03-18011. National Toxicology Program (NTP); National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health (NIH); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) Request for ...

Summary

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM are collaborating with the European Centre for the Validation of Alternative Methods (ECVAM) to conduct a validation study on in vitro test methods for assessing dermal irritation. Future collaborative validation studies may evaluate alternative methods for assessing ocular irritancy or other hazard endpoints. On behalf of ICCVAM, the NICEATM requests the submission of existing data on commercially available chemicals tested for skin irritancy in rabbits using current standardized testing methods (e.g., EPA 1998a; EPA 1998b; OECD 2001). These data will be used to help identify appropriate reference chemicals (i.e., those with high-quality in vivo testing data) for use in the validation study. NICEATM welcomes the submission of existing data from both human and animal studies and is also interested in any human post-marketing or occupational exposure/surveillance data that might be available for these chemicals. NICEATM also requests the submission of existing, high quality ocular irritation data that might be used to identify appropriate reference chemicals for future validation studies of in vitro ocular irritancy test methods. Data are sought from studies conducted to comply with Federal or other national/ international testing requirements that may not be publicly available because, (1) it was submitted to regulatory authorities, but cannot be released to the public by regulatory authorities, or (2) there is no requirement to submit the data to regulatory authorities.

Request for Submission of Chemical and Protocol Information/Test Data

Data and other information submitted in response to this notice should be sent by mail, fax or e-mail to NICEATM [Dr. William S. Stokes, Director, NICEATM, NIEHS, PO Box 12233, MD EC-17, Research Triangle Park, NC, 27709, (phone) 919-541-2384, (fax) 919-541-0947, (e-mail) [e-mail]] by noon on September 2, 2003 in order to ensure their consideration for the upcoming in vitro dermal irritation validation study. However, data and information received after this date will be periodically compiled and added to the database maintained by NICEATM. All chemical and protocol information/test data submitted in response to this notice will be publicly available upon request to NICEATM.

When submitting chemical and protocol information/test data, please reference this Federal Register notice and provide appropriate contact information (name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization, as applicable). NICEATM prefers data to be submitted as copies of pages from applicable study notebooks and/or study reports, if available. Each submission for a chemical should preferably include the following information, as appropriate:

• Common and trade name
• Chemical Abstracts Service Registry Number (CASRN)
• Chemical and/or product class
• Commercial source
• Rabbit skin/eye test protocol used
• Human skin/eye test protocol used
• Individual animal/human responses at each observation time
• The extent to which the study complied with National or International Good Laboratory Practice (GLP) guidelines
• Date and testing organization

Those persons submitting data on chemicals tested for skin and/or ocular irritancy in rabbits are referred to the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Report No. 66: Skin Irritation and Corrosion: Reference Chemicals Data Bank (March 1995) and ECETOC Technical Report No. 48: Eye Irritation: Reference Chemicals Data Bank (Second Edition, June 1998), respectively, for examples of the experimental animal study information and data that are requested in this notice. Both reports may be ordered from the ECETOC Web site at: http://www.ecetoc.org. Those persons submitting data on chemicals tested for skin irritation in humans are referred to Phillips, et al. (1972) for examples of the types of human study information and data that are requested in this notice.

The NICEATM will compile information and test data received by the deadline for consideration by ICCVAM and the ICCVAM Dermal Corrosivity and Irritancy Working Group (DCIWG). These groups will review the data and identify chemicals that might be appropriate for use in the upcoming validation study on in vitro test methods for dermal irritation.

Background Information on ICCVAM and NICEATM

ICCVAM was established in 1997 by NIEHS to coordinate the interagency evaluation of proposed new and alternative test methods, and to coordinate cross-agency issues relating to the validation, acceptance, and national/international harmonization of toxicological testing methods. Composed of representatives from fifteen Federal regulatory and research agencies that use or generate toxicological information, ICCVAM promotes the scientific validation and regulatory acceptance of toxicological test methods that improve agencies' ability to make decisions on health risks, while refining, reducing, and replacing animal use wherever possible. ICCVAM was authorized as a permanent interagency committee of the NIEHS, under the NICEATM, on December 19, 2000, through passage of the ICCVAM Authorization Act of 2000 (Pub. L. 106-545, available at http://iccvam.niehs.nih.gov/​PL106545.htm). Pub. L. 106-545 directs the ICCVAM to coordinate the technical review of new, revised, and alternative test methods of interagency interest. NICEATM provides operational and scientific support for ICCVAM and ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of Federal agencies. Additional information about ICCVAM and NICEATM can be found at the following Web site: http://iccvam.niehs.nih.gov.

References

EPA. 1998a. Health Effects Test Guidelines, OPPTS 870.2500, Acute Dermal Irritation, EPA 712-C-98-196. Available: http://www.epa.gov/​opptsfrs/​OPPTS_​Harmonized/​870_​Health_​Effects_​Test_​Guidelines/​Drafts/​870-2400.pdf.

EPA. 1998b. Health Effects Test Guidelines, OPPTS 870.2400, Acute Eye Irritation, EPA 712-C-98-195. Available: http://www.epa.gov/​opptsfrs/​OPPTS_​Harmonized/​870_​Health_​Effects_​Test_​Guidelines/​Drafts/​870-2400.pdf.

OECD. 2001. Harmonized Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures [ENV/JM/MONO(2001)6] Available: http://www.oecd.org.

Phillips L, Steinberg M, Maibach HI, Akers WA. 1972. A comparison of rabbit and human skin response to certain irritants. Toxicology and Applied Pharmacology. Mar; 21(3): 369-82.

Dated: July 9, 2003.

Samuel Wilson,

Deputy Director, National Institute of Environmental Health Sciences.