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IVD EIT: A Nonanimal Kit and Service for the Detection of Reversible Ocular Irritants

Award Number: R43ES031881
ORGANIZATION: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2020
PERIOD OF PERFORMANCE END DATE: 12/31/2021

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IVD EIT: A Nonanimal Kit and Service for the Detection of Reversible Ocular Irritants - Abstract Currently, the Draize live rabbit eye test is used to distinguish consumer products and materials that are safe from those that are hazardous and can cause reversible or irreversible ocular damage. However, new laws are currently being, or are planned to be, implemented in California, the United States, and the European Union to ban the use of animals in ocular irritation testing. Despite this fact, there is currently no single nonanimal test or combination of nonanimal tests that can accurately classify ocular irritants. It is of particular concern that all nonanimal tests generally overpredict the least damaging class of ocular irritants (EPA IV and GHS nonclassified materials) and cannot determine (or determine with low sensitivity) the most extreme class (EPA I and GHS 1 irreversible/corrosive materials) for which they can have sensitivity rates as low as 50%. More importantly, none of the currently validated alternative tests can detect either reversible irritants (EPA II/III and GHS 2A/B) or those materials that cause irritation that lasts from 7 to 21 days but then clears without permanent corneal damage. This target classification represents a critical UNMET NEED for correctly informing and advising consumers and manufacturers about product safety. We have recently developed and tested a new method—the in vitro depth of injury eye irritation test (IVD EIT) to detect reversible ocular irritants with high sensitivity and specificity. The purpose of this application is to further develop the IVD EIT with the long- term goal of providing a service and/or product kit for the accurate classification of reversible ocular irritants to meet this UNMET NEED as part of a nonanimal ocular irritation testing strategy. This goal will be achieved by accomplishing the following specific aims: Aim 1 (2 months): Assess the repeatability and reproducibility of the IVD EIT by performing a repeat-measures experiment of a four-chemical test set composed of EPA I–IV chemicals to determine the number of corneas and positive controls needed to achieve high repeatability. Aim 2 (4 months): Perform a prevalidation test to assess the ability of the IVD EIT to categorize 30 test substances according to GHS and EPA classifications and further refine the prediction model. Aim 2 will specifically determine the accuracy, sensitivity, and specificity of the IVD EIT and identify any application domain limitations (the range of irritant categories and chemical/physical properties detected). If the results from Aim 2 validate and demonstrate the commercial and regulatory utility of the IVD EIT as defined by the ability to detect reversible irritants, we would then propose a phase II SBIR project. 1


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $1,478 )
2023	2020	LEBRUN LABS LLC	3301 E MIRALOMA AVE	ANAHEIM	CA	92806	ORANGE	USA	Environmental Health	000	1	11/23/2022	NEW	$1,478
														Subtotal = $1,478

Issue Date FY: 2022 ( Subtotal = -$1,478 )
2022	2020	LEBRUN LABS LLC	3301 E MIRALOMA AVE STE 194	ANAHEIM	CA	92806	ORANGE	USA	Environmental Health	000	1	7/28/2022	NEW	-$1,478
														Subtotal = -$1,478

Issue Date FY: 2020 ( Subtotal = $218,252 )
2020	2020	LEBRUN LABS LLC	3301 E MIRALOMA AVE STE 194	ANAHEIM	CA	92806	ORANGE	USA	Environmental Health	000	1	6/18/2020	NEW	$218,252
														Subtotal = $218,252

Grand Total All Awards = $218,252

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IVD EIT: A Nonanimal Kit and Service for the Detection of Reversible Ocular Irritants

Award Number: R43ES031881

ORGANIZATION: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2020

PERIOD OF PERFORMANCE END DATE: 12/31/2021

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