Conventional Test Method:

Mouse LD50 Assay for Botulinum Toxin Potency Testing

Alternative Test Method:

Name & Description:

Mouse Abdominal Ptosis Assay or Flaccid Paralysis
(Non-lethal Mouse Model for Botulinum Toxin Potency Testing)

This method assesses local paralysis of the abdominal muscle. A palsy of the abdominal muscle develops after subcutaneous injection of low level of toxin into the mouse.

Validation Status:

UK: Validated at NIBSC for potency testing of BoNT products

US: ICCVAM workshop panel concluded that the Abdominal Ptosis Assay has the potential to replace the LD50 endpoint, but further validation studies are required (2008)

Regulatory Status:

EU: Listed in the European Pharmacopoeia for BoNT type A for injection (2005)

UK: Used by NIBSC when in vitro test  is inconclusive

US: None

Effect or Potential Effect on Animal Use:

Refinement
(Does not rely on death as an endpoint)

References:
Information Last Reviewed:
May 2012