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EC number: 225-590-9
CAS number: 4948-15-6
In a GLP-compliant
Reproduction/Developmental Toxicity Screening Test according to OECD
guideline 421, the test article was administered orally via gavage to
groups of 10 male and 10 female Wistar rats (F0 animals) at dose levels
of 0 mg/kg bw/d (test group 0), 100 mg/kg bw/d (test group 1), 300 mg/kg
bw/d (test group 2) and 1000 mg/kg bw/d (test group 3). The parents' and
the pups' state of health was checked each day, and parental animals
were examined for their mating and reproductive performances. F0 animals
were mated 13 days after the beginning of treatment to produce a litter
(F1 generation pups). F0 animals were examined for their reproductive
performance including determinations of the number of implantations and
the calculation of the postimplantation loss in all F0 females. The pups
were sexed and examined for macroscopically evident changes on PND 0.
They were weighed on PND 1 and PND 4 and their viability was recorded.
At necropsy on PND 4, all pups were sacrificed under isoflurane
anesthesia with CO2 and examined
macroscopically for external and visceral findings at necropsy. All F0
parental animals were sacrificed by decapitation under isoflurane
anesthesia, and were assessed by gross pathology. Weights of selected
organs were recorded and a histopathological examination was performed.
No signs of general systemic toxicity were observed in male or female
parental animals of all test groups (100, 300 and 1000 mg/kg bw/d)
during the entire study period. All male and female animals of test
group 2 (300 mg/kg bw/d) and 3 (1000 mg/kg bw/d) showed black discolored
feces from study day 1 until the end of the study. Regarding pathology,
macroscopically black discoloration of the content of the digestive
tract in numerous animals was observed. Beside the discoloration no
signs of toxicity in the respective tissues were noted macroscopically.
This finding is regarded to be a consequence to the oral intake of the
violet test substance and therefore treatment related but not adverse in
nature. Regarding fertility and reproductive performance, no signs of
toxicity were observed in male or female parental animals of all test
groups during the entire study. Thus, under the conditions of this
modified reproduction/developmental toxicity screening test the NOAEL
(no observed adverse effect level) for reproductive performance and
fertility was 1000 mg/kg bw/day. The NOAEL for general, systemic
toxicity was 1000 mg/kg bw/day.
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