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EC number: 220-942-8 | CAS number: 2944-06-1
- 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
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1988
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: data retrieved from literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Nonmutagenicity of maleic acid and its sodium salts in Salmonella assays
- Author:
- R.S. Lake, G.L. De Vito, R.J. Szot and E.Schwartz
- Year:
- 1 988
- Bibliographic source:
- Mutation Research, 207 (1988) 1-5
Materials and methods
- Principles of method if other than guideline:
- The determination of the the potential of the substance per se or its indirect pH effects to influence his + revertant rates in Ames Salmonella plate incorporation mutagenicity assays
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Maleic acid
- EC Number:
- 203-742-5
- EC Name:
- Maleic acid
- Cas Number:
- 110-16-7
- Molecular formula:
- C4H4O4
- IUPAC Name:
- (2Z)-2-Butenedioic acid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA1538, TA 98, TA 100.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 938, 1875, 3750 and 7500 µg/plate
- Vehicle / solvent:
- Not specified
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- not specified
- Details on test system and experimental conditions:
- The Ames Salmonella tester strains TA1535, TA1537, TA1538, TA98 and TA100 were used in the standard plate incorporation assay. Tester strains were maintained and checked for retention of properties. Metabolic activation was provided by adding Aroclor-1254-induced male rat liver microsomal enzymes (S9, Organon Teknika, Charleston, SC) supplemented with cofactors. The S9 mix consisted of: 100 mM sodium phosphate, pH 7.4, 8 mM MgC12, 33 mM KC1, 4 mM Na NADP, 5 mM glucose 6-phosphate, and S9 fraction at a concentration of 0.1 ml/ml of mix.
3 plates per dose point were used for treated and control groups. Revertant colonies were quantitated after 2 days of incubation at 37°C on an automatic colony counter. Solutions of test substance were prepared and diluted in Oxoid nutrient broth No. 2.
pH determinations
Individual top agar solutions containing all components except agar were prepared separately for pH determinations. Each reconstructed top agar consisted of 2.0 ml of 0.5% NaC1 (pH 6.18); 0.5 ml 0.2 M NaPO4 (pH 7.50) or S9 mix (pH 7.10); 0.1 ml 20-h nutrient broth culture (pH 8.05); and 0.1 ml of test item stock diluted in nutrient broth.
pH was determined at room temperature using a Corning pH/ion 135 meter equipped with a combination electrode. This measurement was considered initial pH with recognition that pHof the actual plate incorporation top agar would be further buffered by base agar during the incubation at 37°C.
For positive control: TA1535 NaAz 5.00 µg/plate - S9,2-AA 2.5 µg/plate +S9; TA100 NaAz 5.00 µg/plate - S9, 2-AA 2.5 µg/plate + S9; TA1537 NaAz 75.00 µg/plate -S9, 2-AA 2.5 µg/plate + S9; TA1537 2-NF 5.00/µg/plate -S9, 2-AA 2.5 µg/plate + S9; TA98 2-NF 5.00 µg/plate -S9, 2-AA 2.5 µg/plate +S9. - Statistics:
- Each mutagenesis trial was analyzed for treatment-related effects and dose-response trends using the statistical model of Snee and Irr (1984).
Snee, R.D., and J.D. Irr (1984) A procedure for the statistical evaluation of Ames Salmonella assay results, Comparison of results among 4 laboratories, Mutation Res., 128, 115-125
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA1538, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- The substance tself, with a pKa of 1.83, depressed initial pH to as low as 2.4 in the top agar containing S9 mix at 5555 µg/ml. The pH of all top agars containing S9 mix was consistently lower than without S9 mix due to the acidic contribution of NADP.
Applicant's summary and conclusion
- Conclusions:
- The test substance is not mutagenic in the Salmonella/mammalian microsome assay and that background reversion is not sensitive to lowered pH.
- Executive summary:
The test substance was examined in plate incorporation assays at toxicity limited dose levels with the routine tester strains TA1535, TA1537, TA1538, TA98 and TA100. Initial pH of top agar was monitored at each dose level.
The substance failed to induce any significant increases in revertant count in any of the strains tested. At doses as high as 7500 / µg/plate where the initial pH was as low as 2.4, neither phase showed increases which were dose-related or statistically significant. Test substance dose levels above 7500 µg/plate were highly cytotoxic resulting in microcolonies too numerous to count.
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