Conventional Test Method:

Lethal challenge test for Rabies Vaccine

Alternative Test Method:

Name & Description:

Humane Endpoints for Rabies Potency Testing

Observation of clinical signs and application of an end-point earlier than death to reduce animal suffering.

Validation Status:

US: ICCVAM initiative

Regulatory Status:

EU: Accepted in PhEur

US: Accepted (9 CFR 117.e)

Effect or Potential Effect on Animal Use:

Refinement

References:

• Council of Europe (CE) (2008) 2.7.6 Assay of Diphtheria vaccine (adsorbed). In: European Pharmacopoeia, 6^th ed. Strasbourg, France: CE.
• Office of the Federal Register (U.S.) (2008) Title 9 – Animals and Animal Products, Pt.1-199. In: Code of Federal Regulations (C.F.R.), Revised as of January 1, 2009.

Information Last Reviewed:

May 2012