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EC number: 700-071-4
CAS number: 932742-30-8
A 90-day oral (gavage) toxicity study was
performed with SIKA Hardener LI in male and female Hsd.Brl.Han: Wistar
according to OECD Gudeline 408. The test item was administered orally to
the test animals (n=15 animals/sex in the control and high dose groups,
n= 10 animals/sex in the low and middle dose groups) once a day at 0
(vehicle control), 1000, 300 and 100 mg/kg bw/day doses corresponding to
concentrations of 200 mg/mL, 60 mg/mL and 20 mg/mL, applied in a dose
volume of 5 mL/kg bw for 90 days. 5 animals/sex in the control and high
dose groups were observed without administration for four weeks
(recovery observations). Polyethylene glycol 400 was used as vehicle.
Animals were observed for mortality twice a
day in the course of the study. Daily general clinical observations and
weekly detailed clinical observations were performed. A functional
observation battery was conducted in the last week of treatment. The
body weight and food consumption were measured and evaluated weekly.
Clinical pathology examinations (including hematology and clinical
chemistry) and gross pathology were conducted one day after the last
treatment and at the end of the recovery period. The absolute and
relative weights of selected organs were determined. Full histopathology
was performed on the preserved organs or tissues of the animals of the
control and high dose groups including recovery groups. Thymus showing
macroscopic changes was examined histologically in one male animal of
300 mg/kg bw/day group.
SIKA Hardener LI caused salivation (male and
female), changes in white blood cell count (females) and in spleen
weight (females) at 1000 mg/kg bw/day in Hsd.Brl.Han: Wistar rats after
the consecutive 90-day oral (gavage) administration. At 300 mg/kg
bw/day, salivation was observed in some male and female animals during
the treatment period. Slight changes in the white blood cell count and
spleen weight relative to body weight in female animals were judged to
be toxicologically not relevant. At 100 mg/kg bw/day, there was no test
item related effect. Based on these observations the No Observed
Adverse Effect Level (NOAEL) was determined as follows: NOAEL: 1000
mg/kg bw/day for male animals; NOAEL: 300 mg/kg bw/day for female
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