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In Vitro Assay to Determine Skin Corrosivity Packing Groups

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43ES017178-01
Agency Tracking Number: ES017178
Amount: $244,444.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Solicitation Year: 2008
Award Year: 2008
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
United States
DUNS: 147365936
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 () -
Business Contact
Phone: (508) 881-6771
Research Institution

DESCRIPTION (provided by applicant): US Department of Transportation and international regulations require testing of all chemicals for skin corrosivity, which is defined as destruction of human skin at the site of contact. For safe handling and transporta
tion purposes, each corrosive is assigned a packing group designation, which depends on how quickly skin damage occurs. Previously accepted test methods have utilized rabbits to determine packing groups. However, corrosive chemicals are very harsh and ca
n cause considerable discomfort and/or severe pain to the animals. A number of in vitro tests have been developed but none of them adequately meet all of the US regulatory and market needs. The goal of this project will be to utilize a human skin-like in v
itro model, EpiDermTM, to develop and validate an in vitro assay to determine skin corrosivity packing groups. Phase I research will determine the assay parameters necessary to differentiate between the 4 corrosivity packing groups. A preliminary predictio
n model (PM) will be developed using 12 reference chemicals and PM will be tested with an additional 28 test materials. After fine tuning the PM, interlaboratory reproducibility and interlaboratory transferability of the assay will be assessed. Successful
completion of the Phase I goals will constitute the pre-validation process for proceeding to formal assay validation studies in Phase II. PUBLIC HEALTH RELEVANCE: Skin corrosivity testing is necessary to insure the safe handling and transport of chemicals.
Animal-based test methods suffer from animal welfare concerns and current in vitro methods do not meet all US regulatory requirements. This project will develop an in vitro assay to determine skin corrosivity packing groups and fulfill all testing and reg
ulatory needs.

* Information listed above is at the time of submission. *

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