[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]


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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.
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    *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'').
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    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