[Federal Register Volume 68, Number 136 (Wednesday, July 16, 2003)]
[Notices]
[Pages 42067-42068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


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 Existing Dermal and Ocular 
Irritancy Chemical Test Data From Animal and Human Studies Using 
Standardized Testing Methods

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) [email protected]] 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).

[[Page 42068]]

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:
    [sbull] Common and trade name
    [sbull] Chemical Abstracts Service Registry Number (CASRN)
    [sbull] Chemical and/or product class
    [sbull] Commercial source
    [sbull] Rabbit skin/eye test protocol used
    [sbull] Human skin/eye test protocol used
    [sbull] Individual animal/human responses at each observation time
    [sbull] The extent to which the study complied with National or 
International Good Laboratory Practice (GLP) guidelines
    [sbull] 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.
[FR Doc. 03-18011 Filed 7-15-03; 8:45 am]
BILLING CODE 4140-01-P