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27.3.21

Functional observation battery (FOB) or Modified Irwin test

 

The Functional Observational Battery (FOB) is a neurobehavioral valuation tool relating numerous behaviour and neurological activity related parameters of a rat strain. This is a non-invasive process intended to identify gross functional deficits in young adult rats resulting from contact with chemicals and to better enumerate neurotoxic effects sensed in other studies. This battery of tests is not intended to deliver a comprehensive assessment of neurotoxicity. It is planned to be used in combination with neuropathological assessment and/or general toxicity testing. Other functional tests may be essential to evaluate entirely the neurotoxic latent of a chemical.

The modified Irwin test or FOB can be used to accomplish numerous objectives. New chemical entities (NCEs) can be behaviourally separated for nervous system efficacy at different dose level to recognize possible therapeutic uses and in the selection of suitable doses for successive analyses. NCEs can also be estimated in the behavioural battery and associated with reference standards to evaluate obligations in a new compound class, with an assessed therapeutic index being recommended by the doses used in evaluation to therapeutic doses. For the valuation of neurotoxicology, the FOB is frequently used. The differences between the two assays are delicate. The processes used are the same, but when because of neurotoxicology, the FOB is often accompanied using GLP guidelines.

Rats or mice of either or both sexes can be used, and diverse strains of each may be working, keeping in mind that diverse strains may have dissimilar baseline activities. The behavioural observations are completed by uninterrupted home handling observations, cage observations, and open field activity. Some autonomic activity valuations are also involved.

FOB Parameters and how recorded

Sr. No.

Parameters

Recorded as

1.

Measurements

 

 

Bodyweight

Grams

 

Rectal temperature

°C

 

Hind limb grip performance

Grams force

 

Forelimb grip performance

Grams force

 

Landing foot splay

Distance (cm) between hind feet

 2.

Cage-side observations

 

 

Abnormal movements or behaviour

Description

 

Ease of removal

Rank

 3.

Hand-held observations

 

 

General (thin, fat, red ocular nasal crusts, etc.)

Description

 

Palpebral closure

Rank

 

Pupil size

Rank

 

Abnormalities of skin or hair coat

Description

 

Perineal staining

Present or absent

 

Muscle tone

Rank

 

Extensor-thrust response

Rank

 

Abnormal movements (tremors, convulsions)

Description

 

Abnormal respiration (e.g., increased, wheezing)

Description

 

Reactivity to handling

Rank

 4.

Open-field observations

 

 

Responsiveness to a sharp noise

Rank

 

Responsiveness to touch

Rank

 

Responsiveness to tail pinch

Rank

 

Abnormal behaviour (e.g., stereotypies)

Description

 

Level of activity (locomotor, grooming, rearing, etc.)

Rank

 

Gait evaluation

Rank

 

Urine quantity voided during FOB

Rank

 

Number of fecal pellets voided during FOB

Rank

 5.

Neurologic examination

 

 

Body temperature

°C

 

Heart rates

beats/minute

 

Respiratory rates

breaths/minute

 

Capillary refill time

Seconds

 

Lacrimation and salivation

-

 

Sensorimotor/reflex

Seconds

 

Wheel barrowing

-

 

Righting reflex

Seconds

 

Menace reflex

Seconds

 

Pupillary light reflex

Seconds

 

Palpebral reflex

Seconds

 

Nystagmus

-

 

Auditory response

-

 

Pinna sensitivity

-

 

Perineal reflex

Seconds

 

Withdrawal reflex

Seconds

 

Patellar reflex

Seconds

A FOB is suggested as the first-level neurotoxicity screening in the preclinical safety pharmacology testing guidelines and OECD. Functional observational battery (FOB) procedures have been authorized in several species used in nonclinical studies. Functional observational battery (FOB) data were assessed as continuous, expressive, count, and two variables.


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