minor changes in some parameters (haemoglobin, Clinical mean corpuscular haemoglobin concentration, chemistry/ neutrophil count) at high dose levels, but all either Haematology fell within historical control ranges or were not considered of toxicological importance mean triglyceride values elevated at high dose Biochemistry: levels, statistically significant in females, no associated enzyme changes; minor and inconsistent changes in albumin; other biochemical changes were minor and largely within historical control ranges minor changes in liver, kidney and spleen weights Organ weights noted among high dose level females; considered by authors not to be of toxicological importance no treatment related abnormalities (macroscopic or Histopathology: microscopic) were observed; based on the clinical observations at the two higher Comment: doses, the NOEL is 15 mg/kg/day the clinical and biochemical symptoms do not Result: constitute major functional disturbance and so the test substance will not require corresponding health effects labelling Genotoxicity Reverse Mutation Assay Salmonella typhimurium/Escherichia coli (Kitching, 1998) Strains: Salmonella typhimurium TA1535, TA1537, TA98 and TA100 Escherichia coli CM891 1.5 to 5000 Concentration g/plate According to OECD TG 471/472 Test method: no evidence of mutagenic activity observed at any Comment: dose level of test material in either mutation assay, in the absence or presence of metabolic activation provided by rat liver S9 fraction
Clinical chemistry/ Haematology minor changes in some parameters (haemoglobin, mean corpuscular haemoglobin concentration, neutrophil count) at high dose levels, but all either fell within historical control ranges or were not considered of toxicological importance Biochemistry: mean triglyceride values elevated at high dose levels, statistically significant in females, no associated enzyme changes; minor and inconsistent changes in albumin; other biochemical changes were minor and largely within historical control ranges Organ weights minor changes in liver, kidney and spleen weights noted among high dose level females; considered by authors not to be of toxicological importance Histopathology: no treatment related abnormalities (macroscopic or microscopic) were observed; Comment: based on the clinical observations at the two higher doses, the NOEL is 15 mg/kg/day Result: the clinical and biochemical symptoms do not constitute major functional disturbance and so the test substance will not require corresponding health effects labelling Genotoxicity Salmonella typhimurium/Escherichia coli Reverse Mutation Assay (Kitching, 1998) Strains: Salmonella typhimurium TA1535, TA1537, TA98 and TA100 Escherichia coli CM891 Concentration 1.5 to 5000 g/plate Test method: According to OECD TG 471/472 Comment: no evidence of mutagenic activity observed at any dose level of test material in either mutation assay, in the absence or presence of metabolic activation provided by rat liver S9 fraction
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