EpiDerm Approved by EU, U.S. Regulators

Commercially Available, Organotypic In Vitro Test Method Approved for Assessing Dermal Corrosivity by Both U.S. and European Regulators

The United States National Toxicology Program (NTP), in an e-mail on August 1, 2002, announced ICCVAM's evaluation and recommendations regarding MatTek Corp.'s EpiDerm™ human skin model as an in vitro test method for assessing Dermal Corrosivity.

NIH Publication No: 02-4502 contains the "Summary Report of the EpiDerm™ Assay" and the "EpiDerm Test Method Protocol". Table 4.5 in that report summarizes the sensitivity, specificity, and accuracy of the EpiDerm test method. As the data in this table indicate, EpiDerm demonstrated the best sensitivity (92%) and the lowest rate of false negatives (8%) of any of the models tested.

This action by ICCVAM makes MatTek's EpiDerm skin model the only commercially available, organotypic in vitro test method that has been approved for assessing Dermal Corrosivity by both U.S. and European Regulators.

EpiDerm Performance Data (Table 4.5)

NIH/NIEHS/NTP Report Announcement

ICCVAM Evaluation of EpiDerm™ (EPI-200): In Vitro Test Methods for Assessing Dermal Corrosivity Potential of Chemicals (NIH Pub. #02-4502)

U.S. Federal Register Citation
(Vol. 67, No. 147 / Wednesday, July 31, 2002 / Notices)

ECVAM - EpiDerm Approval Statement

ECVAM - EpiDerm Skin Corrosivity Test Protocol
(INVITTOX #119)

OECD TG 431 (Test Guideline 431), “In Vitro Skin Corrosion: Human Skin Model Test”

EpiDerm Data Sheet

EpiDerm Dermal Corrosion Measurement

EpiDerm Specifications

EpiDerm Technical References

==================== Additional Information ==================== European Regulator Summary Conclusions and Recommendations; U.S. Regulator Concurance (Section 3.1, Page 55, ICCVAM Report) "ECVAM concluded that EpiDermTM (EPI-200) was an in vitro replacement assay for in vivo corrosivity testing. ...ECVAM concluded that EpiDermTM (EPI-200) was both reliable and reproducible; NICEATM concurs with that conclusion." ECVAM = European Centre for Validation of Alternative Methods NICEATM = NTP Interagency Center for the Evaluation of Alternative Toxicological Methods ==================== How are these U.S. Agencies related to one another? From the NICEATM Web Site: The National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences (NIEHS), one of the National Institutes of Health (NIH), created the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) in 1998. NICEATM provides support for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). NICEATM organizes meetings and workshops for the development, review, and validation of alternative toxicological testing methods. NICEATM facilitates information sharing among stakeholders. NICEATM also provides an opportunity for public-private partnerships to enhance the level and scope of its activities. ICCVAM and NICEATM initiatives implement Public Law 103-43 that directed NIEHS to develop a process to achieve regulatory acceptance of alternative test methods. Link to ICCVAM / NICEATM Web Site