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EC number: 219-280-2 | CAS number: 2402-58-6
- 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 cytogenicity / chromosome aberration study in mammalian cells
- 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: Acceptable, well-documented study report which meets basic scientific principles (NTP study type).
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Chromosome Aberrations and Sister Chromatid Exchanges in Chinese Hamster Ovary Cells: Evaluations of 108 Chemicals
- Author:
- Galloway, S.M. et al.
- Year:
- 1 987
- Bibliographic source:
- Environmental and Molecular Mutagenesis 10(10):1-175
- Reference Type:
- secondary source
- Title:
- Diesters Category of the Aliphatic Esters Chemicals (Test Plan and Robust Summaries for Substances in the HPV Test Plan)
- Author:
- US-EPA (American Chemistry Council's Aliphatic Esters Panel)
- Year:
- 2 010
- Bibliographic source:
- High Production Volume (HPV) Chemical Challenge Program (201-16837A and 201-16837B)
- Reference Type:
- secondary source
- Title:
- Bis(2-ethylhexyl)adipate (DEHA) CAS N°: 103-23-1
- Author:
- OECD
- Year:
- 2 000
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 10; Tokyo, Japan, 15-17 March 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- (no duplicate culture; no data on cytotoxicity; differing tretament times; no continuous treatment; sampling time not equivalent to about 1.5 normal cell cycles; no data on gaps and gaps are not included in analysis)
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
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
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Details on test material:
- - Name of test material (as cited in study report): Di(2-ethylhexyl)adipate, DEHA
- Analytical purity: no data
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- other: cloned Chinese hamster ovary cells (CHO-W-B1)
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
Mc-Coy's 5a medium with 10% fetal calf serum, L-glutamine and antibiotics
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 40, 130, 400 µg/mL with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water, DMSO, ethanol or acetone in that order of preference
- Justification for choice of solvent/vehicle: depending on solubility
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: triethylenemelamine (TEM, 0.15 µg/mL) (without S9) and cyclophosphamide (CP, 15 µg/mL) (with S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 14 hours without metabolic activation, 2 hours with metabolic activation
- Fixation time (start of exposure up to fixation or harvest of cells): 14 hours
SPINDLE INHIBITOR (cytogenetic assays): colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: Results of one experiment are reported.
NUMBER OF CELLS EVALUATED: 100 cells per dose from each of the three highest dose groups having sufficient metaphases for analysis
DETERMINATION OF CYTOTOXICITY
- Method: cell monolayer confluence and mitotic activity, cell cycle delay
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes - Evaluation criteria:
- The analysis examined the evidence for a dose relation and the absolute increase over the solvent control at each dose. All types of aberrations were recorded seperately, but for data analysis they were grouped into categories of "simple" (breaks and terminal deletions), "complex" (exchanges and rearrangements), "other" (includes puleverized chromosomes) and "total". Gaps and endoreplications were recorded but were not included in the totals. Aberrations and polyploid cells were not scored but metaphases with 19-23 chromosomes were used.
A decision scheme was used to combine the results of the trend test with the evaluation at individual doses for aberration analyses. A test with one dose that is positive but without a positive trend test is considered “?”. The designation “weak-positive’’ (“ + w”) was used in cases for which there was weak evidence for a positive response and is not an indication of potency. However, if there was a very strong trend as a result of a large increase in aberrations at a single dose, we called the result ‘‘w + *” to denote the fact that the level of aberrations was high (see decision table under Any other information on material and methods including tables). - Statistics:
- Linear regression analysis of the percentage of cells with aberrations vs the log-dose was used as the test for trend. To examine absolute increases over control levels at each dose, a binominal sampling assumption (as opposed to Poison) was used, and the test was that described by Margolin et al. (1983). The p values were adjusted by Dunnett's method to take into account the multiple dose comparisons. For data analysis, the "total" aberration category was used, and the criterion for a positive response was that the adjusted P value be < 0.05.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: Initially, dose selection was based on a preliminary growth inhibition test in which cells that excluded trypan blue were counted 24 hours after treatment. The top doses selected for the cytogenetic assay were those estimated to reduce growth by 50%. This approach was subsequently modified such that toxicity estimates were made from observations of cell monolayer confluence and mitotic activity in the same cultures used for analyses of aberration. The aim was to obtain results at the highest dose at which sufficient metaphase cells would be available for analysis. Observations on cell growth and cell cycle kinetics from the SCE test were also used to select the doses and fixation times for the chromosome aberration tests.
COMPARISON WITH HISTORICAL CONTROL DATA: not included in statistical analysis due to variability from day to day and from reader to reader, control data were however valuable in forming the decision scheme for data evaluation and are useful in deciding wether to repeat an assay - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table2a: CA results - Short Overview
|
-S9 |
+S9 |
Summary |
Result |
+W |
- |
+W |
Range |
40 - 400 |
40 - 400 |
|
LEC |
400 |
- |
|
Least Effect Concentration tested (LEC) is 400 µg/mL which is the highest concentration tested. This concentration showed a high trend but due primarily to a statistically significant increase at this single dose.
Table2b: CA results - Detailed overview
without S9 mix |
||||
DOSE |
Cells |
Percent cells with aberrations |
||
(µg/mL) |
|
Total |
Simple |
Complex |
0.0 |
100 |
1 |
1 |
0 |
40.0 |
100 |
3 |
2 |
1 |
130.0 |
100 |
4 |
2 |
2 |
400.0 |
100 |
7* |
5 |
2 |
positive control - TEM |
||||
0.15 |
100 |
28 |
18 |
15 |
|
||||
with S9 |
||||
0.0 |
100 |
2 |
2 |
0 |
40.0 |
100 |
5 |
5 |
0 |
130.0 |
100 |
5 |
5 |
0 |
400.0 |
100 |
6 |
5 |
1 |
positive control CP |
||||
15.0 |
100 |
35 |
18 |
22 |
|
*In the tables, any value significantly greater than the concurrent control (Dunnett's adjusted P < 0.05) is marked with an asterisk.
Simple: breaks and terminal deletions
Complex: exchanges and rearrangements
Total: sum of all types of aberrations (simple + complex + other); Gaps and endoreduplications were recorded but were not included in the totals.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive without metabolic activation
negative with metabolic activation
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