Download Animal Use Protocol – Hazardous Agent Addendum (Chemicals

Animal Use Protocol – Hazardous Agent Addendum (Chemicals / Toxins / Hazardous Drugs)
IACUC # _________________
**All sections of this form must be filled out. Areas highlighted in [red] on this template are either
recommended text to be reviewed for the particular agent (eg. Toxicity information) or
recommended choices (eg. Recommendation of lab coat, gloves, and use of a fumehood/BSCII for a
particular material). Once you have completed all areas of this form for your specific usage, taking
into account the [red] recommendations, please change all text to [black].
Please remove these instructions prior to submission to the IACUC**
1. Identify the chemical / toxin / hazardous drug to be administered: Tamoxifen
a. Briefly describe purpose: Click here to enter text.
b. Specify the amount administered (e.g., dose, concentration, volume): Click here to enter
text.
c. Indicate the route of administration (include range of needle gauge if applicable): Click
here to enter text.
d. Indicate the frequency of administration: Click here to enter text.
e. Indicate the maximum duration of exposure: Click here to enter text.
f. Identify the location (Building / Room) where the chemical / toxin / hazardous drug will
be administered: Click here to enter text.
2. Describe the predicted effects of the chemical / toxin / hazardous drug on the animal, i.e. toxicity
to animal.
Tamoxifen is a nonsteroidal selective estrogen receptor modulator, binding to the estrogen
receptor and thereby modulating estrogen action. Exposure to tamoxifen or tamoxifen metabolites
is associated with an increased risk of cancer, with animal studies showing increased incidence of
hepatocellular and endometrial carcinoma as well as some forms of uterine cancer. Tamoxifen
has been shown to have teratogenic effects on the developing fetus, genotoxic effects by
introducing mutations through formation of DNA adducts, and has shown reproductive toxicity.
3. Chemical / toxin preparation prior to administration:
a. Will any preparation of the chemical/toxin be required prior to administration (e.g.
mixing, dilution, or dissolving of powders)?
☐ Yes ☐ No
If yes, the following questions must be addressed:
i. Describe the preparation process here: Click here to enter text.
ii. Location where preparation will take place: Click here to enter text.
iii. Will preparation be restricted to any of the following types of equipment?
☐ Chemical fume hood
☐ Class II Biosafety Cabinet connected to an exhaust system (hard-ducted
or canopy-connected)
☐ Class II Biosafety Cabinet exhausted into the room
☐ Other, please specify: Click here to enter text.
iv. Which pieces of personal protective equipment will be required for
preparation?
☐ Gloves (material should be chosen to offer protection against the specific
chemical to be used)
☐ Dust mask
☐ N95 respirator (enrollment in EHS fit testing program required)
☐ Other respiratory protection, please specify: Click here to enter text.
☐ Face Shield
☐ Protective laboratory eyewear
☐ Shoe Covers
☐ Laboratory coat, gown or uniform
☐ Additional, please specify: double gloves
AUP Hazardous Agent Addendum (Chemicals / Toxins / Hazardous Drugs)
OAWA Version Date: 07/2015
Animal Use Protocol – Hazardous Agent Addendum (Chemicals / Toxins / Hazardous Drugs)
IACUC # _________________
4. Describe how the chemical / toxin / hazardous drug is metabolized in the animal (include the
excretion products, concentration and timeline).
Tamoxifen itself is a prodrug, having relatively little affinity for the estrogen receptor. It is metabolized in
the liver by cytochrome P450 to several active metabolites, including N-desmethyl-tamoxifen, 4-hydroxytamoxifen, 4-Hydroxy-Ndesmethyl tamoxifen, α-hydroxy-tamoxifen, and α-hydroxy-N-desmethyltamoxifen. The α-hydroxy metabolites may lead to formation of DNA adducts and exhibit potential
carcinogenic, teratogenic, genotoxic, and reproductive toxicity. Tamoxifen is primarily eliminated via the
bile as metabolites and enterohepatic recirculation occurs, with less than 1% is excreted in the urine.
Metabolites may be excreted in both urine and feces.
5. Describe the safety procedures and personnel protective equipment research staff will use while
administering these agents and while handling animals and animal bedding.
a. Will administration occur using any of the following types of equipment?
☐ Chemical fume hood
☐ Class II Biosafety Cabinet connected to an exhaust system (hard-ducted or
canopy-connected)
☐ Class II Biosafety Cabinet exhausted into the room
☐ Other, please specify: Click here to enter text.
b. Which pieces of personal protective equipment will be required for administration and
handling of animals and animal bedding?
☐ Gloves (material should be chosen to offer protection against the specific
chemical to be used)
☐ Dust mask
☐ N95 respirator (enrollment in EHS fit testing program required)
☐ Other respiratory protection, please specify: Click here to enter text.
☐ Face Shield
☐ Protective laboratory eyewear
☐ Shoe Covers
☐ Laboratory coat, gown or uniform
☐ Additional, please specify: double gloves
6. Discuss the length of time the animals will be kept following exposure to the chemical / toxin /
hazardous drug.
Click here to enter text.
7. Animal housing:
a. Following treatment, does the animal or its bedding pose a hazard to other animals,
staff, or the environment? ☐ Yes ☐ No
If yes, explain your answer. Bedding from animals that have been administered
Tamoxifen should be considered hazardous for 72 hrs post-administration. Veterinary staff will
be notified 48 hours before administration and a door sign posted when using Tamoxifen in the
animal facility. The door sign will remain posted until bedding is no longer considered hazardous.
Individuals who are pregnant or who may be pregnant should be advised of the risks associated
with handling Tamoxifen and given the option to remove themselves from related procedures.
b. Identify location(s) of animal housing post-exposure: Click here to enter text.
8. Will animals be returned to the animal facility following exposure?
If no, go to item 11.
☐ Yes ☐ No
If yes, answer questions 9 -11 below.
AUP Hazardous Agent Addendum (Chemicals / Toxins / Hazardous Drugs)
OAWA Version Date: 07/2015
Animal Use Protocol – Hazardous Agent Addendum (Chemicals / Toxins / Hazardous Drugs)
IACUC # _________________
9. Confirm that the animal facility manager or supervisor has been, or will be, consulted to ensure
proper cage documentation and handling prior to initiating this work.
☐ Confirmed.
10. Please list precautions and safety procedures Veterinary Resources staff should follow when
handling the animals and animal bedding. Specifically, identify which category of personal
protective equipment (PPE) will be required for handling the animals and animal bedding:
☐ Standard PPE [facility scrubs or lab coat over street clothes, facility issued shoes, gloves
(only when handling animals or cages) & particle mask (optional)]
☐ ABSL2 PPE (facility scrubs, facility issued shoes, lab coat, shoe covers, gloves & particle
mask)
☐ Additional PPE, please specify: Click here to enter text.
11. If a toxin, is it classified as a select agent, but permissible below certain amounts (see list:
http://www.selectagents.gov/PermissibleToxinAmounts.html)?
☐ Yes
☐ No
a. If yes above, have you registered this toxin through the University’s due diligence
program (https://afcf.umaryland.edu/ehs/sec/duediligence/)?
☐ Yes
☐ No
AUP Hazardous Agent Addendum (Chemicals / Toxins / Hazardous Drugs)
OAWA Version Date: 07/2015