Medical Devices

medical devices 

   

The SkinEthic™ HCE method  has been peer reviewed by ESAC (2016-02) and complies with regulatory use. 

 

CONTEXT

The implementation of the SkinEthic™ HCE  method, as a validated reference method in the OECD test guidelines TG 492 is already considered.

The draft of TG492 on Reconstructed human Cornea-like Epithelium test method for eye hazard potential is currently under review by the states members of OECD with an approval expected by summer 2017. 

 

Our corneal model and corresponding protocols (for liquids and for solids) are designed to comply with regulatory purposes to classify and label chemicals regarding in vitro ocular irritation assessment. 


 

MODELS

 

 
 
  
 
 
 
 

  SkinEthicTM HCE - Human Corneal Epithelium

 

PROTOCOL PRINCIPLE

SkinEthicTM HCE model can be used for in vitro eye irritation assessment with one protocol dedicated to liquids and another to solids.


DETAILED ASSAY PROCEDURE

Do not hesitate to get information on our training sessions or to contact our technical support.

 

REFERENCES

 

Multi-laboratory validation of SkinEthicTM HCE test method for testing serious eye damage/eye irritation using liquid chemicals. N. Alépée, V. Leblanc, E. Adriaens, M.-H. Grandidier, D. Lelièvre, M. Meloni, L. Nardelli, C.S. Roper, E. Santirocco, F. Toner, A. Van Rompay, J. Vinall, J. Cotovio. Toxicology In Vitro, 31: 43-53, 2016.


Multi-laboratory validation of SkinEthicTM HCE test method for testing serious eye damage/eye irritation using solid chemicals and overall performance of the test method with regard to solid and liquid chemicals testing. N. Alépée, E. Adriaens, M.-H. Grandidier, M. Meloni, L. Nardelli, C. J. Vinall, F. Toner, C. S. Roper, A. R. Van Rompay, V. Leblanc, J Cotovio. Toxicology In Vitro, 34: 55-70, 2016.