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Tamoxifen SOP

Introduction: 4-Hydroxytamoxifen is an antiestrogen. Harmful if swallowed, inhaled or absorbed through the skin. Irritating to eyes, respiratory system and skin. May cause reproductive disorders.

Target Users:Research Staff and ARCM/Animal Care and Cagewash Staff

Materials and Equipment:

  • Chemical Fume Hood or total exhaust hood (for chemical preparation in the laboratory)
  • Class II, type B2 or B1 total exhaust bio-safety cabinet with in-date certification
  • Latex gloves
  • Nitrile gloves
  • Fully buttoned disposable lab coat
  • Shoe covers
  • Safety glasses
  • Surgical mask
  • Plastic-backed absorbent chux pad
  • “Toxic Agent- Do not Change” notice
  • “Toxic Agent” sticker (see picture below)
  • Enclosed transport container
  • Red biohazard disposal bags
  • Biohazard burn box with cover

Hazards:

Name of agent / 4-Hydroxytamoxifen
CAS number / # 68047-06-3
Hazard. Check applicable box(es). / Carcinogen (lARC 1, 2A, 2B, 3, or 4). See attachment 1. / Flammable

X

/ Reproductive toxin
(mutagen or teratogen) / Combustible
Water-reactive
Corrosive / Shock-sensitive

X

/ Irritant / Pyrophoric (air-reactive)
Sensitizer / Oxidizer (strong)

X

/ Toxic / Biotoxin

Route of Administration:

Injection (IP)

Water Bottle

Inhalation

Gavage

Applied to skin

Comments (elaboration of hazard or research goal):

Exposure Controls:

Ventilation (check if needed):

Chemical fume hood

Biosafety cabinet (Class II, Type A/B3, B2, B1) *see Table 1 below for specifications

Snorkel Trunk

Glove box (Biosafety cabinet Class III) *see Table 1 below for specifications

Personal protective equipment (check if needed):

Safety glasses (to protect from dust, debris)

Goggles (chemical-splash goggles)

Face shield

Chemical resistant apron/smock (use disposable made from PE or PVC) that ties from behind.

Traditional cotton-polyester white lab coat or scrubs

Protective clothing (e.g. Tyvek sleeves or jump suit, bouffant)

Gloves/Gauntlets (at minimum, double-gloved with latex over nitrile)

Double booties over closed-toe shoes

Respirator (if yes, contact EH&S for additional assistance)

Table 1. Comparison of Biosafety cabinets

Type / Face velocity (lfpm) / Airflow Pattern / Radionuclides/
Toxic Chemicals / Biosafety Level(s) / Product Protection
Class I open front / 75 / In at front; rear and top through HEPA filter / No / 2, 3 / No
Class II Type A / 75 / 70% recirculated through HEPA; exhaust through HEPA / No / 2, 3 / Yes
Type B1 / 100 / 30% recirculated through HEPA; exhaust via HEPA and hard ducted / Yes (low levels/volatility) / 2, 3 / Yes
Type B2 / 100 / No recirculation; total exhaust via HEPA and hard ducted / Yes / 2, 3 / Yes
Type B3 / 100 / Same as IIA, but plena under negative pressure to room and exhaust air is ducted / Yes / 2, 3 / Yes
Class III glove box / NA / Supply air inlets and exhaust through 2 HEPA filters / Yes / 3, 4 / Yes

Source: Biosafety in Microbiological and Biomedical Laboratories, 4th ed., US Department of Health and Human Services, Centers For Disease Control and Prevention, National Institutes of Health

Disposal Requirements:

Recycle bedding (for later composting)

Two red, biohazard, liner bags and one cardboard burn box

Durable, impervious sharps container

SOP:

1. Preparation and transport of inocula

Research staff will:

  1. Prepare the dose in the research lab in a chemical fume hood with current inspection date, and transport it to the animal facility.
  2. Transport the dose to the animal facility in securely sealed tubes or syringes that are contained in an appropriately labeled, enclosed secondary container that is shatterproof and sanitizable (smooth and impervious) and has been packed with sufficient packing material to absorb the fluid in the event of a spill.

c.Deliver the container of dose to the designated supply entry airlock of the animal facility.

d.Animal care staff will perform the usual spraying-in procedures, being careful to not up-end the container of dose.

2. Unpacking the hazardous agent container

Research staff will:

a. Retrieve the container of dose from the designated supply airlock and bring it to a procedure room.

b.Turn on the bio-safety cabinet for at least five minutes before use.

c.Don an additional set of PPE (disposable lab coat and booties) over the PPE that was donned at the entrance of the animal facility.

d.Don two pairs of gloves (latex over nitrile).

e.Spray the work surface of a certified, hard-ducted class II, type A/B3, B2 or B1 bio-safety cabinet with virucidal disinfectant (Quatricide T.B.).

f.Place plastic-backed disposable chux pad on the work surface of the bio-safety cabinet.

g.Spray a low profile sharps container with disinfectant and place into the bio-safety cabinet.

Caution: Do not cover the downdraft grates.

h. Outside the cabinet, spray all surfaces of the transport container with a virucidal disinfectant and place on the plastic backed absorbent chux pad within the bio-safety cabinet.

i.Remove the sealed tubes or syringes from the transport container and place on the absorbent chux pad inside the bio-safety cabinet.

j.Remove the transport container from inside the bio-safety cabinet.

3. Inoculation of animals

Warning: Research staff must perform all dosing of tamoxifen in a total exhaust bio-safety cabinet in a procedure room using full sterile technique:

  1. Wearing the PPE as described in 2c and 2d place a clean mouse cage on the absorbent chux pad in the bio-safety cabinet.
  2. Place the cage containing the subject animals on the absorbent chux pad in the bio-safety cabinet.
  3. Serially remove each subject animal from the cage and restrain on or over the absorbent chux.
  4. Dose the animal and place in the clean mouse cage.
  5. Dispose of the tube and syringe in the sharps container.
  6. Affix a “Toxic Agent” sticker to the back of the cage card and place the cage ID card from the original cage sticker-side out onto the clean cage now containing the subject animals.

g.Record the name of the agent (Tamoxifen), route (injection), treatment date, and initials of the person responsible for the animals on the “Toxic Agent” sticker.

h.Place the dirty mouse cage on a cart or rack, as per standard procedures for the animal facility, for delivery to the cage wash area.

i.Repeat steps a. through h. as above for each cage of animals to be treated.

j.Return all treated cages to the shelf rack in the originating animal room.

Caution: If transporting more than one cage of animals, place them on a wheeled transport cart to move them through the facility.

4. Clean-Up

Research staff will perform the following:

  1. Place red biohazard bag into the biosafety cabinet.
  2. Return the re-sealed tubes or syringes of the dose to the transport box for disposal or future use.

Note: Disposal or storage of the agent must follow EH&S guidelines.

  1. Fold and place the plastic-back absorbent chux in the red bio-hazard bag within the bio-safety cabinet.
  2. Retrieve and place loose bedding and feces in the bio-hazard bag within the bio-safety cabinet.
  3. Spray the interior surfaces of the cabinet with virucidal disinfectant spray, wipe with disposable towel and discard the used towel in the bio-hazard bag.
  4. Change gloves and place used gloves in the bio-hazard bag.
  5. Close the opening of the biohazard bag by twisting (goose-neck fashion) and secure with adhesive tape and place in a burn box lined with another biohazard bag.
  6. Remove outer layer of the PPE, rolling it in on itself, and dispose of it in the burn box before exiting the procedure room.

Animal care staff will dispose of the burn box and deliver dirty cages to the cagewash area.

5. Cage Changing

Note: Research staff will perform all animal husbandry for the first cage change after the dose (or all cage changes during serial dosing). Research staff will change the cage at least 48 hrs after but no later than 72 hrs after the animal has been dosed with the agent.

Warning: Animal technicians will contact the research staff if a cage is found flooded or excessively dirty or moist and needs to be changed before the 48-72 hour time period.

Research staff will perform the following:

  1. Change cages wearing PPE as described in 2c and 2d and using full sterile technique in a biosafety cabinet, as described in ARCM SOP#201.0.
  2. Remove the “Toxic Agent-Do Not Change” notice from the cage.
  3. Return cages to the shelf rack.
  4. Using the bio-safety cabinet as outlined in step 4 above, transfer dirty bedding and uneaten food to a bio-hazard bag within the work area of the biosafety cabinet.
  5. After dumping the soiled bedding inside, wipe out cage with a disposable cloth and dispose of the cloth in the bio-hazard bag.
  6. Place dirty cage set-ups on a cart for delivery to cage wash area.
  7. Change outer gloves and place outer used gloves in the bio-hazard bag.
  8. Seal the bio-hazard bag (goose neck the opening) and secure with adhesive tape. Place bio-hazard bag into a burn box that is lined with another bio-hazard bag.
  9. Remove outer PPE, rolling it in on itself and place in burn box before exiting the procedure room to return to the animal housing room.
  10. The animal care staff will deliver dirty cages to the cage wash area.
  11. The animal care staff will dispose of the burn box.

From this point on, the animal care staff will follow normal cage changing schedule.

Reviewed by: / Review Date / Author / Approval Date
Nancy Mc Gilloway

TOXIC AGENT

Investigator Will Change

Name of Agent: ______

Route: Injection Food Water Other: ______

Treatment Date: ______Initials: ______

Investigator: ______Emergency Phone: ______

Investigator: Change the cage and reverse the card 48-72 hours after final treatment with agent.

“Toxic Agent” sticker

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