USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-95-116

Project Title:

Cytogenetic Analyses of EBDC Applicators

Principle Investigator: Dr. James D. Tucker

Project started in: 1995

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-DOE Federal: National Institute of Occupational Safety & Health (NIOSH)

Amount: $60,000

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: May 17, 1995
IRB Approval Number: 95-116

Number of Human Subjects in the Last Reporting Period for this Project: 86
(Reporting periods vary.)

Type of Human Subjects Involvement:

Chemical Substances:

External use of chemical substances (solid, liquid, or gas) on human subjects.

• Other external use of chemical substances:

  Occupational exposure study only; no subjects were administered chemicals deliberately.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of cells cultured in a laboratory.
• Use of bodily materials collected from subjects specifically for this project.

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of data collected from subjects specifically for this project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The objectives of this work are to determine whether the use of a fungicide known as EBDC (ethylene-bisdithiocarbamate) is associated with genetic damage in people. Two cytogenetic assays are performed on peripheral blood lymphocytes obtained from these people: sister chromatid exchanges, and translocations by chromosome painting. The assays complement each other, and should allow us to determine whether EBDC is genotoxic in humans. An aliquot of the blood is also sent to a local hospital where levels of the thyroid hormones T3, T4, and TSH are measured. The levels of these hormones are important because EBDC is metabolized to ethylene thiourea, which causes thyroid and liver cancer in animals. The data may be used by NIOSH to make regulatory decisions concerning the use of EBDC in this country. Although the subjects may have been occupationally exposed to EBDC, no ionizing radiation or chemicals are administered to these people as part of this project. The risks to the subjects are those associated with venipuncture, and include temporary pain, bruising and/or soreness of the affected tissue or surrounding tissue, formation of scar tissue, infection, and fainting.