Cosmetic Compliance
Intelligence & Solutions
Bacterial Reverse Mutation Assay
Local Title:
细菌回复突变试验
Country/Region:
Chinese Mainland
Competent Authority:
National Medical Products Administration
Type:
Regulation
Status:
In force
Release Date:
2019-03-22
Implementation Date:
2020-01-01
Document
Language Source Title Access
ZH
Official Bacterial Reverse Mutation Assay
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Bacterial Reverse Mutation Assay
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Summary

This specification defines the basic principles, requirements and methods of bacterial reverse mutation test. The specification applies to the detection of gene mutation for cosmetic raw materials and products.

This specification consists of 11 parts as listed below:

  1. Scope

  2. Definition

  3. Principle

  4. Instruments and Equipment

  5. Medium and Reagents

  6. Identification of Test Strains and Their Biological Characteristics

  7. Induction of Rat Liver Licrosomal Enzymes and Preparation of S9

  8. Choice of Solvent

  9. Dosage Design

  10. Test Operation Steps

  11. Data Processing and Result Judgment