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EC number: 242-582-0
CAS number: 18794-84-8
Groups of 50
male and 50 female mice were administered 0, 0.25, 0.5, or 1 g beta-myrcene/kg
body weight in corn oil by gavage, 5 days per week for 104 or 105 weeks.
1 g/kg mice was significantly lessthan
that of the vehicle controls; the cause of the deaths was uncertain. Due
to the early mortality in 1 g/kg mice, data from this group was not
body weights of 1 g/kg males were at least 8% less than those of the
vehicle controls between week 8 and week 56. Mean body weights of 0.5
g/kg females were at least 7% less than those of the vehicle controls
after week 17, and those of 1 g/kg females were at least 8% less from
week 11 to week 96.
was a primary target of beta-myrcene toxicity. and hepatoblastoma in
was clear evidence of carcinogenicity in male mice based on increased
incidences of liver neoplasms. The incidences of hepatocellular adenoma
were significantly increased in 0.25 and 0.5 g/kg males, and the
incidences of hepatocellular carcinoma and of hepatoblastoma were
significantly increased in the 0.5 g/kg group. When these neoplasm types
were combined, the increases were statistically significant in the 0.25
and 0.5 g/kg groups.
mice, the incidence of hepatocellular adenoma or carcinoma (combined)
was increased in the 0.25 g/kg group compared to the vehicle controls,
while those in the 0.5 g/kg group were similar to vehicle controls. The
incidences of these neoplasms were within or slightly higher than the
historical control range for 2-year corn oil gavage studies. The lack of
a dose-response in the 1 g/kg group is likely due to the reduction in
body weight gain combined with somewhat shorter survival in this
The marginally increased incidence in the 0.5 g/kg group was considered
to be equivocal evidence of carcinogenicity in female mice.
the incidences of bone marrow atrophy and lymph node follicle atrophy in
the spleen were significantly increased in 0.5 g/kg females. In the
forestomach, there were significantly increased incidences of
inflammation and epithelial hyperplasia in 0.5 g/kg females.
Under the conditions of the 2-year gavage
study, there was clear evidence of carcinogenic activity of
beta-myrcene in male in male B6C3F1 mice based on increased incidences
of hepatocellular adenoma, hepatocellular carcinoma, and
hepatoblastoma. There was equivocal evidence of carcinogenic activity
of beta-myrcene in female B6C3F1 mice based on marginally increased
incidences of hepatocellular adenoma and carcinoma.
Beta-Myrcene and is not a genotoxic
carcinogen as it does not exert any mutagenic or clastogenic properties.
Therefore, the LOAEL in this chronic mouse study was established to be
250 mg/kg/d, based on the increase incidence in hepatocellular carcinoma
with increasing beta-myrcene dose significantly higher than both the
concurrent and the NTP historical control. In addition, the time to
observation of first hepatocellular carcinoma was also dose-related.
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