ABSTRACT
The phase I and II Small Business Innovation Research (SBIR) applications, from which this application is a
continuation, was in response to the National Institute of Environmental Health Sciences’ solicitation for
“Improved Test Systems for Prioritization and Safety Evaluation.” Specifically, the application was written to
address the need for a nonanimal ocular safety test to differentiate ocular nonirritant substances from irritant
and corrosive substances. Ocular safety tests have routinely been conducted on live animals with a time to
results of up to 21 days and are considered by many to be inhumane. Recent government legislation and
consumer pressure are directed at reducing or eliminating the use of live animals for the routine testing of
consumer products and cosmetics. However, limited options exist for nonanimal testing. Currently, accepted
nonanimal test methods require the advanced purchase (up to three weeks) of live tissues and a technician
skilled in aseptic technique; additionally, such tests do not have a long shelf life or misclassify ocular corrosives
as nonirritants, are time intensive, and require other advanced laboratory techniques including cell culture or
dissection and subjective interpretation of ocular lesions. The subject of this proposal is the production of a
rapid, irritancy-predictive, quantitative, standardized test kit with a one-year shelf life to provide standardized
results more accurately and with higher sensitivity than any other available nonanimal ocular irritation test.
Using chemicals selected and coded by a government agency [National Toxicology Program (NTP)’s
Interagency Center for the Evaluation of Alternative Toxicological Methods] and evaluated by representatives
from other U.S. governmental agencies (NTP’s Interagency Coordinating Committee on the Validation of
Alternative Methods Ocular Toxicology Working Group] during the prior SBIR grants, it was demonstrated that
the test kit has a transferability of 92%, according to results from a blind transferability study. Overall, for the
detection of nonirritants, out of the 90 chemicals evaluated, no false-negative results were obtained (100%
sensitivity) using the Globally Harmonized System of Classification and Labelling of Chemicals. The overall
sensitivity and accuracy outperformed all other available nonanimal ocular irritation test methods. In addition to
the test being rapid and shelf stable, test kit performance for the detection of nonirritant compounds was
excellent.
A major new development for the OptiSafe test is that it is now moving towards international regulatory
acceptance. International regulatory acceptance is anticipated to greatly expand OptiSafe sales, if the product
can be effectively manufactured to meet the need, the subject of this grant application.
The scope of the SBIR/STTR Commercialization Readiness Pilot (CRP) Program, as provided on the funding
opportunity announcement, includes “technical assistance associated with manufacturing.” The aims of this
application are to seek technical assistance to improve manufacturing of the test kit, including a complex part
manufacturing process and packaging so that the kit can be shipped without damage domestically and
internationally to meet the worldwide need for an accurate, shelf-stable nonanimal eye irritation test.
An accurate, rapid, stable, nonanimal eye safety test kit represents a significant business opportunity in the
current market of consumer products and cosmetics and will make a needed solution available to both private
industry and regulatory agencies.
