positive control test was conducted not provided in the study report. induction phase Induction Concentration: intradermal: 20% topical: 20% Signs of Irritation None challenge phase Challenge topical: 20% Remarks - Method Only 3 animals were used for the test. was Freund’s Complete Adjuvant used. A 10% solution of sodium dodecyl sulfate was applied to the skin during the induction phase. Remarks - Results No skin reaction was observed in any test animals during the induction phase and 24 h and 48 h after challenge. There was no evidence of reactions indicative of skin sensitisation to the test substance under the conditions of the test. Confidential Genotoxicity bacteria – Analogue Method similar to OECD TG 471 Bacterial Reverse Mutation Test. Pre incubation procedure Species/Strain TA98 and TA100 S. typhimurium: Metabolic Activation System S9 fraction in a) With metabolic activation: 5-5,000 µg/plate Main Test b) Without metabolic activation: 5-5,000 µg/plate Vehicle Dimethyl sulfoxide Remarks - Method Only one test was conducted. Metabolic Test Substance Concentration (µg/plate) Resulting in: Activation Cytotoxicity Precipitation Genotoxic Effect > 5,000 Negative Absent ≥ 2,000 > 5,000 Negative Present ≥ 2,000 Remarks - Results Cytotoxicity was observed in bacterial strain TA100 only. The positive controls gave satisfactory results confirming the validity of the strain and S9 mix. The test substance was not mutagenic to bacteria under the conditions of the test. Confidential
positive control test was conducted not provided in the study report. induction phase Induction Concentration: intradermal: 20% topical: 20% Signs of Irritation None challenge phase Challenge topical: 20% Remarks - Method Only 3 animals were used for the test. Freund’s Complete Adjuvant was used. A 10% solution of sodium dodecyl sulfate was applied to the skin during the induction phase. Remarks - Results No skin reaction was observed in any test animals during the induction phase and 24 h and 48 h after challenge. There was no evidence of reactions indicative of skin sensitisation to the test substance under the conditions of the test. Confidential Genotoxicity – bacteria Analogue Method similar to OECD TG 471 Bacterial Reverse Mutation Test. Pre incubation procedure Species/Strain S. typhimurium: TA98 and TA100 Metabolic Activation System S9 fraction in Main Test a) With metabolic activation: 5-5,000 µg/plate b) Without metabolic activation: 5-5,000 µg/plate Vehicle Dimethyl sulfoxide Remarks - Method Only one test was conducted. Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity Precipitation Genotoxic Effect Absent ≥ 2,000 > 5,000 Negative Present ≥ 2,000 > 5,000 Negative Remarks - Results Cytotoxicity was observed in bacterial strain TA100 only. The positive controls gave satisfactory results confirming the validity of the strain and S9 mix. The test substance was not mutagenic to bacteria under the conditions of the test. Confidential