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EC number: 200-618-2 | CAS number: 65-85-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited report, non-GLP, the omission of information on status of cell division does not lower the reliability
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 487
- Deviations:
- yes
- Remarks:
- no method included to check cell division status
- Principles of method if other than guideline:
- Mouse lymphoma L5178Y cells were used in this study. Three types of treatment were carried out parallel: two treatments without metabolic activation with or without a recovery period after 24 h continuous treatment and one treatment with metabolic activation by S9 mix. The concentrations of the test substance were 1000, 500, 250 μg/mL in the three type of treatment. Mitomycin C was used as a positive control in the absence of S9 mix and cyclophosphamide was used as a positive control in the presence of S9 mix.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Benzoic acid
- EC Number:
- 200-618-2
- EC Name:
- Benzoic acid
- Cas Number:
- 65-85-0
- Molecular formula:
- C7H6O2
- IUPAC Name:
- benzoic acid
- Details on test material:
- Batch No.: not specifiedPurity: > 99%
Constituent 1
Method
- Target gene:
- None stated
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 1000, 500, 250 μg/mL (cytotoxicity at 200 ug/mL)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO- Justification for choice of solvent/vehicle:
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- In the absence of S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- In the presence of S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in mediumDURATION- Preincubation period: 10-12 h- Exposure duration: 24 h without S9 mix, 4 h with S9 mix- Expression time (cells in growth medium): 0 or 20 hours without S9 mix, 24 hours with S9 mix- Selection time (if incubation with a selection agent):- Fixation time (start of exposure up to fixation or harvest of cells): 10 minSELECTION AGENT (mutation assays):SPINDLE INHIBITOR (cytogenetic assays): ethanol/acetic acidSTAIN (for cytogenetic assays): with 2% Giemsa water solutionNUMBER OF REPLICATIONS: 2NUMBER OF CELLS EVALUATED: 1000DETERMINATION OF CYTOTOXICITY- Method: colometric method
- Evaluation criteria:
- The criteria for determining a positive result were a concentration-related increased in the number of micronucleated cells and a statistically significant increase over the spontaneous level in at least one treatment schedule. Cells with more than 5 micronuclei were excluded from the evaluation to prevent nuclear fragmentation prvent.
- Statistics:
- The statistical significance of differences between groups was determined using the X2 test.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- None stated
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negativeThe test substance gave negative responses both with or without metabolic activation.
- Executive summary:
Mouse lymphoma L5178Y cells were used in this study. Three types of treatment were carried out parallel: two treatments without metabolic activation with or without a recovery period after 24 h continuous treatment and one treatment with metabolic activation by S9 mix. The concentrations of the test substance were 1000, 500, 250 μg/mL in the three type of treatment. Mitomycin C was used as a positive control in the absence of S9 mix and cyclophosphamide was used as a positive control in the presence of S9 mix.
The test substance gave unequivocal negative responses both with or without metabolic activation or cytotoxicity.
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