Bio-Research Laboratories (1994) 7.4. Irritation skin – 7.4.1 Analogue chemical 1 Analogue chemical 1 US 16 CFR 1500 Hazardous Substances Labelling Act. Species/Strain Rabbit/New Zealand White Number of Animals 3 M, 3 F Vehicle None Observation Period 72 hours Type of Dressing Semi-occlusive. Remarks - Method Gauze patch was applied for 24 hours. Scoring was at 24 and 72 hours only. Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Value of Any Effect of Observation Period 0.42 2 > 24 0 Erythema/Eschar 0 0 - - Oedema *Calculated on the basis of the scores at 24 and 72 hours for ALL animals. Remarks - Results The Primary Irritation Index was found to be 0.5 based on erythema and oedema. No evidence of tissue damage was found. The analogue chemical is slightly irritating to the skin. Hill Top Biolabs (1988e) 7.4.2 Analogue chemical 2 Analogue chemical 2 US 16 CFR 1500 Hazardous Substances Labelling Act. Species/Strain Rabbit/New Zealand White Number of Animals 6 F Vehicle None Observation Period 72 Type of Dressing Semi-occlusive. Remarks - Method Gauze patch was applied for 24 hours. Scoring was at 24 and 72 hours only. Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Value of Any Effect of Observation Period 0.67 3 > 72 hours 1 Erythema/Eschar 0.42 2 > 24 hours 0 Oedema *Calculated on the of the scores at 24 and 72 hours for ALL animals. Remarks - Results The Primary Irritation Index was found to be 1.3 based on erythema and oedema. No evidence of tissue damage was found.
Bio-Research Laboratories (1994) 7.4. Irritation – skin 7.4.1 Analogue chemical 1 Analogue chemical 1 US 16 CFR 1500 Hazardous Substances Labelling Act. Species/Strain Rabbit/New Zealand White Number of Animals 3 M, 3 F Vehicle None Observation Period 72 hours Type of Dressing Semi-occlusive. Remarks - Method Gauze patch was applied for 24 hours. Scoring was at 24 and 72 hours only. Lesion Mean Score* Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period Erythema/Eschar 0.42 2 > 24 0 Oedema 0 0 - - *Calculated on the basis of the scores at 24 and 72 hours for ALL animals. Remarks - Results The Primary Irritation Index was found to be 0.5 based on erythema and oedema. No evidence of tissue damage was found. The analogue chemical is slightly irritating to the skin. Hill Top Biolabs (1988e) 7.4.2 Analogue chemical 2 Analogue chemical 2 US 16 CFR 1500 Hazardous Substances Labelling Act. Species/Strain Rabbit/New Zealand White Number of Animals 6 F Vehicle None Observation Period 72 Type of Dressing Semi-occlusive. Remarks - Method Gauze patch was applied for 24 hours. Scoring was at 24 and 72 hours only. Lesion Mean Score* Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period Erythema/Eschar 0.67 3 > 72 hours 1 Oedema 0.42 2 > 24 hours 0 *Calculated on the of the scores at 24 and 72 hours for ALL animals. Remarks - Results The Primary Irritation Index was found to be 1.3 based on erythema and oedema. No evidence of tissue damage was found.
STD1301FR.docx