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Toxicological test methods for pesticides registration -- Part 9: Skin sensitisation test
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GB/T 15670.9-2017
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Basic data | Standard ID | GB/T 15670.9-2017 (GB/T15670.9-2017) | | Description (Translated English) | Toxicological test methods for pesticides registration -- Part 9: Skin sensitisation test | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | B17 | | Classification of International Standard | 65.100 | | Word Count Estimation | 10,173 | | Date of Issue | 2017-07-12 | | Date of Implementation | 2018-02-01 | | Older Standard (superseded by this standard) | GB/T 15670-1995 Partly | | Quoted Standard | GB 14925 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This standard specifies the basic principles, methods and requirements for skin allergy (sensitization) tests. This standard applies to skin allergies (sensitization) tests for pesticide registration. |
GB/T 15670.9-2017: Toxicological test methods for pesticides registration -- Part 9: Skin sensitisation test ---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Toxicological test methods for pesticides registration. Part 9. Skin sensitisation test
ICS 65.100
B17
National Standards of People's Republic of China
Partially replace GB/T 15670-1995
Pesticide registration Toxicology test methods
Part 9. Skin allergy (sensitization) test
Part 9.Skinsensitisationtest
2017-07-12 Posted
2018-02-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
China National Standardization Administration released
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).
This part is proposed by the Ministry of Agriculture of the People's Republic of China.
This part of the People's Republic of China Ministry of Agriculture Planting Management Center.
This part of the drafting unit. Ministry of Agriculture pesticide test.
The main drafters of this section. Zhang Hongwei, Zhang Liying, Qu ็ ็, Tao Chuanjiang.
This part replaces the standards previously issued as.
--- GB/T 15670-1995.
Pesticide registration Toxicology test methods
Part 9. Skin allergy (sensitization) test
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 article
Pieces. 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 skinsensitization
Allergic contact dermatitis alergiccontactdermatitis
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
Induced contact inductionexposure
The body is exposed to the test substance to induce an experimental allergic condition.
3.3
Induction stage inductionperiod
The time required for the body to induce an allergic condition by exposure to the test substance, usually at least 1 week.
3.4
Excite contact with chalengeexposure
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 stimulationindex; 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 < RTI ID = 0.0> deoxythymidine < / RTI> 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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