[Federal Register Volume 59, Number 137 (Tuesday, July 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17444]
[[Page Unknown]]
[Federal Register: July 19, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program; Availability of Technical Report on
Toxicology and Carcinogenesis Studies of Turmeric Oleoresin
The HHS' National Toxicology Program announces the availability of
the NTP Technical Report on the toxicology and carcinogenesis studies
of turmeric oleoresin, the organic extract of turmeric, a ground powder
from the root of the Curcuma plant, which is added to food items as a
spice and coloring agent.
Toxicity and carcinogenicity studies were conducted by
administering turmeric oleoresin in feed containing 0, 2,000, 10,000,
or 50,000 ppm to groups of 60 F344/N rats and B6C3F1 mice of each
sex for 2 years.
Under the conditions of these 2-year feed studies, there was no
evidence of carcinogenic activity* of turmeric oleoresin in male F344/N
rats administered 0, 2,000, 10,000, or 50,000 ppm. There was equivocal
evidence of carcinogenic activity of turmeric oleoresin in female F344/
N rats based on increased incidences of clitoral gland adenomas in the
exposed groups. There was equivocal evidence of carcinogenic activity
of turmeric oleoresin in male B6C3F1 mice based on a marginally
increased incidence of hepatocellular adenoma at the 10,000 ppm level,
and the occurrence of carcinomas of the small intestine in the 2,000
and 10,000 ppm groups. There was equivocal evidence of carcinogenic
activity of turmeric oleoresin in female B6C3F1 mice based on an
increased incidence of hepatocellular adenomas in the 10,000 ppm group.
---------------------------------------------------------------------------
*The NTP uses five categories of evidence of carcinogenic
activity observed in each animal study: two categories for positive
results (``clear evidence'' and ``some evidence''), one category for
uncertain findings (``equivocal evidence''), one category for no
observable effect (``no evidence''), and one category for studies
that cannot be evaluated because of major flaws (``inadequate
study'').
---------------------------------------------------------------------------
Turmeric oleoresin ingestion was also associated with increased
incidences of ulcers, hyperplasia, and inflammation of the forestomach,
cecum, and colon in male rats and of the cecum in female rats. In
female mice, ingestion of diets containing turmeric oleoresin was also
associated with an increased incidence of thyroid gland follicular cell
hyperplasia.
Questions or comments about the Technical Report should be directed
to Central Data Management at P.O. Box 12233, Research Triangle Park,
NC 27709 or telephone (919) 541-3419.
Copies of the Toxicology and Carcinogenesis Studies of Turmeric
Oleoresin (CAS No. 8024-37-1) (Major Component 79%-85% Curcumin, CAS
No. 458-37-7) In F344/N Rats and B6C3F1 Mice (Feed Studies) (TR-
427) are available without charge from Central Data Management, NIEHS,
MD A0-01, P.O. Box 12233, Research Triangle Park, NC 27709; telephone
(919) 541-3419.
Dated: July 12, 1994.
Kenneth Olden,
Director, National Toxicology Program.
[FR Doc. 94-17444 Filed 7-18-94; 8:45 am]
BILLING CODE 4140-01-M