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EC number: 601-485-7 | CAS number: 117570-93-1
Toxicological information
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07-NOV-2008 to 20-NOV-2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial forward mutation assay
Test material
- Reference substance name:
- 2-[2-(carboxymethyl)phenoxy]-3,4-dimethylbenzoic acid
- EC Number:
- 601-485-7
- Cas Number:
- 117570-93-1
- Molecular formula:
- C17 H16 O5
- IUPAC Name:
- 2-[2-(carboxymethyl)phenoxy]-3,4-dimethylbenzoic acid
- Details on test material:
- - Name of test material (as cited in study report): ASA404 C7
- Substance type: Off white powder
- Physical state: Solid
- Analytical purity: 99.9%
- Lot/batch No.: 072301
- Expiration date of the lot/batch: 18 March 2009
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- Main 1
TA100: 3, 10, 33, 100, 333, 3330 and 5000 µg/plate
TA1535, TA97, TA98 and TA102: 100, 333, 3330 and 5000 µg/plate
Main 2:
All strains: 100, 333, 3330 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethyl sulfoxide
- Justification for choice of solvent/vehicle: Accepted and approved by authorities and international guidelines
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cumene hydroperoxide
- Remarks:
- without S9
Migrated to IUCLID6: 0.1 µg/plate in DMSO for TA102
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9
Migrated to IUCLID6: 650 µg/plate in DMSO for TA100
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9
Migrated to IUCLID6: 5 µg/plate in saline for TA1535
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9
Migrated to IUCLID6: 10 µg/plate in DMSO for TA98
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191, 1 µg/plate in DMSO for TA97
- Remarks:
- without S9
- Positive controls:
- no
- Positive control substance:
- other: 2-aminoanthracene, TA1535, TA97, TA100, TA98
- Remarks:
- with S9
- Positive controls:
- yes
- Positive control substance:
- other: 1,8 dihydroxyanthraquinone , 30 µg/plate in DMSO for TA102
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 10E8 bacteria per plate
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, and the reduction of the revertant colonies
OTHER EXAMINATION
- Precipitation of the test substance
- Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in the tester strain TA100, TA97 and TA102 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, and TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100, TA97 and TA102 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535 and, TA98 is greater than three (3) times the concurrent control.
b) In case a positive response will be repeated, the positive response should be reproducible in at least one independently repeated experiment. - Statistics:
- No statistics are performed
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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation on the plates was observed at the start and at the end of the incubation period at the concentration of 5000 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: The results of solvent and positive controls were considered valid and it can be concluded that the test conditions were adequate and that the metabolic activation system functioned properly.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that this test is valid and that ASA404 C7 is not mutagenic in the Salmonella typhimurium reverse mutation assay
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