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EC number: 420-380-5
CAS number: 136465-81-1
An acute oral toxicity assessment was conducted to determine the maximum non-lethal dose of PTH-decahydroamide in rats. Following administration of 200, 1000 and 2000 mg/kg bw doses, deaths occurred at the two higher levels and the maximum non-lethal dose was confirmed to be between 200 and 1000 mg/kg bw. The median lethal oral dose was estimated to exceed the limit dose of 2000 mg/kg bw BUT THIS CANNOT BE CONFIRMED FROM THE STUDY SUMMARY SINCE NO INDICATION OF ANIMAL NUMBERS IS CURRENTLY AVAILABLE.In an acute dermal toxicity study, five male and five female rats were exposed for 24 hours to a dose of 2000 mg/kg bw PTH-dechydroamide dispersed in 1% aqueous CMC. Two males died shortly after completion of exposure but the remaining animals showed no clear signs of reaction to treatment at the limit dose and th median lethal dose was confirmed to exceed 2000 mg/kg bw.
The acute oral toxicity of Ro 31 -9373/000 (PTH-Decahydroamide) was
investigated in rats. The study objective was to determine the maximum
non-lethal oral dose and to this end dose levels of 200, 1000 and 2000
mg/kg bw were administered to groups of rats. Two animals died following
dosing at 2000 mg/kg bw and one rat died after 1000 mg/kg bw
administration. Clinical signs noted ante-mortem included convulsions
and collapse. No necropsy changes of toxicological significance were
observed in the decedents. Clinical signs observed in the surviving rats
included piloerection, ataxia and subdued behaviour. No necropsy
findings were reported for the rats terminated on day 15. The maximum
non-lethal dose was found to be between 200 and 1000 mg/kg bw following
single oral administration of Ro 31 -9373/000 (PTH-Decahydroamide) to
Following test guideline compliant dermal application of
PTH-decahydroamide for 24 hours at 2000 mg/kg bw to a group of five male
and five female Wistar rats, two of the males died within an hour of
completion of the topical exposure. Other effects noted included
lethargy for several males and females on days 1 and/or 2; erythema,
scabs and desquamation for one or two females from Day 5 and
erythematous reactions persisting to termination for one female. Low
bodyweight gains were recorded for several rats in the first week but
gains were normal during the second observation week. Necropsy of the
decedents and the rats surviving to Day 15 revealed no macroscopic
abnormalities. The median lethal dermal dose in both sexes exceeded 2000
mg/kg bw and consequently PTH-Decahydroamide does not require
classification for dermal toxicity according to EU criteria.
The median lethal oral and dermal doses in rats exceeded the limit dose
level of 2000 mg/kg bw based on two key study results. In this case no
classification is required for oral or dermal toxicity in accordance
with Commission Regulation (EC) No 1272/2008.
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