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Colgate-Palmolive 2008 Alternate Research Grant Recipient Develops Alternate Assay for Draize Testing
The Colgate-Palmolive Grants for Alternative Research identify and support efforts that promote, develop, refine, or validate scientifically acceptable animal alternative methods to facilitate the safety assessment of new chemicals and formulations. Daniel R. Cerven of MB Research Laboratories received the grant in 2006 and 2008 to develop and validate the Porcine Cornea Reversibility Assay (PorCORA). This product safety testing assay for ocular irritancy, damage, and damage reversibility may reduce or replace traditional animal-based testing.
The porcine corneas, waste products from abattoirs, can be maintained in long-term culture for up to four weeks, with the superficial corneal layer in a steady state of healing or turn over every 7–10 days. The intact ex vivo corneas are maintained at an air interface culture system with agar gel on the internal surface. Test materials are dosed onto the corneal surface and tissue damage and recovery is assessed using sodium fluorescein retention over time. Several different methods have been used to verify that the PorCORA assay is indicative of actual tissue damage. A 32-reference chemical validation has been completed, with a match to historical Draize test results in 30 of the 32.
The validation funded by the grant provided sufficient data to allow the submission of this assay to the European Centre for the Validation of Alternative Methods (ECVAM) for consideration as an alternative ocular irritation assay. This assay will be on the 2009 ECVAM work schedule and will be considered for full prospective validation after a comprehensive review.
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