LD50 Study 1 LD50 > 21.5 ml/kg – Study 2 LD50 > 2000 mg/kg bw – Remarks Results No information on signs of toxicity and effects in organs. – The analogue is of low toxicity via the oral based on the limited information. Confidential reference 2 B.2. Irritation skin – Analogue (2 studies with limited information) 1 not specified – Study 2 Regulation for the Enforcement of the Federal Hazardous – Substances Act (Title 16, CFR 1500.40, 1500.41, 1500.42) Species/Strain Rabbit in both studies Remarks Method No information is available. – 1 non-irritating – 2 non-irritating (Primary irritation index was 1.0) – The analogue is non-irritating to skin based on the limited information. Confidential reference 2 B.3. Irritation eye – Analogue (2 studies with limited information) Species/Strain Rabbit in both studies Remarks Method No other information is available. – Study 1 Non-irritating – Study 2 Non-irritating (very slight erythema in four rabbits) – The analogue is non-irritating to the eye on the limited information. Confidential reference 2 B.4. Skin sensitisation Analogue (limited information) Not specified Species/Strain Humans Remarks Method No other information is available. – Non-sensitising There is no evidence of reactions indicative of skin sensitisation to the analogue under the conditions of the test (limited information available). Confidential reference 2 B.5. Repeat dose toxicity
LD50 Study 1 – LD50 > 21.5 ml/kg Study 2 – LD50 > 2000 mg/kg bw Remarks – Results No information on signs of toxicity and effects in organs. The analogue is of low toxicity via the oral based on the limited information. Confidential reference 2 B.2. Irritation – skin Analogue (2 studies with limited information) 1 – not specified Study 2 – Regulation for the Enforcement of the Federal Hazardous Substances Act (Title 16, CFR 1500.40, 1500.41, 1500.42) Species/Strain Rabbit in both studies Remarks – Method No information is available. 1 – non-irritating 2 – non-irritating (Primary irritation index was 1.0) The analogue is non-irritating to skin based on the limited information. Confidential reference 2 B.3. Irritation – eye Analogue (2 studies with limited information) Species/Strain Rabbit in both studies Remarks – Method No other information is available. Study 1 – Non-irritating Study 2 – Non-irritating (very slight erythema in four rabbits) The analogue is non-irritating to the eye on the limited information. Confidential reference 2 B.4. Skin sensitisation Analogue (limited information) Not specified Species/Strain Humans Remarks – Method No other information is available. Non-sensitising There is no evidence of reactions indicative of skin sensitisation to the analogue under the conditions of the test (limited information available). Confidential reference 2 B.5. Repeat dose toxicity
STD1299FR-Final.docx