NORTH CAROLINA STATE UNIVERSITY
VERTEBRATE ANIMAL USE
IACUC Office Only
IACUC PROTOCOL
Principal Investigator
Date
Research Materials Hazard Classification Form
The safety approval for use of research materials is based on completion of the following information and
review and approval by BOTH:
Environmental Health and Safety and Management of the Animal Care Facility where the animals will
be housed
Basic Instructions:
1.
Download and complete the form
a. If only the PI and their staff will be handling the animals and hazardous materials and they have their
own approved safety plan, Sections 1 and 2 are required. Section 3 and Appendix A are optional.
Without an approved safety plan, completion of Sections 1-3 and Appendix A are required.
b. If people other than the PI and their staff (i.e., animal care staff, pharmacy, etc.) will be handling
the animals and hazardous materials, the PI will complete Section 1-3 and send this form and the
draft AVAU to the supervisor of animal care and other support staff (i.e. pharmacy etc.)
to complete Appendix A.
2.
Save your completed copy and all Appendix A forms completed by others. (please be sure the
name of the Principal Investigator is included above)
3.
Return the completed forms, along with your completed AVAU or amendment to Judy Schledorn,
IACUC Administrator, at Administrative Services III, Judy_Schledorn@ncsu.edu, 919-515-7507.
Send through email attachment.
4.
The IACUC Office will provide a copy of the “final” application package to EHS and the Animal Care
Facility for their approval.
Section 1. Animals Will Be Housed at:
CVM Laboratory Animal Resources Facility-main building
CVM Laboratory Animal Resources Facility-Research Building
Biological Resources Facility on North Campus
Toxicology Facility on Centennial Campus
University Field Labs
Yates Mill
David Clark Labs
Other (please list)
Section 2. Exposure Groups
Who prepares research materials at NCSU facilities for administering to the animals including reconstituting, mixing with feed, water
etc?. (check all that apply):
PI
Collaborating PIs
PI’s staff- Lab tech, Research tech, Grad student etc.
Pharmacy personnel
Clinic personnel
Animal Care Staff (work directly for Animal Facility personnel- not the PI)
Volunteers
Pet owners
Central Procedures Lab personnel
Hospital personnel
Other (examples-unpaid students, clients, private partners etc. please list)
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NORTH CAROLINA STATE UNIVERSITY
VERTEBRATE ANIMAL USE
Section 2. Exposure Groups (continued)
Who administers the material to the animals including injection, tablet, gavage, food trough, etc.? (check all that apply):
PI
Collaborating PIs
PI’s staff- Lab tech, Research tech, Grad student etc.
Pharmacy personnel
Clinic personnel
Animal Care Staff (work directly for Animal Facility personnel- not the PI)
Volunteers
Pet owners
Central Procedures Lab personnel
Hospital personnel
Other (examples-unpaid students, clients, private partners etc. please list)
Personnel with potential for chemical material/metabolite contact when handling, cleaning facilities/equipment or disposing of animals
PI
Collaborating PIs
PI’s staff- Lab tech, Research tech, Grad student etc.
Pharmacy personnel
Clinic personnel
Animal Care Staff (work directly for Animal Facility personnel- not the PI)
Volunteers
Pet owners
Housekeeping/Maintenance Staff
Other (examples-unpaid students, clients, private partners etc. please list)
The PI’s direction for PPE for him/herself and staff shall be covered under their laboratory safety plan. If no personnel are identified
outside of the PI staffing, the structured chemical risk classification portion of this form and the PPE selection in Appendix A are
optional. However, if you do not have an approved laboratory safety plan you must complete Appendix A.
If pharmacy, clinic, animal care, hospital, Central Procedures Lab, housekeeping/maintenance staff, volunteers, pet owners or others
may be exposed at any stage of material handling and use, the full hazard classification in Section 3 of the form is mandatory. The PI
is not responsible for Appendix A but may need to assist the supervisor of the animal care and support staff in completing it.
Where PIs and their direct staff have a safety plan and are the only persons handling
the materials, and treating, caring for, housing and disposing of the animals and the wastes,
the remaining sections of this form and Appendix A are optional. Otherwise, continue with
the hazard analysis.
Section 3. Chemical Hazard Awareness and Handling Procedures
In the following tables, please list the health effects of the compounds you will be administering as well as half-lives of these materials
in your test animals. This will be necessary to assist in selection of protective measures for those individuals handling these compounds
as well as the personnel caring for the animals.
To assist you, your collaborators and staff, and the personnel caring for animals and handling animal bedding, it is necessary to classify
each material you will be using into its appropriate hazard category (see step 3). Classification will assist you and personnel performing
animal care in determining proper engineering controls, work practices, and protective equipment needed.
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Step 1 – Personnel involved with handling of hazardous chemicals are required to review the NC State on-line Chemical Hygiene Plan
prior to protocol submission. http://www.ncsu.edu/ehs/www99/right/handsMan/lab/Draft_CHP_OSHA_Lab_Safety_Standard.pdf
For people shipping or transporting hazardous materials in vehicles:
Training is required for anyone who ships or transports any quantity of hazardous chemicals or hazardous materials. Training
is available at: http://ncsu.edu/ehs/dot/
For the manner in which materials are carried within the building:
Hazardous materials should be transferred within a building in a manner to reduce the potential of exposure. Please contact
the animal care facility for any limitations or restrictions on the transfer of materials inside buildings.
Step 2 – Complete the Chemical Use Chart (Table 1) by reviewing the literature for information on the physical state and metabolic
properties of the parent material in the test animal you will be using. Include any information on the half-life of the material or its
metabolites in the test animal if they may be harmful to personnel caring for the animals.
Table 1 - Chemical Use Chart – Chemical Dosage and Half Lives
Name of Material to be
administered
Dosage and
Frequency of
Administration
Physical state of material
handled in animal care area
(i.e., fine powder, dissolved
solid, pill, etc)
Half-life of parent
material
administered in test
animal
(list U if unknown)
Are these materials prepared for delivery to the animal in an area covered under a safety plan?
Yes
Is the parent material or are
the metabolites hazardous
as excreted (Y/N)? .
(list U if unknown)
No
If No, briefly describe how the materials are prepared to be delivered to the animal:
Step 3 – Complete Table 2 on Chemical Hazards by reviewing the (Material) Safety Data Sheet [(M)SDS] for each material you will be
using. http://www.ncsu.edu/ehs/MSDS.htm
Please take special note of the following items listed below in a-f and provide as much information as possible in Table 2.
a.
Review the hazards associated with the chemical on the (M)SDS. This information is typically found in Section 2 of the
(M)SDS (Hazards Identification). List the hazard statements (i.e. H301-toxic if swallowed), if available, in the column
labeled “Hazard Description” on Table 2. If hazard statements are not available please list the OSHA hazards, risk
phrases (R-phrases), potential health effects, or other key phrases related to health hazards.
b.
List precautionary statements (i.e., P280-wear protective gloves) in the column labeled “Precautionary Information” on
Table 2. If precautionary statements are not available insert other phrases that are listed on the (M)SDS that relate to
measures to minimize exposure.
c.
Provide the health effects NFPA or HMIS ratings, if available in the (M)SDS. (The health effect rating is the numerical
rating for the blue shaded section of the color coded NFPA diamond often present in the (M)SDS).
d.
Note whether the material is toxic or highly toxic – Take note of both the LD50 and LC50 if included in the (M)SDS or do
a web search and list in Table 2 below.
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NORTH CAROLINA STATE UNIVERSITY
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Test
Toxic
Oral LD50
(Albino rats)
50-500 mg/kg
Skin Contact LD50
(Albino rabbits)
200-1000 mg/kg
Inhalation LC50
(Albino rats)
200-2000 ppm/air
Highly Toxic
<50 mg/kg
<200 mg/kg
<200 ppm/air
Note any information on the MSDS regarding whether the material is a carcinogen or reproductive hazard. See the Proposition 65
listing of carcinogens for additional information: http://www.oehha.org/prop65/prop65_list/files/032108list.pdf . Another useful
reference is a listing of carcinogens, reproductive hazards and systemic toxins (Particularly Hazardous Materials):
http://www.safety.duke.edu/OHS/Documents/PHS_by_CAS.pdf
e.
If the information for columns a through d is unavailable, check the literature for the NOEL (No Observed Effect Level). If
the NOEL is available, list the NOEL rating with units, route of exposure, species tested, and corresponding test
duration
Table 2 - Chemical Hazard Information
Name of
Chemical to be
administered
CAS #
a) Hazard Description
(hazard statements,
R-phrases, OSHA
hazards, potential
health effects)
b) Precautionary
Information
(precautionary
statements for
controlling exposures)
c) NFPA or HMIS
Health Rating
(list numerical
health rating
below)
d) LD50 or LC50
(list test species
and duration)
e) Prop 65 or
PHS Lists
(check the lists
and note if it is
included)
Note:
Any information provided will be helpful in expediting the review process and may provide useful safety information to personnel
administering the materials and persons responsible for housing and caring for the animals. In the case where you have no reference
information, insert “U” for unknown in the appropriate box. If you are using a mixture of substances, please use the (M)SDS for the
mixture to populate Table 2 and categorize hazards. If you are unable to secure an (M)SDS for the mixture (i.e., you are preparing the
solution), please list each chemical component separately.
Supplemental tables are provided at the end of this form to add additional chemicals.
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VERTEBRATE ANIMAL USE
Step 4. Summary of chemical hazards.
Based on the information reviewed above and your entries in Tables 1 and 2, please identify/categorize the associated hazards.
Please list the compound name next to the hazard type. Check all the boxes that apply.
EN - Engineered Nanomaterial (less than 100 nanometers in size)?
See http://www.ncsu.edu/ehs/nano/checklist.htm
T - Toxic chemicals ?
HT – Highly Toxic chemicals?
C - Carcinogens?
RP - Reproductive Hazards? If yes, use designation below where applicable
TR-Teratogens?
A - Abortifactants?
M -Mutagens?
F- Fertility (Male or Female
D- Developmental (Fetus/new born)?
CR – Corrosives
O - Other, please list
Step 5. Indicate the Reference Materials Used in this review by placing a check mark next to EACH of the references that you reviewed
for this hazard review.
1. (Material) Safety Data Sheet [(M)SDS] ?
2. NOEL
(M)SDS
Literature
3. LD50 or LC50
(M)SDS
Literature
4. Proposition 65 list (carcinogens and reproductive hazards)?
5. Particularly Hazardous Substances List- (PHS) (systemic toxins, carcinogens, and reproductive hazards) ?
6. Other, please list
EHS 7/10/2013
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NORTH CAROLINA STATE UNIVERSITY
VERTEBRATE ANIMAL USE
IACUC Office Only
IACUC PROTOCOL
Appendix A. Animal Handler and other Support Staff PPE Assessment
Principal Investigator
Step a: Potential for Contact-Determine if the hazards listed in Section 2 present a dermal and/or inhalation exposure risk to animal
handlers. Using the table below, categorize the level of risk of the dermal and/or inhalation exposure to the animal handler.
Risk Level
Dermal Exposure
High Risk
High potential for splashing or contact with skin,
readily absorbed by the skin, hazard statements
indicating severe skin hazard (i.e., H310-fatal in
contact with skin, H311-toxic in contact with
skin, etc.)
Medium Risk
Potential for contact with the skin, possible
minor splashing, hazard statements indicating
skin hazard (i.e H313-may be harmful in contact
with skin, H316-causes mild skin irritation, etc.)
Low Risk
Very low risk of contact with the skin or
splashing, no hazard statements indicating any
hazards to skin
Inhalation Exposure
High potential for airborne inhalation exposure,
fine, light powders, dust clouds remain in air for
several minutes, liquid boiling point < 112˚F
(<50˚C), liquids sprayed, dripped, aerosolized,
hazard statements indicating severe inhalation
hazard (i.e., may be fatal if swallowed and enters
airways, H330-fatal if inhaled, H331-toxic if
inhaled)
Moderate risk of airborne exposure, crystalline,
granular solids, dust settles quickly, liquid boiling
point 122-203˚F (50-150˚C) , hazard statements
indicating inhalation hazard (i.e., H332-harmful if
inhaled, H335-may cause respiratory irritation,
H334-may cause allergy or asthma symptoms or
breathing difficulties if inhaled)
Very low risk of material becoming airborne,
material is unlikely to become aerosolized or
vaporized, presents minimal risk for inhalation
exposure, pellet-like or larger solids, little dust is
seen during use, liquid boiling point > 302˚F
(150˚C), no hazard statements indicating any
hazards via inhalation
Step b: Contact time-Determine if the amount of time and duration of exposure the animal handler will have with the hazardous
material. This includes all job tasks such as preparing and administering the hazardous material, handling the animal and associated
bedding and excrement, and disposing of animals. Use the chart below to assist you in assigning the proper exposure duration.
Exposure Duration
Short: < 4 hours/day, 2 days/week; <1 hour/day, 3 to 5 days/week
Medium: 4 to 6 hours/day, 3 to 5 days/week
Long: 6 to >8 hours/day, 3 to 5 days/week
Step c: Toxicity Category-For material, determine PPE requirements based on the hazard type (step 4 in the Chemical Hazard
Section) and the exposure risk and duration determined in steps a and b of this Appendix. Use the PPE Requirement Selection Matrix
below to correspond with the PPE requirement groupings listed below. Note: If the hazardous materials present both a dermal and
inhalation exposure risk use the most protective grouping. For example if you have a dermal exposure PPE grouping of 1 and an
inhalation exposure PPE grouping of 3, your PPE selection would be: closed toe shoes with disposable shoe covers, lab coat, safety
glasses, nitrile gloves, and local exhaust ventilation and/or respiratory protection.
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NORTH CAROLINA STATE UNIVERSITY
VERTEBRATE ANIMAL USE
PPE Requirement Selection Matrix
Dermal Exposure
Inhalation
Exposure
Dermal Exposure PPE Groups
1
2
3
Closed toe shoes, lab coat, safety glasses, gloves (nitrile unless chemical compatibility issue)
Closed toe shoes with disposable shoe covers, lab coat, safety goggles, gloves (nitrile unless chemical
compatibility issue)
Closed toe shoes with disposable shoe covers, lab coat, safety glasses and face shield, double gloves (nitrile
unless chemical compatibility issue- verify type of glove from at least two sources including specific
manufacturer of glove used)
Inhalation Exposure PPE Groups
1
Closed toe shoes, lab coat, safety glasses, gloves (nitrile unless chemical compatibility issue), optional N95
masks
2
Closed toe shoes with disposable shoe covers, lab coat, safety glasses, gloves (nitrile unless chemical
compatibility issue), local exhaust ventilation (specify chemical fume hood, certified BSC, exhausted and filtered
cage changing/dumping station), may require respirator when used outside of hood based upon EHS review.
3
Closed toe shoes with disposable shoe covers, lab coat or coverall, safety glasses, gloves (nitrile unless
chemical compatibility issue), local exhaust ventilation (specify chemical fume hood, certified BSC, exhausted
and filtered cage changing/dumping station) and respiratory protection when used outside of hood (contact EHS
for help in proper selection of respirator http://www.ncsu.edu/ehs/www99/right/handsMan/worker/resp/resp.html)
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NORTH CAROLINA STATE UNIVERSITY
VERTEBRATE ANIMAL USE
*Note: these are the minimum requirements for PPE when working with hazardous materials in respective categories. You
may select additional or more protective PPE than what is listed above.
Step d: Document the required PPE for Animal Handlers and other Support Staff
PPE Group (1, 2 or 3):
Was a glove compatibility chart checked and nitrile gloves are confirmed suitable
Yes
No
If No, use Silver Shield gloves with nitrile gloves over top for dexterity (note if Silver Shield is not compatible, contact EHS for
assistance with glove selection).
Check which engineering controls will be used:
Chemical fume hood
Certified BSC
Other:
Exhausted and filtered cage changing/dumping station
If respiratory protection is required, contact EHS to determine the appropriate respirator type and specify the required respirator.
Note: The use of a respirator at NCSU requires users to be part of the respiratory protection program which includes medical evaluation and
clearance as well as annual fit testing and training. Please see http://www.ncsu.edu/ehs/www99/right/handsMan/worker/resp/resp.html
List Make and Model of selected PPE for all items in PPE Groups 2 and 3:
In this section, please document any additional safety and health warnings or concerns (i.e., pregnant women or women considering
becoming pregnant should not be exposed to CHEMICAL X)
Appendix A completed by:
Department:
EHS 7/10/2013
Title:
Date:
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NORTH CAROLINA STATE UNIVERSITY
VERTEBRATE ANIMAL USE
Supplemental Page for Chemical Tables 1 and 2
Table 1 - Chemical Use Chart – Chemical Dosage and Half Lives
Name of Material to be
administered
Dosage and
Frequency of
Administration
Physical state of material
handled in animal care area
(i.e., fine powder, dissolved
solid, pill, etc)
Half-life of parent
material
administered in test
animal
(list U if unknown)
Is the parent material or are
the metabolites hazardous
as excreted (Y/N)? .
(list U if unknown)
Table 2 - Chemical Hazard Information
Name of
Chemical to be
administered
EHS 7/10/2013
CAS #
a) Hazard Description
(hazard statements,
R-phrases, OSHA
hazards, potential
health effects)
b) Precautionary
Information
(precautionary
statements for
controlling exposures)
c) NFPA or HMIS
Health Rating
(list numerical
health rating
below)
d) LD50 or LC50
(list test species
and duration)
e) Prop 65 or
PHS Lists
(check the lists
and note if it is
included)
Page 9
NORTH CAROLINA STATE UNIVERSITY
VERTEBRATE ANIMAL USE
Supplemental Page for Chemical Tables 1 and 2
Table 1 - Chemical Use Chart – Chemical Dosage and Half Lives
Name of Material to be
administered
Dosage and
Frequency of
Administration
Physical state of material
handled in animal care area
(i.e., fine powder, dissolved
solid, pill, etc)
Half-life of parent
material
administered in test
animal
(list U if unknown)
Is the parent material or are
the metabolites hazardous
as excreted (Y/N)? .
(list U if unknown)
Table 2 - Chemical Hazard Information
Name of
Chemical to be
administered
EHS 7/10/2013
CAS #
a) Hazard Description
(hazard statements,
R-phrases, OSHA
hazards, potential
health effects)
b) Precautionary
Information
(precautionary
statements for
controlling exposures)
c) NFPA or HMIS
Health Rating
(list numerical
health rating
below)
d) LD50 or LC50
(list test species
and duration)
e) Prop 65 or
PHS Lists
(check the lists
and note if it is
included)
Page 10
NORTH CAROLINA STATE UNIVERSITY
VERTEBRATE ANIMAL USE
Supplemental Page for Chemical Tables 1 and 2
Table 1 - Chemical Use Chart – Chemical Dosage and Half Lives
Name of Material to be
administered
Dosage and
Frequency of
Administration
Physical state of material
handled in animal care area
(i.e., fine powder, dissolved
solid, pill, etc)
Half-life of parent
material
administered in test
animal
(list U if unknown)
Is the parent material or are
the metabolites hazardous
as excreted (Y/N)? .
(list U if unknown)
Table 2 - Chemical Hazard Information
Name of
Chemical to be
administered
EHS 7/10/2013
CAS #
a) Hazard Description
(hazard statements,
R-phrases, OSHA
hazards, potential
health effects)
b) Precautionary
Information
(precautionary
statements for
controlling exposures)
c) NFPA or HMIS
Health Rating
(list numerical
health rating
below)
d) LD50 or LC50
(list test species
and duration)
e) Prop 65 or
PHS Lists
(check the lists
and note if it is
included)
Page 11