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EC number: 810-260-4
CAS number: 1115251-57-4
In an acute oral toxicity study performed
according to OECD Guideline 423 and in compliance with GLP, three groups
of three female Sprague Dawley rats were given a single oral (gavage)
dose of PI2080 at 300 or 2000 mg/kg bw in DMSO. Since no relevant
toxicity data were available for the estimation of a lethal dose-level,
the starting dose-level was 300 mg/kg bw for animal welfare reasons.
After the first assay, the next higher dose-level of 2000 mg/kg bw was
tested. Then, in view of toxicity observed at 2000 mg/kg bw, the results
previously obtained at 300 mg/kg bw were confirmed in other females.
Each animal was then observed for mortality, clinical signs and
bodyweights for 14 days and were all sacrificed for macroscopic
At 2000 mg/kg bw, one female was found dead
on Day 6 and another one was sacrificed prematurely on Day 5.
Piloerection, hypoactivity, hunched posture, half-closed eyes, soiled
urogenital and mouth regions, then dyspnea and lateral recumbency were
observed in the prematurely sacrificed female. Piloerection was also
observed in the surviving female. At 300 mg/kg bw, no unscheduled deaths
that could be related to treatment were observed. Piloerection and
ptyalism (3/6 females), hypoactivity and dyspnea (2/6 females),
half-closed eyes and chromorhynorrhea (1/6 females) were observed. At
terminal sacrifice, no gross findings were observed.
The oral LD50 for PI2080 is 300-2000 mg/kg
bw in rats therefore it is classified as ‘R22 Harmful if swallowed’
according to the Annex VI to the Directive 67/548/EEC and ‘Category 4’
with a signal word ‘warning’ and the hazard statement ‘H302: Harmful if
swallowed’ according to the CLP Regulation (EC) N° (1272-2008).
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