[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: 94-17453]
[[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 promethazine Hydrochloride
The HHS' National Toxicology Program announces the availability of
the NTP Technical Report on the toxicology and carcinogenesis studies
of promethazine hydrochloride, a drug used for the management of
allergic conditions, motion sickness and nausea, and as a sedative to
treat psychiatric disorders.
Toxicology and carcinogenicity studies were conducted by
administering promethazine hydrochloride (>99% pure) in distilled water
by gavage to groups of 60 male and 60 female F344/N rats and
B6C3F1 mice once daily, 5 days per week for up to 103 weeks. Rats
received doses of 0, 8.3, 16.6, and 33.3 mg/kg; male mice received
doses of 0, 11.25, 22.5, and 45 mg/kg and female mice received 0, 3.75,
7.5, and 15 mg/kg.
Under the conditions of these 2-year gavage studies, there was no
evidence of carcinogenic activity* of promethazine hydrochloride in
male or female F344/N rates receiving 8.3, 16.6, or 33.3 mg/kg. There
was no evidence of carcinogenic activity of promethazine hydrochloride
in male B6C3F1 mice receiving 11.25, 22.5 or 45 mg/kg. There was
no evidence of carcinogenic activity of promethazine hydrochloride in
female B6C3F1 mice receiving 3.75, 7.5, or 15 mg/kg.
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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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The decrease in the incidences of adrenal medullary
pheochromocytoma in male rates was considered to be related to
promethazine hydrochloride administration. The decrease in the
incidences of pituitary gland adenoma in male rates and uterine stromal
polyp in female rates may have been related to promethazine
administration.
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 Toxicology and Carcinogenesis Studies of Promethazine
Hydrochloride (CAS No. 58-33-3) in F344/N Rates and B6C3F1 Mice
(Gavage Studies) (TR-425) 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 13, 1994.
Kenneth Olden,
Director, National Toxicology Program.
[FR Doc. 94-17453 Filed 7-18-94; 8:45 am]
BILLING CODE 4140-01-M
