1st challenge intradermal: none topical: 100, 50, 25, 10% 2nd challenge topical: None Remarks - Method 24 h prior to the topical challenge, 10% sodium lauryl sulphate in vaseline was applied to the skin, as the test article itself was non irritating. Results Animal Challenge Concentration Number of Animals Showing Skin Reactions after: 1st challenge 2nd challenge 24 h 48 h 24 h 48 h 100 0 0 N/A N/A Test Group 0 0 N/A N/A 0 0 0 N/A N/A Control Group 0 0 N/A N/A Remarks - Results Conclusion There was no evidence of reactions indicative of skin sensitisation to the notified polymer under the conditions of the test. Test Facility DST (2004b) Skin irritation- human volunteers (translation) Test Substance Notified polymer Method Single application patch test Study Design The test substance (0.01 g) was placed on a Finn Chamber (Epitest)) and patched to the inner side of forearm of each volunteer for 24 hours under occlusive conditions. At the end of 24 hours exposure period, the test sample was removed, and skin reactions were evaluated after 1 hour later and 24 hours later. Study Group 45 volunteers, 21 MF, 24 M; age range 22-56 Vehicle None Remarks - Method Results Remarks - Results 45 volunteers completed the study. In all volunteers, no reaction was observed 24 h or 48 h after removing the test samples, similarly, no reaction was observed in 48 hours after removing the test samples. Conclusion The test substance was non-irritating under the conditions of the test. Test Facility Japan Hair Science Association (2004) Genotoxicity bacteria – Test Substance Notified chemical Method OECD TG 471 Bacterial Reverse Mutation Test. Plate incorporation method Species/Strain TA1535, TA1537, TA98, TA100, S. typhimurium: WP2uvrA E. coli: Metabolic Activation System Rat liver homogenate metabolising system, from rats induced with phenobarbitone/β-naphthoflavone. Concentration Range in 50, 150, 500, 1500 and 5000 μg/plate (With/without metabolic activation) Main Test
1st challenge intradermal: none topical: 100, 50, 25, 10% 2nd challenge topical: None Remarks - Method 24 h prior to the topical challenge, 10% sodium lauryl sulphate in vaseline was applied to the skin, as the test article itself was non irritating. Results 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 0 0 N/A N/A 0 0 N/A N/A Control Group 0 0 0 N/A N/A 0 0 N/A N/A Remarks - Results Conclusion There was no evidence of reactions indicative of skin sensitisation to the notified polymer under the conditions of the test. Test Facility DST (2004b) Skin irritation- human volunteers (translation) Test Substance Notified polymer Method Single application patch test Study Design The test substance (0.01 g) was placed on a Finn Chamber (Epitest)) and patched to the inner side of forearm of each volunteer for 24 hours under occlusive conditions. At the end of 24 hours exposure period, the test sample was removed, and skin reactions were evaluated after 1 hour later and 24 hours later. Study Group 45 volunteers, 21 MF, 24 M; age range 22-56 Vehicle None Remarks - Method Results Remarks - Results 45 volunteers completed the study. In all volunteers, no reaction was observed 24 h or 48 h after removing the test samples, similarly, no reaction was observed in 48 hours after removing the test samples. Conclusion The test substance was non-irritating under the conditions of the test. Test Facility Japan Hair Science Association (2004) Genotoxicity – bacteria Test Substance Notified chemical Method OECD TG 471 Bacterial Reverse Mutation Test. Plate incorporation method Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100, E. coli: WP2uvrA Metabolic Activation System Rat liver homogenate metabolising system, from rats induced with phenobarbitone/β-naphthoflavone. Concentration Range in Main Test 50, 150, 500, 1500 and 5000 μg/plate (With/without metabolic activation)