Observation Period 72 hours 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 0.7 0.7 0.7 2 < 72 h 0 Conjunctiva: redness 0.7 0.7 0.7 2 < 72 h 0 Conjunctiva: chemosis 0.3 0 0.3 2 < 48 h 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 Yellow coloured staining was observed around the treated eyes of all animals throughout the study. Moderate conjunctival irritation was observed in all treated eyes one hour after instillation of the test substance and minimal conjunctival irritation noted at the 24 and 48 hour observations. At 72 hours all eyes appeared normal. The notified polymer is non-irritating to the eye. Harlan (2012b) Skin sensitisation local lymph node assay (LLNA) – Notified polymer OECD TG 429 Skin Sensitisation: Lymph Node Assay EC Directive 2004/73/EC B.42 Skin Sensitisation (Local Lymph Node Assay) Species/Strain Mouse/CBA/Ca Vehicle Acetone/olive oil (4:1) Remarks - Method No significant protocol deviations. Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100%, this concentration was selected for the main test. Proliferative response Stimulation Index Concentration (DPM/lymph node) (Test/Control Ratio) (% w/w) Test Substance 0 (vehicle control) 1552.49 - 25 1423.58 0.92 50 1284.25 0.83 100 1803.43 1.16 Positive Control 25 Not detailed 5.76 Remarks - Results There were no unscheduled deaths during the study. There were no signs of systemic toxicity noted in either the test or control animals. There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified polymer.
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 0.7 0.7 0.7 2 < 72 h 0 Conjunctiva: chemosis 0.7 0.7 0.7 2 < 72 h 0 Conjunctiva: discharge 0.3 0 0.3 2 < 48 h 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 Yellow coloured staining was observed around the treated eyes of all animals throughout the study. Moderate conjunctival irritation was observed in all treated eyes one hour after instillation of the test substance and minimal conjunctival irritation noted at the 24 and 48 hour observations. At 72 hours all eyes appeared normal. The notified polymer is non-irritating to the eye. Harlan (2012b) Skin sensitisation – local lymph node assay (LLNA) Notified polymer OECD TG 429 Skin Sensitisation: Lymph Node Assay EC Directive 2004/73/EC B.42 Skin Sensitisation (Local Lymph Node Assay) Species/Strain Mouse/CBA/Ca Vehicle Acetone/olive oil (4:1) Remarks - Method No significant protocol deviations. Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100%, this concentration was selected for the main test. Concentration (% w/w) Proliferative response (DPM/lymph node) Stimulation Index (Test/Control Ratio) Test Substance 0 (vehicle control) 1552.49 - 25 1423.58 0.92 50 1284.25 0.83 100 1803.43 1.16 Positive Control 25 Not detailed 5.76 Remarks - Results There were no unscheduled deaths during the study. There were no signs of systemic toxicity noted in either the test or control animals. There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified polymer.