GB/T 21607-2022 in English
VALIDChemicals—Test method of one-generation reproduction toxicity
- Issued on:2022-07-11
- Implemented on:2023-02-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$146.00
《GB/T 21607-2022化学品 一代繁殖毒性试验方法》由TC251(全国危险化学品管理标准化技术委员会)归口,TC251SC1(全国危险化学品管理标准化技术委员会化学品毒性检测分会)执行,主管部门为国家标准化管理委员会。
Introduction
Analysis of the key changes in the standard
Compared with the 2008 version, the new version of GB/T21607-2022 has made major technical adjustments in three areas:
| Technical dimensions | 2008 version regulations | 2022 version updates |
|---|---|---|
| Selection of experimental animals | No clear adaptation period requirements | At least 5 days of adaptation period is required, with special emphasis on the weight requirements of rats/mice (±20%) |
| Poisoning period | 8 weeks for males | Specify that rats should be ≥10 weeks, and mice should be maintained for 8 weeks (complete sperm cycle) |
| Control settings | Blank control only | New requirements for excipient control and diet ratio |
Laboratory Animal Management Standards
When selecting SPF rats for experimental animals, attention should be paid to the following:
According to the 2023 laboratory validation data, the reproductive index of Wistar rats increased by 7.2% after the new standard operation, and the average weight difference between pregnant groups decreased from 12.5% to 4.3%
Implementation optimization suggestions
| Operational links | Risk control points | Technical solutions |
|---|---|---|
| Toxic measurement management | Gestation error | Precise control using electronic gavage system |
| Cub tracking | Individual confusion | Implantable RFID chip identification |
Standard diagram of data analysis
Key evaluation formula:
Conception rate = (number of conceptions/number of mated females) × 100%When the conception rate of the experimental group is significantly lower than that of the control group (p<0.05), in-depth analysis of reproductive toxicology should be initiated

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