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EC number: 200-854-6
CAS number: 75-25-2
The teratogenic potential of the test
ratswas assessed using a study design that pre-dated the OCED 414
guideline, but which nevertheless covered many of the endpoints included
in the guideline.
Test substance was administered in corn oil
by gavage to pregnant Sprague-Dawley rats from day 6 to day 15 of
gestation at doses of 50, 100 or 200 mg/kg/day. A
control group was administered corn oil only. Each
group consisted of 15 rats and each rat was housed individually with
free access to food and water.
On day 22 of gestation rates sacrificed and
their viscera including the uteri were examined for pathological
changes. The foetuses were removed, weighed individually and examined
for viability and external malformations. Two pups from each dam were
fixed in formalin for histological evaluation. Approximately two-thirds
of the remaining live foetuses from each litter were placed in absolute
ethanol for future staining of the skeleton with Alizarin red and
subsequent examination for skeleton abnormalities. The rest of the
foetuses were fixed in Bouin's fluid and studied for visceral changes.
Maternal rats were subject to gross
pathological assessment and the liver, hear, brain spleen and one kidney
were removed and weighed. The following tissue samples
were taken from each animal and fixed: brain, heart, pituitary, thyroid,
parathyroid, thymus, lungs, trachea and bronchi, bronchial node, liver,
kidney, adrenal gland, spleen, skeleton muscle, peripheral nerve,
salivary gland, skin, bone marrow, ovaries, uterus and bladder.
Maternal blood samples were taken for
haematological and clinical chemistry assessments.
Following gross pathological examination a
liver sample was taken from maternal animals for liver protein
aniline hydroxylase (AH) and aminopyrine demethylase (APDM) activity.
Body and Organ Weights: There were no
effects on maternal weight, liver, kidney or spleen weights resulting
from treatment with test substance.
Foetal effects: There were no effects or
litter size, incidence of resorptions, foetal weight or incidence of
visceral anomalies resulting from treatment with test substance.
Histopathology: There were
no dose related histological, changes in mother or foetuses resulting
from treatment with test substance.
haematological parameters assessed showed no affects from treatment with
Clinical Chemistry: Maternal
clinical chemistry parameters assessed showed no affects from treatment
with test substance.
Liver Enzymes: Maternal liver enzyme
parameters assessed showed no affects from treatment with test substance.
Foetal toxicity: There was some of evidence
of dose related increase in sternebra aberrations and observations of
interparietal anomalies in foetuses at 100 and 200 mg/kg bw/day. These
were considered to be the result of a foetal toxicity effect and not
The test substance was not considered
teratogenic to Sprague-Dawley rats. The study No Observed Effect Level
(NOEL) for teratogenicity was 200 mg/kg bw/day (highest dose
There was some evidence of a foetal toxicity
caused by the test substance. The study No Observed Adverse Effect Level
(NOAEL) for foetal toxicity was considered to be 100 mg/kg bw/day.
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