|
Toxicology Excellence for
Risk Assessment (TERA)
2300 Montana Avenue, Suite 409, Cincinnati OH 45211
Phone: 513-542-7475
Fax: 513-542-7487
Email:
TERA@TERA.org
|
| |
|
Perchlorate
CLINICAL STUDIES IN HEALTHY VOLUNTEERS

- Study conducted by Dr. Braverman, Harvard University. Sponsored
by the PSG. Male volunteers were exposed to one dose
level of perchlorate in drinking water for 14 days.
Thyroid hormones and radioactive iodine uptake were
measured. Exposure to a dose of 0.14 mg/kg-day resulted
in significant inhibition of radioactive iodine uptake
compared with controls, but had no effect on thyroid
hormone levels. A second phase of the study will examine
the same endpoints at two lower doses (0.01 and 0.04
mg/kg-day). Study in progress.
- Kinetic studies in humans to support the
development of a PBPK model. Conducted by Dr. Brabant, Germany.
Healthy male volunteers exposed to 0.1, 1.0, or 12
mg/kg-day perchlorate in drinking water (daily dosed
divided into 3, one every 8 hours) for 14 days. Thyroid
hormones and perchlorate in sera and urine will be
measured. This study provides the first phase of kinetics
data in humans that will be used to develop a PBPK model
in humans. When combined with similar data that are being
collected in animals, this study will provide a basis for
extrapolating risk assessment in animals to human
exposure to perchlorate, and it will reduce uncertainty
in derived standards for perchlorate. Study in progress.
- Pharmacokinetics and radioactive iodine uptake
study in humans. Conducted by Dr. Monte Greer of the Oregon Health
Sciences University, Portland, OR. Sponsored by the PSG.
Healthy male and female volunteers were exposed to either 0.01,
0.02, 0.1 or 0.5 mg/kg-day perchlorate in drinking water
for 14 days. Thyroid hormones, inhibition of radioactive
iodine uptake, and elimination rate of perchlorate from
blood and urine were measured. This study provided
kinetic data needed to complete a PBPK model for humans
that can be used to reduce uncertainty in the risk
assessment extrapolation from animals to humans. In
addition, it may provide dose response information about
the effect of perchlorate on iodine uptake into the
thyroid in healthy humans.
-
Protocol for a Study of the Pharmacokinetics of
Fourteen-Day Drinking-Water Exposure to Perchlorate in Human Volunteers,
Including Analysis of the Inhibition of
Radioactive Iodine Uptake (PDF file) Part
A Part
B
-
Results of Study of Pharmacokinetics and radioactive iodine uptake
study in humans
For further information, contact Ms. Joan Strawson at 910-692-7752
or Strawson@tera.org
|
|
|
|
|
© 2004 Toxicology Excellence for Risk Assessment
2300 Montana Avenue, Suite 409, Cincinnati OH
45211
Phone: 513-542-7475
Fax: 513-542-7487
Email: TERA@TERA.org
Last updated: 01/22/2008
|
|