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EC number: 278-855-6
CAS number: 78169-20-7
Sulfonium compounds, C11-14-alkylbis(hydroxyethyl), 2-hydroxyethyl
sulfates (salts) was tested for its prenatal developmental toxicity in
Wistar rats. The test substance was administered
as an aqueous preparation to groups of 25 time-mated female Wistar rats
by gavage at doses of 15, 50 and 200 mg/kg body weight/day (mg/kg bw/d)
on gestation days (GD) 6 through 19. The control group, consisting of 25
females, was dosed with the vehicle (deionized water) in parallel. A
standard dose volume of 10 mL/kg body weight was used for each test
group.The state of health of the animals was checked each day.
The following test substance-related adverse effects/findings were
noted: Test group 3 (200 mg/kg bw/d):
Reduced mean food consumption (GD 6-8, GD 10-13 and GD 19-20; up to -10
% in comparison to the concurrent control) together with a decreased
corrected body weight
gain (-15% compared to control) in combination with the following
findings in pathology: thickened wall of the forestomach, thickened wall
of the glandular stomach,
thickened wall of the duodenum, focus in the glandular stomach,
deposition in the glandular stomach. No test substance-related adverse
effects on gestational parameters or fetuses.
Test group 2 (50 mg/kg bw/d) and Test group 1 (15 mg/kg bw/d): No test
substance-related adverse effects on dams, gestational parameters or
Therefore under the conditions of this prenatal developmental toxicity
study, the oral administration of Sulfonium compounds,
C11-14-alkylbis(hydroxyethyl), 2-hydroxyethyl sulfates (salts) to
pregnant Wistar rats from implantation to one day prior to the expected
day of parturition (GD 6-19) at a dose of 200 mg/kg bw/d caused signs of
maternal toxicity. The combination of different individual findings (a
reduction in food consumption, decrease in corrected body weight gain,
thickened wall in stomach and duodenum) was assessed as adverse. In
conclusion, the no observed adverse effect level (NOAEL) for maternal
toxicity is the mid dose of 50 mg/kg bw/d. The NOAEL for prenatal
developmental toxicity is the highest tested dose of 200 mg/kg bw/d.
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