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EC number: 618-295-5 | CAS number: 897626-46-9
- 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 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 based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 11 Nov 1985 - 28 Jan 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific priciples. Purity of test substance not given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- purity of test substance not given
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 69275-01-0
- Cas Number:
- 69275-01-0
- IUPAC Name:
- 69275-01-0
- Details on test material:
- - Name of test material (as cited in study report): Di-(2-octyl-dodecyl)-sebacate
- Physical state: colourless, viscous liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: CFW 1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann
- Age at study initiation: 7 weeks
- Weight at study initiation: 18 - 31g
- Assigned to test groups randomly: yes
- Fasting period before study: 4 hours for 10000mg/kg bw group, 6-16 hours for other test groups
- Housing: one animal per cage in Makrolon Type I cages (male), 4 animals per cage in Makrolon Type II cages (female)
- Diet: Altromin 1324 diet, ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: oleum arachidis G 166, DAB8
- Amount of vehicle (if gavage or dermal): 10mL/kg bw - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
test substance was diluted using Oleum Arachidis G 166, DAB8 before application by gavage - Duration of treatment / exposure:
- negative control, positive control, 1000 & 5000 mg/kg bw: 24 hours
10000 mg/kg bw: 24, 48, 72 hours - Frequency of treatment:
- single treatment
- Post exposure period:
- 24, 48 and 72 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000, 5000, 10000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 7
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: intraperitoneal
- Doses / concentrations: 10 mg/kg bw
Examinations
- Tissues and cell types examined:
- tissue: bone marrow from the femur
cell type: bone marrow cells - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Range finding study performed to find the maximum tolerated dose.
TREATMENT AND SAMPLING TIMES (in addition to information in specific fields): 24, 48 and 72 hours
DETAILS OF SLIDE PREPARATION: 3 slides per animal were fixed with methanol, stained for 10 minutes with Giemsa-solution (modified from Gollapudi and Kamra, 1979), rigorously washed with bidest water and air-dried over night.
METHOD OF ANALYSIS: 1 slide per animal was analyzed. The number of micronuclei in 1000 polychromatic erythrocytes was counted, additionally the ratio polychromatic erythrocytes to normocytes was determined. - Evaluation criteria:
- Only regions on slides with a good cell distribution, intact cells and sufficient staining were evaluated. The ratio of polychromatic to normochromatic erythrocytes was determined by evaluating the number of bluish to red stained cells.
- Statistics:
- The statistic significance was calculated in comparison to controls using tables by Kastenbaum and Bowman (Mutation Research 2: 527-549; 1970).
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- 5000, 10000 mg/kg bw dose groups: male and female animals showed slightly reduced activity and ruffled fur. Symptoms had disappeared 20 hours after application.
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 5000 - 10000 mg/kg bw
- Clinical signs of toxicity in test animals: none
Any other information on results incl. tables
Table 1: Results of the in vivo micronucleus assay in male animals. | |||||||||
Total micronuclei per 1000 PCEs at sampling time | Mean PCEs / 1000 NCEs at sampling time | ||||||||
Exp group |
Number of animals | Dose [mg/kg bw] | 24 h | 48 h | 72 h | 24 h | 48 h | 72 h | |
Vehicle control (oleum Arachidis, DAB8), 24 h | 7 | 10 mL/kg bw | 2 | n.d. | n.d. | 0.73 | n.d. | n.d. | |
Positive control (cyclophosphamide), 24 h | 7 | 10 | 8.71* | n.d. | n.d. | 0.91 | n.d. | n.d. | |
Test substance | 7 | 1000 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | |
Test substance | 7 | 5000 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | |
Test substance | 7 | 10000 | 0.86 | 1.57 | 1.71 | 0.94 | 1.11 | 1.07 | |
*statistically significant (p>0.01), n.d. = not determined; in the highest dose group (10000 mg/kg bw) the group mean micronucleated cell count was comparable with the concurrent control values, therefore dosages of 1000 and 5000 mg/kg bw have not been evaluated. | |||||||||
Table 2: Results of the in vivo micronucleus assay in female animals. | |||||||||
Total micronuclei per 1000 PCEs at sampling time | Mean PCEs / 1000 NCEs at sampling time | ||||||||
Exp group |
Number of animals | Dose [mg/kg bw] | 24 h | 48 h | 72 h | 24 h | 48 h | 72 h | |
Vehicle control (oleum Arachidis, DAB8), 24 h | 7 | 10 mL/kg bw | 2.14 | n.d. | n.d. | 0.95 | n.d. | n.d. | |
Positive control (cyclophosphamide), 24 h | 7 | 10 | 8.57* | n.d. | n.d. | 0.88 | n.d. | n.d. | |
Test substance | 7 | 1000 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | |
Test substance | 7 | 5000 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | |
Test substance | 7 | 10000 | 1.14 | 1.29 | 1.71 | 0.91 | 1.10 | 1.18 | |
*statistically significant (p>0.01), n.d. = not determined; in the highest dose group (10000 mg/kg bw) the group mean micronucleated cell count was comparable with the concurrent control values, therefore dosages of 1000 and 5000 mg/kg bw have not been evaluated. | |||||||||
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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