mutation into a mutant gene process, this mutation can cause changes in enzymes and functional proteins.

3.2 Base substitutions mutagens

A substance that causes the replacement of one or more base pairs in a DNA molecule.

3.3 Frameshift mutagens

A substance that causes the DNA molecule to increase or lose one or more base pairs.

3.4 Phenotypic expression time

The time required for the newly mutated cells to exhaust the altered gene product.

3.5 Mutant frequency

The ratio of the number of mutant cells observed to the number of surviving cells.

4 Test purposes

This test is used to test the effect of the test substance on the gene mutation of mammalian cells cultured in vitro, including base pair mutation, frameshift mutation and Missing, etc. to evaluate the possibility of the test substance causing the mutation.

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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.

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