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EDRI Federal Project Inventory:
Measurement of Estrogenic Effects of Materials Associated with Medical Devices
- Sponsor Organization: UNITED STATES FOOD AND DRUG ADMINISTRATION - CENTER FOR DEVICES AND
RADIOLOGICALHEALTH, OFFICE OF SCIENCE AND TECHNOLOGY, HEALTH
SCIENCES BRANCH
- Project Title: MEASUREMENT OF ESTROGENIC EFFECTS OF MATERIALS ASSOCIATED WITH
MEDICAL DEVICES
- Project Focus: HUMAN HEALTH EFFECTS, EXPOSURE ASSESSMENT
- Description: Some components of materials; used in medical devices have been shown
to have
estrogenic properties. However, no systematic survey of these
materials for estrogenic
activity has been undertaken. We are
beginning to survey the classes of rnaterials
found in medical devices
f or estrogenic activity using a cell culture screen, confirmed
when
necessary by the mouse uterotrophic assay, when deemed suitable to the
Center's needs, by a molecular gene activation assay.
- References:
- Category: MEASUREMENTS
- Subcategory: HAZARD IDENTIFICATION
- Keywords for Experimental System/Species: LABORATORY STUDY, MOUSE, IN VIVO, CELL CULTURE, IN VITRO
- Keywords for Experimental Endpoints: FEMALE, HORMONE MEASURES, SEX STEROIDS, PHYSIOLOGY, HISTOPATHOLOGY,
STRESSRESPONSE, GENE EXPRESSION
- Chemical Agents: phthalates, acrylate monomers, bisphenol A
- Performing Institution: CDRH/FDA (HFZ-112 ), 12709 Twinbrook Parkway, Rockville, MD 20852
- Contact: Thomas H. Umbreit, PhD; CDRH/FDA (HFZ-112 ), 12709 Twinbrook
Parkway,Rockville, MD 20852 301-443-7173; THU@FDADR.CDRH.FDA.gov
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