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Globally Harmonized In Vitro Skin Irritation Assay

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
88821
Program Year/Program:
2008 / SBIR
Agency Tracking Number:
AR055832
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
MATTEK CORPORATION
200 HOMER AVE ASHLAND, MA -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2008
Title: Globally Harmonized In Vitro Skin Irritation Assay
Agency: HHS
Contract: 1R43AR055832-01A1
Award Amount: $255,954.00
 

Abstract:

DESCRIPTION (provided by applicant):PUBLIC HEALTH RELEVANCE Determination of skin irritation potential is an international regulatory requirement for hazard identification/assessment of chemicals, and is important in establishing procedures for the safe ha ndling, packaging, labeling and transport of chemicals and chemical mixtures, as well as evaluation of irritation potential of cosmetic products, ingredients and household productions. Recently enacted legislation including the European Union Registration, Labeling and Authorization of Chemicals (REACH) program, the US EPA High Production Volume (HPV) Chemical Challenge and EU cosmetics directive ban on the testing of cosmetics on animals will dramatically increase the need for in vitro skin irritation as sessment methods. To fulfill the urgent need for a regulatory accepted in vitro skin irritation test method, the goal of the present grant proposal is to validate the EpiDerm in vitro human skin model for skin irritation according to the Globally Harmoniz ed System (GHS). Validation guidelines developed by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and European Center for the Validation of Alternative Methods (ECVAM) will be utilized. Initially, test chemicals with known in vivo skin irritation potential will be applied to the EpiDerm model to identify in vitro skin irritation biomarkers. A prediction model will be established for converting in vitro biomarker responses into in vivo GHS skin irritation classific ations (i.e. irritant, mild irritant and non-irritants). The model and test methods will be further evaluated with a larger test set of chemicals to determine its validity and overall predictive ability. Finally, additional tests will determine intra-labor atory reproducibility and inter-laboratory transferability of the assay method. Successful completion of these Phase I Aims will constitute the pre-validation process for establishing the feasibility of proceeding to full formal validation in Phase II stud ies. Determination of skin irritation potential is an international regulatory requirement for hazard identification/assessment of chemicals, and is important in establishing procedures for the safe handling, packaging, labeling and transport of chemicals and chemical mixtures, as well as evaluation of irritation potential of cosmetic products, ingredients and household productions. Recently enacted legislation including the European Union Registration, Labeling and Authorization of Chemicals (REACH) progra m, the US EPA High Production Volume (HPV) Chemical Challenge and EU cosmetics directive ban on the testing of cosmetics on animals will dramatically increase the need for in vitro skin irritation assessment methods. To fulfill the urgent need for a regu latory accepted in vitro skin irritation test method, the goal of the present grant proposal is to validate the EpiDerm in vitro human skin model for skin irritation according to the Globally Harmonized System (GHS). Validation guidelines developed by th e Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and European Center for the Validation of Alternative Methods (ECVAM) will be utilized. Initially, test chemicals with known in vivo skin irritation potential will be ap plied to the EpiDerm model to identify in vitro skin irritation biomarkers. A prediction model will be established for converting in vitro biomarker responses into in vivo GHS skin irritation classifications (i.e. irritant, mild irritant and non-irritants) . The model and test methods will be further evaluated with a larger test set of chemicals to determine its validity and overall predictive ability. Finally, additional tests will determine intra-laboratory reproducibility and inter- laboratory transferabi lity of the assay method. Successful completion of these Phase I Aims will constitute the pre-validation process for establishing the feasibility of proceed

Principal Investigator:

Patrick J. Hayden
5088816771
PHAYDEN@MATTEK.COM

Business Contact:


mklausner@mattek.com
Small Business Information at Submission:

MATTEK CORPORATION
MATTEK CORPORATION 200 HOMER AVE ASHLAND, MA 01721

EIN/Tax ID: 042877744
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No