GB/T 15670.10-2017Toxicological test methods for pesticides registration - Part 10: Short-term repeated dose 28-day oral toxicity study (English PDF)

1 Scope

GB/T 15670.10-2017 is the Chinese national standard on toxicological test methods for pesticides registration - part 10: short-term repeated dose 28-day oral toxicity study, in the field of agriculture. The /T suffix marks it as a recommended standard: it is not compulsory by itself, but it becomes binding as soon as a contract, a tender or a customer specification calls it up - which in practice is how most foreign buyers meet it. It was issued on 12 July 2017 by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China, and has been in force since 1 February 2018. Classification: ICS 65.100, CCS B17. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the issuing body are taken from there. The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.

This Part of GB/T 15670 specifies the basic principles, methods, requirements for short- term repeated dose 28-day oral toxicity study. This Part applies to short-term repeated dose 28-day oral toxicity study, for pesticide registration.

2 Normative references

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this standard.

GB 14925 Laboratory animal - Requirements of environment and housing facilities

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Short-term repeated dose oral toxicity Health-damaging effects, which are caused by repeated oral administration of the test substance for a period shorter than 10% of the life span of the experimental animal.

3.2 No observed adverse effect level; NOAEL Under the specified test conditions, using existing technical means and detection indicators, the highest dose or concentration of the test substance, at which harmful effects related to poisoning cannot be observed.

3.3 Lowest observed adverse effect level; LOAEL Under the specified test conditions, using existing technical means and detection indicators, the lowest dose or concentration of the test substance, at which harmful effects related to poisoning are observed.

3.4 Target organ Organs, in which the test substance causes significant toxic effects in the body.

4 Test purpose

Through short-term repeated dose 28-day oral toxicity study, determine the toxic effects, which are caused by repeated oral exposure to the test substance in a short period of time; preliminarily understand the toxicological characteristics, dose-response relationship and target organs of the test substance; obtain the non-observed adverse effect dose level (NOAEL) and the lowest observed adverse effect dose level (LOAEL), so as to provide a basis for the selection of sub-chronic and chronic toxicity test doses and observation indicators.

5 Test overview

The experimental animals are repeatedly orally exposed to the poison for 28 days, in a short period of time. Observe the toxic reactions of the animals. Weigh the body weight and calculate food intake, regularly. Measure the hematological indicators, blood biochemical indicators, histopathological examination indicators, etc., to evaluate the short-term repeated intake toxicity of the test substance, thereby initially determining the dose and target organs of the harmful effects, which are caused by the test substance in animals.

6 Test methods

6.1 Preparation of test substance When the test substance is mixed into feed or drinking water, in order to ensure the uniformity and stability of the preparation of the test substance, it shall measure the stability, content, uniformity. The concentration fluctuation in the feed or drinking water shall be within ±15% of the theoretical concentration; it will not affect the nutritional quality and water balance of the feed. The amount added into the feed shall not exceed 5% of the feed concentration. When the test substance is added to feed or water to affect the palatability of animals, the test substance shall be administered orally. When injecting poison into the stomach, the test substance shall be dissolved or suspended in

6.3.3 Limit test If it is expected that the dose of 1000 mg/kg body weight is unlikely to produce any toxic effects, OR it is predicted that it will not produce toxicity based on the structure, there is no need to set three doses.

6.4 Routes of exposure The test substance can be mixed into feed or drinking water, OR administered by gavage. Animals shall be exposed to the poison for 7 days per week. If the gavage method is used, the gavage method shall be administered once a day at the same time and place; the amount of gavage shall be adjusted regularly, according to the body weight (the body weight shall be weighed twice a week for adjustment), to maintain the dose of the exposure constant. The intragastric volume generally does not exceed 10 mL/kg body weight. The maximum intragastric volume of aqueous solution can reach 20 mL/kg body weight. The intragastric volume of each group is consistent. The exposure time is 28 days. The animals in the additional group are observed for at least 14 days during the recovery period.