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GB/T 15670.9-2017Toxicological test methods for pesticides registration—Part 9: Skin sensitisation test (English PDF)

农药登记毒理学试验方法 第9部分:皮肤变态反应(致敏)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 15670.9-2017 is the English-translated version of 农药登记毒理学试验方法 第9部分:皮肤变态反应(致敏)试验.

GB/T 15670.9-2017 is the part of the Chinese toxicological test methods for pesticide registration that covers the skin sensitisation test. It sets the basic principles, methods and requirements for determining whether repeated skin exposure to a pesticide causes allergic reactions in mammals, and to what extent.

It defines skin sensitisation, or allergic contact dermatitis, induction exposure, induction period, challenge exposure and the stimulation index, and deals with the test animals, positive and negative controls and the evaluation of results, and this edition adds the guinea pig maximisation test and the mouse local lymph node assay, and refers animal facilities to GB 14925.

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 15670.9-2017

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 9.

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 and the GB/T 15670-1995 skin allergy (sensitization) test section compared to the main changes are as follows.

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

--- Added some chapters (see Chapter 1, Chapter 2, Chapter 3, Chapter 5, 6.1, 6.2, 6.3.3.4, 6.3.3.6, 6.4, 6.5 and Chapter 7);

--- Modify the requirements for experimental animals (see 6.3.1, 1995 edition 7.3);

--- Modify the requirements for the setting of positive and negative controls (see 6.3.5.5, 1995 edition 7.5.2);

--- Modify the results of the assessment (see 6.3.4, 1995 version 7.6);

--- Increased guinea pig maximum test and mouse lymph node analysis test two test methods (see 6.4,6.5).

1 Scope

This section GB/T 15670 specifies the skin allergy (sensitization) test the basic principles, methods and requirements.

This section applies to the registration of pesticides for skin allergy (sensitization) 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 Skin allergy; allergic contact dermatitis

Immunogenic skin reaction of a substance to the skin. This reaction in humans may be itching, erythema, papules, blisters, blisters fusion For the characteristics. Different animal reactions may only see the skin erythema and edema.

3.2 Induction exposure

The body is exposed to the test substance to induce an experimental allergic condition.

3.3 Induction period

The time required for the body to induce an allergic condition by exposure to the test substance, usually at least 1 week.

3.4 Challenge exposure

The body receives a tentative exposure to the test substance after it has been exposed to induce exposure to determine whether the skin will develop an allergic reaction.

3.5 Stimulation index (SI)

The binding values of 3H-methyl thymidine or 125I-iodide in the experimental group were similar to those of the control group (solvent or vehicle)

The ratio (rate) of the binding values of deoxythymidine or 125I-iodide.

4 Test purposes

Determine whether repeated exposure to test substances can cause skin allergies in mammals and their extent.

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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

Similar standards

Editions of GB/T 15670.9

EditionTitleRevisionStatus
GB/T 15670.9-2017Toxicological test methods for pesticides registration—Part 9: Skin sensitisation testcurrent editionCurrent
GB/T 15670-1995Toxicological test methods for pesticides registration—Part 9: Skin sensitisation testprevious editionSuperseded

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