1. CPCSEA GUIDELINES FOR LABORATORY ANIMAL FACILITY

2. Contents ; Need of CPCSEA Governing body of CPCSEA
Guidelines of CPCSEA
3 R’s for animal testing
Alternative to animal testing
Reference

3. CPCSEA ;

4. Need of CPCSEA
To ensure that lab animals are well maintained and experiments are conducted according to ethical norms.
To promote humane care of animals used in biomedical and behavioral research.
To enhance animal well being and quality .
To improve laboratory animal facility
To enhance biological knowledge that is relevant to humans and animals.

5. Governing Body MS. Maneka Gandhi- Chairperson of CPCSEA.
It is established under the provision of Prevention of cruelty act of 1960.
The Experiments on animals amendment rules(1998) and Breeding of and experiments on animals(1998) gave powers to the CPCSEA.
To make rules in relation to the conduct of experiments on animals.
To authorize any of its officers to inspect any place at any time.
To prohibit a person or an institute from carrying out experiments on animals.

6. GUIDELINES Veterinary care Animal procurement Quarantine
Daily observation of animals.
Reviewing protocols and proposals
Establishment of appropriate policies and procedures for animal husbandry.
To maintain zoonosis control programmes.
Animal procurement
Animals are procured from CPCSEA registered breeders.
Quarantine
Quarantine is the separation of newly received animals from those already in the animal facility.
It determines microbial status of newly received animals.
Minimizes the chance for introduction of pathogens into an established colony.
Duration- small animals – 1 week
Large animals- 6 week.

7. Stabilization and separation
Physiological, psychological and nutritional stabilization is needed.
Separation is based on species to prevent diseases and transmission.
Animal care and technical personnel
Animal care programmes should be conducted.
People trained in animal science should be appointed.
Personal hygiene
Showers, changing rooms, footwares.
Clothing.
Use disposable wear such as gloves ,masks, head covers, coats, shoe covers.
Avoid eat, drink and smoke in animal facility.

8. Animal experimentation involving hazardous agents
Procedures and facilities involving hazardous agents should be reviewed by,
Institutional Bio-safety Committee.
Institutional Animal Ethics Committee(IAEC).
Multiple surgical procedures on single animal
No animal should be used for experimentation for more than 3 years unless adequate justification is provided.
Physical restraint
for examination , collection of samples and surgical operations.
Accomplished by manually or by devices.
Devices should be suitable in size design for the animal being held and operated properly to minimize stress and avoid injury to the human.
Period of restraint should be minimum.
Less restrictive systems should be used.

9. Animal facility` Functional areas
Separated from personnel areas such as offices and most laboratories.
Located as far away from human habitations as possible.
Not exposed to dust ,smoke, noise , wild rodents, insects and birds.
Sharp fluctuations in temperature, humidity, light, sound and ventilation should be avoided.
Functional areas
Separate areas for food, bedding, surgery ,treatment, storage, washing.
Area for repairing cages and equipment.
Specialized laboratories.

10. Environment Animal husbandry Social environment
Temperature O C .
Humidity %.
Ventilation- air conditioning systems.
Power and lighting- fluorescent lights, emergency power.
Animal husbandry
Adequate space, maintenance of body temp ,urination, defecation and reproduction.
Keep the animals dry and clean.
Polypropylene, polycarbonate and stainless steel cages should be used.
Easy for inspection.
Social environment
Population density can affect reproduction, metabolism, immune responses and behaviour.

11. Emergency weekend and holiday care Personnel and training
Food
Palatable, non contaminated and nutritionally adequate.
Should contain crude fiber crude protein, essential vitamins, minerals ,fat and carbohydrates for providing appropriate nutrition.
Bedding
Absorbent, free of toxic chemicals.
Change the bedding twice a week.
Optimizes normal animal behaviour.
Water
fresh, potable, uncontaminated.
Pest control
Pest control programmes.
Emergency weekend and holiday care
Everyday care is essential
Personnel and training
Animal facility staff is critical component in the management.

12. Sanitation and cleanliness
Cages should be sanitized before the animal is placed.
Cages and water bottles can be disinfected by rinsing at a temperature of C or by chemical agents such as hypochlorite to destroy pathogenic microbes.
Autoclave or gas sterilizers can be used.
Record keeping
Animal house plans.
Staff record.
Standard operating procedures(SOP)
Health records.
Breeding, stock, purchase and sales records.
Death record
Records of experiments on animals.
Clinical record of sick animals.
Waste analysis report.

13. Guidelines for Use of Anaesthesia
Useful for painful procedures.
At no stage of experiment the animal is conscious to perceive the pain.
If any irrepairable injury occurs , the animal should be sacrificed.
Overnight fasting.
Use pre-anaesthetics were ever applicable.
Local or general anaesthetics may be used.
Side effects such as excessive salivation, convulsions, excitation and disorientation.

14. Euthanasia Painless killing.
Animal is required to sacrificed on termination of an experiment or otherwise for ethical reasons, death without causing anxiety, pain with minimum time lag phase.
Location should be separated from animal rooms.
Tranquillizers should be given for larger animals such as monkeys, dogs, cats before an euthanasia procedure.

15. Three R’s for animal testing;

18. Alternative to animal use in testing:
1)avoiding duplicative testing; a) chemical Manu. Asso. b) P’ceutical Manu. Asso. c) soap & detergent Asso. CIIT: Chemical industry institute of toxicology

20. 2) Use of living system in testing-
a)In-vitro system
b) non animal organism;
-Micro organism
-Invertebrates

22. -Micro-organism; Advantage; ●org. can cultivated much more
Easily & quickly than most animal
Or human cell
●genetic make up is simple than
Animal or human.

23. Fungal system used in mutagenecity.
Cilia protozoa respond to smoke or phenols as do the cilia in the human bronchial tube.
Various protozoans used in toxicity testing of cigarette smoke, mutagenesis,reproductive toxicity.

24. 4) Use of non living system in testing;
a)chemical system-
Animal replaced with analytical chemistry.
Determine potency, conc. of drug such as vaccines, anti-cancer drug & vitamins.

25. Mathematical & computer :

26. 5) Skin and eye irritation; a- chick embryo test;
Chick Embryo Chorioallantoic Membrane Assay ;
. Fertile eggs are incubated at 37’’ C.
A window is cut at the top, and 1.5 to 2 millilitres of albumin is removed with a needle and discarded.
The Chorioallantoic membrane forms on the floor of the air space, on top of the embryo. The window is taped.

27. Day 14. A test sample is placed on the embryonic membrane and contained within a plastic ring.
Day 17. The chorioallantoic membrane is evaluated for its response to the test substance, and the embryo is discarded.

29. 6) Repeated – dose toxicity tests;
a) Hepatotoxicity
b) Neurotoxicity
7) Mutagenicity & carcinogenicity;
Ames test-

30. Framework for validation proposed by the Center for Alternatives to Animal Testing validation committee.

32. REFERENCES www.wikipedia.com www.elsevier.com/locate/toxicol
CPCSEA guidelines, Govt. of India.
Indian Journal of Pharmacology, 2003,page no
Kasture S.P., A Handbook of experiments in pre- clinical Pharmacology, 1ST edition,,2006,page

33. THANK YOU