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EC number: 230-896-0
CAS number: 7360-38-5
Short-term (28-day) repeated dose toxicity: oral (OECD 407): NOAEL
(rat, m/f) ≥ 1000 mg/kg bw/day (highest dose tested)
Short-term oral repeated dose toxicity
A subacute oral toxicity study was performed in male and female Wistar
rats according to OECD guideline 407 and in compliance with GLP (Envigo,
2019a). All animals were daily exposed to the test item by oral gavage
for a treatment period of 28 days. The test item was dissolved in corn
oil and administered at doses of 100, 300 and 1000 mg/kg bw/day to each
five male and female animals per dose group. A similar constituted group
received the vehicle only and served as control group.
Detailed physical examination and arena observation revealed no
treatment-related findings. Sensory reactivity, grip strength and motor
activity as well as body weight gain and food consumption were as well
unaffected. Analysis of hematological and blood chemistry parameters
revealed minor findings, which were attributed to normal biological
variation as a dose-response relationship was not observed. In addition,
organ weights were unaffected and there were no treatment-related
macroscopic or histopathological findings.
Based on these results and under the conditions of the study, a NOAEL ≥
1000 mg/kg bw/day was derived for male and female Wistar rats.
The available data on repeated dose toxicity do not meet the
criteria for classification according to Regulation (EC) No. 1272/2008,
and are therefore conclusive but not sufficient for classification.
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