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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
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus 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:
- Doddecanedioic acid
- IUPAC Name:
- Doddecanedioic acid
- Details on test material:
- Dodecanedioic acid of Du Pont Chemicals, purity 100 %, Haskell ID: H-19,272.
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: Charles River Canada Inc., Montreal (Quebec, Canada)
- Age: 56 days (49+6+1)
- Weight at study initiation: males 27.6 - 34.0 g, mean 30.6 g females 22.6 - 28.2 g, mean 25.2 g
- No. of animals per dose: 5 males + 5 females per sampling time
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 0.5 % methyl cellulose in deionized water
- Details on exposure:
- ADMINISTRATION:
- Vehicle: 0.5 % methyl cellulose in deionized water
- Control groups and treatment:
negative: vehicle
positive: 20 mg cyclophosphamide (CPA)/kg bw/day (in sterile water for irrigation)
- Total volume applied: 15 ml/kg bw/administration on 2 days each in all groups
- Duration of test: 72 hours
- Sampling times and number of samples: 24 hours (all dose levels) and 48 hours (all except positive control) after last treatment - Duration of treatment / exposure:
- 2 equal exposures separated by approx. 24 hours
- Post exposure period:
- Clinical observations: First 3-5 hours after administration; once daily thereafter
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000; 2000; 1000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 20 mg cyclophosphamide (CPA)/kg bw/day (in sterile water for irrigation)
Examinations
- Details of tissue and slide preparation:
- EXAMINATIONS:
- Clinical observations: First 3-5 hours after administration; once daily thereafter
- Organs examined at necropsy: femur bone marrow 1000 PCE (polychromatic erythrocytes) per animal were analysed for micronuclei
- Criteria for selection of M.T.D.: Initial study with 2 applications each of 1250; 2500; 5000 mg/kg bw separated by 1 day;
2 males + 2 females / dose level; 2 days post dose observation.
The top dose for the cytogenetic test was selected as the maximal non-lethal dose. - Evaluation criteria:
- - Criteria for evaluating results: Statistically significant (p<=0.05) and biologically relevant increase in frequency of micronucleated polychromatic
erythrocytes of at least one test group as compared to the negative control group - Statistics:
- Following transformation using the arcsine method data were analysed by one-way ANOVA. In case of significance individual dose groups were compared to the negatiove control using Dunnett's test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- MORTALITY: No deaths occurred during dose finding and main study. CLINICAL SIGNS: No significant changes in body weight were observed in any treated group at any sacrifice. Ruffled fur was exhibited by several treated and negative control animals. No other clinical signs were observed. EFFECT ON MITOTIC INDEX OR PCE/NCE RATIO: No significant reduction in PCE/NCE ratio was present in the positive control group or in any test group when compared with the negative control animals. GENOTOXIC EFFECTS: For the positive control a significant and clear increase in the frequency of micronucleated polychromatic erythrocytes was observed. The mean frequencies of micronucleated polychromatic erythrocytes in the groups treated with the test item were equivalent to those of the vehicle control group.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of this study there was no indication for genotoxicity of the test substance dodecanedioic acid (DDDA) in vivo. - Executive summary:
The ability of Dodecanedioic acid (DDDA) to induce micronuclei in bone marrow polychromatic erythrocytes (PCEs) was tested in male and female mice according to OECD TG 474.
Doses of 5000, 2000, or 1000 mg/kg body weight were administered twice, approximately 24 hours apart, by oral intubation. For all groups, bone marrow smears were prepared approximately 24 and 48 hrs after the final dose. Five males and five females per dose group were sacrificed at each sampling time. One thousand polychromatic erythrocytes per animal were evaluated for the presence of micronuclei.
No statistically significant increases in the frequency of micronucleated PCEs were observed in DDDA-treated animals at any sampling time. No significant depression in the ratio of young, polychromatic erythrocytes to mature, normochromatic erythrocytes were observed. Under the conditions of this assay, DDDA did not induce micronuclei; the test material is negative.
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