[Federal Register Volume 67, Number 147 (Wednesday, July 31, 2002)]
[Notices]
[Pages 49706-49707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Institute of Environmental Health Sciences; National 
Toxicology Program; Availability of the Report, Interagency 
Coordinating Committee on the Validation of Alternative Methods 
(ICCVAM) Evaluation of EPISKIN \TM\, EpiDerm \TM\ (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 
\TM\, EpiDerm \TM\ (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,

[[Page 49707]]

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 Web site 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 
[email protected].

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 
\TM\ (EPISKIN SNC, Lyon, France), EpiDerm \TM\ (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. 
49685-49686; Sept. 28, 2001). All public comments received were posted 
on the ICCVAM/NICEATM Web site (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 \TM\, EpiDerm 
\TM\ (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 Public Law 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 Web site 
(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; e-
mail: [email protected]; fax: 919-541-0947; tel. 919-541-2384.

    Dated: July 22, 2002.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 02-19261 Filed 7-30-02; 8:45 am]
BILLING CODE 4140-01-P