In Species/Strain Rabbit/New Zealand White Number of Animals 6 Vehicle None Observation Period 72 hours Type of Dressing Semi-occlusive. [Delete as appropriate] Remarks Method No significant deviations from OECD TG 404 Acute Dermal – Irritation/Corrosion. Lesion Mean Score* Maximum Maximum Maximum Value at Duration of Any End of Effect Observation Period 0 0 N/A 0 Erythema/Eschar 0 0 N/A 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals. Remarks Results No erythema, oedema or abnormal physical signs were noted during the – observation period. The notified polymer is non-irritating to skin. [Delete as appropriate] MB Research Laboratories (1993c) 7.5. Irritation eye – Poly(oxy-1,2-ethanediyl), -[1,4-dimethyl-1,4-bis α, α', (higher level of ethoxylation than the notified polymer) (analogue) In House Species/Strain Rabbit/New Zealand White Number of Animals 6 Observation Period 21 days Remarks Method After the 24 hour reading the eyes of all animals were examined with – sodium fluorescein. No significant deviations from OECD TG 405 Acute Eye Irritation/Corrosion. Lesion Mean Score* Maximum Maximum Maximum Value at Duration of Any End of Observation Effect Period 2.2 3 21 days 1 Conjunctiva: redness 2.7 3 21 days 2 Conjunctiva: chemosis 1.8 3 14 days 0 Conjunctiva: discharge 1.5 3 21 days 2 Corneal opacity 0.8 1 14 days 0 Iridial inflammation *Calculated on the of the scores at 24, 48, and 72 hours for ALL animals.
In Species/Strain Rabbit/New Zealand White Number of Animals 6 Vehicle None Observation Period 72 hours Type of Dressing Semi-occlusive. [Delete as appropriate] Remarks – Method No significant deviations from OECD TG 404 Acute Dermal Irritation/Corrosion. Lesion Mean Score* Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period Erythema/Eschar 0 0 N/A 0 Oedema 0 0 N/A 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals. Remarks – Results No erythema, oedema or abnormal physical signs were noted during the observation period. The notified polymer is non-irritating to skin. [Delete as appropriate] MB Research Laboratories (1993c) 7.5. Irritation – eye Poly(oxy-1,2-ethanediyl), α, α', -[1,4-dimethyl-1,4-bis (higher level of ethoxylation than the notified polymer) (analogue) In House Species/Strain Rabbit/New Zealand White Number of Animals 6 Observation Period 21 days Remarks – Method After the 24 hour reading the eyes of all animals were examined with sodium fluorescein. No significant deviations from OECD TG 405 Acute Eye Irritation/Corrosion. Lesion Mean Score* Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period Conjunctiva: redness 2.2 3 21 days 1 Conjunctiva: chemosis 2.7 3 21 days 2 Conjunctiva: discharge 1.8 3 14 days 0 Corneal opacity 1.5 3 21 days 2 Iridial inflammation 0.8 1 14 days 0 *Calculated on the of the scores at 24, 48, and 72 hours for ALL animals.
STD1067-FR.docx