Conventional Test Method:

Haematotoxicity test for acute neutropenia (use of a second species)

Alternative Test Method:

Name & Description:

Colony Forming Unit-Granulocyte/Macrophage (CFU-GM) Assay

The test compound is incubated with either murine bone marrow, mono nuclear cells, or human cord blood marrow nuclear cells. IC₉₀ is measured (inhibition of cell proliferation).

Validation Status:

EU: Validated by ECVAM (2006)

Regulatory Status:

No information

Effect or Potential Effect on Animal Use:

Reduction
(For use in place of a second species in the haematotoxicity test for acute neutropenia;, not a replacement as it relies on the availability of mouse Maximum Tolerated Dose data)

References:

• ECVAM (2006) ESAC statement on the application of the CFU-GM assay for predicting acute neutropenia in humans.
• ECVAM (2006) INVITTOX Protocol 101.
• Pessina A., Albella B., Bayo M., Bueren J., Brantom P., Casati S., Croera C., Gagliardi G., Foti P., Parchment R., Parent-Massin D., Schoeters G., Sibiril Y., Van Den Heuvel R. & Gribaldo L. (2003) Application of the CFU-GM assay to predict acute drug-induced neutropenia: an international blind trial to validate a prediction model for the maximum tolerated dose (MTD) of myelo-suppressive xenobiotics. Toxicological Sciences 75: 355-367.

Information Last Reviewed:

May 2012