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Environmental Factor, November 2012

Committee recommends using fewer animals in eye hazard testing

By Debbie McCarley and Cathy Sprankle

Cover of ICCVAM Test Method Evaluation Report

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) (http://iccvam.niehs.nih.gov/about/about_ICCVAM.htm) has transmitted recommendations to federal agencies on reducing animal use for identifying chemical eye hazards, according to an Oct. 10 announcement (http://www.gpo.gov/fdsys/pkg/FR-2012-10-10/pdf/2012-24868.pdf)  in the Federal Register.

When it is necessary to use animals for eye safety testing, the recommendations maintain hazard classification equivalent to current testing procedures outlined in U.S. Code of Federal Regulations (CFR) 16 CFR 1500.42, (http://www.gpo.gov/fdsys/pkg/CFR-2012-title16-vol2/pdf/CFR-2012-title16-vol2-sec1500-42.pdf)  while using as many as 50 to 83 percent fewer animals than current testing procedures. The recommendations harmonize the number of animals used for identifying chemical eye hazards across U.S. regulatory agencies and international test guidelines.

NIEHS/NTP Director Linda Birnbaum, Ph.D., forwarded the recommendations, on behalf of Secretary of the U.S. Department of Health and Human Services Kathleen Sebelius. ICCVAM, an interagency committee of the federal government, is administered by the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), (http://iccvam.niehs.nih.gov/about/about_NICEATM.htm) a center within the Division of the National Toxicology Program (NTP) at NIEHS.

“Non-animal methods should always be considered before using animals for this type of testing, and they should be used only when determined appropriate,” commented NICEATM Director Rear Adm. William Stokes, D.V.M. “However, in those situations where it is determined necessary to use animals to meet regulatory safety testing requirements, these recommendations will help ensure that only the minimum number of animals is used.”

Safety testing prevents eye injuries

An estimated 2 million eye injuries occur every year in the U.S. More than 40,000 of these eye injuries cause permanent visual impairment. Chemical products are the third most common cause of eye injuries, many associated with the use of household cleaning products by consumers.

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, and appropriate warning labeling.

Recommendations reduce variation among testing agencies

Eye safety testing procedures currently vary among U.S. agencies. CFR procedures require as many as 18 animals per test substance to reach a hazard decision. Other U.S. and international test guidelines for eye safety testing use a maximum of three animals per test. However, the testing procedures described in 16 CFR 1500.42 do not provide criteria to classify results from three-animal tests.

NICEATM and ICCVAM scientists conducted an analysis, (http://www.ncbi.nlm.nih.gov/pubmed/21745525)  which they published in the journal Regulatory Toxicology and Pharmacology, to determine how results from a three-animal test could be used to maintain eye hazard classification equivalent to current testing procedures. 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 eye hazards will maintain hazard classification equivalent to current testing procedures. 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. This protocol includes the routine use of medications to avoid or reduce any discomfort that might otherwise occur.

The ICCVAM recommendations are detailed in NIH Publication No. 12-7930,   “ICCVAM Test Method Evaluation Report: Identifying Chemical Eye Hazards with Fewer Animals.” (http://iccvam.niehs.nih.gov/methods/ocutox/reducenum-TMER.htm) Federal agencies have 180 days to respond to the recommendations, and agency responses will be posted on the NICEATM-ICCVAM website (http://iccvam.niehs.nih.gov/methods/ocutox/reducenum.htm) as they are received.

Citation: Haseman JK, Allen DG, Lipscomb EA, Truax JF, Stokes WS. (http://www.ncbi.nlm.nih.gov/pubmed/21745525)  2011. Using fewer animals to identify chemical eye hazards: revised criteria necessary to maintain equivalent hazard classification. Regul Toxicol Pharmacol 61(1):98-104.

(Debbie McCarley is a special assistant to Stokes. Cathy Sprankle is a communications specialist with ILS, Inc., support contractor for NICEATM.)




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