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EC number: 203-328-4 | CAS number: 105-76-0
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP study conducted according to the OECD guideline 471.
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:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dibutyl maleate
- EC Number:
- 203-328-4
- EC Name:
- Dibutyl maleate
- Cas Number:
- 105-76-0
- Molecular formula:
- C12H20O4
- IUPAC Name:
- dibutyl but-2-enedioate
- Details on test material:
- Maleic acid dibuty ester min 98% (w/w), colorless liquid, 1003 ml, homogeneous, batch No 120000134114.
Constituent 1
Method
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:
- S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone.
- Test concentrations with justification for top dose:
- EXPERIMENT I
Tester strain Dose-levels (ug/plate)
TA1535 Without S9: 2500, 1250, 625, 313, 156, 78.1
TA1537 Without S9: 156, 78.1, 39.1, 19.5, 9.77
WP2uvrA With S9: 5000, 2500, 1250, 625, 313
TA1535, TA1537 With S9: 5000, 2500, 1250, 625, 313
TA98 With S9: 5000, 2500, 1250, 625, 313, 156
TA100 Without S9: 1250, 625, 313, 156, 78.1
TA100 With S9: 625, 313, 156,78.1, 39.1
EXPERIMENT II
Tester strain Dose-levels (¿g/plate)
TA1535, TA98 Without S9:2500, 1250, 625, 313, 156, 78.1
TA1535, TA1537, TA98 With S9: 5000, 2500, 1250, 625, 313
TA1537 Without S9: 156, 78.1, 39.1, 19.5, 9.77
WP2uvrA With S9: 5000, 2500, 1250, 625, 313
TA100 Without S9: 1250, 625, 313, 156, 78.1, 39.1
TA100 With S9: 625, 313, 156, 78.1, 39.1. 19.5
EXPERIMENT III
Tester strain Dose-levels (¿g/plate)
TA1535 Without S9: 2500, 1250, 625, 313, 156, 78.1
TA1535 With S9: 78.1, 39.1, 19.5, 9.77, 4.88, 2.44
TA1537 With S9: 156, 78.1, 39.1, 19.5, 9.77, 4.88
TA98 Without S9: 313, 156, 78.1, 39.1, 19.5, 9.77
TA100 Without S9: 19.5, 9.77, 4.88, 2.44, 1.22, 0.61 - Vehicle / solvent:
- Nutrient Broth: oxoid nutrient broth No 2 (2.5%) was used for the preparation of liquid cultures of the tester strains
Nutrietn Agar: Oxoid nutrient broth No 2 (25g) and Difco Bacto-agar (15g) wichi were used in the Petri dishes for non-selective growth of the tester strains.
Minimal agar: it was prepared as 1.5% Difco Bacto-agar in Vogel-Bonner Medium E, with 2% glucose and poured into Petri dishes.
Top agar: it was prepared as 0.6% Difco Bacto-agar + 0.5% NaCl in distilled water. Prior to use 10 ml of a sterile solution of 0.5 mM Biotin + 0.5 mM Histidine (or 0.5 mM) tryptophan) was added to the top agar (100 ml).
- Details on test system and experimental conditions:
- A preliminary toxicity test was conducted in order to select the concentrations of the test item to be used in the main test. Also a single plate was used at each test point and positive controls were not included. Three experiments were conducted with and without S9 metabolic activation for the main test using the plate incorporation method. Three replicate plates were used at each test point. The prepared plates were inverted and incubated for approximately 72 hours at 37Celsius degree. After this period of incubation, scoring was effected by counting the number of revertant colonies on each plate.
- Evaluation criteria:
- Toxicity was assessed o the basis of a decline in the number of spontaneous revertants, a thining of the background lawn or a microcolony formation.
- Statistics:
- No specified.
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:
- cytotoxicity
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
Any other information on results incl. tables
Experiment I: slight toxicity was observed at higher dose-levels with all tester strains with the exception of WP2uvrA, with and without S9 metabolism, and TA98 with S9 metabolism. As no relevant increases in revertat numbers were observed with any tester strains, all treatements included a pre-incubation step.
Experiment II: a less pronounced toxic effect was noted with TA1537 and WP2uvrA tester strains without S9 metabolism and with TA98 and WP2uvrA with S9 metabolism.
Experiment III: Toxicity was observed at the two highest dose-levels with all tester strains with exception of TA100 with S9 metabolism. No increases in revertant numbers were observed at any concentration, with any tester strain, with or without S9 metabolic activation.
No precipitation of the test was observed at the end of the incubation period at any concentration in any experiment.
The positive controls gave the responses as expected.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, dibutyl maleate was negative for mutagenic activity at any dose-level with any tester strain, with or without S9 metabolic activation.
- Executive summary:
Dibutyl maleate was tested in three experiments for its ability to induce gene mutations in four strains of S. typhimurium and one strain of E. coli at a maximum dose-level of 5000 u/plate. The test substance does not induce two-fold increases in the number of relevant colonies, at any dose-level, in any tester strain with or without S9 metabolic activation.
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