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Toxicological test methods for pesticides registration -- Part 23: Teratogenicity study
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Basic data Standard ID | GB/T 15670.23-2017 (GB/T15670.23-2017) | Description (Translated English) | Toxicological test methods for pesticides registration -- Part 23: Teratogenicity study | Sector / Industry | National Standard (Recommended) | Classification of Chinese Standard | B17 | Classification of International Standard | 65.100 | Word Count Estimation | 8,826 | Date of Issue | 2017-07-12 | Date of Implementation | 2018-02-01 | Older Standard (superseded by this standard) | GB/T 15670-1995 Partly | Quoted Standard | GB 14925 | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and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 teratogenic testing. This standard applies to teratogenic tests for pesticide registration. |
GB/T 15670.23-2017: Toxicological test methods for pesticides registration -- Part 23: Teratogenicity study ---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 23. Teratogenicity study
ICS 65.100
B17
National Standards of People's Republic of China
Partially replace GB/T 15670-1995
Pesticide registration Toxicology test methods
Part 23. Teratogenicity test
Part 23 .Teratogenicitystudy
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 23.
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 GB/T 15670-1995 teratogenic test section compared to the main changes are as follows.
--- Modify and adjust the standard of the overall structure and layout format;
--- Added some sections (see Chapter 1, Chapter 2, Chapter 3, Chapter 5, Chapter 6, 7.1 and Chapter 9);
--- Modify the requirements of experimental animals (see 7.2,.1995 edition of 15.3);
--- Modified dose and grouping (see 7.3,.1995 version 15.5);
--- In the body surface, visceral and skeletal items, the examination item list is deleted (see 7.4.4.2, 7.4.4.3 and 7.4.4.4.1995
Version 15.9.3 and 15.9.4);
--- Visceral and skeletal observation, an increase of the observation program, bone staining methods and rabbit visceral observation and bone observation content (see
7.4.4.3 and 7.4.4.4.4,.1995 edition 15.9.4).
This part is proposed and managed by the Ministry of Agriculture of the People's Republic of China.
This part of the drafting unit. Ministry of Agriculture pesticide test.
The main drafters of this section. Li Ning, Zhang Liying, Tao Chuanjiang.
This part replaces the standards previously issued as.
--- GB/T 15670-1995.
Pesticide registration Toxicology test methods
Part 23. Teratogenicity test
1 Scope
GB/T 15670 provisions of this part of the teratogenicity test the basic principles, methods and requirements.
This section applies to pesticide registration teratogenicity 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
Teratogenicity
The characteristics of chemicals that cause permanent structural and functional abnormalities in offspring during embryonic development.
3.2
Maternal toxicity
Cause direct or indirect effects of health damage on the parent female pregnancy animal.
4 test purposes
Detection of gestational animal exposure to test substance caused by the generation of teratogenic potential.
5 Test Overview
Sexually matured female animals are mated with male animals, pregnant women are randomly assigned to each dose group,
Pregnancy animal embryonic developmental organism given to the test substance exposure, and the offspring are expected to be born before the birth of the mother, remove the uterus, check the absorption
Fetal, live, stillbirth and fetal appearance, visceral and skeletal deformities.
6 instruments and reagents
6.1 Instrument
Laboratory equipment, biological microscopes and stereomicroscopes, vernier caliper (scale) and so on.
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