Test Item Concentration Stimulation (S.I.) % (w/v) Group 2 10 2.5 Group 3 25* 2.9* Group 4 50* 6.2* EC3 = 25.8% (w/w) * The value was used in calculation of EC3 Remarks Results On the second application day, a slight ear swelling was observed at both – dosing sites in all mice of Group 4 (50%), persisting for the remainder of the in-life phase of the study. No test item-related clinical signs were observed in any animals of the other groups. There was evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. (RCC Ltd, 2003q) Skin sensitisation mouse local lymph node assay (LLNA) – - product containing notified chemical at 5% 5% notified chemical in polypropylene, incorporated by extrusion at 175°C, and then ground and used in the test. OECD TG 429: Skin Sensitisation: Local Lymph Node Assay (adopted 24 April 2002). Species/Strain Mouse/CBA/CaOlaHsd Vehicle Acetone : Olive oil, 4:1 (v/v) Remarks Method No significant protocol deviations. – Test Item Concentration S.I. % (w/v) 2 2.5 1.0 Group 3 5 1.0 Group 4 10 1.0 Remarks Results None. – There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to polypropylene containing 5% notified chemical. (RCC Ltd, 2003r) Skin sensitisation mouse local lymph node assay (LLNA) – - product containing notified chemical at 10% 10% notified chemical in polypropylene, incorporated by extrusion at 175°C, and then ground and used in the test. OECD TG 429: Skin Sensitisation: Lymph Node Assay (adopted 24 April 2002). Species/Strain Mouse/CBA/CaOlaHsd Vehicle Acetone : Olive oil, 4:1 (v/v)
Test Item Concentration % (w/v) Stimulation (S.I.) Group 2 10 2.5 Group 3 25* 2.9* Group 4 50* 6.2* EC3 = 25.8% (w/w) * The value was used in calculation of EC3 Remarks – Results On the second application day, a slight ear swelling was observed at both dosing sites in all mice of Group 4 (50%), persisting for the remainder of the in-life phase of the study. No test item-related clinical signs were observed in any animals of the other groups. There was evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. (RCC Ltd, 2003q) Skin sensitisation – mouse local lymph node assay (LLNA) - product containing notified chemical at 5% 5% notified chemical in polypropylene, incorporated by extrusion at 175°C, and then ground and used in the test. OECD TG 429: Skin Sensitisation: Local Lymph Node Assay (adopted 24 April 2002). Species/Strain Mouse/CBA/CaOlaHsd Vehicle Acetone : Olive oil, 4:1 (v/v) Remarks – Method No significant protocol deviations. Test Item Concentration % (w/v) S.I. 2 2.5 1.0 Group 3 5 1.0 Group 4 10 1.0 Remarks – Results None. There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to polypropylene containing 5% notified chemical. (RCC Ltd, 2003r) Skin sensitisation – mouse local lymph node assay (LLNA) - product containing notified chemical at 10% 10% notified chemical in polypropylene, incorporated by extrusion at 175°C, and then ground and used in the test. OECD TG 429: Skin Sensitisation: Lymph Node Assay (adopted 24 April 2002). Species/Strain Mouse/CBA/CaOlaHsd Vehicle Acetone : Olive oil, 4:1 (v/v)
STD1137FR.docx