Posted 10 October 2012
By Alexander Gaffney
The National Toxicology Program (NTP) has announced a new classification criterion that it says should require between 50% and 83% fewer animals to be used during testing to determine whether a chemical is hazardous to the eye.
The NTP and its various subprograms are responsible for bringing together more than a dozen federal agencies to generate and harmonize testing standards for toxic substances. Through its committees, it evaluates safety testing methods and strategies and works to validate new regulatory science methods.
The announcement, made in the 11 October edition of the Federal Register, comes as the program looks to regulatory science for ways to reduce its dependence on animals in preclinical testing-something now part of its core mission.
In a 13 June announcement, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), a part of the NTP, said it was implementing a five-year plan to foster, develop validate and promote the regulatory acceptance of new toxicology-based testing methods.
"The field of toxicology is evolving from a system based largely on animal testing toward one based on the integration of data from a wide range of sources, including in vitro methods that evaluate changes in biological pathways predictive of adverse outcomes and in chemico and in silico methods," explained DHHS at the time.
ICCVAM Shows Progress
NTP's release of its test method evaluation report (TMER) shows it is already moving to implement those goals.
Under currently acceptable procedures, chemicals are tested using the eyes of rabbits to obtain test results. ICCVAM and the Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) said they set out to assess whether three-animal tests could be used to obtain the same hazard classification as a similar test using additional animals.
Their assessment concluded that, "Using a classification criterion of one or more positive animals in a three-animal test to identify chemicals and products that are eye hazards will maintain hazard classification equivalent to that provided by current testing procedures."
"ICCVAM, therefore, recommends consideration of this classification together with eye safety testing procedures that use a maximum of three animals per test substance," it concluded.
Their recommendation will also be applicable to the US Food and Drug Administration (FDA), one of the agencies involved in ICCVAM and one which is bound to its recommendations.