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EC number: 204-667-0
CAS number: 123-96-6
item,2-OCTANOL, was administered daily to male and female Sprague-Dawley
rats, for 2 weeks before mating, during mating, and until sacrifice for
males, or through gestation and until Day 14 p.p. for females, at
dose-levels of 100, 300 and 1000 mg/kg/day
(100, 300 and 1000 mg/kg/day) were administered orally, by gavage. The
control group received 2% aqueous solution of carboxymethylcellulose.
The dose volume was 10mL/kg body weight. Males were treated daily for 2
weeks prior to pairing and during pairing with females until the day
before necropsy, for a total of 30/31 days. Females were treated for 2
weeks prior to pairing, during pairing, post coitum and post partum
periods until Day 13 post partum (for at least 51 days). Four
non pregnant females were dosed up to the day before necropsy.
observed in one female of the high dose group could not to be clearly
related to treatment due to the absence of clear pathological findings.
A number of
clinical signs indicating toxicity (i.e. salivation, ataxia, hunched
and/or prone posture, lethargy) were observed in both males and females
treated at 1000 mg/kg/day. Salivation was generally observed in the
animals treated at 300 mg/kg/day.
of animals at removal from the cage and in an open arena (neurotoxicity
assessment) did not reveal changes attributable to the test item.
differences of toxicological significance were noted throughout the
study in the body weight and body weight gain of treated males. In
females of the high dose group, a slight decrease in body weight was
noted during the post coitum and post partum periods. An increase in
body weight gain in females of the high dose group was recorded at the
end of the premating period.
on food consumption were observed in males. In females of the high dose
group, food consumption was slightly reduced during the first week of
treatment and during the post coitum and post partum periods.
activity, grip strength and sensory reactivity to stimuli performed at
the end of the treatment period did not reveal changes attributable to
the test item.
neutrophilis (increase) recorded in males treated at dose levels 300
mg/kg/day was considered to be not adverse. No changes were recorded in
prothrombin time measured at the end of the study.
of some biochemical parameters (albumin, bile acids, calcium, sodium and
bilirubin) in males and/or females were considered to be unrelated to
treatment, incidental or considered to be not adverse. No relevant
changes were observed in urine analysis performed in males at the end of
the treatment period.
observed in triiodothyronine in a single male treated at 1000 mg/kg/day
was not considered to be of toxicological significance due to the
minimal incidence and the absence of other related findings (e.g.
changes of the other hormones).
observed in thyroid hormones measured in pups, were considered not
adverse or not related to the test item.
significant reduction in the number of non sequential days in which the
females were in oestrous was observed in high dose group of treated
pre-coital interval, copulatory and fertility indices did not show any
differences that could be related to treatment.
differences were noted in implantation sites, pre-natal loss data and
gestation length of females between treated and control groups, as well
as in sex ratios.
increased incidence of pup loss on Day 4post partumwas observed
in females of the mid- and high dose groups.
in litter weight, and consequently in mean pup weight, were observed on
Day 13post partumin the mid- and high dose groups.
clinical signs were comparable between treated and control groups or
considered incidental. Also thyroid weights recorded in treated pups
were comparable to the control mean value. No nipples were observed in
male pups on Day 13post partum.
effects in anogenital distance were seen in male pups of treated groups.
A slight increase in the anogenital distance values (mean) was noted in
female pups of high dose dams. However, this change was dose-unrelated
and therefore cannot be conclusively attributed to treatment.
findings in decedent pups and in pups sacrificed on Days 4 and 14post
partumdid not reveal any treatment-related effect.
were observed on terminal body weight of study animals of both sexes,
when compared to the control group. A statistically significant increase
was observed in mean liver weight of high dose animals of both sexes.
macroscopic observation performed at post mortem, the most relevant
change was thickening of the non glandular region of the stomach
observed in most high dose rats of both sexes sacrificed at the end of
treatment period, whereas in a single instance, it was observed in one
mid-dose animal of both sexes and in one control male.
changes were present in the non glandular region of the stomach
(forestomach) of mid- and high dose animals of both sexes and consisted
of squamous epithelial hyperplasia associated with hyperkeratosis
(orthokeratotic), chronic inflammation and/or oedema in the submucosa,
in some instances associated with mucosal ulceration/erosion.
changes were also noted in the liver of high dose males and consisted of
minimal centrilobular hepatocellular hypertrophy indicating a possible
microsomal enzyme induction as an adaptive response to the exposure to
the test item."
the results, the parental NOAEL (No Observed Adverse Effect Level) was
considered 300 mg/kg /day for systemic toxicity due to clinical signs
observed at the high dose-level and 100 mg/kg/day for local toxicity due
to microscopic findings noted in the forestomach of animals of the mid-
and high-dose groups.
NOAEL for reproductive toxicity of females was 300 mg/kg/day due to the
effects on oestrous cycle noted in the high dose females. The NOAEL for
reproductive toxicity of males was 1000 mg/kg/day. The NOAEL for pups
development was 100 mg/kg/day considering the observed pup loss and
reduced litter/pup weights noted in mid- and high dose levels.
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