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: chloral hydrate
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.
Chloral hydrate has sedative, hypnotic, and anticonvulsive properties and has been used as an
anesthetic in laboratory animals. It is a suspected human carcinogen and exhibits acute toxicity. It
has been shown to induce liver tumors in mice but not rats. Depending on route of administration
and dosage, chloral hydrate has been found to induce gastric inflammation in guinea pigs, rats,
and calves, and gastric ulcers in rats.
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: Click here to enter text.
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).
Chloral hydrate is absorbed rapidly and metabolized in the liver and kidneys to
trichloroethanol, trichloroethanol glucuronide, and trichloroacetic acid, which are excreted in the
urine. Some trichloroethanol glucuronide may be secreted in bile and excreted in feces. Very little
if any unchanged chloral hydrate is excreted in urine.
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: Click here to enter text.
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. Click here to enter text.
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.
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)
AUP Hazardous Agent Addendum (Chemicals / Toxins / Hazardous Drugs)
OAWA Version Date: 07/2015
Animal Use Protocol – Hazardous Agent Addendum (Chemicals / Toxins / Hazardous Drugs)
IACUC # _________________
☐ 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