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EC number: 220-836-1 | CAS number: 2915-57-3
- 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 from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A well reported non-GLP study conducted to sound scientific principles with the read across substance, bis(2-ethylhexyl) adipate.
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of a Three-Exposure Mouse Bone Marrow Micronucleus Protocol: Results With 49 Chemicals
- Author:
- Shelby M D, Erexson G L, Hook G J, Tice R R
- Year:
- 1 993
- Bibliographic source:
- Environmental and Molecular Mutagenesis 21:160-179
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- (only 1000 rather than 2000 PCEs scored per animal)
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Bis(2-ethylhexyl)adipate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 - 14 weeks
- Weight at study initiation: 25 - 33 g (within 2 g of a mean weight)
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS
Test material doses were suspended in corn oil using a Tek-Mar Tissumizer®. Test material doses were administered within 30 minutes of preparation. - Duration of treatment / exposure:
- Animals were injected on three consecutive days
- Frequency of treatment:
- Daily for three consecutive days
- Post exposure period:
- Animals were sacrificed 24 hours after the third treatment
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
200, 1000, 2000 mg/kg
Basis:
nominal conc.
Preliminary toxicity test
- Remarks:
- Doses / Concentrations:
0, 375, 750, 1500, 2000 mg/kg
Basis:
nominal conc.
Micronucleus test
- No. of animals per sex per dose:
- 5 males per dose level (Preliminary toxicity test)
5 males per dose level (Micronucleus test) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 7,12-dimethylbenzanthracene (DMBA)
- Route of administration: Intraperitoneal injection (administered as a suspension in corn oil)
Examinations
- Tissues and cell types examined:
- Bone marrow smears (two slides per mouse) were prepared.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The dose levels chosen for the main test were based on findings from the preliminary toxicity test in which groups of 5 mice were administered test material suspensions by intraperitoneal injection on three consecutive days. Animals were monitored twice daily, and 48 hours after the third treatment. Surviving mice were sacrificed and bone marrow and peripheral smears (two slides/tissue/mouse) were prepared by a direct technique. Air dried smears were fixed using absolute methanol and stained with acridine orange. Bone marrow smears were evaluated at 1000 X magnification by fluorescent microscopy for determination of the percentage PCE among 200 erythrocytes. Since no toxicity was observed with the test material, the maximum permissible concentration of 2000 mg/kg was selected as the top dose.
DETAILS OF SLIDE PREPARATION: The smears were fixed in methanol, and stained with acridine orange.
METHOD OF ANALYSIS: The slides were evaluated at 1000 X magnification for the number of MN-PCE among 2000 PCE and for the percentage among 200 erythrocytes. - Evaluation criteria:
- Conclusions on the mutagenicity of the test material were based on the statistical analysis of trend and of pair-wise comparisons of the solvent control with individual doses, and the absolute increases in MN-PCE frequency.
- Statistics:
- The data were analysed using the Micronucleus Assay Data Management and Statistical software package. The level of significance was set at an alpha level of 0.05. To determine whether a specific treatment resulted in a significant increase in MN-PCE, the number of MN-PCE were pooled within each dose group and analysed by a one-tailed trend test. The %PCE data were analysed by an analysis of variance (ANOVA) test based on pooled data. Pair-wise comparisons between each group and the concurrent solvent control group was by an adjusted one-tailed Pearson chi-squared test which incorporated the calculated variance inflation factor for the study.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Micronucleus Test Results
Dose level (mg/kg) |
MN-PCE/1000* |
Pair-wise# |
Survival |
% PCE~ |
0 |
2.50 ± 0.41 |
4/5 |
64.4 |
|
375 |
3.40 ± 0.81 |
0.1363 |
5/5 |
39.5 |
750 |
2.30 ± 0.30 |
0.6076 |
5/5 |
59.0 |
1500 |
2.40 0.51 |
0.5537 |
5/5 |
60.2 |
2000 |
2.60 ± 0.58 |
0.4475 |
5/5 |
47.2 |
* Micronucleated PCEs per 1000 PCE scored (± the standard deviation)
# The value of P for pair-wise comparisons between each treatment group and the concurrent solvent control group (α = 0.05)
~ Percentage of erythrocytes that were polychromatic
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of the study the test material was found to be non-mutagenic. - Executive summary:
The potential genotoxicity and clastogenicity of the test material to the bone marrow cells of male mice in vivo was assessed in a study conducted to a methodology which was similar to that outlined in the standardised guideline with OECD 474. Following a preliminary toxicity test, the top dose of 2000 mg/kg was selected for the micronucleus test (the limit dose recommended by the guideline). Under the conditions of the study the test material was found to be non-genotoxic and non-clastogenic.
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