National Toxicology Program

NICEATM requests (Federal Register, Vol. 72, No. 109, page 31582-3, June 7, 2007) the submission of data on substances tested for ocular irritancy in humans, rabbits, and/or in vitro. These data will be used to:

1. Review the state-of-the-science in regard to the availability of accurate and reliable in vitro test methods for assessing the range of potential ocular irritation activity, including whether ocular damage is reversible or not
2. Expand NICEATM’s high-quality ocular toxicity database

1. The Bovine Corneal Opacity and Permeability (BCOP) test
2. The Isolated Rabbit Eye (IRE) test
3. The Isolated Chicken Eye (ICE) test
4. The Hen’s Egg Test—Chorioallantoic Membrane (HET–CAM) test

When submitting data or information on protocols, please reference this Federal Register notice and provide appropriate contact information (name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization, as applicable). NICEATM prefers data to be submitted as copies of pages from applicable study notebooks and/or study reports, if available (view example). We prefer that data for each experiment include the following information, as appropriate:

• Common and trade name of test substance
• Chemical Abstracts Service Registry Number (CASRN) of test substance
• Chemical and/or product class of test substance
• Commercial source of test substance
• In vitro test protocol used
• Rabbit eye test protocol used
• Human eye test protocol used
• Individual animal/human or in vitro responses at each observation time (i.e., raw data)
• The extent to which the study complies with national/international Good Laboratory Practice (GLP) guidelines
• Date and testing organization