substance was administered on each treatment site and the exposure period was 4 hours. Lesion Mean Score* Maximum Maximum Duration of Maximum Value at End Animal No. Value Any Effect of Observation Period 1 2 3 0 0.33 0 1 < 72 h 0 Erythema/Eschar 0 0 0 0 N/A 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Very slight erythema was observed in one of the three treated animals at the 48-hour observation period only. All signs of irritation were resolved at the 72-hour observation period. The notified polymer is slightly irritating to the skin. BSL (2009c) Irritation eye – Notified polymer OECD TG 405 Acute Eye Irritation/Corrosion. EC Council Regulation No 440/2008 B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New White Number of Animals 3 (Females) Observation Period 72 hours Remarks - Method No significant deviation of protocol was noted. 0.1 ml of the test substance was administered for each treatment and Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Animal No. Value of Any Effect of Observation Period 1 2 3 0 0 0.33 1 < 48 h 0 Conjunctiva: redness 0 0 0 0 N/A 0 Conjunctiva: chemosis 0 0 0 0 N/A 0 Conjunctiva: discharge 0 0 0 0 N/A 0 Corneal opacity 0 0 0 0 N/A 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Slight conjunctival redness in all three treated animals was observed at 1 hour after the exposure. Two of them recovered within 24 hours and one recovered in 48 hours. The notified polymer is slightly irritating to the eye. BSL (2009d) Skin sensitisation mouse local lymph node assay (LLNA) – Notified polymer OECD TG 429 Skin Sensitisation: Local Lymph Node Assay EC Directive 2004/73/EC B.42 Skin Sensitisation (Local Lymph Node Assay) Species/Strain Mouse/CBA/J Rj
substance was administered on each treatment site and the exposure period was 4 hours. 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 0.33 0 1 < 72 h 0 Oedema 0 0 0 0 N/A 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Very slight erythema was observed in one of the three treated animals at the 48-hour observation period only. All signs of irritation were resolved at the 72-hour observation period. The notified polymer is slightly irritating to the skin. BSL (2009c) Irritation – eye Notified polymer OECD TG 405 Acute Eye Irritation/Corrosion. EC Council Regulation No 440/2008 B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New White Number of Animals 3 (Females) Observation Period 72 hours Remarks - Method No significant deviation of protocol was noted. 0.1 ml of the test substance was administered for each treatment and 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 0.33 1 < 48 h 0 Conjunctiva: chemosis 0 0 0 0 N/A 0 Conjunctiva: discharge 0 0 0 0 N/A 0 Corneal opacity 0 0 0 0 N/A 0 Iridial inflammation 0 0 0 0 N/A 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Slight conjunctival redness in all three treated animals was observed at 1 hour after the exposure. Two of them recovered within 24 hours and one recovered in 48 hours. The notified polymer is slightly irritating to the eye. BSL (2009d) Skin sensitisation – mouse local lymph node assay (LLNA) Notified polymer OECD TG 429 Skin Sensitisation: Local Lymph Node Assay EC Directive 2004/73/EC B.42 Skin Sensitisation (Local Lymph Node Assay) Species/Strain Mouse/CBA/J Rj