GB/T 15670.19-2017 in English
VALIDToxicological test methods for pesticides registration―Part 19:In vitro mammalian cells chromosome aberration test
- Issued on:2017-07-12
- Implemented on:2018-02-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$97.00
《GB/T 15670.19-2017农药登记毒理学试验方法 第19部分:体外哺乳动物细胞染色体畸变试验》由326(农业农村部)归口,主管部门为农业农村部。
Introduction
1. Analysis of the background of standard formulation and technological evolution
GB/T 15670.19-2017 "Toxicological test methods for pesticide registration Part 19: In vitro mammalian cell chromosome aberration test" is a standard formulated to evaluate the mutagenicity of pesticides. With the increase in the use of pesticides, their potential genetic toxicity risks to humans and the environment are becoming increasingly prominent. By detecting chromosome aberrations through in vitro tests, pesticides with genetic toxicity can be effectively identified, providing a scientific basis for registration management.
2. Comparison of standard frameworks
| Standard dimensions | GB/T 15670.19-2017 | Internationally accepted standards | Evaluation indicators |
|---|---|---|---|
| Purpose of the test | To detect whether pesticides cause chromosome aberrations in mammalian cells in vitro | OECD Guideline 476 | Positive reaction rate |
| Test methods | Use of metaphase blockers and microscopic observation | NMPA/EMA requirements | Aberration type analysis |
| Dose setting | At least 3 analytical concentrations, the highest concentration must significantly reduce cytotoxicity | ICH S2(R1) | Statistical significance |
3. Implementation suggestions
Experimental design suggestions:In actual operation, cell lines with high stability and strong proliferation ability (such as CHO or CHL) should be given priority. The selection of positive controls should be based on the physical and chemical properties of the test, and negative controls are used to exclude the influence of solvents.
Data processing suggestions:During statistical analysis, it is recommended to use the χ2 test to evaluate significant changes in chromosome aberration rates. If positive results of dose dependence and repeatability are observed, judgments should be made based on biological significance and statistical evidence.
4. Technical details and precautions
- Cell culture conditions: Eagle's minimum essential medium with a serum concentration of 10% is recommended. The incubator needs to maintain a 5% CO2 environment.
- Metaphase blocker usage: Colchicine concentration is 1μg/mL, and the treatment time is 4 hours.
- Chromosome analysis: At least 200 metaphase cells were observed in each treatment group. Aberration types include deletion, breakage and recombination.

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