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EC number: 276-431-5 | CAS number: 72162-23-3 The high-boiling fraction separated by distillation from the products obtained from the reaction of nitric acid with cyclododecanol and cyclododecanone. Composed primarily of dodecanedioic acid, undecanedioic acid, and sebacic acid.
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1999-10-05 to 1999-10-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Directive 92/69/EEC, B.14
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dodecanedioic acid
- EC Number:
- 211-746-3
- EC Name:
- Dodecanedioic acid
- Cas Number:
- 693-23-2
- Molecular formula:
- C12H22O4
- IUPAC Name:
- dodecanedioic acid
- Reference substance name:
- Dodecandioic Acid
- IUPAC Name:
- Dodecandioic Acid
- Details on test material:
- Dodecanedioic acid of Creanova Spezialchemie GmbH, batch no. 73. Purity not reported here; 99.4 % according to other test reports
Constituent 1
Constituent 2
Method
- Target gene:
- mutated gene loci responsible for histidine auxotrophy
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100, TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital / beta-naphthoflavone co-induced rat liver S9 fraction
- Test concentrations with justification for top dose:
- 313; 625; 1250; 2500; 5000 µg/plate (+/- metabolic activation)
- Vehicle / solvent:
- dimethyl sulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulfoxide (DMSO)
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: without S9 sodium azide (TA 1535, TA 100); 9-aminoacridine (TA 1537); cumene hydroperoxide (TA 102); 2-nitrofluorene (TA 98) with S9: 2-aminoanthracene
- Details on test system and experimental conditions:
- Ames test
SYSTEM OF TESTING
- Metabolic activation system: Phenobarbital / beta-naphthoflavone co-induced rat liver S9 fraction, batch 99/7,
prepared from male Sprague-Dawley rats
ADMINISTRATION:
- Dosing: Preliminary toxicity test (1 replicate): 50; 158; 500; 1580; 5000 µg/plate (+/- metabolic activation)
Plate incorporation test: 313; 625; 1250; 2500; 5000 µg/plate (+/- metabolic activation) repeated for TA 102 (+/- metabolic activation) due to
gross bacterial contamination of all plates prepared with this strain
Pre-incubation test: 313; 625; 1250; 2500; 5000 µg/plate (+/- metabolic activation)
- Number of replicates: 3
- Application: Solvent dimethyl sulfoxide (CAS No. 67-68-5)
- Positive and negative control groups and treatment:
positive, TA 1535: 1 µg sodium azide/plate (- S9) / 1 µg 2-aminoanthracene/plate (+ S9)
positive, TA 1537: 50 µg 9-aminoacridine/plate (- S9) / 1 µg 2-aminoanthracene/plate (+ S9)
positive, TA 102: 100 µg cumene hydroperoxide/plate (- S9) / 10 or 20 µg 2-aminoanthracene/plate (+ S9)
positive, TA 98: 2 µg 2-nitrofluorene/plate (- S9) / 1 or 2 µg 2-aminoanthracene/plate (+ S9)
positive, TA 100: 1 µg sodium azide/plate (- S9) / 1 or 2 µg 2-aminoanthracene/plate (+ S9)
negative: untreated / solvent control (100 µl/plate) (pre-incubation: 50 µl/plate)
sterility control including positive control
activity of metabolic system: 2-aminoanthracene and benzo(a)pyrene / TA 100
- Pre-incubation: 30 minutes at 37 °C incubation approximately 72 hours at 37 °C - Evaluation criteria:
- CRITERIA FOR EVALUATING RESULTS: ratio of revertant rates treated/control >= 2 with generally positive dose-response relationship in any strain, reproducible
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: strains TA 1535, TA 1537, TA 98, TA 100, TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: No toxicity at <= 5000 µg/plate (= highest dose level)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- GENOTOXIC EFFECTS:
- With metabolic activation: None
- Without metabolic activation: None
The positive controls were functional.
PRECIPITATION CONCENTRATION: The solubility of the test substance in DMSO was initially determined to be 100 mg/ml. - Remarks on result:
- other: other: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100, TA 102
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
No genotoxic effects in a battery of microbial tester strains in the presence or absence of metabolic activation. - Executive summary:
The test substance dodecanedioic acid was examined for mutagenic activity by assaying for reverse mutation to histidine prototrophy in the prokaryotic organism Salmonella typhimurium.tester strains TA1535, TA1537, TA98, TA100 and TA102. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone. Test substance solutions were prepared using dimethylsulphoxide.
No toxicity was observed with any tester strain in the toxicity test with a maximum dose-level of 5000µg/plate.
Using the plate incorporation method, and in a subsequent independent assay the preincubation method the test substance was assayed at a maximum dose-level of 5000 µg/plate and at 2500, 1250, 625 and 313 µg/plate.
The test substance did not induce two-fold increases in the number of revertantcolonies in the plate incorporation or pre-incubation assay, at any dose-level, in any tester strain, in the absence or presence of S9 metabolism.
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