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EC number: 931-082-4
CAS number: -
There were no treatment-related deaths.
One control female was killedin
extremison Day 15. Macroscopic observations revealed evidence of a
physical trauma following the dosing procedure therefore this death was
considered unrelated to test item toxicity.
No toxicologically significant
clinical signs were evident in treated females.
One female treated with 750 mg/kg
bw/day showed an isolated incident of increased salivation on Day 6 and
a further female from this treatment group had a decreased respiratory
rate on Day 16. No such effects were detected in females treated with
200 or 50 mg/kg bw/day. Observations of this nature are commonly
observed following the oral administration of an unpalatable test item
formulation and in isolation are considered not to be of toxicological
One female treated with 200 mg/kg
bw/day and one female treated with 50 mg/kg bw/day showed generalized
fur loss between Days 6 and 7 and Days 16 and 20 (respectively).
Observations of this nature are commonly observed in this type of study
and in isolation are not considered to be related to test item toxicity.
One female treated with 200 mg/kg bw/day had a damaged tail between days
13 and 20. This was a physical injury and unrelated to test item.
The female that was killedin
extremison Day 15 showed red/brown staining around the snout, eyes
and mouth, hunched posture, pilo-erection and respiratory pattern
changes. One female treated with 750 mg/kg bw/day had a mass under the
left forelimb. At necropsy, macroscopic observations for both females
revealed evidence of a physical trauma following the dosing procedure
therefore the clinical observations were considered unrelated to test
No toxicologically significant effects
in body weight development were detected.
Females treated with 750 mg/kg bw/day
showed a statistically significant reduction (p<0.05) in body weight
gain between Days 5 and 6. The statistical significance was minimal and
recovery was evident thereafter. Therefore in isolation and in the
absence of an overall effect on body weight development the intergroup
difference was considered of no toxicological significance.
No adverse effect on dietary intake
Statistical analysis of the data did
not reveal any significant intergroup differences.
Daily visual inspection of water
bottles did not reveal any overt intergroup differences.
No treatment-related macroscopic
abnormalities were detected in treated females at terminal kill.
The female that was killed in
extremis had a fluid filled thoracic cavity, a damaged trachea and
an oil like substance in the stomach. One terminal kill female treated
with 750 mg/kg bw/day had a mass under the left forelimb which was
filled with a food like substance and a small hole in the trachea. These
macroscopic observations were considered to be the result of a physical
trauma following the dosing procedure and therefore unrelated to test
There was no treatment related effects
on in utero offspring survival, as assessed by the mean numbers
of early or late resorptions, live litter size and post-implantation
losses. There were also no toxicologically significant effects on
pre-implantation losses or in sex ratio.
Females treated with 750 and 200 mg/kg
bw/day showed a statistically significant reduction in pre-implantation
loss. A true dose related response was not evident and a reduction in
this parameter is considered not to represent an effect of treatment due
to implantation occurring prior to the administration of the test item.
For all dose groups, there were no
significant treatment-related trends in the proportion of fetuses (or
litters) with evidence of external, visceral or skeletal anomalies. The
type of external, visceral and skeletal anomalies, were those commonly
observed for this type of study. There were no findings that were
considered to represent any known malformations.
During visceral assessment, litters
from females treated with 50 mg/kg bw/day showed a statistically
significant increase in the total percent of affected offspring. No
significant increases were evident in any of the individual parameters
examined and in the absence of a true dose related response the
intergroup difference was considered not to be of toxicological
was performed to investigate the effects of the test item 'Distillates
(Fischer-Tropsch), C8-26 branched and linear' on
embryonic and fetal development following repeated administration by
gavage to the pregnant female during gestation including the period of
complied with the following guidelines:
EPA Health Effects Test Guideline OPPTS 870.3700, ‘Prenatal
Developmental Toxicity Study’ (August 1998)
Ministry of Agriculture, Forestry and Fisheries Testing guidelines for
Toxicology studies, 12 NohSan No 8147, (24 November 2000)
Guidelines for Testing of Chemicals, No 414, ‘Prenatal Developmental
Toxicity Study’ (adopted 22 January 2001)
Regulation (EC) No 440/2008 of 30 May 2008 test methods pursuant to
Regulations (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorization and Restriction
of Chemicals (REACH)
item was administered by gavage to three groups each of twenty-four time
mated Sprague-Dawley Crl:CD®(SD) IGS BR strain rats,
between Days 5 and 19 of gestation inclusive at dose levels 50, 200, and
750 mg/kg bw/day. A further group of twenty-four time mated females was
exposed to the vehicle only (corn oil) to serve as a control.
signs, body weight change, food and water consumptions were monitored
during the study.
All females were terminated on Day 20
of gestation and subjected to gross necropsy including examination of
the uterine contents. The number of corpora lutea, number, position and
type of implantation, placental weights, fetal weight, sex and external
and internal macroscopic appearance were recorded. Half of each litter
were examined for detailed skeletal development and the remaining half
were subjected to detailed visceral examination.
- Mortality: There were no
treatment-related deaths. One control female was killed in extremis on
Day 15 due to a mal-dose.
- Clinical Observations: No clinically
observable signs of toxicity were evident in treated females.
- Body Weight: No toxicologically
significant effects in body weight development were detected.
- Food Consumption: No treatment
related effects were detected in food consumption.
- Water Consumption: No adverse effect
on water consumption was detected.
- Post Mortem Studies: No treatment
related macroscopic abnormalities were detected.
- Litter Data and Litter Placental and
Fetal Weights: No treatment-related effects were detected in the uterine
parameters examined, in fetal viability or in growth and development.
- Fetal Examination: No
treatment-related effects were detected on external development or in
the type and incidence of skeletal or visceral findings.
The oral administration of
'Distillates (Fischer-Tropsch), C8-26 branched and linear' to pregnant
rats by oral gavage during gestation at dose levels of 50, 200 and 750
mg/kg bw/day did not result in any toxicologically significant effects
in parental females. The ‘No Observed Adverse Effect Level’ (NOAEL) was
therefore, considered to be 750 mg/kg bw/day.
No toxicological significant changes
were detected in the offspring parameters measured. The ‘No Observed
Effect Level’ (NOEL) for developmental toxicity was therefore considered
to be 750 mg/kg bw/day.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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