SN/T 2181-2008One-generation reproduction toxicity study (English PDF)

Foreword

This revised standard adopts the United Nations Organisation for Economic Co-operation and Development (OECD) Chemicals Test Method No. 415 "generation reproduction toxicity test Test "(1983).

This standard OECD Chemicals Test Method No. 415 compared with the following differences.

--- To OECD Chemicals Test Method No. 415 were editorial changes;

--- Increased the preamble;

--- Increasing the exposure time and procedures rats;

--- Increasing the breeding index is calculated.

This standard was proposed by the State Administration of Quality Supervision Inspection and Quarantine of People's Republic of China.

This standard by the National Certification and Accreditation Administration Committee.

1 Scope

This standard specifies the generation reproductive toxicity test animal terms and definitions, test animals, dose levels, test procedures, the results of the evaluation, test Inspection reports and interpretation of test results.

This standard applies to the detection of chemicals reproductive toxicity.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

GB 14924.1 animal feed common quality standards GB 14925 Laboratory Animal Facilities and Environment

3 Terms and Definitions

The following terms and definitions apply to this standard.

Female or reduce damage caused by the chemicals in male reproductive function or fertility, such as the decline in reproductive rates; or cause non progeny Hereditary adverse effects, such as growth and developmental toxicity, including teratogenic effects of damage to health and the breast-feeding period.

4 Test animals

5 Dose levels

The experiment included at least three dose groups and a control group. The highest dose should enable the parent animals significant toxicity, but does not cause movement Was dead; intermediate doses can cause mild toxicity; low dose should not induce any toxic effects in animals and their offspring. If that sample Less toxic products, the dose of 1000mg/kg, the reproductive process has not produced any toxic effects, you can use a limited test, that test Test does not need to set up additional dose group. If the pre-test to the effect of high doses of significant maternal toxicity, but had no effect on fertility, can also be used High-dose pilot study conducted limited tests.

6 Test procedure

6.1 and control group Before the exposure dose animals were randomly divided into two groups. If the test sample using a vehicle control group should be used excipients