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EC number: 276-038-9
CAS number: 71808-53-2
The administration of Quaternary ammonium compounds, C12-18-alkylbis
(hydroxyethyl) methyl, chlorides (CAS No 71808-53-2) was well tolerated.
Two females treated with 25 mg/kg bw/day A.I. showed clinical signs of
noisy respiration on some days which may be due to an irritant nature of
the test item. There was no effect of treatment with the test item at
any level on maternal body weight development or associated food
consumption. Additionally, no macroscopic findings were detected for any
of the animals on the study whilst uterine and fetal examination also
did not reveal any effect of the treatment on uterine parameters
examined or fetal development.
A high dose level of 25 mg/kg bw/day A.I. was chosen taken into
consideration the results from a previous OECD 422 study with this test
item (Harlan Study Number: B61198) which showed treatment-related deaths
at dose levels of 50 mg/kg bw/day or above. Additionally, animals
treated with 25 mg/kg bw/day or above showed acute/subacute necrotizing
inflammation and/or hyperkeratosis/acanthosis of the forestomach mucosa,
which were considered to be to be a local effect consequent to an
irritant nature of the test item administered as a bolus of gavage.
The study was performed according to the
study plan and was designed to investigate the effects of the test item
on embryonic and fetal development following repeated administration by
gavage to the pregnant female during gestation including the period of
organogenesis. The study was designed to comply with the following
The test 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 3 and 19 of gestation inclusive at dose
levels 5, 15, and 25 mg/kg bw/day A.I.(active ingredient; incorporating
a correction factor for 75% purity of the test item). A further group of
twenty-four time mated females was exposed to the vehicle only
(Distilled water) to serve as a control.
Clinical 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 weight, 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.
There were no unscheduled deaths.
No clinical signs of systemic toxicity were detected at any dose level.
Two females treated with 25 mg/kg bw/day showed instances of noisy
respiration which were deemed to be due to an irritant nature of the
There were no adverse effects evident in body weight development for
females treated with 5, 15 or 25 mg/kg bw/day A.I.
There were no adverse effects on food consumption to females treated
with 5, 15 or 25 mg/kg bw/day A.I.
Water Consumption There
was no adverse effect on water consumption at any level.
Post Mortem Studies
No macroscopic abnormalities were detected in females from any dose
Litter Data and Litter Placental and
Fetal Weights No
treatment-related effects were detected in the uterine parameters
examined, in fetal viability or growth and development.
No treatment-related effects were detected on fetal external findings.
No treatment-related effects were detected in the type and incidence of
skeletal or visceral findings in fetuses from females treated with 5, 15
or 25 mg/kg bw/day A.I.
The oral administration of Quaternary
ammonium compounds, C12-18-alkylbis (hydroxyethyl)methyl, chlorides (CAS
No 71808-53-2) to pregnant rats by oral gavage from gestation Days 3 to
19 at dose levels of 5, 15 and 25 mg/kg bw/day A.I. (incorporating a
correction factor for 75% purity), resulted in no treatment related
effects. The No Observed Effect Level (NOEL) for the pregnant female was
considered to be 25 mg/kg bw/day A.I.
No treatment-related changes were detected
in the uterine parameters measured or on embryofetal development. The
‘No Observed Effect Level’ (NOEL) for developmental toxicity was
therefore considered to be 25 mg/kg bw/day A.I.
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