Proposed reference substances for optimization and validation studies with in vitro ocular test methods

DG Allen¹, BC Blackard¹, NY Choksi¹, JF Truax¹, RR Tice¹, WS Stokes², K Hamernik³, J Merrill⁴, L Schechtman⁴, M Wind⁵

1. Integrated Laboratory Systems, Inc./NICEATM, RTP, NC, USA
2. NICEATM/NIEHS, RTP, NC, USA
3. U.S. Environmental Protection Agency, Washington, DC
4. U.S. Food and Drug Administration, Rockville, MD, USA
5. U.S. Consumer Product Safety Commission, Bethesda, MD, USA

NICEATM evaluated four in vitro ocular test methods (BCOP, ICE, IRE, and HET-CAM) for their ability to identify substances that cause severe irritation or corrosion. During these evaluations, a proposed list of reference substances for future optimization and validation studies of these and other alternative test methods intended to detect ocular corrosives/severe irritants was developed. Based on the ICCVAM Submission Guidelines (ICCVAM 2003; http://iccvam.niehs.nih.gov/docs/guidelines/subguide.htm), substances included in this list are intended to: 1) represent the range of ocular responses (i.e., corrosive, severe irritant, nonsevere irritant, noncorrosive) that is expected to be detected; 2) represent the classes of chemicals that are expected to be tested; 3) have produced high quality results in the Draize in vivo rabbit eye test and/or in humans; 4) have well-defined chemical composition; 5) be readily available; and 6) not be associated with excessive hazard or costs (purchase and/or disposal). Following completion of any optimization and validation studies for each test method, reference substances from this list could be selected for inclusion in performance standards and for proficiency testing. This proposed list of substances is intended to represent the minimum number of substances that should be used to evaluate the accuracy and reliability of an in vitro ocular test method proposed for the detection of ocular corrosives and severe irritants. Testing the complete list of all reference substances will facilitate future validation efforts and comparison of performance among different test methods and protocols. ILS staff supported by NIEHS contract N01-ES 35504.

P161

Date: Tuesday, August 23, 2005, 13.00-14.00 h

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