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EC number: 609-461-8
CAS number: 376653-36-0
Acute toxicity: oral
LD50 > 2000 mg/kg bw in
female CRL:(WI) rats.
Acute Toxicity: oral
Initially, three females
(Group 1) were treated at a dose level of 2000 mg/kg bw. The test item
was administered formulated in Poly (ethylene glycol) 400 (PEG 400) at a
concentration of 200 mg/mL at a dosing volume of 10 mL/kg bw. A single
oral treatment was carried out by gavage for each animal after food had
been withdrawn overnight. Food was made available again 3 hours after
the treatment. Clinical observations were performed at 30 minutes, 1, 2,
3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body
weight was measured on Days -1, 0 and 7 and Day 14. All animals were
subjected to a necropsy and a macroscopic examination.
As no mortality was observed
in group 1 a second group (Group 2) of 3 animals was treated at the same
dose level using the methods described for group 1.
did not cause mortality at a dose level of 2000 mg/kg bw.
Clinical Observations: Treatment
with BAL0001022 at the dose level of 2000 mg/kg bw did not cause any
adverse clinical signs.
Body Weight and Body Weight
Gain: There was no
relevant treatment related effects on body weight or body weight gain
during the observation period. One animal given 2000 mg/kg bw (No: 627)
showed a reduced body weight gain (0.39%) in the second week of the
observation period. This change was considered incidental and not
ascribed to treatment.
Macroscopic Findings: There
was no evidence of treatment-related macroscopic changes at necropsy in
animals given 2000 mg/kg bw.
this study was not designed to determine the acute oral LD50, under the
conditions of this study, it is assumed for BAL0001022 to be above
2000 mg/kg bw in female CRL:(WI) rats.
In the absence of any acute
toxicity, BAL0001022 can be ranked as "Category 5" or "Unclassified" for
acute oral toxicity according to the GHS criteria.
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