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Diss Factsheets
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EC number: 208-013-5 | CAS number: 505-54-4
- 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1999-10-05 to 1999-10-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
Dicarboxylic acids are organic compounds that contain two carboxylic acid functional groups. They have the general type formula HOOC-(CH2)n-COOH. The present defined category comprises dicarboxylic acids with straight carbon chain having a “n” value from 6 to 16.
The physical and chemical properties as well as the toxicology and environmental fate and effects show that substances in this category have a similar order of toxicological and environmental fate properties, which supports the grouping of these substances as a category. (see attached justification)
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL)
There are number of unifying considerations justifying the similarity between these substances in some important aspects. These include:
(1) Similarity of Use: these dicarboxylic acids have several industrial uses in the production of adhesives, plasticizers, lubricants, copolymers (such as polyamides and polyesters), etc.
(2) Similarity of Functional groups: all these substances contain two common functional groups (2 carboxyl groups). The only difference between the substances of this group lies in the length of the carbon chain.
(3) Similarity of Physical / Chemical properties: the similarity of physical / chemical properties for these substances (see attached justification)
(4) Similarity of Metabolism: Dicarboxylic acids were shown to be rapidly absorbed from the gastrointestinal tract, introduced into the fatty acid catabolism and therefore extensively metabolized by the organism and excreted (Passi, S. et al, 1983).
(5) Similarity of Mammalian Toxicity: The constituents of this class have similar toxicological properties. They are not acutely toxic, irritating to skin or sensitizing. However, they all present, except for dodecanedioic acid, irritating effects on the eyes (from moderate to high effects). They do not produce systemic effects in repeated dose studies. They are neither mutagenic nor carcinogenic and do not produce developmental/reproductive toxicity. (see attached justification)
(6) Similarity of Environmental Toxicity and Fate Properties: The substances in this category have similar environmental effects properties. The environmental effects data are similar for most category members in that most members do not exhibit acute toxicity. (see attached justification)
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)
- 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
- 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
Method
- Target gene:
- mutated gene loci responsible for histidine auxotrophy
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and 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:
- 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 TA 1535, TA 1537, TA 98, TA 100 and 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 were detected for dodecanedioic acid in a battery of microbial tester strains in the presence or absence of metabolic activation. Based on a read across (category approach), no classification regarding the genetic toxicity is required for hexadecanedioic acid.
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