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EC number: 230-256-0 | CAS number: 6990-06-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental work started on 24-Jan-2007 and was completed on 20-Feb-2007.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 1997
- Deviations:
- yes
- Remarks:
- plate counts were slightly above the historical ranges, they were all sufficiently comparable to be considered as characteristic and acceptable for demonstrating the correct strain and assay functioning.
- Qualifier:
- according to guideline
- Guideline:
- other: UKEMS Guideline
- Version / remarks:
- 1990
- Deviations:
- yes
- Remarks:
- plate counts were slightly above the historical ranges, they were all sufficiently comparable to be considered as characteristic and acceptable for demonstrating the correct strain and assay functioning.
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Harmonised Tripartite Guideline
- Version / remarks:
- 1997
- Deviations:
- yes
- Remarks:
- plate counts were slightly above the historical ranges, they were all sufficiently comparable to be considered as characteristic and acceptable for demonstrating the correct strain and assay functioning.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fusidic acid
- EC Number:
- 230-256-0
- EC Name:
- Fusidic acid
- Cas Number:
- 6990-06-3
- Molecular formula:
- C31H48O6
- IUPAC Name:
- 2-[(1Z,2S,3aS,3bS,5aS,6S,7R,9aS,9bS,10R,11aR)-2-(acetyloxy)-7,10-dihydroxy-3a,3b,6,9a-tetramethyl-hexadecahydro-1H-cyclopenta[a]phenanthren-1-ylidene]-6-methylhept-5-enoic acid
- Test material form:
- liquid
- Details on test material:
- Yellow liquid
Constituent 1
- Specific details on test material used for the study:
- Spiked Fusidic acid, batch number 0704514701
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- both in the absence and in the presence of metabolic activation by an Aroclor 1254-induced rat liver post-mitochondrial fraction (S-9), in two separate experiments
- Test concentrations with justification for top dose:
- Concentrations based on range-finding study where toxicity was observed at a concentration of 200 ug/plate or higher
Experiment 1, using final concentrations of Spiked Fusidic Acid at 0.032, 0.16, 0.8, 4, 20, 100 and 500 μg/plate
Experiment 2, concentration ranges of 5.12 to 500 or 1250 μg/plate - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Negative controls comprised treatments with the vehicle sterile anhydrous analytical grade dimethyl sulphoxide (DMSO).
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- 2-aminoanthracene (AAN)
- Details on test system and experimental conditions:
- Bacteria Strain Type of mutation in the histidine gene
S. typhimurium TA98 frame-shift
S. typhimurium TA100 base-pair substitution
S. typhimurium TA1535 base-pair substitution
S. typhimurium TA1537 frame-shift
S. typhimurium TA102 base-pair substitution - Statistics:
- The m-statistic was calculated to check that the data were Poisson-distributed (10), and Dunnett's test was used to compare the counts at each concentration with the control.
The presence or otherwise of a concentration response was checked by linear regression analysis (10). As multiple regression analysis calculations are
performed (at each concentration level), there is an increased incidence of values which will fall outside the 95 or 99% probability range, but are not due to compound related increases.
Therefore, a statistically significant regression analysis is not considered as a biologically relevant event unless accompanied by a statistically significant Dunnett’s test.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxicity was only observed in experiment 2
- Untreated negative controls validity:
- valid
- Remarks:
- The mean numbers of revertant colonies on negative control plates were all considered acceptable,
- Positive controls validity:
- valid
- Remarks:
- The mean numbers of revertant colonies were significantly elevated by positive control treatments.
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxicity was only observed at the highest concentration tested (500 ug/plate and/or 1250 ug/plate)
- Untreated negative controls validity:
- valid
- Remarks:
- The mean numbers of revertant colonies on negative control plates were all considered acceptable,
- Positive controls validity:
- valid
- Remarks:
- The mean numbers of revertant colonies were significantly elevated by positive control treatments.
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxicity was only observed at the highest concentration tested (500 ug/plate and/or 1250 ug/plate)
- Untreated negative controls validity:
- valid
- Remarks:
- The mean numbers of revertant colonies on negative control plates were all considered acceptable,
- Positive controls validity:
- valid
- Remarks:
- The mean numbers of revertant colonies were significantly elevated by positive control treatments.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxicity was only observed at the highest concentration tested (500 ug/plate and/or 1250 ug/plate)
- Untreated negative controls validity:
- valid
- Remarks:
- The mean numbers of revertant colonies on negative control plates were all considered acceptable,
- Positive controls validity:
- valid
- Remarks:
- The mean numbers of revertant colonies were significantly elevated by positive control treatments.
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxicity was only observed at the highest concentration tested (500 ug/plate and/or 1250 ug/plate)
- Untreated negative controls validity:
- valid
- Remarks:
- The mean numbers of revertant colonies on negative control plates were all considered acceptable,
- Positive controls validity:
- valid
- Remarks:
- The mean numbers of revertant colonies were significantly elevated by positive control treatments.
Any other information on results incl. tables
Experiment 1, using final concentrations of Spiked Fusidic Acid at 0.032, 0.16, 0.8, 4, 20, 100 and 500 μg/plate, plus negative (vehicle) and positive controls. Following these treatments, evidence of toxicity was observed in the absence and presence of S-9 at 500 μg/plate in all strains except TA98. Although no clear evidence of toxicity was seen in strain TA98, treatments in this strain were considered to have been performed at concentrations approaching toxic levels, based on the observations seen in the other test strains.
Following Experiment 2 treatments, clear evidence of toxicity was observed at either 500 μg/plate or 1250 μg/plate in all strains in the absence of S-9, and at either 200 μg/plate and above or 500 μg/plate (and above where applicable) in all strains in the presence of S-9.
Following Spiked Fusidic Acid treatments of all the tester strains, both in the absence and in the presence of a rat liver metabolic activation system (S-9), only Experiment 1 treatments of strain TA102 in the presence of S-9 resulted in any increase in revertant numbers that was statistically significant.
As the increase in Experiment 1 was neither doserelated nor reproducible, it was not considered to have been a biologically relevant or compound-related effect.
As no other strain treatments resulted in an statistically significant increases in revertant numbers, this study was considered to have provided no evidence of any Spiked Fusidic Acid mutagenic activity in this assay system.
Applicant's summary and conclusion
- Conclusions:
- Spiked Fusidic Acid was assayed for mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in the absence and in the presence of metabolic activation (S-9) , in two separate experiments. The study was performed in accordance to OECD 471. No toxicological significant increases in the frequecy of revertant colonies were recorded, thus it was concluded that Spiked Fusidic Acid does not induce mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium when tested under the conditions of this study. These conditions included treatments at concentrations up to or approaching the lower limit of toxicity, in the absence and in the presence of a rat liver metabolic activation system (S-9). Hence, Spiked Fusidic Acid was found to be non-mutagenic.
- Executive summary:
Spiked Fusidic Acid was assayed for mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in the absence and in the presence of metabolic activation (S-9) , in two separate experiments. The study was performed in accordance to OECD 471.
Two experiments (refered to as experiment 1 and 2) were conducted:
Experiment 1, using final concentrations of Spiked Fusidic Acid at 0.032, 0.16, 0.8, 4, 20, 100 and 500 μg/plate, plus negative (vehicle) and positive controls. Following these treatments, evidence of toxicity was observed in the absence and presence of S-9 at 500 μg/plate in all strains except TA98. Although no clear evidence of toxicity was seen in strain TA98, treatments in this strain were considered to have been performed at concentrations approaching toxic levels, based on the observations seen in the other tester strains.
Following Experiment 2 treatments, clear evidence of toxicity was observed at either 500 μg/plate or 1250 μg/plate in all strains in the absence of S-9, and at either 200 μg/plate and above or 500 μg/plate (and above where applicable) in all strains in the presence of S-9.
No toxicological significant increases in the frequecy of revertant colonies were recorded, thus it was concluded that Spiked Fusidic Acid does not induce mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium when tested under the conditions of this study. These conditions included treatments at concentrations up to or approaching the lower limit of toxicity, in the absence and in the presence of a rat liver metabolic activation system (S-9). Hence, Spiked Fusidic Acid was found to be non-mutagenic.
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