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EC number: 220-298-8 | CAS number: 2706-75-4
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:
- The study was conducted between 30 May 2008 and 24 June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Testing Methods Concerning New Chemical Substances (Notification No. 1 1 21002, PFSB, MHLW; No. 2 of November 13, 2003, MIB, METI; No. 031 1 21002, EPB, MOE; dated November 21, 2003)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium glyoxylate
- EC Number:
- 220-298-8
- EC Name:
- Sodium glyoxylate
- Cas Number:
- 2706-75-4
- Molecular formula:
- C2H2O3.Na
- IUPAC Name:
- sodium oxoacetate
Constituent 1
- Specific details on test material used for the study:
- Name of new chemical: Sodium glyoxylate
Other name: GOA-Na
Purity: 100%
Lot No.: C080501
Appearance at ambient temperature: White powder
Storage conditions: Kept at room temperature, shielded from light in airtight container filled with nitrogen
Method
- Target gene:
- The histidine operon in the S. typhimurium strains and the tryptophan operon in the E.coli strain
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 was prepared from the livers of 7-week old male Sprague-Dawley rats treated with phenobarbital and 5, 6-benzoflavone.
- Test concentrations with justification for top dose:
- Dose-finding test
According to the test guideline, the dose-finding test was performed at the following doses:
All strains with and without S9-mix: 1.22, 4.88, 19.5, 78.1, 313, 1250 and 5000 μg/plate
Main test
According to the results of the dose-finding test, revertant colonies did not increase in any tester strains with or without S9 mix. Microbial growth inhibition was not observed in any strains. Based on these results, main test was performed at the following doses:
All strains with and without S9-mix: 313, 625, 1250, 2500 and 5000 μg/plate in any strains. - Vehicle / solvent:
- According to the information from the sponsor, the test substance was soluble in water and insoluble in dimethylsulfoxide (DMSO) and in acetone. In the solvent selection test, the test substance was dissolved in distilled water (DW) at 50 mg/mL, but was not dissolved or suspended in DMSO at 50 mg/mL and in acetone at 100 mg/mL. Increases in temperature, discoloration and foaming were not observed when the test substance was mixed with DW. According to these results, DW was selected as the solvent for the test substance in this study.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.01 and 0.1 μg/plate for strains TA100 and TA98 respectively
- Positive control substance:
- other: 2-(2-Fury )-3-( 5-nitro-2-furyl)acrylamide
- Remarks:
- Without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.5 μg/plate for strain TA1535
- Positive control substance:
- sodium azide
- Remarks:
- Without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 80 μg/plate for strain TA1537
- Positive control substance:
- other: 9-Aminoacridine hydrochloride
- Remarks:
- Without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2.0 μg/plate for strain WP2 uvr A
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.5, 1.0, 2.0, 2.0 and 10 μg/plate for strains TA98, TA100, TA1535, TA1537 and WP2 uvr A respectively
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable):
Dose finding test (x 10^9/ml): TA100 - 3.17, TA1535 - 3.86, WP2uvrA - 5.92, TA98 - 2.51, TA1537 - 1.97
Main test (x 10^9/ml): TA100 - 3.11, TA1535 - 4.00, WP2uvrA - 5.05, TA98 - 3.60, TA1537 - 2.49
DURATION
- Exposure duration: 48hrs
- Expression time (cells in growth medium): 48hrs
- Selection time (if incubation with a selection agent): 48hrs
SELECTION AGENT (mutation assays): agar deficient in either histidine or tryptophan
NUMBER OF REPLICATIONS: 2 plates/dose
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
CONFIRMATION OF GENETIC PROPERTIES
The genetic properties of the tester strains had already been checked with regard to the following phenotypic characteristics. Strains having the required properties were used for this study.
(1) Amino acid requirement
(2) UV sensitivity
(3) Membrane mutation
(4) Drug resistance - Evaluation criteria:
- The test substance was judged to have mutagenicity (positive) when the test substance induced a dose-dependent increase in the number of the revertant colonies (mean) to a level equal to or greater than 2-fold of the negative (solvent) control value (mean value) in any one of the tester strains with or without S9 mix, and when the dose-dependent increase was reproducible. Other results were judged to be negative. When the test substance was positive, mutation activity (number of revertant colonies/mg) was calculated. No statistical analysis was performed with the test results in this study.
Results and discussion
Test resultsopen allclose all
- 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:
- not applicable
- 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:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Dose-finding test
Number of revertant colonies: The number of revertant colonies in the test substance-treated groups was less than twice that in the corresponding negative (solvent) control in all tester strains with and without S9 mix.
Microbial growth inhibition: Microbial growth inhibition was not observed at any dose levels.
Precipitation: Precipitation of the test substance was not observed at any dose levels.
Main test
Number of revertant colonies: The number of revertant colonies in the test substance-treated groups was less than twice that in the corresponding negative (solvent) control in all tester strains with and without S9 mix.
Microbial growth inhibition: Microbial growth inhibition was not observed at any dose levels.
Precipitation: Precipitation of the test substance was not observed at any dose levels.
Sterility test
Bacterial or fungous contamination was not observed in plates of the highest dose of the test substance solution or S9 mix in the dose-finding test and the main test.
The solvent control values and positive control values are within the ranges calculated from historical data.
Applicant's summary and conclusion
- Conclusions:
- In the dose-finding test and the main test, the number of revertant colonies induced by the test substance was less than twice the corresponding negative (solvent) control value for all tester strains with and without S9 mix. Furthermore, all tests indicated that they were performed accurately as the tests satisfied acceptable the specified criteria. From the results described above, it was concluded that GOA-Na was not mutagenic under the conditions employed in this study.
- Executive summary:
Mutagenicity of the test substance, GOA-Na, was assessed in the bacterial reverse mutation test using five strains, Salmonella typhimurium TA I OO, TA1535, TA98, and TA!537 and Escherichia coli WP2uvrA. The test was conducted by the plate method with and without S9 mix.
A dose-finding test was performed at 5000 μg/plate as the maximum dose using 7 doses with a common ratio of 4. According to the results, the number of revertant colonies treated with the test substance was less than twice that treated with the negative (solvent) control in all tester strains with and without S9 mix. Moreover, microbial growth inhibition and precipitation were not observed at any dose in all tester strains with or without S9 mix.
Main test was performed at the 5000 μg/plate as the maximum using 5 doses with a common ratio of 2 based on the results of the dose-finding test. According to the results, the number of revertant colonies treated with the test substance was less than twice that treated with the negative (solvent) control in all tester strains with and without S9 mix.
Moreover, microbial growth inhibition and precipitation were not observed at any dose in all tester strains with or without S9 mix.
From the results described above, it was concluded that GOA-Na was not mutagenic under the conditions employed in this study.
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