ICCVAM progress in evaluating in vitro test methods for identifying severe ocular irritants/corrosives

J Merrill¹, K Hamernik², WS Stokes³, LM Schechtman¹, Marilyn Wind⁴

U.S. FDA, Rockville, MD, USA
2. U.S. EPA, Washington, DC, USA
3. NICEATM, NIEHS, RTP, NC, USA
4. U.S. CPSC, Bethesda, MD, USA

ICCVAM, with the assistance of NICEATM and in response to a nomination by the U.S. Environmental Protection Agency, recently initiated a review of the validation status of four in vitro ocular toxicity test methods with potential for use in screening chemicals for severe eye irritation or corrosion. The four test methods are the bovine corneal opacity and permeability (BCOP) assay, the hen's egg test-chorioallantoic membrane (HET-CAM) assay, the isolated chicken eye (ICE) assay, and the isolated rabbit eye (IRE) assay. NICEATM compiled available data and information for the four methods and prepared a background review document (BRD) for each. An expert panel was then convened to evaluate the usefulness and limitations of the in vitro tests based on information in the BRDs. The conclusion of the panel was that each of the four test methods could be used in a tiered testing strategy to identify severe eye irritants and corrosives, with specific limitations and caveats. Several modifications to optimize the standardized protocols were proposed by the panel and it was also recommended that additional data be requested from test method users. Subsequently, additional data received in response to a Federal Register Notice were included in accuracy and reliability analyses for the ICE, IRE and HET-CAM assays. The panel also recommended the inclusion of known human severe eye irritants as reference chemicals. Collaborative interactions between ICCVAM, NICEATM, and ECVAM to review the validation status of other available methods for assessing ocular corrosion or irritancy will also be discussed.

Date: Wednesday, August 24, 2005, 14.00Ð16.00 h, ECC Hall D

5.5 Session: Advancements and Needs for Developing and Validating Alternatives for Ocular Irritancy and Corrosivity Testing