Conventional Test Method:

Mouse LD50 Assay for Botulinum Toxin Potency Testing

Alternative Test Method:

Name & Description:

In Vitro Cell-Based Assay

The release of neurotransmitter from embryonic spinal cord neurons after 16 h exposure to BoNT/A, and the reduction in the inhibition of release when antibodies neutralize BoNT/A, are measured.

Validation Status:

US: ICCVAM workshop panel found that no cell-based method could currently be used to reduce or replace animals for BoNT potency testing or for detecting botulinum toxin in environmental or biological samples. In their current state of development, cell-based methods are not sufficiently sensitive. Which cell types and/or cell lines are the most appropriate is also not known (2008).

Regulatory Status:

None

Effect or Potential Effect on Animal Use:

Replacement

References:
Information Last Reviewed:
May 2012