ChemLinked earlier reported that China NMPA had approved 5 newly-added and 4 amended testing methods [1] in the Cosmetic Safety and Technical Standards 2015. Among these 5 new testing methods, the following are newly approved alternatives to animal testing:
Short Time Exposure In Vitro Test Method (STE)
In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA)
Skin Sensitization: Local Lymph Node Assay: DA(LLNA: DA)
Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA(LLNA: BrdU-ELISA)
According to China cnpharm.com [2], the four alternatives are developed based on OECD guidelines for the testing of chemicals. The former two methods—STE assay for eye irritation and DPRA for skin sensitization—are new in-vitro assays. The latter two methods implement the 3Rs principles (Replacement, Reduction and Refinement) for animal welfare by replacing guinea pigs with mice as the test subject.
As of 2019, China has 6 alternatives to animal testing in all (please contact us at [email protected] if translations are needed):
| Approved Time | Alternative Methods | Test Items | Status |
| 2016 | In-vitro 3T3 Neutral Red Uptake Phototoxicity Test Method for Chemicals used in Cosmetics | Phototoxicity | In effect |
| 2017 | In Vitro Skin Corrosion Transcutaneous Electrical Resistance Test (TER) for Chemicals Used in Cosmetics | Skin Corrosion | In effect |
| 2019 | Short Time Exposure In Vitro Test Method (STE) | Eye Irritation | To be effective from Jan. 1, 2020 |
| In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA) | Skin Sensitization | ||
| Skin Sensitization: Local Lymph Node Assay: DA(LLNA: DA) | Skin Sensitization | ||
| Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA(LLNA: BrdU-ELISA) | Skin Sensitization |
For more relevant information, please refer to the news “Development in Alternatives to Animal Testing of Cosmetics in China”.
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