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EC number: 942-466-6 | CAS number: -
For the purpose of the study the test material was freshly prepared, as required, as a solution at the appropriate concentration in arachis oil BP. Preparation
was aided by the use of a vortex mixer and by heating the formulation in a warming bath at approximately 80 °C. The formulation was allowed to cool
prior to dosing. Determination by analysis of the concentration, homogeneity and stability of the test material preparations was not appropriate because it was not specified
in the Study Plan and is not a requirement of the Test Guideline.
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was
calculated according to its fasted bodyweight at the time of dosing.
Table 1. Individual Clinical Observations and Mortality Data in the Range-finding Study
0 = no signs of systemic toxicity
Table 2. Individual Clinical Observations and Mortality Data in the Main Study
H = hunched posture; 0 = no signs of systemic toxicity
Table 3. Individual Bodyweights and weekly Bodyweight Changes in the Main Study
Table 4. Individual Necropsy Findings in the Main Study
Evaluation of Data
Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities
including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.
A OECD Guideline 401 study was performed to assess the acute oral toxicity of phosphoric acid, mono- and di-(C8 -C10) ester, compds. with C12 -14 amine in the Sprague-Dawley CD strain rat in compliance with GLP. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material as a solution in arachis oil BP at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.
There were no deaths. Hunched posture was noted in all animals up to one day after dosing. All animals showed an expected gain in bodyweight during the study. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
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