Bill to Outlaw Rabbit Eye Tests May Benefit Firm : Legislation: If the animal-rights measure is signed into law, Ropak Laboratories has a good shot at a $500-million market with its alternative test methods.

In an apparent victory for animal-rights advocates and an upstart Orange County company, the state Senate on Thursday approved a bill outlawing eye and skin tests on rabbits to determine the safety of cosmetics and household products.

If the animal-rights legislation is signed by the governor, California would become the first state to outlaw the eye and skin irritancy tests on rabbits. And Irvine-based Ropak Laboratories, which has developed an alternative testing method, would get a big boost.

While Ropak has stayed out of the political fray, the company has taken the lead in developing and marketing test kits that it contends are more effective and less costly for certain applications than putting products on rabbits and watching their reaction.

Ropak has developed a vegetable protein matrix that it says can mimic human eye and skin responses. The matrix is contained in a clear liquid that clouds when an irritant is dropped into it. The more opaque the liquid becomes, the more irritating is the product.

The company’s Eytex and SkinTex tests are used now by more than 80 firms and independent laboratories in the United States, Europe and Japan, including such big corporate cosmetics companies as Avon Products, Revlon, L’Oreal and Mary Kay Cosmetics.

Some industry analysts have great expectations for Ropak.

Jeffrey Berg, an analyst in medical technologies for William K. Woodruff and Co., a Dallas securities firm, said that while there are other alternative tests in various stages of development, Ropak is “the leading contender in a growth market and has captured the attention of most of the major companies.”

He estimates that the potential market for alternative testing could top $500 million a year.

Ropak’s testing process was developed by Virginia Gordon, who has a Ph.D. in biophysical chemistry and is vice president of Ropak, and by Hy Bergman, a physiologist.

The firm’s chief executive is Christopher Kelly of Newport Beach, who 14 years ago developed one of the first laboratory tests that replaced rabbit tests for detecting pregnancy. He is the company’s major stockholder and has invested $3.5 million in the firm.

The company’s name reflects its association with Ropak Corp., a Fullerton-based manufacturer of plastic packaging that last year bought a third interest in the test-making firm for $1 million.

Ropak officials have tried to steer clear of the political battle by animal-rights activists to restrict the use of animals in product testing. One reason is to not alienate the cosmetic industry--the company’s main market--which has staunchly opposed such legislation contending that “test tube assays” are not yet reliable enough to completely replace animals.

Nonetheless, Gordon acknowledges that the market for Ropak’s tests is being driven by the opposition to animal testing. Gordon, who previously was a cardiovascular researcher, said she was prompted to delve into cosmetics testing when she noticed in the early 1980s that “there were a lot of pickets at Revlon.”

Over the years, the animal-rights movement has gained momentum. According to the Cosmetic Toiletry and Fragrance Assn., currently seven states are considering legislation to ban certain testing on animals.

In California, AB 2461, authored by Assemblyman Jack O’Connell (D-Santa Barbara), would prohibit eye and skin tests on rabbits in the development of cosmetics and household products such as waxes and soaps. Although the bill has passed both houses of the Legislature, supporters of the bill worry that it will be vetoed by the governor, who they believe will be swayed by industry opposition.

While the legislation only applies to California, Ropak officials say it could be precedent setting. “It will be the first domino that will influence the various state legislatures and then Congress. And the rest of the world will follow,” Kelly said.

Getting industry scientists to voluntarily convert to a new testing technology has been difficult, Ropak officials say. Ropak got a chilly reception when in 1987 it attended a conference of the Johns Hopkins Center for Alternatives to Animal Testing where it proposed its new Eytex product as an alternative to the Draize rabbit test.

Gordon said she believes that toxicologists at the conference were antagonistic because the new test was developed by a profit-seeking venture, rather than in a university laboratory. “We started as a commercial venture, and the origins of all other proposed alternatives (to animal testing) came out of universities,” she said.

Also, Gordon said the company’s scientific methodology “was out of the mainstream” because it used molecular cell parts while most other scientists were working with whole cells in cultures.

Lastly, Gordon said toxicology for years has been a rather stodgy field, closed to innovation. She noted, for instance, that the Draize test has been a standard for measuring eye irritants since it was developed in 1944 by a scientist at the U.S. Food and Drug Administration.

Ropak sponsored a series of tests at a dozen laboratories in 1987 and found that its Eytex procedure matched results of Draize tests in 95% of the cases. But manufacturers remained skeptical.

Ropak officials say the company’s big break came early last year when S.C. Johnson and Avon published the results of their own preliminary studies that showed Ropak’s Eytex performed remarkably well.

“Those two reports ignited a fire in the U.S. in terms of attracting the attention of other companies.” Gordon said. “Their studies carried tremendous weight in taking us into Europe and Japan, while Ropak Corp. provided the financial backing and financial network to do that.”

In response, Ropak says its sales soared. The company projects sales should double to more than $1.2 million this year from last year.

Still there are more hurdles to overcome. Many toxicology authorities insist that all procedures proposed as alternatives to animal testing have flaws.

“The Eytex is not an alternative to the Draize because it does not detect some irritants,” said Sidney Green, in charge of the unit at the FDA that reviews tests on new cosmetic products.

He said that while FDA regulations do not say animal testing is needed for cosmetics, the agency’s policy requires it. “Somewhere along the line the substance must be tested in animals or the FDA will not accept it,” Green said.

Alan Goldberg, director for the Johns Hopkins Center for Alternatives to Animal Testing, agrees. “There is no single test or panel of tests that can as yet replace the Draize test.” he said.

Some companies, including Shaklee and Avon, have completely stopped using animal tests and begun using Eytex and other alternatives. But even these companies stress that they are relying on a vast database of animal testing on virtually all of the ingredients that go into both existing and new products. They say they use the Eytex test to confirm results that they have already predicted.

Michael Dickens, manager of toxicology for Avon, said that company has just completed validation studies with Eytex involving 466 products and raw ingredients--”and it has turned out very well.”

But he said most other companies do not have as much historical data from the Draize test. “If I was in another company without the database I have I might not be as comfortable” about discontinuing animal tests, he said.

Ropak officials contend that if they were manufacturers of consumer products, they too would insist on making a final test on animals before using a new ingredient. But they add that the vast majority of ingredients in such products already have been tested on animals.

Supporters of Eytex say that at minimum the test is valuable for initial screening of new products, allowing only those that pass to be tested on rabbits.

Rebecca Allen, director of product development for Shaklee Corp. in San Francisco, said her company has been “working through problems” with the Ropak tests and helping the company make improvements.

Currently, she said, the company uses the Eytex test as well as another non-animal testing method as a double check and then compares the results of both against a database. But if such alternatives were not available, she said, the company “would never have stopped rabbit tests.”