Skin Sensitization

Conventional
test method

Alternative Test Method

Last Reviewed
Name & Description Validation Status Regulatory Status Effect or Potential Effect on Animal Use
Skin Sensitization
(Guinea Pig Maximization Test;
Buehler Test)
(OECD TG 406)
Classical Local Lymph Node Assay (LLNA)
Description and references
EU: Endorsed as valid by ECVAM (2000)

US: Endorsed as valid by ICCVAM and recommended for use as a stand-alone substitute for the guinea pig sensitization test (1999)

OECD: TG 429 (2010)

International Standards Organization [ISO] 10993-10: Tests for Irritation and Sensitization (2002)

EU: Method B.42 in Annex to 440/2008/EC (2004, 2008)

US: EPA Health Effect Testing Guidelines on Skin Sensitization (2003)

Reduction

Refinement
(Does not require dermal hypersensitivity reactions be elicited in the animals; does not require administration of an adjuvant which causes pain and distress)

May 2012
Classical Local Lymph Node Assay (LLNA)
(OECD TG 429)
rLLNA (Reduced Local Lymph Node Assay: Limit Dose Procedure)
Description and references
EU: Endorsed by ECVAM as a substitute method for the LLNA to distinguish between skin sensitizers and non-sensitizers when used as part of a tiered testing strategy (2007).

US: When dose-response information is not required, ICCVAM recommends use of the LLNA limit dose procedure as for hazard identification to identify sensitizers and non-sensitizers. 

When dose-response information is required, ICCVAM recommended rLLNA be used as the initial testing procedure to identify sensitizers and non-sensitizers.

OECD: TG 429 (2010) Reduction
(Chemicals that test negative in the rLLNA will not proceed to the full LLNA test and therefore reduce animal use)
May 2012

 

List of Abbreviations

Test Methods Categories

Toxicity
Dermal Tests
Vaccines