of silica was found within the untreated control and was considered to be the background level. Dermal absorption of silica contents of the test substance was considered by the study authors to be negligible under the conditions of the test. Dermal Technology Laboratory (2013) Skin sensitisation mouse local lymph node assay (LLNA) – Bindzil CC 301 (Notified chemical at < 50% concentration) 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 Vehicle formamide (DMF) N,N-Dimethyl Preliminary study Yes Positive control Positive control was not conducted in parallel with the test substance but had been conducted previously in the test laboratory using Remarks - Method No significant deviations of protocol were noted. Number and sex of Proliferative response Stimulation Index (SI) Concentration animals (DPM/lymph node) (Test/Control Ratio) (% w/w) Test Substance 0 (vehicle control) 5 F 623 1.0 25 5 F 532 0.9 50 5 F 476 0.8 100 5 F 423 0.7 Historical Positive Control* 0 (vehicle control) 5 F 543 1.0 5 5 F 583 1.1 10 5 F 1696 3.1 25 5 F 1994 3.7 * α-Hexylcinnamaldehyde Remarks - Results The test substance did not elicit a SI 3 when tested up to 100% ≥ concentration (with notified chemical at < 50% concentration). There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical under the conditions of the test. WIL Research Genotoxicity bacteria – Bindzil CC 301 (Notified chemical at < 50% concentration) OECD TG 471 Bacterial Reverse Mutation Test EC Directive 2000/32/EC B.13/14 Mutagenicity Reverse Mutation Test – using Bacteria incorporation procedure Species/Strain TA1535, TA1537, TA98 and TA100 S. typhimurium: WP2uvrA E. coli: Metabolic Activation System Rat liver S9 fraction mix induced by Aroclor 1254
of silica was found within the untreated control and was considered to be the background level. Dermal absorption of silica contents of the test substance was considered by the study authors to be negligible under the conditions of the test. Dermal Technology Laboratory (2013) Skin sensitisation – mouse local lymph node assay (LLNA) Bindzil CC 301 (Notified chemical at < 50% concentration) 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 Vehicle N,N-Dimethyl formamide (DMF) Preliminary study Yes Positive control Positive control was not conducted in parallel with the test substance but had been conducted previously in the test laboratory using Remarks - Method No significant deviations of protocol were noted. Concentration (% w/w) Number and sex of animals Proliferative response (DPM/lymph node) Stimulation Index (SI) (Test/Control Ratio) Test Substance 0 (vehicle control) 5 F 623 1.0 25 5 F 532 0.9 50 5 F 476 0.8 100 5 F 423 0.7 Historical Positive Control* 0 (vehicle control) 5 F 543 1.0 5 5 F 583 1.1 10 5 F 1696 3.1 25 5 F 1994 3.7 * α-Hexylcinnamaldehyde Remarks - Results The test substance did not elicit a SI ≥ 3 when tested up to 100% concentration (with notified chemical at < 50% concentration). There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical under the conditions of the test. WIL Research Genotoxicity – bacteria Bindzil CC 301 (Notified chemical at < 50% concentration) OECD TG 471 Bacterial Reverse Mutation Test EC Directive 2000/32/EC B.13/14 Mutagenicity – Reverse Mutation Test using Bacteria incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98 and TA100 E. coli: WP2uvrA Metabolic Activation System Rat liver S9 fraction mix induced by Aroclor 1254
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