Federal Agencies Urged to Accept Data From Eye Safety Test Using Fewer Animals

Federal agencies should consider accepting results from an eye safety test that uses fewer rabbits than some current testing procedures to classify chemicals and products, an interagency committee said in a report released Oct. 10.

Alternative, non-animal test methods “should always be considered and used where appropriate for eye safety testing,” the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) said in its test method evaluation report, Identifying Chemical Eye Hazards with Fewer Animals.

Eye hazard classifications based on the alternative approach, which uses fewer rabbits, would provide equivalent protection to eye safety tests that are required by some regulations, such as a Consumer Product Safety Commission rule at 16 C.F.R. 1500.42, the report said.

The availability of the report was announced Oct. 10 (77 Fed. Reg. 61,610).

The commission had asked ICCVAM in 2011 to evaluate the alternative approach, which is used to classify chemicals under the Globally Harmonized System of Classification and Labelling of Chemicals. The commission wondered whether chemicals and products classified using the alternative approach would provide consumers the equivalent level of protection that its regulation provides.

EPA has accepted data from tests using the alternative approach since 1998, ICCVAM's report said, referring to EPA's Health Effects Test Guidelines OPPTS 870.2400 Acute Eye Irritation.

CPSC's regulation requires six albino rabbits per test, and it may require up to three sequential tests to classify each substance, thereby requiring six, 12, or 18 rabbits, ICCVAM's report said.

The alternative approach uses 50 percent to 83 percent fewer rabbits, it said.

OECD Already Endorsed Alternative Approach.

The alternative approach was approved in 2002 by the Organization for Economic Cooperation and Development (OECD) as Test Guideline 405 for acute eye irritation and corrosion.

The Animal Welfare Act requires that “only the minimum number of animals necessary to obtain scientifically valid results be used for testing,” the ICCVAM report said.

Linda Birnbaum, director of the National Toxicology Program, which manages ICCVAM, notified federal agencies of its recommendations in letters in mid-September. Under the ICCVAM Authorization Act of 2000, which established the committee, agencies have 180 days, or until March 2013, to let the committee know how they will respond to its recommendations. For example, they could tell ICCVAM they do not use nor require this type of test, that it does not generate data they can accept, or that they will use it and accept data generated by it.

Kristie Sullivan, director for regulatory testing issues with the Physicians Committee for Responsible Medicine, told BNA the organization is pleased anytime a U.S. agency recommends using fewer animals in a toxicity test.

“However, we find it difficult to laud the CPSC for bringing its regulations on corrosive eye testing into line with EPA guidelines published in 1998,” Sullivan said Oct. 10.

EPA Pilot Accepts Non-Animal Data.

Meanwhile, EPA has explored moving beyond the 1998 guidelines by accepting data from a suite of three in vitro tests for eye irritation, she said.

Sullivan referred to a pilot program launched in 2009 by EPA's Office of Pesticide Programs for labeling antimicrobial products (33 CRR 572, 6/8/09).

Under the pilot program, OPP would accept for labeling decisions data from any or all of three non-animal tests: the bovine corneal opacity and permeability assay, the EpiOcular™ model, and the cytosensor microphysiometer assay.

Mark Lafranconi, section head for product safety at Procter & Gamble Co., told BNA he hopes OPP will make the pilot program a formal policy, meaning it would permanently be willing to accept data from the non-animal tests.

The tests generate data that are more objectively measured than are the subjective results from animal tests, which must be interpreted by carefully trained professionals, Lafranconi said. He also thinks the results are more predictive of potential eye harm.

Procter & Gamble hopes EPA's pesticides program will also expand its acceptance of non-animal data to include results from sensitization, skin, and other tests that have been validated, Lafranconi said.

EPA did not reply to questions as to whether it would make the pilot program's acceptance of non-animal data a permanent policy.

By Pat Rizzuto  


The ICCVAM Test Method Evaluation Report: Identifying Chemical Eye Hazards with Fewer Animals is available at http://iccvam.niehs.nih.gov/docs/ocutox_docs/reducenum/TMER-all.pdf.