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EC number: 278-855-6
CAS number: 78169-20-7
Administration of the test itemsulfonium
compounds, C11-14-alkylbis (hydroxyethyl), 2-hydroxyethyl sulfates
(salts) at dose levels of 30, 100 and 300 mg/kg body
weight/day to Wistar rats for at least 29 consecutive days was
associated withthe following relevant findings:
Treatment at 300 mg/kg bw/day caused transient body weight loss
(most pronounced in males) andreduction of body weight gain by21%
inmales and in females by approximately 20-26% during premating and
gestation periods,mild changes in
clinical chemistry parameters (slight increase inalanine
aminotransferase activityin both sexesslightly
elevated serum urea concentration in males andlower
serum glucose level in females)minimal to moderate
parakeratotic hyperkeratosis occasionally associated with influx of
mixed cell infiltrate/inflammation, ulceration or erosion in stomach,
hypertrophy of cortical cells in the zona fasciculate of adrenal glands
corresponded with enlargement of adrenal glands and lymphoid atrophy in
the thymus.An increasedintrauterine
and postnatal mortality,lower number of born pups,increased mortality
and lower body weight of pupswere considered to be probably secondary to
Treatment at 100 mg/kg bw/day caused parakeratotic hyperkeratosis
changes in mucosa of stomach, hypertrophy of cortical cells in the zona
fasciculate of adrenal glands and thymus atrophy. Increased intrauterine
and postnatal mortality,lower number of born pups andincreased mortality
of pupswere considered to be probably secondary to maternal toxicity.
No adverse effects or test item related findings were observed at
the low dose level.
In conclusion, for systemic and developmental toxicity as well as
local effects, the NOAEL of sulfonium compounds, C11-14-alkylbis
(hydroxyethyl), 2-hydroxyethyl sulfates (salts) administered by the oral
route to Wistar rats for at least 29 consecutive days is considered to
be the low-dose level of 30 mg/kg bw/day.
The NOAEL for reproductive performance and fertility was 300 mg/kg
bw/d in male and female Wistar rats.
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