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
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. This page was last updated May 9, 2007 Contact the webmaster Return to the NICEATM/ICCVAM Home Page |