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 Corrosion

Acute dermal irritation/corrosion(In Vivo Rabbit Skin (Corrosivity Test)(OECD TG 404)

Corrositex®
Description and references

EU: Endorsed as valid by ECVAM for
testing acids, bases and their derivatives (2000)

US: Corrositex® endorsed as valid by ICCVAM as a stand-alone assay for evaluating the corrosivity or noncorrosivity of acids, bases, and acid derivatives. For other chemical and product classes Corrositex is valid for use as part of a tiered assessment strategy (1999)

OECD: TG 435 (2006)

US: Accepted as an alternative to a procedure specified in the U.S. Department of Transportation (DOT) Hazardous Materials Regulations (DOT-SP 10904) for DOT packing group classification of corrosive materials (1999)

Replacement
(for  testing acids and bases)

OR

Reduction
(Other substances identified as corrosive will not progress to animal tests)

April 2009

Transcutaneous Electrical Resistance (TER) Test (In Vitro Skin Corrosion)
Description and references

EU: Endorsed as  valid by ECVAM for  distinguishing between corrosive and non-corrosive chemicals (1998)

US: Endorsed as valid by ICCVAM to identify corrosive chemicals (substances identified as non-corrosive will require confirmation with animal-based tests) (2002)

OECD: TG 430 (2004)

EU: The European Scientific Committee for Cosmetic Products and Non-food products (SCCNFP) supports use of this method for the safety assessment of chemicals used as cosmetic ingredients. (1998); Accepted for corrosivity testing (Method B.40 in Annex of  Commission Regulation 440/2008/EC) (2000, 2008)

Reduction
(skin from one
rat may be used to test up to five chemicals; in US substances identified as non-corrosive will require confirmation with animal-based tests)

Refinement
(Uses killed instead of live animal)

April 2009

Human Skin Model Test  (EPISKINTM, EpiDermTM  and SkinEthicTM)
Description and references

EU: EPISKINTM, EpiDermTM  and SkinEthicTM endorsed as valid by ECVAM (1998, 2000, 2006)

US: EPISKINTM and  EpiDermTM endorsed as valid by ICCVAM (2002)

OECD:  TG 431 (EPISKINTM and  EpiDermTM 2004; SkinEthicTM included retroactively in 2006)

EU: EPISKINTM and  EpiDermTM  accepted for corrosivity testing (Method B.40 bis. in Annex of  Commission Regulation 440/2008/EC) (2000, 2008)

US: Accepted for corrosivity testing as part of the integrated testing strategy for corrosivity/irritation

Replacement (EU)

OR

Reduction (US)
(Substances identified as corrosive will not progress to animal test)

April 2009

List of Abbreviations