The following changes were considered to be treatment-related in the study: Decreases in food consumption and bodyweight gain in high-dose male rats. Decreases of the mean relative spleen and adrenal weights in high-dose female rats. Conclusion The No Observed Adverse Effect Level (NOAEL) was established as 150 mg/kg bw/day in this study, based on the decreases of bodyweight gain and food consumption in high-dose male rats and the mean relative spleen and adrenal values in high-dose female rats. Bioservice Scientific Laboratories GmbH (1999f). Test Facility Genotoxicity - bacteria Komplexseife TH17 Test Substance OECD TG 471 Bacterial Reverse Mutation Test. Method Plate incorporation procedure & Pre incubation procedure Species/Strain TA1535, TA1537, TA98, TA100, TA102 S. typhimurium: Metabolic Activation System S9-mix Concentration in With metabolic activation: 0 - 5 000 Main Test Without metabolic activation: 0 5 000 µg/plate. – Vehicle DMSO Remarks - Method GLP & QA. Experiment I was an incorporation test, and experiment II was a pre- incubation test. Results Metabolic Test Substance Concentration Resulting in: Activation Cytotoxicity in Cytotoxicity PreliminaryTest in Main Precipitation Genotoxic Effect Test >5 000 000 Absent ≥1 Test 1 Not seen 000 Not seen ≥1 Test 2 Not seen 000 Not seen ≥1 >5 000 000 Present ≥1 Test 1 Not seen 000 Not seen ≥1 Test 2 Not seen 000 Not seen ≥1 Remarks - Results No significant increases in revertant colony numbers of any tested strains were observed following treatment with the notified chemical either in the presence or absence of metabolic activation in both incorporation test and pre-incubation test. The positive controls induced a distinct increase of induced revertant colonies. The notified chemical was not mutagenic to bacteria under the conditions Conclusion of the test. Bioservice Scientific Laboratories GmbH (1999g). Test Facility
The following changes were considered to be treatment-related in the study: Decreases in food consumption and bodyweight gain in high-dose male rats. Decreases of the mean relative spleen and adrenal weights in high-dose female rats. Conclusion The No Observed Adverse Effect Level (NOAEL) was established as 150 mg/kg bw/day in this study, based on the decreases of bodyweight gain and food consumption in high-dose male rats and the mean relative spleen and adrenal values in high-dose female rats. Test Facility Bioservice Scientific Laboratories GmbH (1999f). Genotoxicity - bacteria Test Substance Komplexseife TH17 Method OECD TG 471 Bacterial Reverse Mutation Test. Plate incorporation procedure & Pre incubation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100, TA102 Metabolic Activation System S9-mix Concentration in Main Test With metabolic activation: 0 - 5 000 Without metabolic activation: 0 – 5 000 µg/plate. Vehicle DMSO Remarks - Method GLP & QA. Experiment I was an incorporation test, and experiment II was a pre- incubation test. Results Metabolic Test Substance Concentration Resulting in: Activation Cytotoxicity in PreliminaryTest Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent >5 000 ≥1 000 Test 1 Not seen ≥1 000 Not seen Test 2 Not seen ≥1 000 Not seen Present >5 000 ≥1 000 Test 1 Not seen ≥1 000 Not seen Test 2 Not seen ≥1 000 Not seen Remarks - Results No significant increases in revertant colony numbers of any tested strains were observed following treatment with the notified chemical either in the presence or absence of metabolic activation in both incorporation test and pre-incubation test. The positive controls induced a distinct increase of induced revertant colonies. Conclusion The notified chemical was not mutagenic to bacteria under the conditions of the test. Test Facility Bioservice Scientific Laboratories GmbH (1999g).
Complex-soap-TH17-secondary-notification-assessment.docx