concentration 0.5. 1.0 and 2.0% active ingredient in distilled water Challenge procedure: day 36 patch applied for 24 hours; concentration 1% active ingredient in distilled water Challenge outcome: no positive results at challenge, no positive or negative controls in Test method: according to Stotts, 1980 (16) Result: not a sensitiser under these test conditions 9.2 Repeated Dose Toxicity (17) this study was conducted on an analogue of the notified chemical, Stepantex VS 90 Species/strain: rat/Sprague-Dawley CD Number/sex of animals: 10M/10F per dose Method of administration: orally in distilled water Dose/Study duration:: doses: 0, 100, 300, 1 000 mg.kg-1.day-1 for 96 days , 131 days for main study Clinical observations: 3 mortalities during study, all males, 2 deaths attributed to ether anaesthesia, third was in high dose group; this high dose animal also showed daily weight loss Clinical an intermediate haematological examination showed an increased thromobocytes in chemistry/Haematology 300 mg.kg-1 males, a final examination showed a decrease in mean cell volume in high dose females; an intermediate biochemical examination showed high dose males to have an increase in alanine transaminase (ALT) and calcium content, high dose females also had an increased ALT content; in the final examination the high dose animals again had elevated ALT, males in addition had a slight increase in potassium and females an increase in creatin and chloride and a slight increase in alkaline phosphatase (AP)
concentration 0.5. 1.0 and 2.0% active ingredient in distilled water Challenge procedure: day 36 patch applied for 24 hours; concentration 1% active ingredient in distilled water Challenge outcome: no positive results at challenge, no positive or negative controls in Test method: according to Stotts, 1980 (16) Result: not a sensitiser under these test conditions 9.2 Repeated Dose Toxicity (17) this study was conducted on an analogue of the notified chemical, Stepantex VS 90 Species/strain: rat/Sprague-Dawley CD Number/sex of animals: 10M/10F per dose Method of administration: orally in distilled water Dose/Study duration:: doses: 0, 100, 300, 1 000 mg.kg-1.day-1 for 96 days , 131 days for main study Clinical observations: 3 mortalities during study, all males, 2 deaths attributed to ether anaesthesia, third was in high dose group; this high dose animal also showed daily weight loss Clinical chemistry/Haematology an intermediate haematological examination showed an increased thromobocytes in 300 mg.kg-1 males, a final examination showed a decrease in mean cell volume in high dose females; an intermediate biochemical examination showed high dose males to have an increase in alanine transaminase (ALT) and calcium content, high dose females also had an increased ALT content; in the final examination the high dose animals again had elevated ALT, males in addition had a slight increase in potassium and females an increase in creatin and chloride and a slight increase in alkaline phosphatase (AP)
NA468FR.docx