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EC number: 203-090-1 | CAS number: 103-23-1
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Remarks:
- Litton Bionetics Inc.
- Type of assay:
- bacterial reverse mutation 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
- Details on test material:
- - Name of test material (as cited in study report): DEHA
- Physical state: clear colourless liquid
- Lot/batch No.: 6109
Constituent 1
Method
- Target gene:
- Histidine operon: his C, D and G.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: lipopolysaccharide coat deficient. For TA98 and TA100, the strain contains a resistent transfer factor plasmid pKM101.
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- other: lipopolysaccharide coat deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix activation system
- Test concentrations with justification for top dose:
- 7 doses of 0.15 µl to 150 µl per plate. The assays were conducted using three plates per dose level.
- Vehicle / solvent:
- Solvent used: N,N Dimethyl Formamide.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: As positive control for nonactivation for strains TA-1535 and TA-100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: As positive control for nonactivation for strains TA-1538 and TA-98.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: As positive control for nonactivation for strain TA-1537.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine as positive control for activation of all strains
- Details on test system and experimental conditions:
- Media:
The bacterial strains were cultured in Oxoid Media #2 (nutrient Broth). The selective medium was Vogel Bonner Medium E with 2% glucosel. The overlay agar consisted of 0.6% purified agar with 0.5 mM histidine, 0.05 mM biotin and 0.1 M NaCl.
Determination of cytotoxicity:
To a sterile test tube containing 2.0 ml of overlay agar (placed in a 43ºC-45ºC water bath) the following was added:
* 0.1 ml to 0.2 ml of a solution of the test material to give the appropriate dose.
* 0.2 ml of 10-6 dilution of overnight culture.
* 0.5 ml of 0.2M phosphate buffer, pH 7.4.
This mixture was swirled gently and then poured on to nutrient agar plates. After the overlay agar was set, the plates were incubated at 37ºC for approximately 24 hours. The number of colonies growing an the plates were counted and recorded.
Mutagenicity testing:
Nonactivation assay:
To a sterile 13 x 100 mm test tube placed in a 43ºC water bath the following was added in order:
(a) 2.00 ml of 0.6% agar containing 0.05 mM histidine and 0.05 mM biotin.
(b) 0.05 ml of a solution of the test chemical to give the appropriate dose.
(c) 0.1 ml - 0.2 lnl of indicator organism(s).
(d) 0.50 ml of 0.2M phosphate buffer, pH 7.4.
This mixture was swirled gently and then poured onto minimal agar plates. After the top agar has set, the plates were incubated at 37ºC for approximately 2 days. The number of his+ revertant colonies growing on the plates was counted and recorded.
Activation assay:
The activation assay was run concurrently with the nonactivation assay. The only difference was the addition of 0.5 ml of S9 mix to the tubes in place of 0.5 ml of phosphate buffer which is added in nonactivation assays. All other details are similar to the procedure for nonactivation assays. - Evaluation criteria:
- Evaluation criteria for Ames Assay:
Because the procedures used to evaluate the mutagenicity of the test material were semiquantitative, the criteria used to determine positive effects were inherently subjective and were based primarily on a historical data base. Most data sets were evaluated using the following criteria:
(1) Strains TA-1535, TA-1537 and TA-1538
If the solvent control value was within the normal range, a test material producing a positive response equal to three times the solvent control value was considered mutagenic.
Strains TA-98 and TA-100
Il the solvent control value was within the normal range, a test material producing a positive response equal to twice the solvent control value for TA-98 and TA-100 was considered mutagenic. The following normal range of revertants for solvent controls were generally considered acceptable:
TA-1535: 8-30
TA-1537: 4-30
TA-1538: 10-35
TA-98: 20-75
TA-100: 80-250 - Statistics:
- Statistical methods were not currently used, and evaluation was based on the criteria included in the protocol.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- No significant toxicity was observed at doses ranging from 0.02 µl to 150 µl per plate using strain TA-100.
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- No significant toxicity was observed at doses ranging from 0.02 µl to 150 µl per plate using strain TA-100.
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test material Di-2-ethyl hexyl adipate (DEHA) did not exhibit genetic activity in any of the assays conducted in this evaluation and was considered not mutagenic under these test conditions according to the evaluation criteria.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
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