Method OECD 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White. Number of Animals 6 females. Observation Period 72 hours. Vehicle Distilled water. Type of Dressing Semi-occlusive. Remarks - Method GLP & QA. Results Lesion Mean Score* Maximum Maximum Maximum Value Duration of at End of Any Effect Observation Period 0 1 30-60 min 0 Erythema/Eschar 0 0 - 0 Oedema *Calculated on the basis of the scores at 24, 48, & 72 hours for ALL animals. Remarks - Results Two animals had Draize scores of 1 during 30-60 minutes after treatment. Conclusion The notified chemical is non-irritating to skin. Test Facility MB Research Labs (1997c) 9.2.5 Eye Irritation Test Substance TKA 45009 Method OECD 405 Acute Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3/sex Observation Period 72 hours Remarks - Method GLP & QA. Vehicle was not stated. Results Lesion Mean Score* Maximum Maximum Maximum Value Duration of Value at End of Any Effect Observation Period redness 0.39 2 48 hours 0 Conjunctiva: 0.17 2 24 hours 0 Conjunctiva: chemosis 0.22 2 24 hours 0 Conjunctiva: discharge
Method OECD 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White. Number of Animals 6 females. Observation Period 72 hours. Vehicle Distilled water. Type of Dressing Semi-occlusive. Remarks - Method GLP & QA. Results Lesion Mean Score* Maximum Value Maximum Duration of Any Effect Maximum at End of Observation Period Erythema/Eschar 0 1 30-60 min 0 Oedema 0 0 - 0 *Calculated on the basis of the scores at 24, 48, & 72 hours for ALL animals. Remarks - Results Two animals had Draize scores of 1 during 30-60 minutes after treatment. Conclusion The notified chemical is non-irritating to skin. Test Facility MB Research Labs (1997c) 9.2.5 Eye Irritation Test Substance TKA 45009 Method OECD 405 Acute Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3/sex Observation Period 72 hours Remarks - Method GLP & QA. Vehicle was not stated. Results Lesion Mean Score* Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period Conjunctiva: redness 0.39 2 48 hours 0 Conjunctiva: chemosis 0.17 2 24 hours 0 Conjunctiva: discharge 0.22 2 24 hours 0
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