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EC number: 479-930-8
CAS number: 613222-52-9
The test item was assessed in a
reproduction/developmental toxicity screening test according to OECD
guideline 421 and draft OECD guidance document 43. The test item was
administered orally (by gavage) to Hsd.Brl.Han: Wistar rats at repeated
doses of 60, 240 and 1000 mg/kg bw/day compared to control animals, for
28 days in the male animals and up to 52 days in female animals. The
dose setting was based on findings obtained in previous studies (see
section 7.2 and 7.5). The test item was formulated in sunflower oil at
concentrations of 30, 120 or 500 mg/mL, corresponding to a 2 mL/kg bw
dose volume. Analysis of dose formulations (concentration and
homogeneity) were conducted during the first and last week of treatment
of the study from all the concentrations employed. Recovery showed that
dose formulations were homogenous and concentrations within an
acceptable range of 100 ± 10 % (actual 87 % to 104 % of nominal).
For the present study, 12 animals/sex/group
were used. All animals of the parent (P) generation received test item
or control item prior to mating (14 days) and throughout 14 days mating
(and in one case an attempted re-mating of four days, for details see
chapter “Mating Procedure”). Test item or control item was administered
to male animals until 11 days post mating. For females, test item was
administered through the gestation period and up to lactation day 3, 4
or 5, i.e. up to the day before the necropsy. Observations included
mortality, clinical symptoms, body weight, food consumption, mating,
pregnancy and delivery process.
The dams were allowed to litter, and rear
their young up to termination on days 4, 5 or 6 postpartum. All parental
animals were subjected to gross pathology one day after the last
treatment and offspring were euthanized. Histopathology examination was
performed on reproductive organs and pituitary in the control and high
dose groups. In the low and middle dose groups, histopathological
examinations were conducted on sexual organs of infertile males; in
addition to females that did not exhibit signs of mating, did not
deliver or were not pregnant as well as on the organs showing
macroscopic findings at necropsy.
No mortality was observed in parent animals
prior to scheduled necropsy. Clinical signs related to the test item
were not detected during the entire treatment period. The general state
and behaviour of animals was normal in all groups. The detected alopecia
and minor wounds found in single animals at 240 mg/kg bw and at 1000
mg/kg bw/day were considered to be individual signs, meaning that they
may occur commonly also in untreated animals of this rat strain.
The body weight development was undisturbed
in each treatment group during pre-mating and post mating periods in
male animals and in pre-mating, gestation and lactation periods in
female animals. There were no test item related effects on food
consumption of male and female animals at any dose level during the
entire observation period.
There were no differences between the
control and test item treated groups in the reproductive ability of male
and female animals and in delivery data of dams.
Necropsy, organ weight and histopathological
examinations of male and female genital organs (ovaries, uterus, cervix
vagina, testes, epididymides, prostate and seminal vesicles with
coagulating gland) and pituitary did not reveal any toxic or other test
item related lesions at any dose level.
There was no extra uterine mortality in the
test item treated groups. The only dead pup was found in the control
group. The survival indices were similar between all groups. There were
no differences between control and test item treated groups in the ratio
or in the litter means of genders. There were no clinical signs in pups
in the control group and in the test item treated groups.
The mean litter weight of the high dose
group (1000 mg/kg bw/day) was statistically significantly lower (14 %)
when compared to the control group on postnatal days 0 and 4. During
that time period, the mean litter weight gain was also lower (14 %)
compared to the control group. However, there were no significant
differences between the control and test item treated groups in the mean
individual body weigh and body weight gain of pups. In summary, the
statistical significances found in the litter weight were of a minor
degree and were within historical control ranges therefore they were
considered to be of no toxicological relevance.
In the control group, two pups were found
dead and subjected to necropsy on postnatal day 0. In one of them, the
performed lung flotation test was negative, indicating that this pup was
stillborn. Autolysis of abdominal organs did not allow further
inspection. Results of the lung flotation test of the second pup
indicated that it died after delivery. No macroscopic alterations were
found in the organs and tissues of the second pup.
In the 1000 mg/kg bw/day group, one pup was
found dead on day 0. A lung flotation test performed was negative,
indicating that this pup was stillborn. Macroscopic alterations were not
found. In summary, no test item related macroscopic alterations were
found in offspring subjected to gross pathological examination. The
number of stillborns was equal in the control group and high dose group.
Under the conditions of the present study,
SIKA Hardener LH caused no toxic alterations in male and female
Hsd.Brl.Han: Wistar rats after repeated dose oral administration at 60,
240 or 1000 mg/kg bw/day. SIKA Hardener LH did not influence male and
female reproductive performance (gonad function, mating behavior,
conception, pregnancy, parturition). Based on these observations the No
Observed Adverse Effect Level (NOAEL) was determined as follows:
NOAEL for male rats: 1000 mg/kg bw/day
NOAEL for female rats: 1000 mg/kg bw/day
NOAEL for reproductive performance of the
male rats: 1000 mg/kg bw/day
NOAEL for reproductive performance of the
female rats: 1000 mg/kg bw/day
NOAEL for F1 Offspring: 1000 mg/kg bw/day
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