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EC number: 266-104-5 | CAS number: 66069-34-9
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1983 - 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Potassium clavulanate
- IUPAC Name:
- Potassium clavulanate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- 2 test materials were tested within this study, these were as follows:
BRL 25000 : Lot No. C.T. 10715 (839 ug/mg as free acid) (568 ug/mg as amoxicillin free acid and 271 ug/mg as BRL 14151K free acid).
BRL 14151K : Lot No. C.T. 10716 (819 ug/mg as free acid). The drug concentrations and doses used when performing the tests are all expressed as weights of free acid.
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- TA1535 , TA1537 and TA1538 (all provided vy Dr. Tsuneo Kada, National Institute of Genetics),
TA100, TA98 (provided by Dr. Kunie Yoshikaea, National Institute of Hygenic Sciences) - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2
- Details on mammalian cell type (if applicable):
- E. coli WP2 (hcr-) (provided by Dr. Kunie Yoshikawa, National Institute of Hygenic Sciences)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- TA98 and TA 100 - the following concentrations were used 0, 5, 10, 20, 30, 40, 50mcg
TA1535, TA1537, TA 1538 and E coli Wp2 hcr: 0, 100, 150, 200, 250, 300 and 350 mcg
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitroguanidine (MNNG) , 4-nitroguinoline-1-oxide (4NQO), 9-aminoacridine (9AA), 2-(2-furyl)-3-(5-nitro- 2-furyl)-acrylamide (AF2) and 2-aminoanthracene (2AA) were used as positive controls depending on the bacterial strain.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Additional information on results:
- There were no significant differences between the solvent control results and the BRL 25000 and BRL 14151K results for the six test strains of Salmonella typhimurium and E. coli with or without S9 mix.
Any other information on results incl. tables
Please see tables 1 to 4 which are located in the attached background information section.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In Ames test. the numbers of revertant colonies showed no major differences from the negative controls for either BRL 25000 and BRL 14151K. No mutations were induced in any of the test strains. There were also no effects for either compound in the metabolic activation method by adding 59 mix. Therefore. it is assumed that BRL 25000 and BRL 14151K do not induce genetic mutations either in the presence or absence of metabolic activation. - Executive summary:
BRL 25000 and BRL 14151K were tested for induction of gene mutation and chromosomal aberration. BRL 25000 and BRL14151K did not induce revertant colonies against Salmonella typhimurium TA1535, TA1537, TA1538, TA100 and TA98 and E. coli WP2 hcr- with and without S9 mix.
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