Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations Lesion Mean Score* Maximum Maximum Maximum Value at End Animal No. Value Duration of Any of Observation Period Effect 1 2 3 0 0 0 1 < 24 hours 0 Erythema/Eschar 0 0 0 0 - 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Very slight erythema was noted in one treated animal immediately after patch removal and at the 30-60 minute scoring interval, and had cleared by the 24 hour observation. No signs of irritation were noted in the other animals. There were no deaths or test substance-related clinical signs or remarkable body weight changes during the study period. The test substance was slightly irritating to the skin. DuPont (2010b) Irritation eye – Notified polymer (LTD/1671, < 25% concentration in water) OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 3 female Observation Period 72 hours 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 0 0 0.3 1 < 48 hours 0 Conjunctiva: redness 0 0 0 0 - 0 Conjunctiva: chemosis 0 0 0 2 < 24 hours 0 Conjunctiva: discharge 0 0 0 0 - 0 Corneal opacity 0 0 0 0 - 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results A single application of 0.1 mL of the test material to the non-irrigated eye of three rabbits produced conjunctival irritation in all animals. Two treated eyes appeared normal at the 24 hour observation, with the remaining eye showing no signs of irritation at the 48 hour observation. There were no effects from the test substance on the cornea or iris. There were no signs of systemic toxicity and bodyweight gains were with the normal range. The test substance was slightly irritating to the eye. DuPont (2010c) Skin sensitisation mouse local lymph node assay (LLNA) –
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 0 0 0 1 < 24 hours 0 Oedema 0 0 0 0 - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Very slight erythema was noted in one treated animal immediately after patch removal and at the 30-60 minute scoring interval, and had cleared by the 24 hour observation. No signs of irritation were noted in the other animals. There were no deaths or test substance-related clinical signs or remarkable body weight changes during the study period. The test substance was slightly irritating to the skin. DuPont (2010b) Irritation – eye Notified polymer (LTD/1671, < 25% concentration in water) OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 3 female Observation Period 72 hours 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 Conjunctiva: redness 0 0 0.3 1 < 48 hours 0 Conjunctiva: chemosis 0 0 0 0 - 0 Conjunctiva: discharge 0 0 0 2 < 24 hours 0 Corneal opacity 0 0 0 0 - 0 Iridial inflammation 0 0 0 0 - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results A single application of 0.1 mL of the test material to the non-irrigated eye of three rabbits produced conjunctival irritation in all animals. Two treated eyes appeared normal at the 24 hour observation, with the remaining eye showing no signs of irritation at the 48 hour observation. There were no effects from the test substance on the cornea or iris. There were no signs of systemic toxicity and bodyweight gains were with the normal range. The test substance was slightly irritating to the eye. DuPont (2010c) Skin sensitisation – mouse local lymph node assay (LLNA)