Analogue A was severely irritating to the eye of rabbits Result: Eye Irritation Test Substance Eye Irritancy Analogue B Severe Analogue C Severe Analogue D Moderate Analogue F Severe Analogue G Severe 9.2.1. Skin Sensitisation No data on skin sensitisation were submitted. The notifier indicates evidence of skin sensitivity was not reported in a dermal repeat dose study in rabbits or rats using analogues (see below). Repeated Dose Toxicity 28 day Repeated Dermal Dose Toxicity (Hewstone 1994) The following is summarised from the published paper. No results were presented or tabulated. The original data was not provided for assessment. Analogue G Test Substance Phase 1 Rabbit (male and female); Species/Sex – Phase 2 Rabbits and Rats (young and mature males). – mL/kg/day, Concentration and 5 days/week for 4 Dosing Schedule: Phase 2 1 25% solution applied topically at 2 mL/kg/day, 0, 1, 3, 5, 25% solutions 5 days/week for 4 followed by a 28 day recovery period. applied topically at 2
Result: Analogue A was severely irritating to the eye of rabbits Eye Irritation Test Substance Eye Irritancy Analogue B Severe Analogue C Severe Analogue D Moderate Analogue F Severe Analogue G Severe 9.2.1. Skin Sensitisation No data on skin sensitisation were submitted. The notifier indicates evidence of skin sensitivity was not reported in a dermal repeat dose study in rabbits or rats using analogues (see below). Repeated Dose Toxicity 28 day Repeated Dermal Dose Toxicity (Hewstone 1994) The following is summarised from the published paper. No results were presented or tabulated. The original data was not provided for assessment. Test Substance Analogue G Species/Sex Phase 1 – Rabbit (male and female); Phase 2 – Rabbits and Rats (young and mature males). Concentration and Dosing Schedule: 1 0, 1, 3, 5, 25% solutions applied topically at 2 mL/kg/day, 5 days/week for 4 Phase 2 25% solution applied topically at 2 mL/kg/day, 5 days/week for 4 followed by a 28 day recovery period.
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