Standard Operating Procedure for Tamoxifen

Title

Standard Operating Procedure for Tamoxifen

EHS SOP #: 008

Version No.: 1.0

Supercedes: N/A

Tamoxifen Formula

Purpose

Tamoxifen is a white, odorless, crystalline solid with a melting point of 140-144 degrees Celsius. It is an antineoplastic agent used to treat breast cancer and is used in campus laboratories and animal facilities for cancer research studies. This document establishes procedures for the safe handling and use of Tamoxifen (CAS# 10540-29-1).

Health Effects

Tamoxifen is a known carcinogen (IARC Group 1), toxic, and is considered a reproductive hazard. Pregnant women should not be exposed to or handle this chemical in any form. The Oral LD50 for Tamoxifen is 4,100 mg/kg.

Acute effects

  • Eyes: Irritation
  • Skin: Irritation
  • Ingestion: Harmful if swallowed
  • Inhalation: Irritation of the respiratory tract.

Chronic effects

Carcinogen, Teratogen, Reproductive hazard.

Regulatory Limits

There are no current established occupational exposure limits for Tamoxifen.

Requirements

Based on the risk associated with the use of Tamoxifen, the safety procedures outlined below are required by all research staff.

Administrative Controls

  • Institutional Animal Care and Use Committee (IACUC) protocols that include Tamoxifen should reference this SOP to verify that the standard operating procedures are being followed.
  • Anyone who handles Tamoxifen is required to review this SOP and the attached Safety Data Sheet (SDS) prior to work.
  • Lab surfaces or equipment contaminated with Tamoxifen should be cleaned using dilute bleach or another appropriate disinfectant. Any rinsate or debris should be collected for EHS waste pickup.
  • Glassware and other non-porous materials may be decontaminated by soaking them in bleach.
  • An emergency eyewash station should be located inside lab spaces and a safety shower should be accessible nearby where Tamoxifen is handled.
  • Tamoxifen use in animals must follow the Division of Comparative Medicine (DCM; formerly the Division of Laboratory Animal Medicine (DLAM)) SOP - Handling Cages Dosed with Chemical Hazards. Notify the DCM Facility Manager prior to use.

Engineering Controls

  • When preparing solutions, Tamoxifen powder must be handled and weighed in a functioning chemical fume hood. Dosing of animals with Tamoxifen solutions should occur under a chemical fume hood, biological safety cabinet or ventilated cage changing station.

Personal Protective Equipment (PPE)

  • When working with Tamoxifen in laboratories, PPE should include, at a minimum, a lab coat, double Nitrile gloves, and safety glasses. Wear goggles and/or a face shield when splashes may occur.
  • When in DLAM facilities, PPE use must be consistent with the facility policy.

Waste Disposal

  • All Tamoxifen waste, including dilute solutions and contaminated solid waste must be disposed of through EHS.
  • Needles used for Tamoxifen injections must be properly disposed of in a Sharps container and must never be bent, sheared, or recapped.

Accidents or Injuries

Spill Procedures

  • Do not attempt to clean-up if you feel unsure of your ability to do so or if you perceive the risk to be greater than normal laboratory operations.
  • If a small spill occurs within a chemical fume hood, clean up with dilute bleach. Collect spilled material and clean up material into appropriately labeled, nonmetallic waste container. Submit a request through EHS for hazardous material pickup of all spill clean-up material.
  • If a large spill occurs, notify others in the area and evacuate room immediately. Contact EHS (919-962-5507) during working hours and 911 if after hours.

Contact Information

Policy Contact

Environment, Health & Safety
1120 Estes Drive
Campus Box #1650
Chapel Hill, NC 27599-1650
Phone: 919-962-5507

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