SDSU Institutional Animal Care and Use Committee
Animal Protocol Form
Administration of Substances
Supplement 4
For official Use Only
APF #:
Submission Date:
Approval Date:
PI Name:
Click here
*NOTE: Per the The Guide for the Care and Use of Laboratory Animals (Page 30) the use of
pharmaceutical-grade chemicals and other substances ensures that toxic or unwanted side effects are
not introduced into studies conducted with experimental animals. They should therefore be used,
when available, for all animal-related procedures (USDA 1997b). Pharmaceutical grade chemicals
should be used, when available, for all animal-related procedures. When the chemical is not available
in pharmaceutical grade, the use of non-pharmaceutical grade substances should be described and
justified in Section 2 below. The use of non-pharmaceutical- grade chemicals or substances when
pharmaceutical grade is available should be described and justified in Section 3 below. Justification is
also required for the use of expired materials. These items must be reviewed and approved by the
IACUC prior to use. See the SDSU Use of Non-Pharmaceutical Grade Compounds and Expired
Materials Policies and Procedures for more information.
1. BIOHAZARDOUS MATERIAL*, HAZARDOUS CHEMICAL+, OR RADIOACTIVE MATERIAL~
Name all substances that will be administered to the animals, including any substances that will be
used for euthanasia, anesthesia, analgesia, sedatives, tranquilizers, therapeutic, biologics, reagents,
adjuvants, hormones, nutritional supplements, experimental compounds, and any other substances
or other hazardous materials you will use.
☐ N/A
A. BIOLOGICAL MATERIALS*
Route of
Administration or
Exposure *
Vehicle (i.e.,
water, food, saline
injection, etc.)
Reason for
Administration
Duration and
Frequency
Route of shedding
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Concentration
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Dose
Volume
Biological Material
(Ex: Recombinant/Synthetic Nucleic Acid Molecules, Oncogenes, Viral Vectors, Infectious
Agents, Human` or Non-Human Primate Source Materials, Xenografts, Select Agents/Toxins,
Biological Toxins) *Biohazardous Substances will require completion and submission of a
Biological Use Authorization (BUA) to the SDSU Institutional Biosafety Committee (IBC)
ibc@mail.sdsu.edu for approval prior to start of work.
Click
here
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SDSU Institutional Animal Care and Use Committee
Animal Protocol Form
Administration of Substances
Supplement 4
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* Ex. Injection, Water/Food, Nasal/Aerosol Challenge, Topical, Other, Specify
☐ N/A
B. HAZARDOUS CHEMICALS+
(Ex: Substances with a High Acute Toxicity, Carcinogens, Environmental Contaminants,
Cytotoxic/Antineoplastic Drugs, Reproductive/Developmental Toxins, Corrosives, Flammable)
+
Concentration
Volume
Route of Administration
or Exposure*
Vehicle (i.e., water, food,
saline injection, etc.)
Duration and Frequency
* Pharmaceutical Grade?
Reason for
Administration (i.e.,
experimental compound,
etc.)
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☐ Yes
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☐ Yes
☐ No
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☐ Yes
☐ No
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☐ Yes
☐ No
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☐ Yes
☐ No
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☐ Yes
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☐ No
☐ Not
Available
☐ Yes
☐ No
☐ Not
Available
☐ Yes
☐ No
☐ Not
Available
☐ Yes
☐ No
☐ Not
Available
☐ Yes
Route of Shedding
Dose
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Produce metabolites?
Hazardous Chemical/
Substance
Hazardous Chemicals will require the completion and submission of a Laboratory Specific
Standard Operating Procedure to Environmental Health & Safety for approval prior to start of
work.
SDSU Institutional Animal Care and Use Committee
Animal Protocol Form
Administration of Substances
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Supplement 4
☐ No
☐ Not
Available
☐ No
* Ex. Injection, Water/Food, Nasal/Aerosol Challenge, Topical, Other, Specify
☐ N/A
C. CONTROLLED SUBSTANCES^
To see a list of Controlled Substances, click here.
Use, possession, or storage of controlled substances will also require submission of an
Authorization Use Application to Environmental Health & Safety for approval prior to purchase
and use; see Section L below.
Concentration
Volume
Route of
Administration or
Exposure *
Vehicle (i.e., water,
food, saline injection,
etc.)
Duration and
Frequency
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* Ex. Injection, Water/Food, Nasal/Aerosol Challenge, Topical, Other, Specify:
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☐ Yes
☐ No
☐ Not
Available
☐ Yes
☐ No
☐ Not
Available
☐ Yes
☐ No
☐ Not
Available
☐ Yes
☐ No
☐ Not
Available
☐ Yes
☐ No
☐ Not
Available
Reason for
Administration (i.e.,
analgesic, anesthetic,
experimental
compound, abuse or
withdrawal, etc.)
Dose
Click here
* Pharmaceutical
Grade?
Drug
^
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SDSU Institutional Animal Care and Use Committee
Animal Protocol Form
Administration of Substances
Supplement 4
Route of
Administration or
Exposure*
Vehicle (i.e.,
water, food, saline
injection, etc.)
Duration and
Frequency
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* Ex. Injection, Water/Food, Nasal/Aerosol Challenge, Topical, Other, Specify
See SDSU Policies, Guidelines and Standard Operating Procedures
Anesthetic Gas Use & Scavenging Policy
Anesthetic Gas Use & Scavenging SOP
Co2 Chamber Use (OLAC SOP)
Isoflurane Gas Anesthetic Machine….. (OLAC Policy)
Shared folder not on web
Volatile Anesthetic Use and appropriate Scavenging (OLAC SOP)
E. RADIOACTIVE MATERIALS~
(Ex: Radioisotopes, Radiation Producing Machine, etc.)
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Reason for
Administration
(i.e., analgesic,
anesthetic,
experimental
compound, etc.)
Volume
Click
here
☐ N/A
* Pharmaceutical
Grade?
Concentration
Click here
Substance
Dose
D. ANESTHETICS, ANESTHETIC GAS, ANALGESICS, TRANQUILIZERS, ETC.
☐ Yes
☐ No
☐ Not
Available
☐ Yes
☐ No
☐ Not
Available
☐ Yes
☐ No
☐ Not
Available
☐ Yes
☐ No
☐ Not
Available
☐ Yes
☐ No
☐ Not
Available
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SDSU Institutional Animal Care and Use Committee
Animal Protocol Form
Administration of Substances
Supplement 4
Volume
Administered
Route of
Administration
or Exposure*
Frequency of
Administration
Reason for Use
Volume of
Compound
Excreted
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Compound
Activity (mC)
~Radioactive Materials will require completion and submission of a Radiological Use
Authorization (RUA) to the SDSU Radiation Safety Committee (RSC) for approval prior to start of
work.
* Ex. Injection, Water/Food, Nasal/Aerosol Challenge, Topical, Other, Specify:
2. Justification for use of Non-Pharmaceutical Grade Substances
☐ N/A
If the substance is not available as a human or veterinary pharmaceutical-grade product, provide a
scientific justification for their use and describe methods that will be used to ensure appropriate
preparation, sterilization, administration and duration of efficacy of dilution.
Click here
3. Justification for NOT using Pharmaceutical Grade Substances (when available)
☐ N/A
If any of the substances listed above are not human or veterinary pharmaceutical-grade substances
when there is a pharmaceutical-grade available, provide a scientific justification for their use and
describe methods that will be used to ensure appropriate preparation, administration and duration
for efficacy of dilution.
Click here
4. Insertion of tissues or products of animal or human origin into live animals
Material or Organism
(i.e. cell lines, antiserum, etc)
Source
Material
Sterile?
Material
Attenuated?
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☐ Yes
☐ Yes
☐ No
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☐ Ye
☐ No
☐ Yes
☐ No
☐ Yes
☐ No
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☐ No
☐ Yes
☐ No
☐ Yes
☐ No
☐ Yes
☐ No
☐ N/A
Material Tested for
Pathogens or
Infectious Agents?
☐ Yes
☐ No
☐ Yes
☐ No
☐ Yes
☐ No
☐ Yes
☐ No
SDSU Institutional Animal Care and Use Committee
Animal Protocol Form
Administration of Substances
Supplement 4
5. If the tissues or products have been derived from animals, has the material or organism been
screened for contaminants or tested PCR Primer testing for wild rodent or other lab animal viruses?
If yes, attach a copy of the pathogen testing results. If no, provide rational for not testing and
describe measures to protect animals and personnel. If the tissues or products are human source
(including cells or cell lines) attach a copy of the testing results, or give rational for not testing and
describe measures to protect animals and personnel. If xenografting is proposed, this work may
require the review and approval of the IBC. Contact the Division of Research Affairs or the
Biosafety Officer for more information. Human Source Materials that will be used in animals may
require additional Institutional Review Board oversight.
☐ By checking this box, I certify that the tested materials to be used have not been passed through rodent species
outside of the animal facility in question and/or the material is derived from the original tested sample. To the
best of my knowledge the material remains uncontaminated with rodent pathogens.
6. Additional Institutional Compliance Needs
(Check all that apply and supply the necessary information)
Does this research involve
IBC Approval
☐ Yes ☐ No
Biohazardous Substances?
Pending ☐
Does this research involve
EHS Approval
☐ Yes ☐ No
Hazardous Chemicals?
Pending ☐
Does this research involve
EHS Approval
☐ Yes ☐ No
Controlled Substances?
Pending ☐
Does this research involve
RSC Approval
☐ Yes ☐ No
Radiological Use Authorization?
Pending ☐
Does this research involve
IRB Approval
☐ Yes ☐ No
Institutional Review Board
Pending ☐
approval?
Protocol #:
Expiration
Date
EHS Approval Date:
EHS Approval Date:
Protocol #:
Protocol #:
Expiration
Date
Expiration
Date
Biohazardous Substances will require completion and submission of a Biological Use Authorization (BUA)
to the SDSU Institutional Biosafety Committee (IBC) for approval prior to start of work.
Hazardous Chemicals will require the completion and submission of a Laboratory Specific Standard
Operating Procedure to Environmental Health & Safety for approval prior to start of work.
Controlled Substances will require submission of an Authorization Use Application to Environmental
Health & Safety for approval prior purchase and use.
Radioactive Materials will require completion and submission of a Radiological Use Authorization (RUA)
to the SDSU Radiation Safety Committee (RSC) for approval prior to start of work.
Human Source Materials that will be used in animals may require additional Institutional Review Board
oversight. For more information contact the SDSU IRB at irb@mail.sdsu.edu or 619-594-6622.
II. Hazardous Materials and/or Substance Standard Operating Procedure
(Complete this Table for each hazardous material or substance listed in Sections I. 1.A-E.)
This section is a standard operating procedure (SOP), which is written health and safety guidelines for
use of the hazardous materials or substance with animals. This document serves as training material
and must be shared by PI or Lab Manager to all personnel in lab prior to start of work with hazardous
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SDSU Institutional Animal Care and Use Committee
Animal Protocol Form
Administration of Substances
Supplement 4
materials or substance and animals listed in this SOP. Refresher training will need to be provided when
there is a change to the work procedure, an accident occurs, or repeat non-compliance
1. Name of agent, substance, or chemical:
Click here
2. This material/substance is hazardous to the health
of:
☐ Humans Only
☐ Animals Only
☐ Humans and Animals
3. What are the health hazards?
4. Route of Transmission:
Click here
5. Location (Building, Room) of hazard
administration/exposure:
6. Location of Storage (Ex. refrigerator, flammable
Click here
☐
☐
☐
☐
☐
☐
Blood
Saliva/Nasal Droplets
Feces/Urine
Vector
Does Not Leave the Animal
Other Specify: Click here
Click here
cabinet, building and room number)
7. Housing location after hazard
administration/exposure:
8. Duration of housing:
9. What engineering controls will be used to reduce
exposure to personnel and other animals?
Click here
10. What work practices are in place to reduce
exposure to the hazardous material or substance?
11. The following PPE will be worn:
Click here
12. Will animals exposed to hazardous substances be
transferred/transported between facilities?
If yes, include transfer/transport methods and
locations:
13. The following items will be assumed contaminated
with hazardous materials:
Click here
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Click here
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
Micro-Isolator cages
Fume Hood
Biosafety Cabinet
Isoflurane/Scavenging Machine
Other Specify: Click here
Disposable gown
Gloves
N95 Mask
Eye and Face Protection
Lab Coat
Shoe Covers
Other Specify: Click here
Click here
☐ Bedding
☐ Cage
☐ Carcass
SDSU Institutional Animal Care and Use Committee
Animal Protocol Form
Administration of Substances
Supplement 4
☐ Water Bottle
☐ Food
☐ Other Specify: Click here
14. Describe how wastes including bedding will be
collected and disposed:
15. Bedding will be disposed as:
16. Carcass will be disposed as:
17. Cages, water bottles, enrichment toys will be
disinfected by:
18. Other materials (water, food) will be disposed as:
19. Cage will be labeled with:
20. Decontamination Procedures (for equipment, work
Click here
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
Chemical Waste
Biological Waste (red bag)
Radioactive Waste
Biological Waste (red bag)
Radioactive Waste
Autoclaved Prior to Washing
Chemical Disinfection Prior to Washing
High Temperature Washing
Regular Cleaning Method
Chemical Waste
Biological Waste (red bag)
Radioactive Waste
Click here
Click here
surfaces, normal operations)
21. Spill response/Accident Clean-up (ex. absorbent
Click here
materials, neutralization chemical etc.)
22. Emergency Response for Affected Individual
Fire/Evacuation:
Refer to SDSU Standard Operating Procedures
when applicable.
For large spills or fires, activate nearest fire alarm
and call SDSU police at 911. Evacuate building
and assemble at the buildings evacuation assembly
point, unless otherwise instructed.
A representative from the lab will need to inform
fire department or police of chemical hazards
within the lab as well as details on the spill or
cause of fire if chemical.
Remain at evacuation assembly point and do not
re-enter building until authorized by emergency
personnel.
Describe any specific laboratory procedures for
evacuations and notification procedures: Click
here
Medical Emergency:
For serious or life threatening emergency,
immediately call 911 from a campus phone or
(619) 594-1991 from a mobile phone.
If inhaled, close container and move person to
fresh air.
If splashed on skin or eye: For chemical burns to
the face or eye, call 911.
If ingested, seek medical attention immediately
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SDSU Institutional Animal Care and Use Committee
Animal Protocol Form
Administration of Substances
Supplement 4
and/or contact Poison Control Center at 1-800-2221222.
If injected, seek medical attention immediately
and/or contact Poison Control Center at 1-800-2221222.
Describe any chemical specific procedures for
Medical Emergencies: Click here
23. Safety Data Sheet Location
Click here
SOP Training Record
PI or lab managers must train all users in the proper practices and safety procedures when using
biohazardous materials, hazardous chemicals or radioactive materials. To document the training, click
here for a template training record. http://bfa.sdsu.edu/ehs/labsafety/labsafety.htm
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