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EC number: 931-259-6
CAS number: -
test substance, Semi Dry Absorption (SDA) Product, was tested for
reproduction toxicity using the OECD Test Guideline No. 421
Reproduction/Developmental Toxicity Screening Test, Adopted by the
Council on July 27th 1995.
rats of SPF quality were used for testing. The test substance was
administered dissolved in olive oil using a stomach tube; oral
application of rats was made daily. The concentrations of suspensions at
all dose levels were adjusted to ensure the administered volume of 1 mL
per 100 g of body weight. Four groups of animals were included in the
study - 3 treated groups (doses 160, 400, 1000 mg/kg of body weight/day)
and one control group (vehicle only). Each group consisted of 10 males
and 10 females. The dose levels for study – 160, 400 and 1000 mg/kg/day
were chosen on the basis of the results of the Study No. 67/09/8: Semi
Dry Absorption (SDA) Product – Repeated Dose 90-day Oral Toxicity Study, Dose-range
finding experiment with 28-day application period.
treated groups were administered daily for the following periods:
and females – 2 weeks prior to the mating period and during the mating
during pregnancy and till the 3rd day of lactation,
males – after
mating period – totally for 28 days,
females (mated females without parturition) – for 26 days after the
the study clinical observation and health status control were performed
daily. The body weight and food consumption were measured weekly or in
specified time intervals. Vaginal smears were prepared daily during
mating period (until the presence of spermatozoa). Reproduction
parameters relevant to pups (number of pups, weight of litters, sex or
vitality) were also recorded.
study was finished by gross necropsy of animals. In all males of all
groups the sperm parameters: sperm motility and sperm morphology were
examined. The selected organs from parental animals were removed for
weighing and histopathological examination.
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