Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA (LLNA:BrdU-ELISA)
Local Title:
皮肤变态反应:局部淋巴结试验 (LLNA: BrdU-ELISA)
Country/Region:
China
Status:
In force
Type:
Regulation
Release Date:
2019-03-22
Implementation Date:
2020-01-01
Competent Authority:
National Medical Products Administration
Document:
Summary

On March 22, 2019, NMPA approved and included nine testing methods in the Cosmetic Safety and Technical Standards 2015, of which four standards are newly approved alternatives to animal testing. These standards are Short Time Exposure In Vitro Test Method (STE), Skin Sensitization: Local Lymph Node Assay: DA (LLNA: DA), In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA) and Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA (LLNA: BrdU-ELISA). They came into effect for the relevant cosmetic registration/filing and post-market surveillance testing on January 1, 2020.

This method - Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA (LLNA:BrdU-ELISA) specifies the basic principles and test requirements of the local lymph node assay in mice (LLNA: BrdU-ELISA) and applies to the determination of skin sensitization of chemical ingredients used in cosmetics.

This method consists of 9 parts, as shown below:

  1. Scope

  2. Test Purposes

  3. Definition

  4. Test Principles

  5. Basic Principles of theTest 

  6. Test Method

  7. Data Processing

  8. Results Determination

  9. Interpretation of Test Results

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