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EC number: 203-825-6
CAS number: 111-01-3
No mortality was recorded in any sex. One male was sacrificed
after showing signs of illness, such as pallor, hunched back, blood
secretion from nose and ruffled fur. This animal had findings related to
an incorrect administration such as red-brownish areas in two lobes of
No test-item-related clinical signs were recorded.
Functional Performance Test
Slightly lower locomotor activity was recorded in males at 300 and
1000 mg/kg. No differences were recorded in females.
No relevant differences from the control group were recorded in
the grip strength test in either sex.
Sensory Reactivity Assessments
No differences from the control group were recorded.
No relevant differences from the control group were recorded.
No test-item-related differences from the control group were
recorded in males. Lower body-weight gain was recorded in females at
1000 mg/kg during the prepairing period and afterwards body-weight gain
was similar to the control group.
No relevant differences
No relevant differences were observed.
A trend to higher values of creatine kinase was recorded in males
No test item-related differences were recorded in mean or median
No test item-related differences were recorded in the percentage
of mating, gestation index, fertility index or conception rate.
No test-item-related differences in corpora lutea, implantation
sites, pre- and postimplantion losses or sex ratio were observed with
respect to the control group.
The length of pregnancy (days) was similar in all groups.
The presence of milk on day 1 postpartum was significantly lower
at 300 mg/kg.
Offspring Litter Size and Viability
No test-item-related differences were recorded in live and total
pups at first litter check.
There were no differences in sex ratio with respect to the control
Higher postnatal losses on day 4 postpartum were recorded at 300
and 1000 mg/kg, but they were not dose-dependant.
No test item-related differences were recorded.
No test-item-related alterations were recorded.
No test item-related alterations were recorded.
No findings were recorded in the offspring at necropsy.
Small thymus was recorded in all groups, including the control
group. However, the number of animals affected was higher at 300 and
All remaining lesions recorded were considered to be within the
normal range of background alterations observed in rats of this strain
and age and under the experimental conditions used in this study.
No noticeable differences
were observed. However, lower thymus weights were recorded in females at
Sperm Stage Evaluation
The study was designed to investigate the systemic
toxicity and potential adverse effects of the test item on reproduction
(including offspring development) and is compatible with the
requirements of the OECD Guidelines for Testing of Chemicals No. 422
“Combined Repeated Dose Toxicity Study with the
Reproduction/Developmental Toxicity Screening Test” (adopted 22 March
The test item Phytosqualan was administered orally
(by gavage) to three groups, each consisting of ten male and ten female
RccHan®:WIST rats, daily for at least 4 weeks (including
two weeks prior to mating, through mating, pregnancy and early lactation
for females) at the following dose levels: 0, 100, 300 and 1000
mortality was recorded in any sex. No
test-item-related differences from the control group were recorded in
test item-related alterations were recorded.
NOEL was 1000 mg/kg/day for male (mating and reproductive performance)
and female (breeding).
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