0.3 1 < 96 h 0 Conjunctiva: redness 0 0 0 0 Conjunctiva: chemosis 0 1 < 24 h 0 Conjunctiva: discharge 0 0 0 0 Corneal opacity 0 0 0 0 Iridial inflammation *Calculated on the of the scores at 24, 48, and 72 hours for ALL animals. Remarks - Results Slight conjunctival inflammation was observed in all six test animals one hour after instillation. Slight conjunctival discharge was observed in two of the animals one hour after instillation, but this had resolved 24 hours after instillation. The number of animals affected decreased over the test period, with no animals affected 96 hours after instillation. The notified polymer is slightly irritating to the eye. Hoechst-Roussel 7.4. Skin sensitisation Notified polymer (~90% purity) In house method. Species/Strain Guinea pig/Hartley-derived albino preliminary study Maximum Non-irritating Concentration: topical: 100% main study Number of Animals Test Group: 5M, 5F Control Group: 5M, 5F induction Induction Concentration: topical: 100% of Irritation Slight, patchy erythema (score of ) was observed in 7 of the 10 animals. challenge phase 1st challenge topical: 100% Remarks - Method The only significant protocol deviations from OECD TG 406 Skin Sensitisation Buehler were: – The number of animals in the test group was only half the number required by OECD TG 406 (20 animals required). The dermal grading system included an additional rating of , (score of 0.5) for slight, patchy erythema. Animal Challenge Concentration Number of Animals Showing Skin Reactions after: 1st challenge 2nd challenge 24 h 48 h 24 h 48 h 100% 2/10 0/10 Test Group 100% 3/10 1/10 Control Remarks - Results The only signs of dermal irritation observed were slight, patchy erythema (a dermal grading score of ). This was observed after 24 hours in 2 of the 10 test animals and 3 of the 10 control animals. Therefore, there was no significant difference between test and control animals. A rechallenge was not performed. The positive control confirmed the sensitivity of the test. There was no evidence of reactions indicative of skin sensitisation to the notified polymer under the conditions of the test.
Conjunctiva: redness 0.3 1 < 96 h 0 Conjunctiva: chemosis 0 0 0 0 Conjunctiva: discharge 0 1 < 24 h 0 Corneal opacity 0 0 0 0 Iridial inflammation 0 0 0 0 *Calculated on the of the scores at 24, 48, and 72 hours for ALL animals. Remarks - Results Slight conjunctival inflammation was observed in all six test animals one hour after instillation. Slight conjunctival discharge was observed in two of the animals one hour after instillation, but this had resolved 24 hours after instillation. The number of animals affected decreased over the test period, with no animals affected 96 hours after instillation. The notified polymer is slightly irritating to the eye. Hoechst-Roussel 7.4. Skin sensitisation Notified polymer (~90% purity) In house method. Species/Strain Guinea pig/Hartley-derived albino preliminary study Maximum Non-irritating Concentration: topical: 100% main study Number of Animals Test Group: 5M, 5F Control Group: 5M, 5F induction Induction Concentration: topical: 100% of Irritation Slight, patchy erythema (score of ) was observed in 7 of the 10 animals. challenge phase 1st challenge topical: 100% Remarks - Method The only significant protocol deviations from OECD TG 406 Skin Sensitisation – Buehler were: The number of animals in the test group was only half the number required by OECD TG 406 (20 animals required). The dermal grading system included an additional rating of , (score of 0.5) for slight, patchy erythema. Animal Challenge Concentration Number of Animals Showing Skin Reactions after: 1st challenge 2nd challenge 24 h 48 h 24 h 48 h Test Group 100% 2/10 0/10 Control 100% 3/10 1/10 Remarks - Results The only signs of dermal irritation observed were slight, patchy erythema (a dermal grading score of ). This was observed after 24 hours in 2 of the 10 test animals and 3 of the 10 control animals. Therefore, there was no significant difference between test and control animals. A rechallenge was not performed. The positive control confirmed the sensitivity of the test. There was no evidence of reactions indicative of skin sensitisation to the notified polymer under the conditions of the test.
STD1195FR.docx