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EC number: 224-052-0
CAS number: 4180-23-8
This study was designed to evaluate the safety of trans-anethole when
administered daily in the diet of rats for at least 90 days and to
establish a NOAEL. Sprague-Dawley rats in Groups 2 -5 (20
rats/sex/group) received the test material in their food at target dose
levels of 150, 300, 600, or 900 mg/kg/day, respectively. Rats in Group 1
(20 rats/sex) served as negative (vehicle) controls and received the
basal diet only. Formulated diets were made available to the animals for
approximately 12 hours daily (during the daily dark cycle). Assessment
of potential toxicity was based on body weight gains, food consumption,
efficiency of food utilization, ophthalmoscopic findings, clinical
pathology findings (hematology, coagulation, and serum chemistry
evaluations), gross pathology findings, and histopathological
Results of routine concentration analyses indicated that all
formulations were within 5% of tarfet. Once the target dose levels were
instituted, the avarage achieved compound consumptions for the Group 2
-5 males were 151.5, 303 .4, 602.9, and 892.7 mg/kg/day, respectively,
whereas the achieved compound consumptions for the Group 2 -5 females
were 151.5, 305.5, 605.8 and 888.1 mg/kg/day, respectively. In general,
the dietary concentration of trans-anethole in each treatment group
increased each week for the duration of the study. Greater difficulty
was noted in achieving and maintaining the high target dose level (900
mg/kg/day) relative to the lower target dose levels, as a result of the
adverse affect the test material had on diet palatability.
All animals survived to scheduled sacrifice. There were no obvious
treatment-related clinical signs or ophthalmoscopic findings.
A number of findings, considered indirect treatment related findings,
resulted largely from the reduced palatability of the diet, especially
at the higher doses.
Several of the clinical pathology and histopathology findings, aslo
considered indirect treatment-related findings, are associated with the
treatment-related decrease in body weight and food consumption. In
addition to these, certain clinical chemistry parameters and liver
histopathology were directly associated with treatment.
Mild, although significant, increases in liver-to-body-weight ratops
were noted in rats treated with trans-anethole at dose levels =>300
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