ICCVAM Recommends Procedures to Reduce Animal Testing for Eye Irritation by Up to 83%

As announced in today’s Federal Register, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) has forwarded recommendations to U.S. Federal agencies that will provide for identifying chemical eye hazards with fewer animals. When it is determined necessary to use animals for eye hazard testing, the recommendations provide procedures that use 50% to 83% fewer animals than some current testing procedures. The recommendations also harmonize the number of animals used for eye safety testing across U.S. regulatory agencies and international test guidelines.

ICCVAM also recommends that in vitro test methods should always be considered before using animals for eye safety testing, and these should be used where determined appropriate. When it is necessary to use animals for eye safety testing, ICCVAM recommends that medications and humane endpoints should always be used to avoid or minimize pain and distress.

A test method evaluation report containing the ICCVAM recommendations is available on the NICEATM-ICCVAM website.

Additional information about the recommendations are available on the NICEATM-ICCVAM website.

The Federal Register notice announcing the ICCVAM recommendations is also available on the NICEATM-ICCVAM website, and PDF.

Eye Safety Testing Can Prevent Eye Injuries

Each year, an estimated 2 million eye injuries occur in the United States. Of these, more than 40,000 cause permanent visual impairment. Chemicals and compounds are the third most common cause of eye injuries, with many eye injuries in consumers associated with the use of household cleaning products.

To warn consumers and workers of the potential for chemicals and products to cause eye injuries, eye safety testing is performed to determine if substances may cause temporary or permanent eye damage. Test results are then used for hazard classification of chemicals and products using appropriate national and/or international hazard classification systems.

Using Fewer Animals for Eye Safety Testing

Eye safety testing procedures vary among U.S. agencies. Current testing procedures specified in the U.S. Code of Federal Regulations (16 CFR 1500.42) require 6 animals pertest and may require up to three sequential tests for each substance, thereby requiring 6, 12, or 18 animals to reach a hazard decision.

Based on previous initiatives in the United States to reduce the number of animals used for eye safety testing, some U.S. and international test guidelines for eye irritation/corrosion testing have been modified, with a maximum of 3 animals typically used. However, current testing procedures (16 CFR 1500.42) do not provide criteria to classify results from 3-animal tests. Therefore, ICCVAM and theNational Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) conducted an analysis (reported in Haseman et al., Regul Toxicol Pharmacol 61: 98-104, 2011) to determine classification criteria based on results from a 3-animal test that would maintain eye hazard classification equivalent to current testing procedures (16 CFR 1500.42). The ICCVAM recommendations are based on this analysis. ICCVAM concluded that using a classification criterion of one or more positive animals in a three-animal test to identify chemicals and products that are eye hazards will maintain hazard classification equivalent to that provided by current testing procedures (16 CFR 1500.42).

ICCVAM recommends that alternative in vitro test methods should always be considered and usedwhere appropriate for eye safety testing. While currently approved in vitrotest methods can identify some eye hazards, they are not sufficiently validated and accepted to completely replace all animal testing. When eye safety testing using animals is necessary, testing should be conducted using the minimum number of animals in the most humane manner possible consistent with testing objectives. Consistent with ICCVAM’s duty to foster interagency and international harmonization (42 U.S.C. 285l-3), this recommendation harmonizes the number of animals used for eye safety testing across U.S. regulatory agencies and international test guidelines.

ICCVAM Test Method Evaluation Report Now Available

The ICCVAM recommendations are detailed in the “ICCVAM Test Method Evaluation Report: Identifying Chemical Eye Hazards with Fewer Animals” (NIH Publication No. 12-7930), available on the NICEATM-ICCVAM website.

ICCVAM recommendations have been transmitted to U.S. Federal agencies, which have 180 days to respond to the recommendations. Transmittal letters are posted on the NICEATM-ICCVAM website. Agency responses will be posted on this page as they are received.