Functional Observational Battery (FOB)
The Functional Observational Battery (FOB) is a neurobehavioral assessment tool describing various behaviourlogical and activity related parameters of a rat strain.
In the assessment and evaluation of the potential human health effects of substances that have been observed to cause neurotoxic signs (e.g., convulsions, tremors, and ataxia) in other toxicity tests, as well as those having a structural similarity to known neurotoxicants, should be evaluated for neurotoxicity.
The functional observational battery (FOB) is a noninvasive procedure designed to detect gross functional deficits in young adults rats resulting from exposure to chemicals and to better quantify neurotoxic effects detected in other studies. This battery of tests is not intended to provide a detailed evaluation of neurotoxicity. It is designed to be used in conjunction with neuropathologic evaluation and/or general toxicity testing. Additional functional tests may be necessary to assess completely the neurotoxic potential of a chemical.
The material is administered by an appropriate route to laboratory rodents. The animals are observed under carefully standardized conditions with sufficient frequency to ensure the detection of behavioral and/or neurologic abnormalities, if present. Various functions that could be affected by neurotoxicants are assessed during each observation period.
Test procedures:
- Animal selection
- Species and strain. The laboratory rat or mouse is recommended.
- Age: Young adult animals (at least 42 days old for the rat or mouse) shall be used.
- Sex: (A) Equal numbers of animals of each sex are required for each dose level.
- The females shall be nulliparous and nonpregnant.
- Number of animals:
- At least eight animals of each sex should be used at each dose level and should be designated for behavioral testing. If interim sacrifices are planned, the number should be increased by the number of animals scheduled to be sacrificed before the end of the study. Animals shall be randomly assigned to treatment and control groups.
- Control groups: A concurrent ("sham" exposure or vehicle) control group is required. Subjects shall be treated in the same way as for an exposure group except that administration of the test substance is omitted.
- Concurrent or historic data: will provide evidence of the ability of the procedures used to detect major neurotoxic endpoints such as limb weakness or paralysis (e.g., acrylamide), CNS stimulation (e.g., ß, ß'-iminodiproprionitrile) autonomatic signs (e.g., physostigmine).
- A satellite group may be treated with the high dose level for the duration of exposure and observed for reversibility, persistence, or delayed occurrence of toxic effects for a post-treatment period of appropriate duration, normally not less than 28 days.
- Any unusual responses with respect to body position, activity level, coordination of movement, and gait.
- Any unusual or bizarre behavior including, but not limited to, headflicking, head searching, compulsive biting or licking, self-mutilation, circling, and walking backwards.
- The presence of:
- Convulsions.
- Tremors.
- Increased levels of lacrimation and/or red-colored tears.
- Increased levels of salivation.
- Piloerection.
- Pupillary dilation or constriction.
- Unusual respiration (shallow, labored, dyspneic, gasping, and retching) and/or mouth breathing.
- Diarrhea.
- Excessive or diminished urination.
- Vocalization.
- Forelimb/hindlimb grip strength.
- Sensory function. Assessment of sensory function (vision, audition, pain perception) will be made.
- Data reporting and evaluation.