[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: 94-17449]
[[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 Benzyl Acetate
The HHS' National Toxicology Program announces the availability of
the MTP Technical Report on the toxicology and carcinogenesis studies
of benzyl acetate, which is used as a flavoring agent in foods, as a
fragrance in soaps and perfumes, as a solvent for cellulose acetate and
nitrate, and as a component of printing inks and varnish removers. The
NTP previously studied the toxicology and carcinogenicity of this
chemical in F344/N rats and B6C3F1 mice using the gavage route of
administration and corn oil as a vehicle. Benzyl acetate increased the
incidences of pancreatic acinar cell adenomas in male rats and the
incidences of hepatocellular adenomas and forestomach neoplasms in male
and female mice. Because of the confounding effect of corn oil on the
incidences of pancreatic neoplasms and because of controversy over the
use of the gavage route of administration, the NTP decided to restudy
benzyl acetate using the dosed feed route of administration.
Toxicology and carcinogenesis studies were conducted by feeding
groups of 60 male and female F344/N rats diets containing 0, 3,000,
6,000, or 12,000 ppm benzyl acetate and groups of 60 male and female
B6C3F1 mice diets containing 0, 330, 1,000, or 3,000 ppm benzyl
acetate for 2 years.
Under the conditions of these 2-year feed studies, there was no
evidence of carcinogenic activity* of benzyl acetate in male or female
F344/N rats receiving 3,000, 6,000, or 12,000 ppm; however, rats may
have tolerated higher doses. There was no evidence of carcinogenic
activity of benzyl acetate in male or female B6C3F1 mice receiving
330, 1,000, or 3,000 ppm.
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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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Nasal lesions associated with benzyl acetate exposure in male and
female mice included nasal mucosa atrophy and degeneration (primarily
of the olfactory epithelium), cystic hyperplasia of the nasal
submucosal gland, and luminal exudate and pigmentation of the nasal
mucosal epithelium.
In premius 2-year gavage studies, benyzl acetate increased the
incidence of acinar cell adenomas of the exocrine pancreas in male
F344/N rats; the gavage vehicle may have been a contributing factor.
There was no evidence of carcinogenic activity in female F344/N rats
receiving 250 or 550 mg/kg a day.
There was some evidence of carcinogenic activity in male and female
B6C3F1 mice, indicated by the increased incidences of
hepatocellular adenomas and squamous cell neoplasms of the forestomach.
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 Benzyl Acetate
(CAS No. 140-11 1) in F344/N Rats and B6C3F1 Mice (Feed Studies)
(TR-431) 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.
Kenneth Olden,
Director, National Toxicology Program.
[FR Doc. 94-17449 Filed 7-18-94; 8:45 am]
BILLING CODE 4140-01-M
