Modified Irwin test has been brought exclusive to all where the relevant information has been provided regarding the test procedure.

1. FUNCTIONAL OBSERVATION BATTERY TESTS
(MODIFIED IRWIN TEST)
The Irwin test is an observational screening test that is a battery of test used to assess a mouse or
rats neurobiological and physiological state. Parameters that are evaluated include autonomic and sensorimotor
functions, convulsive behavior and other activities produced by a drug after administration. Conducted by an
experienced tester the Irwin test can provide insight into a drugs activity including potential motor targets,
therapeutic benefits and deleterious side effects.
However the modified Irwin test describe is used to identify subtle neurological perturbations
produced by a drug and used to control for other behavioral and locomotor assays. Although a behavioral test of
sorts it is not directed towards a specific indication. The assay system will also be used during the pharmacokinetic
and maximal tolerated dose preliminary studies to establish dose-response ranges for subsequent efficacy studies.
The functional observational battery test is a non-invasive procedure designed to detect gross
functional deficits in young adults 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
used in conjunction with neuropathologic evaluation testing.
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 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 should be used (at least 42 days old for the rat or mouse)
Sex: Equal no. of animals of each sex are required for each dose level. The females should be nulliparous (who has
never given birth either by choice or for any other reason) and non-pregnant.
No. of animals: At least 8 animals of each sex should be used at each dose level and should be designated for
behavioral testing. If interior sacrifices are planned, the number should be increased by the number of animals
scheduled to be sacrificed before the end of study. Animals shall be randomly assigned to treatment and control
groups.
Control groups: A concurrent 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, CNS stimulation. 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.
MDS’s minimal lists of observations include:
1. Any unusual responses with respect to body position, activity level, co-ordination of movement and gait.
2. Any unusual orbizarre behavior including but not limitedto head flicking, headsearching, compulsive biting or
licking.
3. Presence of convulsion, tremors, increasedlevels of lacrimation, salivation, pupillary dilatation andconstriction.
4. Forelimb/ hind limb grip strength.
5. Sensory function. Assessment of sensory function (vision, audition, pain, perception) will be made.
6. Data reporting and evaluation.