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EC number: 214-288-2
CAS number: 1119-86-4
The NOAEL of the 28-day oral repeat dose toxicity study in rats (OECD407) was 100 mg/kg/day.
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.
Oral administration of decan-1,2 -diol to Wistar rats at doses of 100,
300 and 1000 mg/kg/day, for 28 days resulted in no deaths, no clinical
signs of toxicological relevance during daily or weekly observations, as
well as functional observational battery (including no changes in grip
strength), no differences in body weight development, no toxicologically
relevant differences in hematology, clinical biochemistry or urinalysis
parameters, no differences in absolute or relative organ weights and no
test item-related macroscopical changes. Test item-related findings were
generally restricted to reduced mean locomotor activity at 1000
mg/kg/day, reduced food consumption in females at 1000 mg/kg/day, and a
dose related severity and incidence of squamous epithelial hyperplasia
of the forestomach in rats treated with 300 mg/kg/day or 1000 mg/kg/day
dose group, whereas ulceration and inflammation was restricted to rats
treated with 1000 mg/kg/day only. Although the squamous epithelial
hyperplasia was still present after the recovery period in the animals
previously treated with 1000 mg/kg/day, the severity and incidence seen
in after the treatment period was largely reversible.
Repeat dose studies by the dermal and inhalation routes have not been
With a NOAEL of 100 mg/kg/day from a 28-day oral exposure, and with only
moderate pathological changes in the forestomach of rats dosed orally at
300 mg/kg/day, decan-1,2 -diol was considered to be on the limits of the
classification criteria for Specific Target Organ Toxicity -Repeat
Exposure (STOT-RE) Category 2 which is generally considered to be within
30 to 300 mg/kg/day for oral administration to rats (ECHA CLP Guidance
V4.1 June 2015). However, the pathology in the forestomach was
considered not to be of systemic exposure origin and classification for
this endpoint was not achieved.
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