SFDA 3T3 NRU phototoxicity Test is to became China’s first in vitro alternative method for cosmetic phototoxicity.
China State Food and Drug Administration (SFDA) has issued on 10 Feb a draft proposal of 3T3 NRU Phototoxicity Test Method for public consultation in order to promote the application of toxicological animal testing alternative method in cosmetics. Public comments shall be submitted to the agency by the deadline of 29 February 2012.
The proposed method uses Balb/c 3T3 fibroblast mouse cell line, neutral red and other testing materials to assess acute phototoxic effects of cosmetic ingredients on the skin. It has been deemed as the country’s first in vitro alternative test in the concerned cosmetic field.
China’s 3T3 NRU phototoxicity Test is aligned with “OECD guidelines for the testing of chemicals: 3T3 NRU phototoxicity test (No 432, 2004)” and requirements under “Directive 67/548/ EEC on the Classification, Packaging and Labelling of Dangerous Substances”. The standard is said to have combined both international academic practice and realistic conditions of the domestic labs. During its drafting, SFDA has carried out twice interlab comparisons and consulted a large number of scientific institutes and cosmetic enterprises.
Reference Links
- China SFDA notice
- SFDA’s 3T3 NRU Phototoxicity Test Method (draft proposal and feedback sheet)
- Guidance of drafting purpose
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