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GB/T 15670.29-2017: Toxicological test methods for pesticides registration -- Part 29: Metabolism and toxicokinetic study
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Toxicological test methods for pesticides registration -- Part 29: Metabolism and toxicokinetic study
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GB/T 15670.29-2017
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Basic data | Standard ID | GB/T 15670.29-2017 (GB/T15670.29-2017) | | Description (Translated English) | Toxicological test methods for pesticides registration -- Part 29: Metabolism and toxicokinetic study | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | B17 | | Classification of International Standard | 65.100 | | Word Count Estimation | 13,133 | | Date of Issue | 2017-07-12 | | Date of Implementation | 2018-02-01 | | Older Standard (superseded by this standard) | GB/T 15670-1995 Partly | | Quoted Standard | GB 14925 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection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 metabolic and toxicological tests. This standard applies to metabolic and toxicokinetic tests for pesticide registration. | GB/T 15670.29-2017: Toxicological test methods for pesticides registration -- Part 29: Metabolism and toxicokinetic study
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Toxicological test methods for pesticides registration. Part 29. Metabolism and toxicokinetics 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 29. Metabolic and toxicokinetic tests
Part 29.Metabolismandtoxicokineticsstudy
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 29.
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 toxicokinetic test part compared to the main changes are as follows.
--- Modify and adjust the overall structure and layout format;
--- Added "Normative references" (see Chapter 2);
--- Added "terms and definitions", especially terms and definitions on toxicokinetics (see Chapter 3);
--- Detailed description of the purpose of the experiment (see Chapter 4);
--- The test substance made a clear request, pointed out that if the use of radioactive isotope labeled test substance, only observed in biological samples of the total release
The dynamic change of radioactivity, since it is not possible to determine what the chemical was measured, in addition to obtaining a total radioactivity
Except for the apparent elimination of half-periods, all other toxicokinetic parameters may not be reliable, and any conclusions that may be drawn therefrom must be held
Cautious attitude (see 6.1,.1995 edition 20.4.2);
--- Proposed biological samples and/or their metabolites in the separation and determination of the establishment of the method is toxicokinetic test before
As far as possible, should be used as far as possible to detect a specific test substance and/or its metabolite prototype method, but also pointed out the use of radioactive
The advantages and limitations of isotope labeling of test substances for toxicokinetic testing (see 6.3);
--- Exposure routes In addition to intravenous injection and oral exposure, increased transdermal and inhalation exposure, and made the corresponding requirements (see 6.4.2,
1995 version 20.3);
--- Added "biological sample collection", the sampling time, observation period, sampling approach, sampling methods, sampling and other requirements
(See 6.5);
--- With the "observation item" instead of the original "test steps", respectively, the basic characteristics of toxicokinetics analysis, absorption, distribution, excretion and elimination
In addition to the biological conversion into observation targets, specific test steps have been proposed that enhance the workability of metabolic and toxicokinetic tests
Sex, and provide richer, more comprehensive scientific data and information to elucidate the metabolic and toxicokinetic characteristics of pesticides (see para. 7
Chapter,.1995 edition of 20.5);
--- Increase the "research time", the different stages of the toxicology of pesticides proposed a reasonable arrangement of metabolism and toxicokinetic test
(See Chapter 8);
--- Increase the "test report" content requirements (see Chapter 10).
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. Zhang Baozhen, Zhang Liying, Tao Chuanjiang.
This part replaces the standards previously issued as.
--- GB/T 15670-1995.
Pesticide registration Toxicology test methods
Part 29. Metabolic and toxicokinetic tests
1 Scope
This section GB/T 15670 specifies the basic principles, methods and requirements of metabolic and toxicokinetic tests.
This section applies to the registration of pesticides for metabolic and toxicokinetic tests.
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
Toxicokinetics
Study of chemical substances in the body of quantitative laws of science. From the point of view of speed theory, it studies the absorption, distribution and biology of chemical substances
Transformation and excretion of quantitative changes in the law over time, using mathematical models to systematically analyze and clarify the location of chemical substances in the body, the number
And the relationship between time to explore the relationship between this kinetic process and the intensity of poison and time.
3.2
Speed rate
Changes in the amount or concentration of chemicals transported or eliminated by a body or a body within a unit of time, expressed in dx/dt. For constant speed
Process, available average speed Δx/Δt said. The unit is mg · h-1 or μg · min-1.
3.3
Rate constant rateconstant
The ratio of the rate at which a chemical substance is transported or eliminated at a part of the body or body to the amount or concentration of a chemical substance at that part of the body, ie (dx/dt) /
X. The unit is the reciprocal of hours h-1 or min-1.
3.4
Zero speed process zeroorderrateprocess
The rate at which chemicals are transported or eliminated is proportional to the zero power of the amount or concentration of the chemical, ie (dx/dt) = KX0. because
X0 = 1, so (dx/dt) = K, that is zero-speed process is a constant speed process, regardless of the amount or concentration of chemical substances available speed
measure.
3.5
A first-rate process firstorderrateprocess
The rate at which chemicals are transported or eliminated is proportional to the square of the amount or concentration of chemical, ie (dx/dt) = KX1, the available rate
The constant is used as the inverse of hours h-1 or min-1.
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