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ICCVAM is proposing eye hazard classification criteria that will provide the same or greater level of eye
hazard classification as current U.S. Federal Hazardous Substances Act (FHSA) regulations, while
using 50% to 83% fewer animals. The draft recommendations are based on an analysis conducted in
collaboration with NICEATM. The analysis shows that using a classification
criterion of at least one positive animal in a 3-animal test to identify eye hazards will provide
the same or greater level of eye hazard classification as current FHSA regulations, which require
the use of 6 to 18 animals. A manuscript describing the NICEATM analysis has been published in the
journal Regulatory Toxicology and Pharmacology. A Federal Register notice published in
August 2011 announced availability of the draft recommendations and opportunity for public
comments. ICCVAM will consider all public comments and comments made by the
Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) when finalizing its
recommendations. Final ICCVAM recommendations will be made available on this page and forwarded to
relevant Federal agencies for their consideration.
Reference:
Haseman JK, Allen DG, Lipscomb EA, Truax JF, Stokes WS. 2011. Using fewer animals to identify
chemical eye hazards: revised criteria necessary to maintain equivalent hazard classification. Regul Toxicol Pharmacol.
View publication PDF [PDF]
View article online
View ICCVAM draft recommendations [PDF]
View Federal Register notice announcing availability of ICCVAM draft recommendations
(76 FR 50220, August 12, 2011) [PDF]
View January 24, 2011, CPSC request for a data analysis in support of
revised classification criteria necessary to maintain equivalent eye hazard labeling when using fewer animals
[PDF]
Background
Current FHSA regulations provide procedures to determine the eye hazard classification and
labeling requirements for chemicals and products to which consumers may be exposed. The current
procedure requires a minimum of 6 animals per test and may require up to 3 sequential tests
for each substance, thus requiring 6, 12, or 18 animals to reach a hazard classification
decision. The requirement for second and third sequential tests is based on the number of positive
responses in the previous test.
Procedures for using 3-animal tests are described in test guidelines issued by the
Organisation for Economic Co-operation and Development (OECD Test Guideline 405)
and by the U.S. Environmental Protection Agency (OPPTS 870.2400).
U.S. policies and regulations require that only the minimum number of animals necessary to obtain scientifically
valid results should be used and that a rationale for the appropriateness of the number of animals used
be provided. Thus, most in vivo ocular safety testing is expected to adhere to
these 3-animal procedures. However, current FHSA regulations do not provide hazard classification
criteria for results obtained from a 3-animal test.
NICEATM conducted an analysis to
determine classification criteria based on results from a 3-animal test that would provide eye hazard
classification equivalent to procedures in current FHSA regulations. Based on these results, ICCVAM developed draft
recommendations to use this classification criterion for ocular safety testing procedures
that use a only maximum of 3 animals per test substance.
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