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EC number: 701-083-2
CAS number: -
1.1 OBSERVATIONS AND MEASUREMENTS Groups of male and female rats
received 68512-53-8 by oral gavage at dose levels of 0, 62.5, 250 or
1000 mg/kg body weight per day for a period of 28 days. On day 29 all
males and all females from each group were killed and necropsied
Behavior and state of health were observed daily in all groups. Body
weights and food consumption were recorded twice weekly. Once before the
first treatment and once a week thereafter, detaiIed clinical
observations were performed in all animals outside the home cage in a
standard arena ('open field'). Additionally, the animals were examined
for opacity of the refracting media of the eyes, damage to the oral
mucosa, and impairment of dental growth. Neurotoxicological
measurements, including assessment of sensory function, motor activity,
forelimb and hindlimb grip strength, were conducted at the end of the
treatment period. I. Hematological examinations, clinical chemistry and
urine analyses were carried out at the end of the treatment period.
During necropsy the animals were examined for macroscopically visible
abnormalities, the main organs were weighed and the organ to body weight
ratios calculated. Organs and tissues were processed for
histopathological examination and checked for microscopically visible
changes. Body weights, hematological and clinical chemistry data, urine
data (volume, specific weight), absolute and relative organ weights and
neurotoxicological measurements (motor activity, forelimb and hindlimb
grip strength) were analyzed with the aid of a statistical program to
show differences compared to the controls.
- No deaths occurred throughout the study. Behavior, state of health,
body weight development and food consumption, were not affected by
administration of the test substance. No treatment-related clinical
signs were observed in all animals. No changes of the oral mucosa or
impairment of dental growth was observed in all study groups. There were
no substance related adverse findings either in hematological
examinations, clinical chemistry or urine analyses throughout the study
period. As a non-adverse finding, the test substance induced slightly
lower total bilirubin, cholesterol and triglycerides in high dose group
rats (1000 mgkg body weight) and possibly marginally lower
hemoglobinhematocrit content when compared to the controls at the end of
the study period. These changes were at the lower range of the
historical control data for this rat strain and age and hence, not
considered to be of toxicological significance. The test substance did
not influence any of the neurotoxicological parameters. No test article
related changes in organ weights were observed. Necropsy at terminal
sacrifice revealed no gross pathology findings in the animals of all
experimental groups. All microscopic findings sporadically observed in
different organs of single animals were interpreted as not compound
In conclusion, repeated administration of 68512-53-8 at dose levels of
62.5, 250 and 1000 mg/kg body weight and day did not cause any adverse
substance related alterations. With regard to the present study the 'No
Observed Effect Level' (NOEL) is 250 mg/kg body weight. The 'No Observed
Adverse Effect Level' (NOAEL) is 1000 mg/kg body weight per day.
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