1.0 OBJECTIVE
1.1
To lay down a standard procedure to be followed for observation of clinical signs in experimental animals in Animal House
Facility.
2.0
SCOPE
2.1
This Standard Operating Procedure (SOP) shall be
applicable for observation of clinical signs in experimental
animals in Animal House
Facility.
3.0
RESPONSIBILITY
3.1
Study Director / In-charge - Animal House Facility
3.2
All personnel involved in the observation of clinical signs
in experimental animals.
4.0
DEFINITIONS
4.1
Nil
5.0
PROCEDURE
5.1
General Procedure
5.1.1
As a Necropsy and gross observations should be
performed by a trained person and should be performed as soon as possible to
ensure tissue integrity by fixing them in 10% Neutral Buffered Formalin (NBF)
after the death of the animal in a manner that avoids the occurrence of artifacts
or post mortem changes in the collected tissues/organs.
5.1.2
Identify the cage (s) based on cage no/cage card and
carefully shift the respective cages from the cage rack to the working area.
5.1.3
Identify the animal from the cage by animal number/
markings and observe for clinical signs.
5.1.4
For further examination, if required, carefully hold the
animal to detect abnormalities. This activity should be performed by trained
personnel.
5.1.5
For any abnormal clinical signs or symptoms observed,
record the observation by identifying an appropriate clinical sign in Format
no. F………. of the currently running version of SOP. Any additional clinical signs /
abnormality observed shall be recorded in a format no. F…….. of a current running
version of S………….
5.1.6
After completion, gently close the cage lid and keep
the animal cage back to its original place ensure water and feed is provided to
the animals or as per the study plan (SP).
5.1.7
If the animal is found moribund or dead in the cage
during the observation of clinical signs in a particular study, then subject
the animal(s) for a necropsy.
5.1.8
Follow the above-mentioned procedures for observing
clinical signs for all the animals in toxicological studies.
5.1.9
Clinical signs in toxicity studies can be broadly
classified as mentioned below but not limited to:
5.1.9.1
Respiratory
5.1.9.1.1
Dyspnea: Difficult
or labored breathing, essentially gasping for air, respiration rate usually slows.
5.1.9.1.2
Abdominal
Breathing: Breathing by the diaphragm, greater deflection of abdomen upon
inspiration.
5.1.9.1.3
Gasping: Deep
labored inspiration, accompanied by a wheezing sound.
5.1.9.1.4
Apnea: A
transient cessation of breathing following a forced respiration
5.1.9.1.5
Cyanosis: Bluish the appearance of the tail, mouth, and or footpads usually due to lack of oxygen.
5.1.9.1.6
Tachypnea: Quick
and usually shallow respiration.
5.1.9.1.7
Nostril
discharges: Red or colorless.
5.1.9.2
Motor
activities; changes in frequency and nature of movements
5.1.9.2.1
Somnolence: Animal
appears drowsy but can be aroused by prodding and resumes normal activities.
5.1.9.2.2
Catalepsy: Animal
tends to remain in the same position in which it is placed.
5.1.9.2.3
Ataxia: Inability
to control and coordinate movements while the animal is walking.
5.1.9.2.4
Unusual
locomotion: Toe walking, pedaling, hopping, and low body posture.
5.1.9.2.5
Prostration: Immobile
and rests on the belly.
5.1.9.2.6
Tremors: Involving
trembling and quivering of the limbs or entire body.
5.1.9.2.7
Paralysis: Loss
of motor function in all or part of the body.
5.1.9.2.8
Hemiplegia: Paralysis
of one side of the body.
5.1.9.2.9
Paraplegia: Paralysis
of the hindquarters.
5.1.9.2.10
Quadriplegia: Paralysis
of all four limbs.
5.1.9.2.11
Clonic
convulsion: Alternating contraction and relaxation of muscles, observed as a
cyclin of the forelimbs.
5.1.9.2.12
Tonic
convulsion: Persistent contraction of muscles with the rigid extension of the hind
limbs.
5.1.9.2.13
Kyphosis: Curvature
of the vertebral column creating a humpback.
5.1.9.3
Eye
5.1.9.3.1
Lacrimation: Excessive
tears clear or colored.
5.1.9.3.2
Chromodacryorrhea:
red tears or red lacrimation.
5.1.9.3.3
Exophthalmos: abnormal
protrusion of eye from orbit.
5.1.9.3.4
Enophthalmos: abnormal
retraction of the eye in the orbit.
5.1.9.3.5
Ptosis: Dropping
of upper eyelids, not reversed by prodding the animal.
5.1.9.3.6
Mydriasis - dilatation
of pupils regardless of the presence or absence of light.
5.1.9.3.7
Miosis - constriction
of pupil regardless of the presence or absence of light.
5.1.9.3.8
Chemosis – swelling
or oedema of the conjunctival tissue.
5.1.9.3.9
Conjunctivitis -
inflammation of the conjunctiva.
5.1.9.3.10
Blepharospasm – rapid
or spasmodic eyelid movement.
5.1.9.3.11
Nystagmus – involuntary
rotational, horizontal, or vertical movement of eyes.
5.1.9.3.12
Keratitis – inflammation
of the cornea.
5.1.9.3.13
Epiphora – excessive flow of tears.
5.1.9.3.14
Cataract – opacity
of lens.
5.1.9.3.15
Corneal opacity
– translucent and opaque to the transmission of light.
5.1.9.4
Cardiovascular
5.1.9.4.1
Vasodilation - redness
of skin, tail, tongue, ear, footpad, conjunctivae, and warm body.
5.1.9.4.2
Vasoconstriction
- blanching or whitening of the skin and cold body.
5.1.9.4.3
Bradycardia – decreased
heart rate.
5.1.9.4.4
Tachycardia – increased
heart rate.
5.1.9.5
General
5.1.9.5.1
Piloerection – contraction
of the erectile tissue of hair follicles resulting in rough hairs or raising of the
hair/fur.
5.1.9.5.2
Alopecia – deficiency
of hair or hair loss.
5.1.9.5.3
Diarrhea – watery
stools or frequent defecation of fluid stools.
5.1.9.5.4
Hematuria – red
urine.
5.1.9.5.5
Anuria – absence
of urine excretion.
5.1.9.5.6
Polyuria- increase
above the normal in the amount of urine excreted.
5.1.9.5.7
Emaciation – lean
wasting muscle mass.
5.1.9.5.8
Diuresis – involuntary
urination
5.1.9.5.9
Edema – swelling
of tissue filled with fluid.
5.1.9.5.10
Erythema – redness
of skin.
5.1.9.5.11
Prolapsus – slipping
forward or down of the part of an organ, usually uterus or rectum.
5.1.9.5.12
Ear - abnormal
discharge or sebaceous secretion.
5.1.9.5.13
External
genitalia - abnormal discharge.
5.1.9.6
Moribundity
5.1.9.6.1
The experimental animal will be considered moribund if
any one of the following criteria mentioned below is observed:
·
Body
weight change loss (from the highest body weight in the study): >25%
·
Posture:
Severe hunching impairs movement
·
Activity:
Stationary unless stimulated
5.1.10
Fur texture:
Severe ruffling/poor grooming
6.0 ENCLOSURES
6.1 Formats
|
Sr. No. |
Format Title |
Format No. |
No. of pages |
|
1 |
Clinical signs of toxicity observation datasheet |
F…………………. |
01 |
|
2 |
Additional Clinical sign and symptoms record |
F………………….. |
01 |
7.0
ABBREVIATIONS
7.1
SOP : Standard Operating Procedure
7.2
QAD : Quality Assurance Department
7.3
AHF : Animal House Facility
7.4 SP : Study plan
8.0 REFERENCES
8.1
The Laboratory Rat – Second Edition,
Academic Press, Edited By – Mark A Suckow, (2006), 665-678.
8.2
The Laboratory Mouse – Elsevier Academic Press, edited by Hans Hedrich,
2004, 117-132,495-516.
8.3 Principles and methods of toxicology; Hayes A. W.
9.0 REVISION HISTORY
|
Sr. No. |
Change Control No. |
Reason for change |
|
|
|
|
END OF DOCUMENT
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