No toxicity data were submitted. 7.8. Genotoxicity - bacteria EUCAROL APG/SS OECD TG 471 Bacterial Reverse Mutation Test. Plate incorporation procedure & Pre incubation procedure Species/Strain TA1535, TA1537, TA98, TA100, TA102. S. typhimurium: Metabolic Activation System S9 mix Concentration Range in Test 1: Main Test a) With metabolic activation: 0-5 000 µg/plate (plate incorporation). b) Without metabolic activation: 0-5 000 µg/plate (plate incorporation). Test 2: a) With metabolic activation: 0-1 500 µg/plate (pre-incubation). b) Without metabolic activation: 0-1 500 µg/plate (plate incorporation). Vehicle Water Remarks - Method GLP & QA Metabolic Test Substance Concentration Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect PreliminaryTest Main Test Present Test 1 1 500 Not observed. Not observed. Test 2 1 500 Not observed. Not observed. Absent Test 1 1 500 Not observed. Not observed. Test 2 1 500 Not observed. Not observed. Remarks - Results The positive controls had appropriate responses in the The notified chemical was not mutagenic to bacteria under the conditions of the test. Istituto di Ricerche Biomediche (1996). 7.9. Genotoxicity in vitro – No toxicity data were submitted. 7.10. Genotoxicity in vivo – No toxicity data were submitted. 7.11. Irritation vaginal – EUCAROL APG SS In house protocol. Species/Strain Rat/Wistar Number of Animals 10 for the test group and 10 for the control group. Vehicle None. Observation Period Treatment 0.2 mL test substance was instilled into vagina by a cathetere. This procedure was repeated 3 times/day for 4 days. All animals were sacrificed 24 hours after treatment. Remarks - Method The control group had physiological solution. A modified Draize scale system was used for evaluation.
No toxicity data were submitted. 7.8. Genotoxicity - bacteria EUCAROL APG/SS 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 Range in Main Test Test 1: a) With metabolic activation: 0-5 000 µg/plate (plate incorporation). b) Without metabolic activation: 0-5 000 µg/plate (plate incorporation). Test 2: a) With metabolic activation: 0-1 500 µg/plate (pre-incubation). b) Without metabolic activation: 0-1 500 µg/plate (plate incorporation). Vehicle Water Remarks - Method GLP & QA Metabolic Activation Test Substance Concentration Resulting in: Cytotoxicity in PreliminaryTest Cytotoxicity in Main Test Precipitation Genotoxic Effect Present Test 1 1 500 Not observed. Not observed. Test 2 1 500 Not observed. Not observed. Absent Test 1 1 500 Not observed. Not observed. Test 2 1 500 Not observed. Not observed. Remarks - Results The positive controls had appropriate responses in the The notified chemical was not mutagenic to bacteria under the conditions of the test. Istituto di Ricerche Biomediche (1996). 7.9. Genotoxicity – in vitro No toxicity data were submitted. 7.10. Genotoxicity – in vivo No toxicity data were submitted. 7.11. Irritation – vaginal EUCAROL APG SS In house protocol. Species/Strain Rat/Wistar Number of Animals 10 for the test group and 10 for the control group. Vehicle None. Observation Period Treatment 0.2 mL test substance was instilled into vagina by a cathetere. This procedure was repeated 3 times/day for 4 days. All animals were sacrificed 24 hours after treatment. Remarks - Method The control group had physiological solution. A modified Draize scale system was used for evaluation.