[Federal Register: July 16, 2003 (Volume 68, Number 136)]
[Notices]
[Page 42067-42068]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jy03-103]
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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) iccvam@niehs.nih.gov] 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