Conventional Test Method:

Classical Local Lymph Node Assay (LLNA)(OECD TG 429)

Alternative Test Method:

Name & Description:

rLLNA (Reduced Local Lymph Node Assay: Limit Dose Procedure)

A “reduced” version of the LLNA using only a negative control group and the high-dose group from the full LLNA, as a screening test to distinguish between sensitizers and non-sensitizers.

Validation Status:

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.

Regulatory Status:

OECD: TG 429 (2010)

Effect or Potential Effect on Animal Use:

Reduction
(Chemicals that test negative in the rLLNA will not proceed to the full LLNA test and therefore reduce animal use)

References:

• ECVAM (2007) ESAC Statement on the reduced local lymph node assay (rLLNA).
• NICEATM-ICCVAM (2008) Independent Scientific Peer Review Panel Report. Validation status of new version and applications of the Murine Local Lymph Node Assay: a Test Method for Assessing the Allergic Contact Dermatityis Potential of Chemicals and Products. Research Triangle Park NC: National Institutes of Health (NIH).
• OECD (2010) Test No. 429: Skin Sensitisation: Local Lymph Node Assay, OECD Guidelines for the Testing of Chemicals, Section 4 Health Effects.
• ICCVAM (2012) ICCVAM Evaluation of the Validation Status of New Versions and Applications of the Murine Local Lymph Node Assay

Information Last Reviewed:

May 2012