Federal Register: July 16, 2003 (Volume 68, Number 136)
DOCID: FR Doc 03-18011
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: National Toxicology Program:
SUBJECT CATEGORY:
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
DOCUMENT SUMMARY:
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 highquality
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 postmarketing 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 email to NICEATM [Dr. William S. Stokes, Director, NICEATM, NIEHS, PO Box 12233, MD EC17, Research Triangle Park, NC, 27709, (phone) 9195412384, (fax) 9195410947, (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, email, 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 crossagency 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. 106545, available at http://iccvam.niehs.nih.gov/PL106545.htm ). Pub. L. 106545 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 ICCVAMrelated 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 712C98196. Available: http://www.epa.gov/opptsfrs/OPPTS_ Harmonized/870HealthEffects TestGuidelines/
Drafts/8702400.pdf.
EPA. 1998b. Health Effects Test Guidelines, OPPTS 870.2400, Acute Eye Irritation, EPA 712C98195. Available: http://www.epa.gov/opptsfrs/ OPPTSHarmonized/870Health EffectsTest Guidelines/
Drafts/8702400.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): 36982.
Dated: July 9, 2003.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences. [FR Doc. 0318011 Filed 71503; 8:45 am]
BILLING CODE 414001P
SUMMARY:
National Institute of Environmental Health Sciences, National Institutes of Health—; Dermal and ocular irritancy chemical test data from animal and human studies using standard testing methods,
DOCUMENT BODY 2:
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 highquality
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 postmarketing 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 email to NICEATM [Dr. William S. Stokes, Director, NICEATM, NIEHS, PO Box 12233, MD EC17, Research Triangle Park, NC, 27709, (phone) 9195412384, (fax) 9195410947, (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, email, 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 crossagency 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. 106545, available at http://iccvam.niehs.nih.gov/PL106545.htm ). Pub. L. 106545 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 ICCVAMrelated 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 712C98196. Available: http://www.epa.gov/opptsfrs/OPPTS_ Harmonized/870HealthEffects TestGuidelines/
Drafts/8702400.pdf.
EPA. 1998b. Health Effects Test Guidelines, OPPTS 870.2400, Acute Eye Irritation, EPA 712C98195. Available: http://www.epa.gov/opptsfrs/ OPPTSHarmonized/870Health EffectsTest Guidelines/
Drafts/8702400.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): 36982.
Dated: July 9, 2003.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences. [FR Doc. 0318011 Filed 71503; 8:45 am]
BILLING CODE 414001P