Notified chemical OECD TG 429 Skin Sensitisation: Local Lymph Node Assay Species/Strain Mouse/ CBA/CaOlaHsd Vehicle Acetone:olive oil (AOO) 4:1 v/v Remarks - Method No significant protocol deviations. GLP Compliance. A pre-test was conducted to determine the appropriate vehicle and the highest non-irritant test concentrations for the main study. The maximum technically achievable concentration (75%) was used. A concurrent positive control test was conducted using in AOO 4:1 v/v. Proliferative response Stimulation Index Concentration (DPM/lymph node) (Test/Control Ratio) (% w/w) Test Substance 0 (vehicle control) 93 ± 41 - 25 241 ± 69 2.6 50 669 ± 270 7.2 75 613 ± 189 6.6 Positive Control 25 831 ± 128 8.9 Remarks - Results No clinical signs of irritation on the ears or systemic toxicity were observed in any of the animals during the study period. There was no ear thickness increase 25%. ≥ An EC3 value of 27.2% was determined. The control groups produced satisfactory responses, thus confirming the validity of the test system. There was evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. Harlan (2014f) Genotoxicity bacteria – Notified chemical OECD TG 471 Bacterial Reverse Mutation Test. Plate incorporation procedure Species/Strain TA1535, TA1537, TA98, TA100 S. typhimurium: WP2uvrA E. coli: Metabolic Activation System S9 fraction from phenobarbitone/β-naphthoflavone-induced rat liver Concentration Range in a) With metabolic activation: 1.5 5,000 µg/plate – Main Test b) Without metabolic activation: 1.5 5,000 µg/plate – Vehicle Dimethyl sulphoxide (DMSO) Remarks - Method No significant protocol deviations. GLP Compliance. No preliminary toxicity study was conducted. Positive control tests were conducted in parallel to the main test using
Notified chemical OECD TG 429 Skin Sensitisation: Local Lymph Node Assay Species/Strain Mouse/ CBA/CaOlaHsd Vehicle Acetone:olive oil (AOO) 4:1 v/v Remarks - Method No significant protocol deviations. GLP Compliance. A pre-test was conducted to determine the appropriate vehicle and the highest non-irritant test concentrations for the main study. The maximum technically achievable concentration (75%) was used. A concurrent positive control test was conducted using in AOO 4:1 v/v. Concentration (% w/w) Proliferative response (DPM/lymph node) Stimulation Index (Test/Control Ratio) Test Substance 0 (vehicle control) 93 ± 41 - 25 241 ± 69 2.6 50 669 ± 270 7.2 75 613 ± 189 6.6 Positive Control 25 831 ± 128 8.9 Remarks - Results No clinical signs of irritation on the ears or systemic toxicity were observed in any of the animals during the study period. There was no ear thickness increase ≥ 25%. An EC3 value of 27.2% was determined. The control groups produced satisfactory responses, thus confirming the validity of the test system. There was evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. Harlan (2014f) Genotoxicity – bacteria Notified chemical OECD TG 471 Bacterial Reverse Mutation Test. Plate incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100 E. coli: WP2uvrA Metabolic Activation System S9 fraction from phenobarbitone/β-naphthoflavone-induced rat liver Concentration Range in Main Test a) With metabolic activation: 1.5 – 5,000 µg/plate b) Without metabolic activation: 1.5 – 5,000 µg/plate Vehicle Dimethyl sulphoxide (DMSO) Remarks - Method No significant protocol deviations. GLP Compliance. No preliminary toxicity study was conducted. Positive control tests were conducted in parallel to the main test using
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