METHOD OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents. EC Directive 96/54/EC B.7 Repeated Dose (28 Days) Toxicity (Oral). Species/Strain Rat/Wistar. Route of Administration Oral gavage. – Exposure Information Total exposure days: 28 days; Dose regimen: 7 days per week; Post-exposure observation period: 14 days. Vehicle RESULTS Group Number and Sex mg/kg bw/day Dose of Animals Mortality (control) 5/sex 0 None. (low dose) 40 “ “ (mid dose) 200 “ “ (high dose) 1000 “ “ (control recovery) 0 “ “ (high dose recovery) 1000 “ “ Mortality and Time to Death None. Clinical Observations Lower motor activity was observed in high dose males. Laboratory Findings Clinical Chemistry, Haematology, Urinalysis – No significant findings. A reduction in levels of alanine aminotransferase was noted in high dose males but no dose-relationship was observed. Effects in Organs High dose recovery animals exhibited lower relative thymus weights, an effect not observed in the high dose treatment group. No effects were noted at necropsy or on histopathological examination. Remarks Results – The lower relative thymus weights in the high dose recovery animals was not correlated with any other indicators of immunotoxicity and was, therefore, judged to be of limited toxicological significance. The lower motor acitivity in high dose males was judged to have limited significance as there was no other indicator of neurotoxicity and there was a high variability in scores. The No Observed Effect Level (NOEL) was established as 200 mg/kg bw/day in this study, based on an effect on motor activity in high dose males. TEST FACILITY Bayer AG (1997h). Genotoxicity - bacteria TEST SUBSTANCE Iminodisuccinic acid, sodium salt. METHOD OECD TG 471 Bacterial Reverse Mutation Test.
METHOD OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents. EC Directive 96/54/EC B.7 Repeated Dose (28 Days) Toxicity (Oral). Species/Strain Rat/Wistar. Route of Administration Oral – gavage. Exposure Information Total exposure days: 28 days; Dose regimen: 7 days per week; Post-exposure observation period: 14 days. Vehicle RESULTS Group Number and Sex of Animals Dose mg/kg bw/day Mortality (control) 5/sex 0 None. (low dose) “ 40 “ (mid dose) “ 200 “ (high dose) “ 1000 “ (control recovery) “ 0 “ (high dose recovery) “ 1000 “ Mortality and Time to Death None. Clinical Observations Lower motor activity was observed in high dose males. Laboratory Findings – Clinical Chemistry, Haematology, Urinalysis No significant findings. A reduction in levels of alanine aminotransferase was noted in high dose males but no dose-relationship was observed. Effects in Organs High dose recovery animals exhibited lower relative thymus weights, an effect not observed in the high dose treatment group. No effects were noted at necropsy or on histopathological examination. Remarks – Results The lower relative thymus weights in the high dose recovery animals was not correlated with any other indicators of immunotoxicity and was, therefore, judged to be of limited toxicological significance. The lower motor acitivity in high dose males was judged to have limited significance as there was no other indicator of neurotoxicity and there was a high variability in scores. The No Observed Effect Level (NOEL) was established as 200 mg/kg bw/day in this study, based on an effect on motor activity in high dose males. TEST FACILITY Bayer AG (1997h). Genotoxicity - bacteria TEST SUBSTANCE Iminodisuccinic acid, sodium salt. METHOD OECD TG 471 Bacterial Reverse Mutation Test.