induction phase Induction Concentration: intradermal: 2% topical: 50% of Irritation Following intradermal injections with 2% test substance, 3/10 animals displayed slight or well-defined erythema. Following intradermal injection of 4% test substance with Freunds’ Complete Adjuvant (FCA), well-defined to severe erythema or necrosis were observed, and in the corresponding control animals, slight to moderate erythema were observed. Moderate erythema was observed in all animals, including the control group, following intradermal injection with FCA and water alone. Following epidermal application, some animals displayed scabbing, with one animal showing slight erythema and another animal showing severe erythema. Observations in the corresponding control groups were similar. Such reactions were considered to have been enhanced by treatment with SDS. challenge phase 1st challenge topical: 50% Remarks - Method 10% sodium dodecyl sulfate (SDS) was applied to the injection sites 24 hours prior to topical induction. The vehicle used for dilution of test substance was corn oil. Remarks - Results None of the animals were observed to have been sensitised. There was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. NOTOX (1999e) Repeat dose toxicity Notified chemical OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents. EC Directive 96/54/EC B.7 Repeated Dose (28 Days) Toxicity (Oral). Species/Strain Rat/Wistar Crl: (WI) BR of Administration Oral gavage – Exposure Information Total exposure days: 28 days Dose regimen: 7 days per week Vehicle Propylene glycol Remarks - Method No significant protocol deviations. Dose Number and Sex Mortality mg/kg bw/day of Animals control 5 males, 5 females 0 50 5 males, 5 females 0 150 5 males, 5 females 1 1000 5 males, 5 females 0 Mortality and Time to One female treated with 50 mg/kg/day died following blood sampling on the day of scheduled necropsy. This was considered to be incidental. Laboratory Findings Clinical Chemistry, Haematology, Urinalysis –
induction phase Induction Concentration: intradermal: 2% topical: 50% of Irritation Following intradermal injections with 2% test substance, 3/10 animals displayed slight or well-defined erythema. Following intradermal injection of 4% test substance with Freunds’ Complete Adjuvant (FCA), well-defined to severe erythema or necrosis were observed, and in the corresponding control animals, slight to moderate erythema were observed. Moderate erythema was observed in all animals, including the control group, following intradermal injection with FCA and water alone. Following epidermal application, some animals displayed scabbing, with one animal showing slight erythema and another animal showing severe erythema. Observations in the corresponding control groups were similar. Such reactions were considered to have been enhanced by treatment with SDS. challenge phase 1st challenge topical: 50% Remarks - Method 10% sodium dodecyl sulfate (SDS) was applied to the injection sites 24 hours prior to topical induction. The vehicle used for dilution of test substance was corn oil. Remarks - Results None of the animals were observed to have been sensitised. There was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. NOTOX (1999e) Repeat dose toxicity Notified chemical OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents. EC Directive 96/54/EC B.7 Repeated Dose (28 Days) Toxicity (Oral). Species/Strain Rat/Wistar Crl: (WI) BR of Administration Oral – gavage Exposure Information Total exposure days: 28 days Dose regimen: 7 days per week Vehicle Propylene glycol Remarks - Method No significant protocol deviations. Dose mg/kg bw/day Number and Sex of Animals Mortality control 5 males, 5 females 0 50 5 males, 5 females 0 150 5 males, 5 females 1 1000 5 males, 5 females 0 Mortality and Time to One female treated with 50 mg/kg/day died following blood sampling on the day of scheduled necropsy. This was considered to be incidental. Laboratory Findings – Clinical Chemistry, Haematology, Urinalysis
STD1312FR.docx