groups showed eosinophilic inclusions in the olfactory epithelium in the nasal turbinates with an increased incidence and/or severity in treated and higher dose animals. Remarks Results – The clinical signs in this study were consistent with exposure to an irritant atmosphere. However, the test substance may cause serious damage to respiratory tract by prolonged exposure through inhalation. The Low Observed (Adverse) Effect (LO(A)EL) was established as 0.0038 mg/L/6 h/day in this study, based on evidence of respiratory tract irritation at all doses. Huntingdon Life Sciences Ltd (2001) Genotoxicity bacteria – Notified chemical (92.8%) OECD TG 471 Bacterial Reverse Mutation Test (1997). EC Directive 92/69/EC B.13/14 Mutagenicity Reverse Mutation Test – using Bacteria (1992). incorporation (Test 1)/Pre incubation (Test 2) Species/Strain TA1535, TA1537, TA98, TA100, TA102 S. typhimurium: Metabolic Activation System S9 microsomal fraction from rat β-naphthoflavone/phenobarbital-induced Concentration Range in a) With metabolic activation: 33-5000 Main Test b) Without metabolic activation: 33-5000 µg/plate Vehicle DMSO Remarks - Method No deviation from standard protocol Metabolic Test Substance Concentration (µg/plate) Resulting in: Activation Cytotoxicity in Cytotoxicity in Main Precipitation Genotoxic Effect Preliminary Test Test Absent Test 1 > 5000 > 5000 > 5000 Negative Test 2 > 5000 > 5000 Negative Present Test 1 > 5000 > 5000 > 5000 Negative Test 2 > 5000 > 5000 Negative Remarks - Results No significant increase in revertant colony numbers of any of the five tester strains was observed at any dose level in the presence or absence of metabolic activation. Negative controls were within the historical limits and positive controls demonstrated the sensitivity of the The test substance was not mutagenic to bacteria under the conditions of the test. RCC (1998a) Genotoxicity in vitro Mammalian Chromosome Aberration Test – Troysol LAC (containing the notified chemical at ~50% concentration) OECD TG 473 In vitro Mammalian Cytogenetic Test (1998). EC Directive 92/69/EC B.10 Mutagenicity - In vitro Mammalian Chromosome Aberration Test (1992).
groups showed eosinophilic inclusions in the olfactory epithelium in the nasal turbinates with an increased incidence and/or severity in treated and higher dose animals. Remarks – Results The clinical signs in this study were consistent with exposure to an irritant atmosphere. However, the test substance may cause serious damage to respiratory tract by prolonged exposure through inhalation. The Low Observed (Adverse) Effect (LO(A)EL) was established as 0.0038 mg/L/6 h/day in this study, based on evidence of respiratory tract irritation at all doses. Huntingdon Life Sciences Ltd (2001) Genotoxicity – bacteria Notified chemical (92.8%) OECD TG 471 Bacterial Reverse Mutation Test (1997). EC Directive 92/69/EC B.13/14 Mutagenicity – Reverse Mutation Test using Bacteria (1992). incorporation (Test 1)/Pre incubation (Test 2) Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100, TA102 Metabolic Activation System S9 microsomal fraction from β-naphthoflavone/phenobarbital-induced rat Concentration Range in Main Test a) With metabolic activation: 33-5000 b) Without metabolic activation: 33-5000 µg/plate Vehicle DMSO Remarks - Method No deviation from standard protocol Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 > 5000 > 5000 > 5000 Negative Test 2 > 5000 > 5000 Negative Present Test 1 > 5000 > 5000 > 5000 Negative Test 2 > 5000 > 5000 Negative Remarks - Results No significant increase in revertant colony numbers of any of the five tester strains was observed at any dose level in the presence or absence of metabolic activation. Negative controls were within the historical limits and positive controls demonstrated the sensitivity of the The test substance was not mutagenic to bacteria under the conditions of the test. RCC (1998a) Genotoxicity – in vitro Mammalian Chromosome Aberration Test Troysol LAC (containing the notified chemical at ~50% concentration) OECD TG 473 In vitro Mammalian Cytogenetic Test (1998). EC Directive 92/69/EC B.10 Mutagenicity - In vitro Mammalian Chromosome Aberration Test (1992).
STD1560-FINAL-FR.DOCX