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EC number: 814-155-4
CAS number: 13188-82-4
LD50(oral, rat): >300 - 2000 mg/kg bw
Dose (mg/kg bw):
No. of animals:
In an acute oral toxicity study performed according to the Acute Toxic Class Method, doses of 2000 and 300 mg/kg bw of the test item Laromer IPGA (undiluted or preparations in corn oil) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 300 mg/kg bw in 6 females). Clinical signs occurred within the first day after administration of 2000 mg/kg bw, mortality in two animals, one animal was sacrificed moribund, impaired general state in all animals, dyspnoea in all animals, gasping in one animal, piloerection in all animals, cowering position in all animals, abdominal position in one animal, reduced defecation in all animals, none defecation in one animal, poor general state in one animal, macroscopic pathological findings in the two animals that died and the single animal which was sacrificed moribund, red to dark brown discoloration of the small intestine and its contents in two animals, dark spotted discoloration of the liver in two animals, enlarged, dark red spotted stomach in all animals (haemorrhages in the sacrificed animal). In the 300 mg/kg neither mortality nor clinical signs were observed, macroscopic pathological findings in the surviving animals that were sacrificed at the end of the study period, red discoloration of the small intestine and its contents in one animal of the second 300mg/kg bw test group. All animals gained weight in a normal range throughout the study period. Under the conditions of this study the median lethal dose of Laromer IPGA after oral administration was found to be > 300 mg/kg bw - 2000 mg/kg bw in rats.
In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item IPGA to the clipped application site (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing during the 24-hour exposure period. The application area comprised at least 10% of the total body surface. The animals were observed for 14 days.Neither mortality nor clinical signs were observed.The following test item-related local effects were recorded during the course of the study, local skin effects occurred until the last day of observation at the latest:- Very slight to moderate erythema (grade 1 to 3)- Very slight to slight edema (grade 1 to 2)- Incrustations- Scaling- Additionally, erythema and edema were noted beyond the application site.All animals gained weight in a normal range throughout the study period.No macroscopic pathologic abnormalities were noted in any animal examined at the end of the study (5 males and 5 females).Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw
on the available studies data on acute toxicity properties the test item
would have to be classified as harmful if swallowed, cat.4 (H302) to
Regulation (EC) No 1272/2008 (CLP).
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