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Appendix A 
Testing Guidelines 
Testing Guidelines 
Testing guidelines are developed for a variety of rea- 
sons: to allow results of various test substances or spe- 
cies to be easily compared, to encourage the use of cer- 
tain protocols so that testing need not be repeated, and 
to facilitate the work of those who design and carry 
out tests. Many organizations have developed testing 
guidelines. Three such compilations have been selected 
for discussion. 
FDA Guidelines Involving 
Whole Animal Testing 
To the extent possible, the Food and Drug Adminis- 
tration (FDA) makes its animal testing guidelines con- 
sistent throughout the agency and consistent with those 
of other agencies and organizations. However, special 
uses of products require special testing, and guidance 
is available from agency staff to help manufacturers 
meet those requirements. In this table, tests that gen- 
erally can be considered common or standard toxico- 
logical tests usually used throughout the agency are 
grouped together. Those that are more specific for 
evaluation of the safety of certain products are identi- 
fied with the FDA Center responsible for regulating 
that product. 
I. Agency -wide 
A. General Toxicity 
1. Acute oral— rodent, nonrodent 
2. Acute dermal-rodent, nonrodent 
3. Acute inhalation— rodent 
4. Subchronic oral— rodent, nonrodent 
5. Chronic oral— rodent, nonrodent 
6. Carcinogenicity— rodent 
7. Combined chronic/carcinogenicity— rodent 
B. Specific Effects 
1. Dermal sensitization— guinea pig 
2. Dermal irritation— rabbit 
3. Eye irritation— rabbit 
4. Teratogenicity— rodent, rabbit 
5. Reproduction— rodent 
6. Absorption, distribution, metabolism, 
elimination— rodent, nonrodent 
7. Neural-behavioral— rodent, rabbit 
II. Center-oriented 
A. Human Drugs 
1. Subchronic inhalation— rodent, nonrodent 
2. Subchronic dermal— rodent, nonrodent 
3. Vaginal and rectal administration— rodent, 
nonrodent 
4. Immunotoxicity— rodent 
B. Food Additives/Color Additives 
1. Immunotoxicity— rodent 
2. Protein quality— rodent 
3. Vitamin D assay— rodent 
C. Biologies 
1. All biologies administered by injection 
a. Safety— guinea pigs, mice 
b. Pyrogenicity— rabbits 
2. Vaccines 
a. Safety— mice, suckling mice, 
chimpanzees, monkeys, guinea pigs, 
rabbits 
b. Potency— guinea pigs, mice, monkeys 
c. Hypersensitivity— guinea pigs 
d. Toxicity— mice 
3. Antitoxins 
a. Potency— guinea pigs, mice 
4. Toxins 
a. Potency— mice 
5. Toxoids 
a. Potency— mice 
6. Immune globulins 
a. Potency— guinea pigs 
7. Tuberculin 
a. Safety— guinea pigs 
b. Potency— mice 
D. Devices 
1. Corneal metabolism— rabbit 
2. Biomaterial implant— rabbit, primate, cat 
3. U.S.P. intracutaneous— rabbit 
E. Cosmetics 
1. Primary skin irritation and corrosivity— 
rabbit 
2. Phototoxicity— nude mouse, rabbit, guinea 
Pig 
F. New Veterinary Drugs 
1. Safety, efficacy— target species 
2. Drug tolerance— target species 
3. Reproduction studies— target species 
4. Tissue irritation— target species 
5. Combination drug— target species 
6. Drug disposition— target species 
7. Route of administration— target species 
8. Intramammary infusion— dairy cows, goats 
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