Harlan (2010k) Irritation skin (in vitro) – Analogue 1 (100 %) Similar to OECD TG 431 In Skin Corrosion - Human Skin Model Test –EpiDerm. Vehicle Water Remarks - Method The test substance (25 µL) wetted with 25 µL of water was applied to the tissues in duplicate. Following exposure periods of 3 minutes or 1 hour, the tissues were rinsed, treated with MTT bromide; 1.0 mg/mL] and then incubated at 37.5 °C for 3 hours. Positive and negative controls were run in parallel with the test substance: Negative control (NC): water Positive control (PC): potassium hydroxide (8M) Test material Test 1 (3 minute exposure period) Test 2 (1 hour exposure period) Mean OD570 of Relative mean Mean of Relative mean duplicate tissues viability (%) duplicate tissues viability (%) 1.538 100 1.476 100 Negative control 1.705 110.9 1.501 101.7 Test substance 0.276 18.0 0.006 0.4 Positive control OD = optical density Remarks - Results The positive and negative controls gave satisfactory results, confirming the validities of the test systems. Analogue 1 was non-corrosive to the skin under the conditions of the test. RCC (2007) Irritation skin – Analogue 1 (100%) OECD TG 404 Dermal Irritation/Corrosion. EC Directive 2004/73/EC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Number of Animals 3 (2 female, 1 male) Vehicle Water Observation Period 14 Days Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Animal No. Value of Any Effect of Observation Period 1 2 3 3 3 3 3 > 14 days 1 Erythema/Eschar 2.3 2.3 2 3 < 14 days 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Well-defined erythema was seen in all animals 1 hour after removal of the dressing. This increased to moderate/severe erythema in all animals at the
Harlan (2010k) Irritation – skin (in vitro) Analogue 1 (100 %) Similar to OECD TG 431 In Skin Corrosion - Human Skin Model Test –EpiDerm. Vehicle Water Remarks - Method The test substance (25 µL) wetted with 25 µL of water was applied to the tissues in duplicate. Following exposure periods of 3 minutes or 1 hour, the tissues were rinsed, treated with MTT bromide; 1.0 mg/mL] and then incubated at 37.5 °C for 3 hours. Positive and negative controls were run in parallel with the test substance: Negative control (NC): water Positive control (PC): potassium hydroxide (8M) Test material Test 1 (3 minute exposure period) Test 2 (1 hour exposure period) Mean OD570 of duplicate tissues Relative mean viability (%) Mean of duplicate tissues Relative mean viability (%) Negative control 1.538 100 1.476 100 Test substance 1.705 110.9 1.501 101.7 Positive control 0.276 18.0 0.006 0.4 OD = optical density Remarks - Results The positive and negative controls gave satisfactory results, confirming the validities of the test systems. Analogue 1 was non-corrosive to the skin under the conditions of the test. RCC (2007) Irritation – skin Analogue 1 (100%) OECD TG 404 Dermal Irritation/Corrosion. EC Directive 2004/73/EC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Number of Animals 3 (2 female, 1 male) Vehicle Water Observation Period 14 Days Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 3 3 3 3 > 14 days 1 Oedema 2.3 2.3 2 3 < 14 days 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Well-defined erythema was seen in all animals 1 hour after removal of the dressing. This increased to moderate/severe erythema in all animals at the