National Toxicology Program

[Federal Register: July 31, 2002 (Vol. 67, No. 147]
[Notices]
[Pages 49706 - 49707]

Notice of the Availability of the Report, Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Evaluation of EPISKIN™, EpiDerm™ (EPI-200), and the Rat Skin Transcutaneous Electrical Resistance (TER) Assay: In Vitro Test Methods for Assessing the Dermal Corrosivity Potential of Chemicals

Summary

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the availability of the report entitled, "ICCVAM Evaluation of EPISKIN™, EpiDerm™ (EPI-200), and the Rat Skin Transcutaneous Electrical Resistance (TER) Assay: In Vitro Test Methods for Assessing the Dermal Corrosivity Potential of Chemicals," NIH Publication 02-4502. The report contains test method summary reports, protocols, and the ICCVAM's final recommendations on the three methods.

Availability of Report

The report is available electronically (PDF and HTML) on the NICEATM/ICCVAM website at http://iccvam.niehs.nih.gov. A limited number of printed reports are available. To receive a printed report, please contact the NICEATM at P.O. Box 12233, MD EC-17, Research Triangle Park, NC 27709, phone: 919-541-2384, fax: 919-541-0947, or niceatm@niehs.nih.gov.

Background

ICCVAM initiated evaluation of the validation status of three in vitro test methods for assessing the dermal corrosivity potential of chemicals and chemical mixtures in 2001. The test methods are EPISKIN™ (EPISKIN SNC, Lyon, France), EpiDerm™ (EPI-200) (MatTek, Ashland, MA), and the Rat Skin TER assay. The European Centre for the Validation of Alternative Methods (ECVAM) conducted validation studies on the three test methods. The ECVAM Scientific Advisory Committee and the European Commission's Scientific Committee for Cosmetic Products and Non-food Products subsequently reviewed and recommended the methods for regulatory acceptance. The NICEATM prepared a background review document (BRD) summarizing available data and prior reviews for the three corrosivity test methods. ICCVAM considered this compendium of information and concluded that further evaluation by an independent scientific peer review panel was not necessary. The BRD and proposed ICCVAM recommendations on the test methods were made available for public comment in a Federal Register notice (Vol. 66, No. 189, pp. 49685-6; Sept. 28, 2001). All public comments received were posted on the ICCVAM/NICEATM website (http://iccvam.niehs.nih.gov) and considered by ICCVAM prior to finalizing its test recommendations.

Based on an evaluation of the ECVAM validation studies and all other available data, the ICCVAM recommends that EPISKIN™, EpiDerm™ (EPI-200), and the Rat Skin TER assay can be used to assess the dermal corrosivity potential of chemicals and chemical mixtures in a weight-of-evidence approach using an integrated testing scheme for dermal irritation/corrosion. In this approach, positive in vitro corrosivity responses will not generally require further testing and the results can be used for classification and labeling without the need for animal testing. Accordingly, these methods provide for the replacement of animal use when positive results are obtained.

In accordance with P. L. 106-545, the ICCVAM test recommendations will be forwarded to Federal agencies for their consideration and appropriate action. Agency responses to ICCVAM test recommendations will be made available on the ICCVAM/NICEATM website (http://iccvam.niehs.nih.gov). Inquiries or comments about the report should be addressed to: Dr. William S. Stokes, Director, NICEATM, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC, 27709; email: niceatm@niehs.nih.gov; fax: 919-541-0947; tel. 919-541-2384.

Date: July 22, 2002

Samuel Wilson, M.D.
Deputy Director, National Institute of Environmental Health Sciences

[Billing Code 4140-01-P]