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EC number: 242-893-1
CAS number: 19223-55-3
Cumulative Mortality over the 14-day observation period
hydroxysultaine, as a 42% aqueous solution, has been tested for acute
oral toxicity in Wistar rats. The test article was administered as such
using different dosing volumes to reach the desired dose levels. Three
groups of 5 rats per gender received a dose volume of 2.33, 4.65 and
6.98 mL/kg, equivalent to 1000, 2000 and 3000 mg active ingredient/kg,
respectively. Examinations for mortality and clinical signs were
performed daily during the 14-day study period. Body weights were
measured just before dosing, and 7 and 14 after dosing. A macroscopic
examination was performed at the necropsy of survivors on day 14.
A high incidence of pre-terminal deaths occurred at 2000 and 3000 mg/kg,
whereas no death occurred at 1000 mg/kg: 3/5 male rats were found dead
or sacrificed in extremis within 24 hours of dosing in the 3000 mg/kg
dose group, and 2/5 female rats were found dead or sacrificed in
extremis within 24 hours of dosing in each of the 2000 mg/kg and 3000
mg/kg dose groups. Marked clinical signs, such as general reduced
activity together with diarrhea, squatting position, piloerection and/or
reduced skin turgor were observed at 3000 mg/kg within 3 days
post-dosing. Body weight gain was normal in surviving animals over the
observation period. Hemorrhagic and lytic mucous membrane alterations in
the gastro-intestinal tract, considered test-article related, were
observed at necropsy in animals found dead or sacrificed in extremis
within 24 hours of dosing in the 2000 mg/kg and 3000 mg/kg dose groups.
At terminal sacrifice, no test-related macroscopic findings were
observed in the other animals.
The oral LD50 in rats was calculated to be 3020 or 2950 mg active
ingredient/kg bw, for females or both genders, respectively, at 24 hours
and 14 days after administration. The oral LD50 in male rats could not
be calculated because deaths occurred only in the high-dose group.
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