Species/Strain: Route of Administration: Oral gavage – Duration: Total exposure days: 28 days Dose: Dose mg/kg Group Number and sex of animals bw/day Control 10/sex (5) 0 Low-dose 10/sex 100 Mid-dose 10/sex 300 High-dose 10/sex (5) 900 Number in parenthesis indicates the number of recovery animals (14 to 15-day recovery period) Frequency of Dose: Dose regimen: 7 days per week. Vehicle: 1% carboxymethylcellulose (medium viscosity) in deionised water Statistical methods used: Statistical differences between the control and treated groups were determined along with an analysis of variance of the treated groups of the same sex compared to the control group at common time points. Statistically significant probabilities were reported as either p0.05 or p0.01. Description of method: The purpose of the study was to evaluate the toxicity potential associated with the oral administration (gavage) of the test material in Sprague-Dawley rats for a 28-day repeated dose with a 14 to 15- day recovery period. The highest dose level chosen was aimed to induce toxic effects but not death or severe suffering, with the descending sequence of dose intended to demonstrate any dosage related response and no- observed-adverse effects at the lowest dose level (NOAEL). The dosage levels were chosen based on the results of the above- mentioned oral dose-finding study. Results: Clinical signs: Clinical observations included localised alopecia on the back, limbs, neck and underside; scabbed area on back and neck; soft or liquid faeces; and urine stained abdominal fur. All these observations are considered to be incidental because they were not dosage related. Body weight: No treatment-related effects on body weight and body weight gain were noted. During the recovery period, a significant decrease (p 0.05) of approximately 7% of control values in mean body weight in males treated at 900 mg/kg bw/day was recorded on Study Day 36. The mean body weight in the control and 900 mg/kg bw/day treatment groups was 421.024.4 and 39324.4
Species/Strain: Route of Administration: Oral – gavage Duration: Total exposure days: 28 days Dose: Group Number and sex of Dose mg/kg animals bw/day Control 10/sex (5) 0 Low-dose 10/sex 100 Mid-dose 10/sex 300 High-dose 10/sex (5) 900 Number in parenthesis indicates the number of recovery animals (14 to 15-day recovery period) Frequency of Dose: Dose regimen: 7 days per week. Vehicle: 1% carboxymethylcellulose (medium viscosity) in deionised water Statistical methods used: Statistical differences between the control and treated groups were determined along with an analysis of variance of the treated groups of the same sex compared to the control group at common time points. Statistically significant probabilities were reported as either p0.05 or p0.01. Description of method: The purpose of the study was to evaluate the toxicity potential associated with the oral administration (gavage) of the test material in Sprague-Dawley rats for a 28-day repeated dose with a 14 to 15- day recovery period. The highest dose level chosen was aimed to induce toxic effects but not death or severe suffering, with the descending sequence of dose intended to demonstrate any dosage related response and no- observed-adverse effects at the lowest dose level (NOAEL). The dosage levels were chosen based on the results of the above- mentioned oral dose-finding study. Results: Clinical signs: Clinical observations included localised alopecia on the back, limbs, neck and underside; scabbed area on back and neck; soft or liquid faeces; and urine stained abdominal fur. All these observations are considered to be incidental because they were not dosage related. Body weight: No treatment-related effects on body weight and body weight gain were noted. During the recovery period, a significant decrease (p 0.05) of approximately 7% of control values in mean body weight in males treated at 900 mg/kg bw/day was recorded on Study Day 36. The mean body weight in the control and 900 mg/kg bw/day treatment groups was 421.024.4 and 39324.4
Potassium-perfluorobutane-sulfonate-hazard-assessment.docx