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EC number: 925-259-5
CAS number: 140921-24-0
The 28-Day Repeated Dose Oral Toxicity
Study with Incozol EH in Rats was conducted according the OECD TG 407
(12 May 1981) and Directive 84/449/EEC, B.7 (19 September 1984).
Incozol EH was repeatedly administered
by oral gavage at dose levels of 0 (control group), 40 (low dose), 200
(mid dose), and 1000 mg/kg bw/day (high dose) to male and female Wistar
rats (Bor:WISW) for 29 consecutive days to assess the toxicological
effects of Incozol EH. The control group was given 1,2-propandiol only.
Each group consisted of 5 males and 5 females.
There was no mortality during the
entire study period. No clinical signs were observed in all test item
treated animals. Male and female animals of the high dose group (1000
mg/kg bw/day) showed ruffled fur from the 3rdweek of
administration on. An increased water consumption compared to control
group was observed in male and female animals of the high dose group.
Food consumption was only increased in female animals of the 1000 mg/kg
bw/day dose group.
In hematological and histopathological
analysis, no test item related effects could be observed on blood
parameters and hematopoietic organs up to 200 mg test item/kg bw/day in
male animals and up to 1000 mg/kg bw/day in female animals. There was a
significant decrease in hemoglobin concentration and hematocrit value
and a lower reticulocyte count compared to control group in male animals
of the 1000 mg/kg bw/day dose group. In addition a significant increase
of the platelet count compared to control group was noted. Blood
coagulation was not affected in all treatment groups.
As a result of the blood biochemical
analysis and macroscopic and microscopic pathology, there was no
treatment related effect on the intermediary metabolism and organ
morphology in male and female animals up to a dose level of 200 mg/kg
bw/day. Administration of 1000 mg/kg bw/day revealed an increased AST
activity in female animals and a reduced ALT activity in male animals
compared to control group. Albumin and total protein level were
significantly increased in both sexes of the 1000 mg/kg bw/day dose
There was a significant increase of
liver weights in male and female animals of the 1000 mg/kg bw/day dose
group. In the same dose group, an increased adrenal gland and kidney
weight was observed in male and female animals, respectively. As there
was no macroscopic or microscopic pathological correlation a test item
related kidney damage is not considered. Organ weights were not affected
up to 200 mg test item/kg bw/day in male and female animals.
There was no test substance related
change in urinalysis. In male animals of the high dose group protein
concentration in urine was significantly increased compared to control.
This observation was not considered to be test item related as there was
no pathological correlation and female animals were not affected.
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