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EC number: 293-263-8
CAS number: 91053-01-9
There is a 28 day repeat oral dosing study with triisobutylene with 14 day recovery. There are also repeat dose toxicity studies with other higher olefins spanning the range C8 to C20. The data for these studies indicate that the location of the double bond or the addition of branching to the structure do not appear to affect the toxicity. Higher olefins are of low toxicity in rats. Male rat kidney effects indicative of alpha-2u-globulin nephropathy consistently occur with the C8 to C14 higher olefins. Alpha-2u-globulin nephropathy is considered to be male rat-specific and is not relevant for humans. Treatment-related liver effects (increased organ weights, hepatocyte cytoplasmic vacuolation, and centrilobular hepatocyte hypertrophy) are also observed in rats exposed to higher olefins, which may reflect adaptive changes as a result of the high liver burden of these substances. There is no evidence of neurotoxicity.
The remaining higher olefins have
been tested in oral gavage studies. In a 28-day oral study, male and
female CD rats were given by gavage 0, 100, 300 or 1000 mg/kg
2,4,4-trimethylpentene (HLS, 1997 b). Compared to controls, kidney
weights were increased in the 1000 mg/kg males and liver weights were
increased in the 1000 mg/kg males and females. No adverse
histopathological effects were noted. The NOAEL was 300 mg/kg-day. In an
OECD 421 study, male and female CD rats were dosed by oral gavage with
0, 100, 300 or 1,000 mg/kg (HLS, 1997 c). Males received 44 to 46 doses
and females received 40-45 doses. Liver and kidney weights were
increased in both males (300 and 1,000 mg/kg) and females (1,000 mg/kg)
compared to controls. Histopathological effects, however, were observed
only in the kidneys of all treated male rats, and consisted of
basophilic cortical tubules and proteinaceous casts and interstitial
cells (300 and 1,000 mg/kg groups only). The kidney effects were further
investigated in a special study (Shell, 2004) and concluded to bemale
rat-specific kidney effects indicative of alpha-2u-globulin nephropathy
which are considered not to be relevant to humans. The NOAEL for this
study is 300 mg/kg.
a 28 day study with triisobutylene (CAS 7756 -94 -7, Biosafety Research
Centre Japan) there were no treatment related clinical signs and no
effects on body weight or food consumption at doses up to 750 mg/kg/day. Small
blood cell counts were seen in females of the 150 and 750mg/kg
and the prothrombin time was slightly shorter than control in females of
the 750mg/kg bw/daygroup.
Histopathological examination revealed swelling of liver cells in both
sexes of the 150 and 750 mg/kg bw/day groups, and eosinophilic bodies in
renal tubules in males of the 150 and 750 mg/kg groups. These changes
were accompanied by increases in absolute and relative liver weights in
both sexes at 750 mg/kg bw/day and in males at 150 mg/kg bw/
day. Absolute or relative kidney weights were increased in males of the
150 and 750 mg/kg groups but not in females. Absolute and relative
spleen weights were decreased in females of the 750 mg/kg group. A
systemic toxicity NOEL of 30 mg/kg/day was established based on,
haematology, organ weight, and histopathology changes in the liver and
kidneys at a dose level of 150 mg/kg bw/day. In animals dosed with for
28 days and then maintained for a 14 day recovery period the only
finding was basophilic change in the kidneys of both sexes.
1-Tetradecene (CAS 1120 -36 -1, a C16
olefin) was administered by oral gavage to rats at doses of 0, 100, 500
or 1000 mg/kg/day in corn oil in an OECD 422 study (Springborn
laboratories, 1995). The males and an unbred satellite
group of females were dosed for 28 days prior to mating and until
euthanasia (43-47 days of dosing). Breeding females were dosed for 14
days prior to mating, during mating, gestation, and lactation until
euthanasia (42-51 days of dosing). Increased liver
weights and minimal-to-moderate hepatocyte cytoplasmic vacuolation were
observed in the 500 and 1000 mg/kg animals; and increased hyaline
droplets in the proximal convoluted tubules only in male rats at all
doses. The male
rat hydrocarbon nephropathy was concluded to be unique to the male rat,
and not suggestive of an adverse effect for human risk assessment.
In an OECD 421 study, male and
female rats were dosed with 0, 100, 500 or 1000 mg/kg C18 branched and
linear olefins (CAS 27070 -58 -2 and CAS 18236 -02 -8) for approximately
6 weeks (Springborn Laboratories, 2003). There were no treatment-related
effects. The NOAEL was 1000 mg/kg-day.
C20-24 branched and linear olefins
were given by oral gavage to male and female rats for 13 weeks at doses
of 0, 100, 500 or 1,000 mg/kg (HLS, 1999). An additional group of male
and female rats were dosed with either 0 or 1000 mg/kg test material for
13 weeks followed by a 4-week recovery period. In treated females, liver
weights were significantly increased, which was associated with
centrilobular hepatocyte hypertrophy (statistically significant only in
the 1000 mg/kg group. Adrenal weights were also significantly increased
in all treated females, with a statistically significant increased
incidence of minimal or slight adrenal cortical hypertrophy in the 1000
mg/kg females compared with controls.
Several of these repeat dose studies
have neurotoxicity screening assessments in the repeat dose toxicity
studies (isooctene, 2,4,4-trimethylpentene, C14 alpha olefin, and C20-24
linear/branched internal olefins). No treatment-related effects were
No human information is available.
There are sufficient data available on
olefins from C8 to C18 to conclude that the butylenes oligomers are of
low repeat dose toxicity by the oral and inhalation routes with no
indication of serious functional or morphological
effects. Classification is not warranted for butylene oligomers under
Dir 67/548/EEC or GHS/CLP.
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