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EC number: 205-465-5 | CAS number: 141-17-3
- 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 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
- Study period:
- 22 July to 17 August 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Reference Type:
- secondary source
- Title:
- EPA High Production Volume Chemical Challenge Program CAS 141-17-3 adipic acid, bis[2-(2-butoxyethoxy)ethyl] ester
- Author:
- US EPA
- Year:
- 2 011
- Bibliographic source:
- High Production Volume Chemical Challenge Program
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5100 (Escherichia coli WP2 and WP2 UVRA Reverse Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis(2-(2-butoxyethoxy)ethyl) adipate
- EC Number:
- 205-465-5
- EC Name:
- Bis(2-(2-butoxyethoxy)ethyl) adipate
- Cas Number:
- 141-17-3
- Molecular formula:
- C22H42O8
- IUPAC Name:
- bis(2-(2-butoxyethoxy)ethyl) adipate
Constituent 1
Method
- Target gene:
- his operon (Salmonella typhimurium strains); trp operon (E.coli strains)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- 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:
- Preliminary Toxicity Test
0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Experiment 1 and 2
50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethyl sulfoxide
The test material was immiscible in sterile distilled water at 50 mg/mL but was fully miscible in dimethyl sulphoxide at the same concentration.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthtracene (2AA)
- Remarks:
- +S9: 2AA (all strains); -S9: N-ethyl-N-nitro-N-nitrosoguanidine (ENNG), benzo(a)pyrene (BP), 9-aminoacridine (9AA), 4-nitroquinoline-N-oxide (4NQO)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Standard plate incorporation method (experiment 1) and preincubation method (experiment 2)
DURATION
- Preincubation period: 20 min (only exp 2)
- Exposure duration: 48 h at 37 °C (exp 1 and 2)
NUMBER OF REPLICATIONS:
3 replicates/strain
DETERMINATION OF CYTOTOXICITY
Any toxic effects of the test substance would be detected by a substantial reduction in revertant colony counts or by the absence of a complete bacterial lawn. - Evaluation criteria:
- Acceptance Criteria:
The following criteria must be met for acceptance:
- All tester strain cultures must exhibit a characteristic number of spontaneous revertants per plate in vehicle and untreated controls.
- The appropriate characteristics of each tester strain must be confirmed, eg rfa cell-wall mutation and pKM101 plasmid R-factor.
- All tester strain cultures should be in the range of 0.9 to 9.9 x 10^9 bacteria per mL.
- Each mean positive control value should be at least 2x the respective vehicle control value for each strain, thus demonstrating both the intrinsic sensitivity of the tester strains and the integrity of the S9-mix
- The test should include a minimum of four non-toxic dose levels.
Evaluation Criteria:
There are several criteria for determining a positive result. Any, one, or all of the following may be used to determine the overall result of the study:
- A dose-related increase in mutant frequency over the dose range tested.
- A reproducible increase at one or more concentrations.
- The biological relevance against in-house historical control ranges.
- Statistical analysis of data as determined by the UKEMS (Mahon et al., 1989).
- Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Statistics:
- Mean values with standard deviations were calculated.
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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING STUDIES
In order to select appropriate dose levels for use in the main test, a preliminary test were conducted in the presence or absence of metabolic activation. Ten dose levels and controls were tested up to and including 5000 µg/plate at approximately half-log intervals. The assay was conducted by mixing 0.1 mL the bacterial culture (TA 100 or WP2uvrA-), and 0.1 mL of the vehicle or test chemical mixture, 0.5 mL of S9-mix or phosphate buffer and 2.0 mL of molten agar supplemented with trace histidine or tryptophan and overlaying onto sterile plates of Vogel-Bonner Minimal agar (30 mL/plate). After approximately 48 hours incubation at 37 °C, the plates were assessed for numbers of revertant colonies using a Domino colony counter and examined for effects on the growth of the bacterial background lawn. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Numbers of revertant colonies in the preliminary toxicity test
With (+) or without (-) S9-mix | Strain | Dose (µ/plate) | ||||||||||
0 | 0.15 | 0.5 | 1.5 | 5 | 15 | 50 | 150 | 500 | 1500 | 5000 | ||
- | TA 100 | 90 | 88 | 99 | 108 | 113 | 114 | 107 | 86 | 114 | 118 | 113* |
+ | TA 100 | 120 | 112 | 108 | 121 | 100 | 98 | 92 | 96 | 90 | 98 | 105* |
- | WP2 uvrA- | 43 | 40 | 40 | 43 | 48 | 42 | 38 | 38 | 45 | 41 | 42* |
+ | WP2 uvrA- | 47 | 43 | 48 | 43 | 38 | 37 | 42 | 41 | 37 | 38 | 42* |
* Precipitate present
Table 2: Range-finding test without metabolic activation
Revertant colony counts (mean of 3 replicates) | |||||
Test substance concentration (µg/plate) | TA 100 | TA 1535 | WP2 uvrA- | TA98 | TA1537 |
0 | 105 | 19 | 28 | 24 | 13 |
50 | 111 | 16 | 24 | 25 | 10 |
150 | 120 | 14 | 28 | 29 | 12 |
500 | 105 | 15 | 31 | 25 | 11 |
1500 | 109P | 17P | 26P | 28P | 12P |
5000 | 115P | 14P | 30P | 24P | 13P |
ENNG (3) | 497 | ||||
ENNG (5) | 162 | ||||
ENNG (2) | 283 | ||||
4NQO (0.2) | 116 | ||||
9AA (80) | 2530 |
P - precipitate
Abbreviations: ENNG, N-ethyl-N’-nitro-N-nitrosoguanidine; 9AA, 2-aminoacridine; BP, benzo(a)pyrene; 2AA, 2-aminoanthracene; 4NQO, 4- nitroquinoline-1-oxide
Table 3: Range-finding test with metabolic activation
Revertant colony counts (mean 3 replicates) | |||||
Test substance concentration (µg/plate) | TA 100 | TA 1535 | WP2 uvrA- | TA98 | TA1537 |
0 | 115 | 14 | 33 | 29 | 12 |
50 | 98 | 13 | 32 | 27 | 12 |
150 | 109 | 16 | 32 | 30 | 11 |
500 | 99 | 10 | 29 | 29 | 12 |
1500 | 115P | 14P | 31P | 29P | 12P |
5000 | 116P | 14P | 32P | 29P | 14P |
2AA (1) | 801 | ||||
2AA (2) | 292 | 95 | |||
2AA (10) | 130 | ||||
BP (5) | 189 |
P - preicipitate
Table 4: Main Test without metabolic activation
Revertant colony counts (mean 3 replicates) | |||||
Test substance concentration (µg/plate) | TA 100 | TA 1535 | WP2 uvrA- | TA98 | TA1537 |
0 | 117 | 21 | 26 | 34 | 9 |
50 | 115 | 20 | 35 | 27 | 11 |
150 | 117 | 20 | 30 | 27 | 9 |
500 | 115 | 21 | 31 | 30 | 10 |
1500 | 117P | 20P | 31P | 31P | 11P |
5000 | 124P | 18P | 30P | 32P | 7P |
ENNG (3) | 439 | ||||
ENNG (5) | 174 | ||||
ENNG (2) | 182 | ||||
4NQO (0.2) | 122 | ||||
9AA (80) | 730 |
P - precipitate.
Table 5: Main Test with metabolic activation
Revertant colony counts (mean 3 replicates) | |||||
Test substance concentration (µg/plate) | TA 100 | TA 1535 | WP2 uvrA- | TA98 | TA1537 |
0 | 124 | 24 | 41 | 29 | 13 |
50 | 117 | 18 | 38 | 24 | 10 |
150 | 127 | 18 | 36 | 30 | 9 |
500 | 119 | 11 | 34 | 33 | 12 |
1500 | 114P | 13P | 29P | 26P | 10P |
5000 | 130P | 18P | 35P | 22P | 9P |
2AA (1) | 952 | ||||
2AA (2) | 261 | 217 | |||
2AA (10) | 202 | ||||
BP (5) | 309 |
P - precipitate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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