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EC number: 600-033-6
CAS number: 1001416-18-7
In a Repeated Dose, 28-day Oral
Toxicity Study performed according to OECD guideline 407, 2008 the
substance (in polyethylene glycol 400) was administered to groups of 30
Wistarrats male and female by oral gavage at dose levels of 30, 100 and
300 mg/kg bw/day for 28 days. The control group received the vehicle
All animals survived to study
Higher liver weights, lower total
bilirubin levels and/or higher cholesterol levels among males at 100
mg/kg bw/day and animals at 300 mg/kg bw/day were of a minor nature and
values of these parameters were within or only marginally outside the
range considered normal for rats of this age and strain. Furthermore, no
supportive microscopic findings were recorded. Therefore these findings
were considered of no toxicological significance.
No toxicological significant changes
were noted in any of the remaining parameters investigated in this study
(i.e. clinical appearance, functional observations, body weight, food
consiumption, haematology investigations, macroscopic examination and
microscopic examination). An NOAEL of 300 mg/kg bw/day was established
in this study
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