Cosmetic Compliance
Intelligence & Solutions
In Vivo Mammalian Alkaline Comet Assay (Draft for Comments)
Local Title:
体内彗星试验(征求意见稿)
Country/Region:
China
Status:
Draft
Type:
Regulation
Release Date:
2021-11-12
Implementation Date:
/
Competent Authority:
National Institutes for Food and Drug Control
Document:
Summary

On November 12, 2021, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation on a draft testing standard for cosmetic ingredient—In Vivo Mammalian Alkaline Comet Assay. Stakeholders with any comments can send them to the NIFDC via email at hzpbwh@nifdc.org.cn before November 28, 2021.

This method specifies the basic principles, requirements, and methods of in vivo mammalian alkaline comet assay and applies to the genotoxicity test of cosmetic ingredients.

Main contents of the draft are as follows:

  1. Scope

  2. Normative references

  3. Definitions

  4. Theory

  5. Basic principles of test

  6. Solution preparation (all solutions are freshly used and prepared)

  7. Test animals and breeding environment

  8. Test conditions

  9. Dosage design

  10. Way of exposure

  11. sampling time

  12. Test methods

  13. Results judgment method

  14. Evaluation of test results

  15. Test report

Document
Original Language
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