In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)
Local Title:
化妆品用化学原料体外皮肤变态反应: 直接多肽反应试验
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 - In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA) is to assess chemical ingredients used in cosmetics. Direct polypeptide test method will replace the white rabbit test which was previously used to assess skin sensitization. The "Direct Peptide Test" is an in-vitro alternative which can be used to examine the corrosivity of 10 kinds of chemicals. This method applies to the evaluation of the potential allergenicity of single-component (Quantitatively composed substances, and one of the main components contains at least 80% (W/W)) cosmetic ingredients or multi-component (Quantitatively composed substances, and the content of one or more components is greater than or equal to 10% and less than 80%) cosmetic ingredients with known composition.

This method consists of 10 parts, as shown below:

  1. Scope

  2. Test Purposes

  3. Definitions

  4. Test Principles

  5. Test Materials and Reagents 

  6. Test Procedures

  7. Data Processing

  8. Establishment Conditions of Test

  9. Results Determination Criterias

  10. Matters Need Attention

Details
Log in to Access More Information
LOG IN
Not a member yet? Sign up here.
hide
Document
Original Language
Log in to access the document
LOG IN
Not a member yet? Sign up here.