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one-generation reproduction toxicity introduction analysis control group chemicals test method technical solutions toxic measurement management gestation error precise control blank control process optimization skin contact devices online transaction message
GB/T 21607-2022 in English

GB/T 21607-2022 in English

VALID

Chemicals—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
Price(USD): $150.00
$146.00
Standard No: GB/T 21607-2022
Document status: VALID
Title in English: Chemicals—Test method of one-generation reproduction toxicity
Title in Chinese: 化学品 一代繁殖毒性试验方法
Language: English
File Format: Electronic (PDF)
Delivery: Via email within 1~3 business days
Issued on: 2022-07-11
Implemented on: 2023-02-01
Superseding: GB/T 21607-2008 Test method of one-generation reproduction toxicity for chemicals
ICS Classification: 13.300-Protection against dangerous goods
Chinese Classification: A80-Marking, packaging, transport and storage in general
Professional Classification: GB-National Standard
Related Keywords: one-generation reproduction toxicity introduction analysis
control group
chemicals test method
technical solutions toxic measurement management gestation error precise control
blank control
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GB/T 21607-2022
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Toxicology Experimental Methods and Techniques
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《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

Sample only — not a preview of GB/T 21607-2022
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