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NICEATM invites (Federal Register,
Vol. 73, No. 66, page 18535-18536, April 4, 2008) the submission of relevant data and information on AMCPs or related substances obtained from
- Human testing or experience, including reports from accidental exposures
- Rabbits using the standard eye test or the low volume eye test
- In vitro test methods for assessing ocular irritation, such as the Bovine Corneal Opacity
and Permeability test, the Cytosensor Microphysiometer test, and the EpiOcular test, including
data supporting the accuracy and reproducibility of these methods
Although data can be accepted at any time, data received by May 19, 2008,
will be considered during the ICCVAM evaluation process. Relevant data received after this date will be
considered during the ICCVAM evaluation process, if feasible. All information submitted in response to
this notice will be made publicly available and may be incorporated into future NICEATM and ICCVAM reports
and publications as appropriate.
When submitting data, please reference the April 4, 2008,
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 study notebooks and/or study reports, if available
(view example). Raw data and analyses available
in electronic format may also be submitted. Each submission for a substance 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
- Physical and chemical properties (e.g. molecular weight, pH, water solubility, etc.)
- In vivo or in vitro test protocol used
- Individual animal or in vitro responses at each observation time (i.e., raw data)
- The extent to which the study complies with national/international Good Laboratory Practice (GLP) guidelines
- Date and testing organization
View an example of data in preferred submission format
For more information on data submission, please contact NICEATM
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