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EC number: 214-202-3 | CAS number: 1113-38-8
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- strain with an AT base pair missing
Data source
Reference
- Reference Type:
- publication
- Title:
- Salmonella Mutagenicity Test Results for 250 Chemicals
- Author:
- Haworth, S. et al.
- Year:
- 1 983
- Bibliographic source:
- Environ Mutagen. (1):3-142.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 July 1997
- Deviations:
- yes
- Remarks:
- strain with an AT base pair missing
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Oxalic acid
- EC Number:
- 205-634-3
- EC Name:
- Oxalic acid
- Cas Number:
- 144-62-7
- Molecular formula:
- C2H2O4
- IUPAC Name:
- oxalic acid
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats or hamsters treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- 100, 333.3, 1000, 3333.3 and 6666.7 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: 4-Nitro-o-phenylenediamine (5 µg/plate) for TA98, sodium azide (1 µg/pate) for TA100 and TA1535, respectively, 9-aminoacridine (50 µg/plate) for TA1537; +S9: 2-Aminoanthracene (1 or 2.5 µg/plate) for all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Reduction in numbers of revertant colonies per plate and/or thinning or absence of the bacterial lawn - Evaluation criteria:
- A positive response was indicated by a reproducible, dose-related increase, whether it be twofold over background or not.
- Statistics:
- Mean values and standard deviations were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 6666.7 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 6666.7 µg/mL with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 6666.7 µg/mL with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 6666.7 µg/mL with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test substance precipitated at 3333.3 µg/plate in all strains with metabolic activation.
RANGE-FINDING/SCREENING STUDIES: The test substance was checked for toxicity in TA100 up to a concentration of 10 mg/plate (data not shown).
Any other information on results incl. tables
Table 1: Summary of Results
| With or without S9-Mix | Test substance concentration [µg/plate] | Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
|||
| Base-pair substitution type | Frameshift type | ||||
| TA 100 | TA1535 | TA98 | TA1537 | ||
| – | 0 | 79 ± 0.6 | 13 ± 0.9 | 15 ± 1.7 | 9 ± 2.3 |
| – | 100 | 95 ± 4.5 | 9 ± 0.6 | 19 ± 1.2 | 11 ± 1.9 |
| – | 333.3 | 86 ± 10.3 | 8 ± 2.0 | 13 ± 2.3 | 7 ± 0.9 |
| – | 1000 | 94 ± 2.0 | 10 ± 1.5 | 14 ± 2.9 | 7 ± 2.4 |
| – | 3333.3 | 80 ± 3.5 | 9 ± 2.0 | 18 ± 1.0 | 6 ± 0.9 |
| 6666.7 | 61 ± 5.2 s | 8 ± 3.5 s | 9 ± 1.2 s | 4 ± 1.5 s | |
| Positive controls, –S9 | Name | SA | SA | NOPD | 9-AA |
| Concentrations (μg/plate) | 1.0 | 1.0 | 5.0 | 50.0 | |
| Mean No. of colonies/plate (average of 3 ± SD) | 458 ± 10.7 | 375 ± 4.9 | 320 ± 18.8 | 63 ± 7.8 | |
| +S9 mix (rat) | 0 | 91 ± 7.0 | 6 ± 0.3 | 18 ± 1.8 | 13 ± 2.6 |
| +S9 mix (rat) | 100 | 107 ± 14.5 | 7 ± 1.0 | 20 ± 4.3 | 15 ± 1.3 |
| +S9 mix (rat) | 333.3 | 88 ± 6.3 | 7 ± 1.3 | 22 ± 2.7 | 12 ± 2.0 |
| +S9 mix (rat) | 1000 | 100 ± 8.4 | 6 ± 0.6 | 18 ± 0.3 | 10 ± 1.2 |
| +S9 mix (rat) | 3333.3 | 76 ± 9.7 P | 6 ± 1.8 P | 17 ± 1.9 P | 8 ± 2.3 P |
| +S9 mix (rat) | 6666.7 | 92 ± 6.2 s | 2 ± 2.0 s | 18 ± 1.5 s | 7 ± 0.9 s |
| Positive controls, +S9 mix (rat) | Name | 2-AA | 2-AA | 2-AA | 2-AA |
| Concentrations (μg/plate) | 1.0 | 2.5 | 1.0 | 2.5 | |
| Mean No. of colonies/plate (average of 3 ± SD) | 553 ± 5.5 | 271 ± 15.5 | 320 ± 18.8 | 311 ± 10.5 | |
| +S9 mix (hamster) | 0 | 134 ± 4.0 | 18 ± 1.0 | 18 ± 3.2 | 9 ± 1.5 |
| +S9 mix (hamster) | 100 | 101 ± 7.1 | 8 ± 0.9 | 22 ± 2.0 | 9 ± 1.8 |
| +S9 mix (hamster) | 333.3 | 91 ± 6.8 | 9 ± 1.5 | 17 ± 0.9 | 8 ± 3.0 |
| +S9 mix (hamster) | 1000 | 93 ± 7.2 | 7 ± 1.2 | 20 ± 3.8 | 8 ± 0.7 |
| +S9 mix (hamster) | 3333.3 | 77 ± 5.9 P | 8 ± 0.7 P | 18 ± 4.4 P | 6 ± 0.7 P |
| +S9 mix (hamster) | 6666.7 | 25 ± 22.2 s | 8 ± 0.9 s | 4 ± 0.0 s | 1 ± 0.7 s |
| +S9 mix (hamster) | Name | 2-AA | 2-AA | 2-AA | 2-AA |
| Concentrations (μg/plate) | 1.0 | 2.5 | 1.0 | 2.5 | |
| Mean No. of colonies/plate (average of 3 ± SD) | 553 ± 5.5 | 375 ± 4.9 | 864 ± 46.7 | 348 ± 4.0 | |
SA: sodium azide
NOPD: 4-nitro-o-phenylenediamin
9-AA: 9 -aminoacridine
2-AA: 2 -aminoanthracene
Applicant's summary and conclusion
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