Short Time Exposure in Vitro Test Method (STE)
Local Title:
化妆品用化学原料体外兔角膜上皮细胞短时暴露试验
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 - Short Time Exposure in Vitro Test Method (STE) uses white rabbit cornea cells to examine eye irritation and applies to the determination of eye irritation of chemical ingredients used in cosmetics. It is an in-vitro alternative to replace the animal eye irritation test. The new test method follows toxicological principles outlined in Cosmetic Safety and Technical Standard 2015 and aligns with international eye irritation alternative testing method standards. 

This method consists of 7 parts, as shown below:

  1. Scope

  2. Test Purposes

  3. Terms and Definitions

  4. Test Principles

  5. Test Materials and Reagents 

  6. Test Procedures

  7. Results Interpretation

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