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EC number: 309-665-4 | CAS number: 100683-96-3
Mean values of body weight on day 13 and overall body weight gain (Days 0-13) of males and females
Dose (mg/kg bw/d)
Body weight (g)
Body weight gain (g) das 0-13
N.S. = not significant
Mean values of selected clinical chemistry parameters
Sodium concentration (mmol/L)
N.S. = not significant DN. = Duncan’s multiple Range test * = p<0.05; **=p<0.01
The study was designed to obtain preliminary information on the toxicity of the test item administered by oral gavage to Wistar rats at three dose levels for 14 consecutive days and to allow selection of appropriate dose levels for use in a subsequent Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422).
The test item was formulated in distilled water and the control group was treated with the vehicle only.
The dose formulations were of adequate concentrations (20, 60 and 200 mg/mL, respectively) to meet the study objectives. The measured concentrations were within the 97-102% of nominal concentrations.
Male and female Wistar rats were treated at doses : 0, 100, 300, 1000 mg/kg b.w./d.
The parameters investigated daily during the study included mortality/morbidity, and clinical signs. Body weight and food consumption were measured on Days 0, 3, 6 and 13 with a fasted body weight recorded prior to necropsy on Day 14. One day after the last treatment, blood samples were collected and evaluated for hematology and clinical chemistry parameters. Gross macroscopic examination was performed at necropsy. Selected organs were weighed. No histopathology examination was performed.
There were no clinical signs or unscheduled mortality during the study.
There were no adverse effects on bodyweight or body weight gain at any dose levels.
The food consumption was not affected by the test item administration.
There were no significant treatment related changes observed on investigated hematology or clinical chemistry parameters.
No test item-related macroscopic findings were observed at necropsy.
There were no toxicologically significant effects in organ weight at any of dose levels. treatment, blood samples were collected and evaluated for hematology and clinical chemistry parameters. Gross macroscopic examination was performed at necropsy. Selected organs were weighed. No histopathology examination was performed.
Administration of Carbohydrates and Sugars, hexitols, anhydro - LAB 4623 to Wistar rats by oral gavage, daily for 14 days, was not associated with any adverse effect.
NOAEL = 1000 mg/kg b.w./d
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