[Federal Register: July 31, 2002 (Volume 67, Number 147)]
[Notices]
[Page 49706-49707]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31jy02-82]
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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
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
\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: niceatm@niehs.nih.gov; 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