Alternative Test Methods: Validation and Regulatory Status

Conventional test method Alternative Test Method Infor- mation Last Updated
Name & Description Validation Status Regulatory Status Effect or Potential Effect on Animal Use
Skin Irritation

Acute dermal irritation/corrosion (Draize rabbit skin irritation test)  
(OECD TG 404)

EPISKINTM
Description and references

EU: Endorsed as valid by ECVAM for the prediction of both irritant and non-irritant substances (April 2007)

OECD: Draft New Test Guideline (2009)

EU: Test method B.46 in COM regulation 440/2008/EC (2008)

Replacement

OR

Reduction
(When part of a tiered testing strategy that results in use of  fewer animals)

 April 2009

EpiDermTM (SIT)
Description and references

EU: Endorsed as valid by ECVAM for prediction of R38 skin irritating and no-label (non-skin irritating) test substances (2008)

OECD: Draft New Test Guideline (2009)

EU: Test method B.46 in COM regulation 440/2008/EC (2008)

Replacement

OR

Reduction
(When part of a tiered testing strategy that results in use of  fewer animals)

 April 2009

 SkinEthicTM RHE (Reconstituted Human Epidermal) model
Description and references

EU:  Endorsed as valid by ECVAM for prediction of R38 skin irritating and no-label (non-skin irritating) test substances (2008)

OECD: Draft New Test Guideline (2009)

EU: Test method B.46 in COM regulation 440/2008/EC (2008)

Replacement

OR

Reduction
(When part of a tiered testing strategy that results in use of  fewer animals)

 April 2009

List of Abbreviations