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EC number: 213-361-6 | CAS number: 939-48-0
- 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 based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Peer-reviewed scientifically valid study, as evaluated in the expert panels in the WHO CICAD and OECD SIDS reviews.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Benzoic acid
- EC Number:
- 200-618-2
- EC Name:
- Benzoic acid
- Cas Number:
- 65-85-0
- IUPAC Name:
- benzoic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Benzoic Acid, certified A.C.S., FDA Material # 73-70.
- Physical state: White Crystalline flakes
Constituent 1
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The tissue homogenates and 9,000 x ~ supernatants were prepared from tissues of the following mammalian species: Mouse-ICR random bred adult males; rat-Sprague-Dawley adult males; and primate-Macaca mulatta adult males.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The tissue homogenates and 9,000 x ~ supernatants were prepared from tissues of the following mammalian species: Mouse-ICR random bred adult males; rat-Sprague-Dawley adult males; and primate-Macaca mulatta adult males.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The tissue homogenates and 9,000 x ~ supernatants were prepared from tissues of the following mammalian species: Mouse-ICR random bred adult males; rat-Sprague-Dawley adult males; and primate-Macaca mulatta adult males.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Species / strain / cell type:
- Saccharomyces cerevisiae
- Additional strain / cell type characteristics:
- other: strain D4
- Metabolic activation:
- with and without
- Metabolic activation system:
- 1. TPN (sodium salt) 6.0 µM 2. Isocitric acid 49 µM 3. Tri s buffer, pH 7.4: 28 µM 4. MgCl 2: 1.7 µM 5. Ti ssue homogenate fraction 72.0 mgs
- Test concentrations with justification for top dose:
- 0.25, 0.50 and 1.00 percent
and in plate test: 0.50 percent - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test compound soluble under treatment conditions.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water, saline or Dimethylsulfoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- ethylmethanesulphonate
- other: Quinacrine mustard
- Remarks:
- Non activation assay
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water, saline or Dimethylsulfoxide
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- N-dimethylnitrosamine
- Remarks:
- Activation Assay
- Details on test system and experimental conditions:
- The solubility, toxicity and doses for all chemicals were determined prior to screening. Each chemical was tested for survival against the specific indicator strains over a range of doses to determine the 50% survival dose. The 50% survival curve and he 1/4 and 1/2 50% doses were calculated. A maxiumum dose of 5% (w/v) was used.
Plate tests: In the nonacti vati on proced ure, approximately 10E9 cells of a log-phase culture of the bacterial indicator strains were spread over the surface of a minimal plate, and a measured amount of the test chemical was placed in the center of the test plate. In activation tests, the test chemical was added to the cells, and an aliquot of the mixture was spread on the surface of the test plate. The reaction mixture (0.1 ml ) plus tissue extract was then spotted on the surface of the plate. Positive and solvent controls were included. All plates were incubated at 37°C for four days and then scored. Each compound (test, posi tive control and solvent control) was done in duplicate.
Suspension (preincubation) tests: Log-phase bacteri a and stationary-phase yeast culures of the indicator organisms were grown in compl ete broth, washed and resuspended in 0.9% saline to densi ties of 1E9 cel ls/ml and 5E7 cells/ml , respectively. This constituted the working stock for tests of a group of test chemicals and their respecti ve controls. Tests were conducted in plastic tissue culture plates. The solvent repl aced the test chemical in the negati ve controls. Treatment was at 30°C for four hours for yeast tests and at 37°C for one hour for bacterial tests. All flasks were shaken during treatment . Following treatment, the pl ates were set on ice. Aliquots of cells were removed, diluted in sterile saline (4°C) and pl ated on the appropriate complete media. Undiluted samples from flasks containing the bacteria were pl ated on minimal selective medium in reversion experiments. Samples from a 1/10 dilution of treated cells were plated on the selected media for enumeration of gene conversion wi th strain 04. Bacterial plates were scored after incubation for 48 hours at 37°C. The yeast plates were incubated at 30°C for 3-5 days before scoring.
Activation: Bacteri a and yeast cells were grown and prepared as described in the nonactivation tests. Measured amounts of the test and control chemicals plus 0.25 ml of the stock-cell suspension were added to wells of the plate containing the appropriate tissue fraction and reaction mixture . All flasks (bacteria and yeast) were incubated at 37°C in an oxygen atmosphere with shaking. The treatment times as well as the dilutions, plating proced ures and scoring of the plates were the same as described for nonactivation tests. - Evaluation criteria:
- Positive gene mutation in TA 1535, and TA 1537 and TA 1538 strains of the bacteria S. typhimurium.
- Statistics:
- Data recording and reporting: Following the specified incubation periods all population plates were scored by an automatic colony counter and the results from each plate of a set were recorded , in ink , on data processing forms. All minimal or other types of selective media plates were hand scored and the results recorded along with the respective population data. Other rel vant experimental data were recorded on experimental definition forms. For bacteri strains the number of colonies recorded from either the population or selective plates represents that number in 1 ml of test suspension plated. The numbers recorded for the yeast strain D4 represent the number in 0.5 ml of test suspension plated. The data were then processed and printed from a computer program.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Saccharomyces cerevisiae
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: The 50% survival level was determined for bacteria and yeast indicator organisms by conducting survival curves with the test compound at the following concentrations: Percent (w/v or v/v) 5.0, 0.5, 0.05, 0.005, 0.0005.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No increase in the incidence of mutations occurred at any dose of the test material in any of the strains of Salmonella or yeast. There was no increase with metabolic activation. The conclusion is that the test substance is not mutagenic.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Benzoic Acid, was not considered to be mutagenic in the Ames assays (Salmonella typhimurium strains 1535, 1537 and 1538, and Saccharomyces cervesia straom D4) used in this evaluation. This study is informative for evaluation of the toxicity and environmental fate of members of the Alkyl Benzoates category, and is adequate for filling the data requirement for the registration of this substance. It is valid for hazard classification and risk assessment.
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