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Basic dataStandard ID: GB/T 15670.1-2017 (GB/T15670.1-2017)Description (Translated English): Toxicological test methods for pesticides registration -- Part 1: General principles Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: B17 Classification of International Standard: 65.100 Word Count Estimation: 9,957 Date of Issue: 2017-07-12 Date of Implementation: 2018-02-01 Quoted Standard: GB 14923; GB/T 14924.1; 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 principles, test contents and safety evaluation of pesticide registration toxicology tests. This standard applies to toxicological tests for pesticide registration. GB/T 15670.1-2017: Toxicological test methods for pesticides registration -- Part 1: General principles---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 1.General principles ICS 65.100 B17 National Standards of People's Republic of China Pesticide registration toxicology test method Part 1.General Provisions 2017-07-12 released 2018-02-01 Implementation General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Issued by China National Standardization Administration ForewordGB/T 15670 "Pesticide Registration Toxicology Test Method" is divided into the following parts. ---Part 1.General Provisions; ---Part 2.Horn's method for acute oral toxicity test; ---Part 3.Sequential method of acute oral toxicity test; ---Part 4.Probability unit method of acute oral toxicity test; ---Part 5.Acute dermal toxicity test; ---Part 6.Acute inhalation toxicity test; ---Part 7.Skin irritation/corrosion test; ---Part 8.Acute eye irritation/corrosion 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 reverse 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.Chromosome aberration test of mammalian spermatogonia/spermocytes; ---Part 18.Rodent Dominant Lethal Test; ---Part 19.In vitro mammalian cell chromosome aberration test; ---Part 20.In vitro mammalian cell gene mutation test; ---Part 21.In vivo unscheduled DNA synthesis (UDS) test of mammalian liver cells; ---Part 22.In vitro mammalian cell DNA damage and repair/extraprocedural DNA synthesis test; ---Part 23.Teratogenicity test; ---Part 24.Two-generation reproduction toxicity test; ---Part 25.Acute delayed neurotoxicity test; ---Part 26.Chronic toxicity test; ---Part 27.Carcinogenicity test; ---Part 28.Chronic toxicity and carcinogenic combined test; ---Part 29.Metabolism and toxicokinetics test. This part is Part 1 of GB/T 15670. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part is proposed and managed by the Ministry of Agriculture of the People's Republic of China. Drafting unit of this section. Pesticide Inspection Institute of Ministry of Agriculture. The main drafters of this section. Xu Haibin, Ye Jiming, Wei Qiwen, Qin Yuhui, Tao Chuanjiang, Zhang Liying, Li Shuang, Qu Luluo, Tao Lingmei. Pesticide registration toxicology test method Part 1.General Provisions1 ScopeThis part of GB/T 15670 specifies the principle requirements, test content and safety evaluation of pesticide registration toxicology test. This section applies to toxicological tests for pesticide registration.2 Normative referencesThe following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB 14923 Laboratory Animals Genetic Quality Control of Mammals Laboratory Animals GB/T 14924.1 General quality standard for compound feed for laboratory animals GB 14925 Laboratory Animal Environment and Facilities3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Pesticide Used to prevent, eliminate or control diseases, pests, grasses and other harmful organisms that endanger agriculture and forestry, and to regulate plants and insects purposefully The chemical synthesis of growth or a substance or a mixture of several substances derived from biological or other natural substances and their preparations. 3.2 Active ingredient The biologically active part of the original drug or preparation. 3.3 Technicalmaterial The final product composed of active ingredients and impurities directly obtained in the production process. 3.4 Preparation The effective ingredients of pesticides can effectively achieve the so-called control effect and the pesticide processing form with certain components. 3.5 Testsubstances The single chemical or mixture being tested. 3.6 Allowable daily intake; ADI Human beings consume a certain substance daily throughout their lives without producing detectable estimates of health hazards. Ingestible scale per kilogram of body weight Show, the unit is mg/kg body weight. 3.7 Target organ An organ that causes a significant toxic effect in the body. 3.8 Dose The amount of the test substance given is expressed by the mass of the test substance received per unit body weight of the experimental animal (mg/kg body weight). 3.9 Medianlethaldose LD50 The statistical dose of the toxicant that caused half of the deaths of the experimental animals after one time or multiple administrations of the test substance within 24 hours. Expressed by the weight of the test substance per unit body weight of the experimental animal (mg/kg body weight). 3.10 Dose-responserelationship The relationship between dose and the incidence of specific effects. 3.11 Dose-effect relationship Within a certain range, the relationship between dose increase and decrease and effect size change. 3.12 No adverse effects observed Dose level noobservedadverseeffectlevel; NOAEL Under the specified test conditions, using the existing technical means and detection indicators, the test substance that failed to observe the harmful effects related to the poisoning is the most High dose or concentration. 3.13 The lowest dose level of adverse effects observed lowest observedadverseeffectlevel;LOAEL Under the specified test conditions, using existing technical means and detection indicators, the lowest dose of the test substance with harmful effects related to the poisoning Amount or concentration. 3.14 Laboratoryanimal After artificial feeding, the microorganisms they carry are controlled, and the genetic background is clear or the source is clear, and it is used for scientific research, teaching, and health. Animals for production, verification and other scientific experiments.4 Principles and requirements of pesticide toxicology test4.1 Basic principles of experimental design 4.1.1 The basic principles of toxicology trial design. there should be a control group with repeatability, follow the principle of random sampling, and have uniformity. Balance. 4.1.2 Control group. In addition to the animals in the control group, the other conditions should be the same as those in the test group (exposed group). The control group is divided into blank pair There are three types of control, solvent or vehicle control and positive (standard or effective) control. All or part of the control is selected according to the specific test. To observe The dose-response and (or) dose-response relationship needs to be compared between the exposure groups. 4.1.3 Repetition. It has two meanings. One means that there should be a certain number of animals in the poisoned group and the control group. The more individuals repeat, the more individuals can be reduced. The error caused by the difference; another meaning is that the experiment carried out according to the same experimental design, different laboratories or the same laboratory Repeatability of the same test over time should be able to obtain approximate results. 4.1.4 Randomization. It is an important means to reduce systematic errors in toxicology tests. It is necessary to group animals and select test subjects in operational links. This principle must be applied. 4.1.5 Balance. To evaluate the effects of different factors at the same time, pay attention to the balance of the design, and compare each group (control group and test group) The other known reasons that may affect the response in this article should be as homogeneous as possible. 4.2 Test substance 4.2.1 The basic information and properties of the test substance should be mastered before the test, including but not limited to the following. ---Product name and dosage form; ---Common name of active ingredients (Chinese and English); ---Chemical Name; ---Chemical Structure; ---Product composition (name and content of active ingredients and other ingredients); ---Physical and chemical properties (appearance, vapor pressure, solubility, boiling point, melting point, hydrolysis, density, viscosity, corrosivity, optical rotation, explosiveness, and Other pesticide compatibility) etc. 4.2.2 The relevant information about the production, processing, storage and use of the test substance should be understood, including the production process and method of the original drug, and the addition of the preparation. Industrial production method and process, application method, application range and dosage, etc. 4.2.3 For the formulated feed used in the animal feeding test, the uniformity, stability and content of the test substance shall be determined, and the test report shall be included. Provide the necessary description. 4.2.4 When conducting different tests, special treatment should be carried out according to the characteristics of the test, and the solvent, emulsifier or auxiliary suitable for the test substance should be selected. Suspension. The selected solvent, emulsifier or suspending agent itself should not produce toxic effects, and there should be no chemical reaction with each component of the test substance, and it should be guaranteed Maintain its stability. Generally, distilled water, edible oil, starch, gelatin, sodium carboxymethyl cellulose, etc. can be used. 4.3 Experimental animals 4.3.1 The preferred experimental animal should be that its biochemical transport of the test substance is similar to that of the human body. If this information is not available, a sensitive experimental animal should be selected. Test animals. 4.3.2 Experimental animals shall meet the relevant requirements of GB 14923.When carrying out animal experiments, the relevant Claim. 4.3.3 Experimental animal feed should meet the relevant requirements of GB 14924.1.Vegetables and fruits used directly as feed must be cleaned and disinfected. The drinking water of laboratory animals raised in the barrier and isolation environment should be sterilized. 4.3.4 The litter of experimental animals should be treated according to the needs of different grades of experimental animals, so as to be clean, dry, absorbent, and free of water. Poisonous, insect-free, no source of infection, no pollution, etc. 4.3.5 Experimental animal breeding, production and experimental environmental conditions and facilities should meet the relevant requirements of GB 14925. 4.4 Route of exposure To evaluate the safety of pesticides, it is necessary to combine the characteristics of pesticide use. Toxicological tests are conducted under simulated human exposure conditions, so the experimental The route of exposure to the substance should be as consistent as the route of human exposure. Humans can be exposed through the respiratory tract, digestive tract (such as food and drinking water), skin The three methods of exposure to pesticides are generally applicable to pesticide registration toxicology tests. 4.5 Number of groups and dose 4.5.1 Generally, at least three exposure dose groups and a control group should be set up in the overall animal experiment. The control group should not be given the test substance. The treatment method should be the same as that of the exposure dose group. For some reason, the test substance used some unknown toxicity solvent, emulsifier or suspension If it is an agent, a blank control and the solvent, emulsifier or suspending agent control should be set at the same time. In vitro tests can generally set more than three effective doses. 4.5.2 The dose should be set according to the principle of gradual and orderly progress, that is, acute toxicity test provides dose design basis for subchronic toxicity test, and the latter It also provides dose design basis for chronic toxicity test. If the dose design of the stepwise trial is exceeded, it may cause errors in the dose design and affect Affect the evaluation of the test substance. In the repeated exposure test with three dose groups, the animals in the high-dose group should have obvious toxic effects. Generally, death should not occur; animals in the low-dose group should not have any toxic effects, but should be higher than the actual exposure level of humans; animals in the middle-dose group can be There is a mild toxic effect. 4.6 Limit test Since the exogenous test substance will cause health hazards under excessive exposure, but the toxicology test is based on the human body under the maximum exposure conditions (more It is not necessary to simulate the situation to observe whether harmful effects occur. When the purpose of safety evaluation has been met, it is not necessary Conduct multiple dose groups of toxicology tests, only one dose group test can show that the test substance "exists" or "does not exist" a certain toxicity The toxicity test of this single-dose group is a limit test. 4.7 Test quality control Laboratory management should meet the requirements of relevant national regulations, standards and norms, and encourage the compliance with good laboratory practices (goodlabo- To carry out pesticide registration toxicology test under the conditions of ratorypractice, GLP). 4.8 "3R" principle To understand and consider “replacement”, “reduction” and “refine- ment)” (ie, “3R”) principle, under the premise of protecting human health, taking into account animal welfare.5 The content of pesticide toxicology test5.1 Acute toxicity test Acute toxicity refers to a single dose or multiple doses within 24 hours after oral exposure or skin contact with the test substance, or 4 hours after inhalation contact Now the harmful effects. According to the acute toxicity test LD50 (LC50) for toxicity classification, the toxicity intensity of the test substance can be determined. Obtained real The type, nature, dose-response relationship and possible target organs of the animal's toxic effects can be tested for the dose and toxicity of further toxicity tests. Provide basis for the selection of observation indicators. 5.2 Skin and eye irritation test For the test substance that may come into contact with the skin and eyes, it is necessary to study these local toxic effects. If the test substance has a corrosive effect on the skin, In principle, no eye irritation test is necessary. 5.3 Skin sensitization test Since percutaneous contact with allergens can cause allergic reactions, the sensitization data of the test substance can be obtained by detecting the skin sensitization of the test substance. Predict whether the population may have allergic reactions, and put forward the necessary protective measures. 5.4 Short-term repeated exposure toxicity and subchronic toxicity test The most common condition of human exposure to the test substance is repeated exposure or long-term exposure. Due to the accumulated toxicity of the test substance or other mechanisms, Lead to delayed toxicity, short-term repeated exposure toxicity test and subchronic toxicity test should be carried out. On the basis of general toxicity test dose design, According to the actual situation of the test substance and the request of the client, additional dose groups can be added. The current definition of "subchronic" means that the exposure period is about 10% of the lifespan of experimental animals. Short-term repeated poisoning Sex tests, the most representative ones are the 14d and 28d tests. Subchronic toxicity test, 90 days for rats, 52 weeks for dogs Poisoned. Generally speaking, the longer the exposure time, the more toxicity data may be obtained. Well-designed short-term repeated exposure toxicity test and sub-slow Sexual toxicity test should obtain toxic effects, target organs, reversibility, lowest dose level (LOAEL) or no harmful effects observed Toxicity data such as NOAEL. In the safety toxicology evaluation test, the 90d subchronic toxicity test has become a common The subchronic toxicity test. 5.5 Genotoxicity test 5.5.1 Genotoxicity test is used to detect the genetic damage directly or indirectly caused by different mechanisms of the test substance. Germ cell mutations may cause Dominant lethal or hereditary diseases, somatic mutations may cause cancer. 5.5.2 The principles of the genetic toxicity test combination are. a) Include multiple genetic end points; b) Test indicator organisms include prokaryotes and eukaryotes; c) Including in vivo tests and in vitro tests. 5.5.3 The genetic toxicity standard test combination includes. a) Bacterial reverse mutation test; b) In vitro mammalian cell gene mutation test; c) In vitro mammalian cell chromosome aberration test; d) In vivo micronucleus test of mammalian bone marrow cells. When a)~c) test has a positive result, and d) is negative, another in vivo test should be added (optional in vivo lactation). DNA synthesis test outside the liver cell procedure or other tests). When a)~c) test is negative, and d) is positive, then Increase in vivo mammalian germ cell chromosomal aberration test or dominant lethal test. 5.5.4 Changes or additions to the genetic toxicity standard test combination. a) When the bacterial reverse mutation test is not suitable, if the test substance has obvious bacterial toxicity (such as antibiotics), or the test is known or suspected When substances interfere with the DNA replication system of mammalian cells (e.g. topoisomerase inhibitors, nucleoside analogues, DNA metabolism inhibition 物), can use in vitro mammalian cell gene mutation test. In this case, use two different mammalian cell lines for Detection of genetic mutations. b) When the result of the test substance in the standard test combination is positive, and the test substance with similar structure gets a negative result, it should be supplemented Other tests. c) The in vivo test in the standard test combination is not suitable for certain test substances, such as toxicokinetics data indicating that it is not absorbed or not To reach the target tissue (such as bone marrow), other methods should be used. 5.6 Teratogenicity test Exposure to a test substance with teratogenic effects during pregnancy may affect embryonic development, cause abnormal organ differentiation, and cause morphological changes. Functional defects, fetal malformations. After the embryo of a conceived animal is implanted, it has begun to enter the cell and organ differentiation phase, or organ differentiation to The test substance is given to the whole organ formation process, which can predict the teratogenic effect or embryo toxicity of the test substance on the fetus. 5.7 Reproductive toxicity test Where the test substance can cause reproductive dysfunction, interfere with the formation of gametes or damage germ cells, the result is not only affecting the implantation of the fertilized egg. In addition to causing infertility, it can still affect the occurrence and development of embryos, such as embryonic death leading to spontaneous abortion, embryonic development retardation and embryo malformation. in case Unfavorable effects on the mother will resul......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 15670.1-2017_English be delivered?Answer: Upon your order, we will start to translate GB/T 15670.1-2017_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 15670.1-2017_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 15670.1-2017_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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