Guidance of RhCE Method for the Safety Assessment of Cosmetics and Quasi Drugs

  • Japan
  • 医薬部外品・化粧品の安全性評価における眼刺激性試験代替法としての 再構築ヒト角膜様上皮モデル法(RhCE 法)に関するガイダンス
  • In Force
  • 2019-06-24
  • Japan MHLW

On June 24, Japan MHLW issued technical guidance on the use of the Reconstructed human Cornea-like Epithelium (RhCE) test method (OECD Test Guideline 492) as a new alternative to the eye irritation test of quasi drugs and cosmetics.

The guidance specifies the experimental principle, preparation, procedure, determination results, etc. Since there are several models of the RhCE method, the explanations of eye irritation test method for each model are also included in it.

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