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EC number: 214-288-2
CAS number: 1119-86-4
In this subacute toxicity study, decan-1,2 -diol was administered daily
by oral gavage to SPF-bred Wistar rats of both sexes at dose levels of
100, 300 and 1000 mg/kg body weight/day for a period of 28 days. A
control group was treated similarly with the vehicle, 2.5% ethanol in
distilled water, only. The groups comprised 5 animals per sex which were
sacrificed after 28 days of treatment. Additional 5 rats per sex and
group were used at 0 and 1000 mg/kg. These animals were treated for 28
days and then allowed a 14-day treatment-free recovery period after
which they were sacrificed.
All animals survived until scheduled necropsy.
No clinical signs of toxicological relevance were noted during daily
observations or during weekly behavioural observations (weeks 1-3). No
clinical signs of toxicological relevance were noted during the
functional observational battery (week 4). Grip Strength The fore- and
hind limb grip strength values of the test item-treated rats compared
favourably with those of the controls. Locomotor Activity The mean
locomotor activity of the males and females treated with 1000 mg/kg/day
were significantly reduced during several measurement intervals. These
differences were considered to be test item-related.
Reduced food consumption was noted during the treatment period in
females at 1000 mg/kg/day. During the recovery period, the mean daily
food consumption was similar in all females. The mean daily food
consumption of the test item-related males compared favourably with
those of the control males during treatment and recovery.
The mean body weights of the test item-treated males and females were
generally similar to those of their respective controls during the
treatment and recovery periods. No test item-related differences of
toxicological relevance were noted in the hematology or clinical
biochemistry parameters after 4 weeks of treatment or 2 weeks of
recovery. After the treatment period, ketone were evident in the urine
of males and females treated with 1000 mg/kg/day. This finding was
considered likely to represent metabolic adaptation to the test item, as
it was no longer evident after the recovery period.
Treatment for 28 days resulted in squamous epithelial hyperplasia,
ulceration and inflammation of the forestomach in the 1000 mg/kg/day
dose group, whereas treatment with 300 mg/kg/day resulted in squamous
epithelial hyperplasia of the forestomach at a reduced severity and
incidence. Following a 14-day recovery period, squamous epithelial
hyperplasia was still present in the animals previously treated with
1000 mg/kg/day, but the severity and incidence seen in after the
treatment period was largely reversible.
Based on the results of this study, the no-observed-effect-level (NOEL)
and the no-observed adverse- effect-level (NOAEL) of decan-1,2 -diol was
established as 100 mg/kg body weight/day.
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