Only a summary of the study was reviewed. Other than information provided above, no details of the method used was provided Remarks Results – The average weight, length and rate of development of the injected rats showed no significant variations compared to the control. Other than the information above, no detailed results were provided. Test data has not been reviewed. Due to insufficient information it is not possible to establish a No Observed Adverse Effect (NOAEL) in this study. European Chemicals Bureau (2000) 7.8. Genotoxicity bacteria – Maleic acid & Remarks - Method The following information was provided for five bacterial mutation assays. Only a summary of studies was reviewed. Other than information provided below, no details of the method used was provided Method Species/Strain Metabolic activation Result not provided not provided with and without negative not provided no data negative Salmonella typhimurium TA 100 not provided Sd-4-73 no data negative Escherichia coli Not provided with and without negative Salmonella typhimurium TA1535, TA1537, TA1538, TA98, TA100 preincubation method with and without negative Salmonella typhimurium TA97, TA98, TA102, TA104 Remarks - Results Other than the information above, no detailed results were provided. Test data has not been reviewed. The test substance was not mutagenic to bacteria the conditions of these tests. European Chemicals Bureau (2000) 7.9.1 Genotoxicity in vitro DNA synthesis inhibition test – Maleic Acid Cell Type/Cell Line Human Fibroblasts, YH-1 cells Metabolic Activation System Polychlorinated biphenyl induced rat S9 fraction Vehicle Eagle’s minimum essential medium (MEM) supplemented with 10% fetal calf serum. Remarks - Method Basic method details are as follows:
Only a summary of the study was reviewed. Other than information provided above, no details of the method used was provided Remarks – Results The average weight, length and rate of development of the injected rats showed no significant variations compared to the control. Other than the information above, no detailed results were provided. Test data has not been reviewed. Due to insufficient information it is not possible to establish a No Observed Adverse Effect (NOAEL) in this study. European Chemicals Bureau (2000) 7.8. Genotoxicity – bacteria Maleic acid & Remarks - Method The following information was provided for five bacterial mutation assays. Only a summary of studies was reviewed. Other than information provided below, no details of the method used was provided Method Species/Strain Metabolic activation Result not provided not provided with and without negative not provided Salmonella typhimurium TA 100 no data negative not provided Escherichia coli Sd-4-73 no data negative Not provided Salmonella typhimurium TA1535, TA1537, TA1538, TA98, TA100 with and without negative preincubation method Salmonella typhimurium TA97, TA98, TA102, TA104 with and without negative Remarks - Results Other than the information above, no detailed results were provided. Test data has not been reviewed. The test substance was not mutagenic to bacteria the conditions of these tests. European Chemicals Bureau (2000) 7.9.1 Genotoxicity – in vitro DNA synthesis inhibition test Maleic Acid Cell Type/Cell Line Human Fibroblasts, YH-1 cells Metabolic Activation System Polychlorinated biphenyl induced rat S9 fraction Vehicle Eagle’s minimum essential medium (MEM) supplemented with 10% fetal calf serum. Remarks - Method Basic method details are as follows:
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