1.0 OBJECTIVE
1.1 To lay down a standard procedure to be followed for various activities pertaining to the maintenance of laboratory animals in Animal House Facility.
2.0 SCOPE
2.1 This Standard Operating Procedure (SOP) shall be applicable to the procedure (which includes housing, breeding, weaning and sexing of laboratory animals) by which laboratory animals are maintained in Animal House Facility.
3.0 RESPONSIBILITY
3.1 Head- Animal House Facility
3.2 All personnel involved in housing, breeding, weaning and sexing of laboratory animals
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 General
5.1.1 The temperature inside the animal facility shall be maintained between 22 ± 3
degree Celsius and relative humidity between 30% and 70% except during the room
cleaning.
5.1.2 The 12 hours light cycle from 7 am to 7 pm and 12 hours dark cycle from 7 pm to 7 am shall be maintained by an analog time switch.
5.2 Housing of Animals
5.2.1 Housing of mouse and rat
5.2.1.1 Both rat and mouse shall be housed in standard
polypropylene / polycarbonate / polysulphone cages purchased from commercial
source.
5.2.1.2 Usually, five animals shall be housed in a caged sex-wise. The average floor space should be at least 40-100 sq. cm/animal for
mice with a cage height of at least 12 cm and 110-400 sq. cm/animal for rats
with a cage height of at least 14 cm. If necessary rats with greater body
weight shall be kept 2 or 3 per cage.
5.2.1.3 Cages shall be closed with stainless steel top grill
with the provision for feed and water.
5.2.1.4 Cage is labeled with detail mention as per format no.
F--------------.
5.2.1.5
Animal rearing record shall be documented as per format
no. F---------------.
5.2.1.6
A maximum of 5 animals per cage shall be kept and total
24 cages for rat and 24 cages for mice can be housed in rat and mouse rearing
room.
5.2.2
Housing of Rabbit
5.2.2.1 The rabbit shall be housed in stainless steel cages of
a minimum height of 450 mm (18”) and average floor space of at least 216-432
sq. inches per animal.
5.2.2.2 All rabbits shall be housed individually. Stainless
steel cages with the sanitized finish, base grills, and removable dirt trays beneath
shall be used for housing the rabbits.
5.2.2.3 The front side (door) of the cage is provided with a feed
hopper and a water bottle holder.
5.2.2.4 Animal rearing record shall be documented as per format
no. F………………….
5.2.2.5 A total of no more than 3 animals per cage shall be
housed and a total of 12 rabbits shall be housed in rabbit rearing room.
5.2.3 Housing of guinea pigs
5.2.3.1
Animals shall be housed in 3 compartments made.
5.2.3.2
Male and female shall be housed separately.
5.2.3.3 A total of 7 guinea pigs shall be housed in one compartment.
5.3 Breeding of Animals
5.3.1
Breeding of mouse and rat
5.3.1.1
Selection of
Breeding Stock
5.3.1.1.1
Adult healthy animals free of physical abnormalities
shall be selected for breeding.
5.3.1.1.2
Animal exhibiting signs of viciousness such as
unwillingness to permit the handler to touch shall not be selected for
breeding.
5.3.1.1.3
The animals for breeding shall be selected from the
weaned animals. If the animals procured from outside sources, they shall be
used for breeding only after the quarantine period.
5.3.1.2
Mating Procedure
5.3.1.2.1
Animals selected for mating shall be identified by ear
notching/punching.
5.3.1.2.2
Rats and mice shall be allowed to mate for the first
time when they are at least 12-16 weeks and 7-10 weeks of age, respectively.
5.3.1.2.3
Monogamous or polygamous (harem) mating system shall be
used based upon suitability.
5.3.1.2.4
In a monogamous mating system, one selected healthy male
and one female shall be kept together in a cage. In the polygamous mating system
one selected healthy male and three or more females shall be kept together in a
cage.
5.3.1.2.5
They shall be kept together for at least 10 days and
then the male shall be separated.
5.3.1.2.6
The females in a cage shall be separated (if polygamous
mating) and shall be kept in individual cages for at least after 5 days from the
day of separation of the male.
5.3.1.2.7
A minimum of 30 days of the resting period shall be given
in between two consecutive mating’s for females and at least 10 days for males.
5.3.1.2.8
If necessary, the animals which are mated as a
monogamous pairs shall not be separated and kept as a continuous/permanent pair
for breeding purposes.
5.3.1.2.9 Details of the breeding animals shall be entered on the
breeding cage card format no. F-------.
5.3.1.2.10 The breeding life of mice is eight months and rat is of one and half years.
5.4 Procedures during Gestation and Parturition
5.4.1 The
conceived animals shall be confirmed for pregnancy by gently lifting with the base of the tail and observing the abdominal enlargement and these animals shall be
closely observed for nearing parturition.
5.4.2 On day
21 to 23, pregnant animals shall give birth to pups.
5.4.3 After
delivery the date of delivery of the pups, number of pups, and other related
details shall be entered in a format no. F-----------.
5.4.4 Parturient the animal shall be closely observed for any abnormal ethological changes like
cannibalism, biting and circling, etc.
5.4.5 Animal
showing neurobehavioral changes shall be euthanized.
5.4.6 Cross fostering if required shall be done either in the animals showing abnormal neurobehavioral changes or deceased animals but it shall be done only on the same age group of animals in order to achieve a homogenous population of animals.
5.5 Pup Sexing
5.5.1 Sexing
of pups shall be done at least 3 days after birth. Sexing shall be done cage
wise.
5.5.2 The lid
from the cage shall be removed and the mother shall be transferred to the spare
holding cage.
5.5.3 The one
pup at a time shall be taken from the cage holding it gently with the thumb and
first two fingers around the thorax and abdomen.
5.5.4 A visual
assessment of the anogenital distance shall be made.
5.5.5 In
females the anogenital distance is less while in males it is considerably
greater. This is distinguishable even in a day old pups.
5.5.6 The sex
of the pup is noted and it is placed in a petri dish/separate cage/in a separate
cage in which the mother is kept after which the next pup shall be taken from the
cage. The same procedure shall be repeated for all the pups.
5.5.7 The mother and the pups shall be returned to the same cage after the completion of sexing.
5.6 Weaning and Selection of Animals for Breeding Stock
5.6.1
Weaning
shall be carried out at least 21 days after delivery.
5.6.2
Five
animals of same-sex shall be housed per cage.
5.6.3
The
animals for breeding stock shall be selected from the weaned animals at the
time of weaning. In the case of outbred strains, due care shall be taken to avoid
the selection of siblings for breeding purpose, while in the case of inbred strains
siblings shall be selected for the foundation colony for breeding purposes.
5.6.4
Details
of the weaned animals or holding, animals shall be documented properly. The
animals selected for the breeding stock shall be monitored for the health
status.
5.6.5 The remaining animals shall be supplied as and when required for the studies.
5.7 Sexing of Rabbits
5.7.1
Slight
gentle pressure is applied to the genital region. In the case of buck, the genital
opening shall be oval and protrusion of genital papillae takes place. In the case
of doe only a slit-like opening shall be observed.
6.0
ENCLOSURES
6.1
Formats
|
Sr. No. |
Format Title |
Format No. |
No. of pages |
|
1 |
Breeding Record |
F-------------------------. |
01 |
|
2 |
Rearing Record of Animal |
F-------------------------. |
01 |
|
3 |
Rearing Cage Detail |
F--------------------------. |
01 |
|
4 |
Breeding Cage Detail |
F--------------------------. |
01 |
7.0
ABBREVIATIONS
7.1
SOP : Standard Operating Procedure
7.2
QAD : Quality Assurance Department
7.3 AHF : Animal House Facility
8.0 REFERENCES
8.1 Guide for the care & use of laboratory animals, 8th Edition, National Research Council, National Academy Press, Washington, D.C. 2010.
8.2 The Handbook of Experimental Animals, The Laboratory Mouse, Hans Hedrich and Gillian Bullock, Elsevier Academic Press, 2004.
8.3 The Laboratory Rat, Mark A. Suckow, Steven H. Weisbroth and Craig L. Franklin, Second Edition, American College of Laboratory Animal Medicine series, Elsevier Academic press, 2006.
8.4 Handbook of Laboratory Animal Management and Welfare, Sarah Worfenson and Maggie Llyod, Second Edition, Blackwell Science, 1998.
8.5 Guidelines for Breeding and Care of Laboratory Animals, World Health Organization (WHO) and International Council for Laboratory Animal Science (ICLAS), WHO/ZOON./93.169, WHO Library, 1993.
8.6 Committee for the purpose of control and supervision of experiments on animals (CPCSEA) guidelines for laboratory animal facility-2005, CPCSEA, Standard Operating Procedures for Institutional Animal Ethics Committee (IAEC), Animal Welfare Division, Ministry of Environment and Forests, January, 2010.
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Sr. No. |
Change Control No. |
Reason for change |
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END OF
DOCUMENT
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