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EC number: 219-411-3 | CAS number: 2432-87-3
- 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity Testing of Di (2- ethylhexyl)phthalate and Related Chemicals in Salmonella
- Author:
- Errol Zeiger, Steve Haworth, Kristien Mortelmans, and William Speck
- Year:
- 1 985
- Bibliographic source:
- Environmental Mutagenesis 7:213-232 (1985)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Bacterial reverse mutation assay was performed for the test chemical Di(2-ethylhexy1)adipate using Salmonella typhimurium strain TA100, TA1535, TA98, TA1537 with and without metabolic activation system
- GLP compliance:
- not specified
- 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: Di(2-ethylhexy1)adipate
- Molecular formula: C22H42O4
- Molecular weight: 370.57 g/mol
- Substance type: Organic
- Physical state: No data
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Di(2-ethylhexy1)adipate
- Molecular formula: C22H42O4
- Molecular weight: 370.57 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: Analyzed purity: 97.6 %
- Impurities (identity and concentrations): No data
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver homogenates (S-9 fraction) from Aroclor 1254-induced male Sprague-Dawley rats (RLI) or male Syrian hamsters (HLI)
- Test concentrations with justification for top dose:
- Lab 1: 0, 100, 333, 1000, 3333 or 10000 µg/plate
Lab 2: 0, 100, 333, 1000, 3333 or 10000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Lab 1: ET95 and Lab 2: DMSO
- Justification for choice of solvent/vehicle: Chemical solubility in respective solvents mentioned
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Lab 1: ET95 and Lab 2: DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine (for TA98; without S9) and 2-amino-anthracene (2 AA; with S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: All tests were repeated atleast once
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- A mutagenic response was defined as a reproducible, dose-related increase in the number of histidine-independent colonies over the spontaneous incidence; there was no requirement for a specific magnitude of increase.
- Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA100, TA1535, TA98, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: The final dose level selection was based on the results of a preliminary range-finding study conducted with TA100 in the presence and absence of S-9.
COMPARISON WITH HISTORICAL CONTROL DATA: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table: Mutagenic behavior of Di (2-ethylhexyl)adipate
Lab 1: Solvent ET95
Doseµg/plate |
TA100 |
TA1535 |
||||||||||
NA |
10% HLI |
10% RLI |
NA |
10% HLI |
10% RLI |
|||||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
115 |
5.5 |
82 |
11.5 |
140 |
4.1 |
19 |
1.8 |
14 |
3.5 |
16 |
2.6 |
100 |
110 |
5.7 |
113 |
5.8 |
136 |
3.3 |
23 |
2.5 |
14 |
0.9 |
17 |
0.7 |
333 |
117 |
10.1 |
116 |
5.5 |
132 |
7.5 |
21 |
3.2 |
11 |
2.0 |
21 |
0.3 |
1000 |
119 |
6.4 |
107 |
5.3 |
128 |
5.9 |
20 |
1.7 |
19 |
2.4 |
20 |
1.9 |
3333 |
122 |
10.1 |
114 |
10.8 |
123 |
8.9 |
19 |
3.2 |
15 |
3.7 |
17 |
0.3 |
10000 |
109 |
13.0 |
108 |
15.1 |
129 |
6.7 |
17 |
3.8 |
14 |
2.2 |
19 |
1.3 |
Pos |
2060 |
34.4 |
1093 |
6.8 |
1045 |
21.6 |
1331 |
34.8 |
108 |
8.7 |
64 |
4.5 |
Doseµg/plate |
TA1537 |
TA98 |
||||||||||
NA |
10% HLI |
10% RLI |
NA |
10% HLI |
10% RLI |
|||||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
6 |
2.2 |
5 |
2.4 |
8 |
0.9 |
28 |
1.7 |
23 |
1.0 |
30 |
3.8 |
100 |
8 |
0.7 |
8 |
1.2 |
9 |
2.3 |
26 |
1.0 |
24 |
1.5 |
30 |
3.1 |
333 |
7 |
0.6 |
5 |
0.3 |
5 |
1.0 |
21 |
2.1 |
30 |
0.6 |
28 |
4.0 |
1000 |
8 |
3.1 |
9 |
1.7 |
7 |
1.2 |
27 |
1.2 |
30 |
4.6 |
34 |
2.3 |
3333 |
8 |
1.5 |
6 |
1.5 |
6 |
0.3 |
26 |
2.2 |
29 |
1.5 |
28 |
2.0 |
10000 |
6 |
1.5 |
7 |
1.8 |
6 |
2.4 |
24 |
3.8 |
31 |
1.5 |
25 |
2.7 |
Pos |
422 |
92.9 |
111 |
7.0 |
122 |
1.5 |
1957 |
85.7 |
1008 |
13.3 |
847 |
33.9 |
Lab 2: Solvent DMSO
Doseµg/plate |
TA100 |
TA1535 |
||||||||||
NA |
10% HLI |
10% RLI |
NA |
10% HLI |
10% RLI |
|||||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
81 |
11.2 |
133 |
8.7 |
93 |
4.2 |
9 |
2.3 |
14 |
0.6 |
9 |
1.7 |
100 |
91 |
10.5 |
84 |
4.1 |
90 |
6.7 |
8 |
0.3 |
8 |
0.0 |
11 |
3.0 |
333 |
79 |
3.2 |
94 |
9.1 |
80 |
3.7 |
8 |
0.9 |
5 |
0.3 |
10 |
2.5 |
1000 |
83 |
3.8 |
92 |
5.5 |
89 |
10.2 |
10 |
2.2 |
7 |
0.9 |
6 |
1.5 |
3333 |
74 |
3.8 |
89 |
10.1 |
86 |
2.8 |
11 |
2.6 |
5 |
0.9 |
7 |
2.7 |
10000 |
70p |
6.3 |
86p |
3.8 |
87p |
3.2 |
11p |
1.5 |
4p |
0.6 |
5p |
1.8 |
Pos |
458 |
10.7 |
1161 |
10.3 |
553 |
5.5 |
375 |
4.9 |
315 |
3.8 |
271 |
15.5 |
Doseµg/plate |
TA1537 |
TA98 |
||||||||||
NA |
10% HLI |
10% RLI |
NA |
10% HLI |
10% RLI |
|||||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
11 |
2.2 |
13 |
3.8 |
5 |
0.6 |
11 |
3.3 |
118 |
1.7 |
17 |
1.5 |
100 |
6 |
1.5 |
7 |
0.9 |
8 |
3.3 |
16 |
1.2 |
18 |
3.5 |
23 |
5.2 |
333 |
5 |
1.5 |
6 |
0.7 |
6 |
1.2 |
15 |
1.7 |
19 |
3.5 |
23 |
4.7 |
1000 |
9 |
2.0 |
8 |
0.9 |
7 |
1.2 |
10 |
1.8 |
18 |
1.5 |
21 |
3.9 |
3333 |
7 |
2.4 |
7 |
0.9 |
7 |
0.9 |
8 |
2.3 |
19 |
0.6 |
15 |
1.0 |
10000 |
6p |
1.3 |
4p |
0.3 |
7p |
1.2 |
14p |
2.7 |
16p |
0.7 |
16p |
0.9 |
Pos |
63 |
7.8 |
348 |
4.0 |
311 |
10.5 |
498 |
19.7 |
864 |
46.7 |
320 |
18.8 |
Applicant's summary and conclusion
- Conclusions:
- Di(2-ethylhexy1)adipate did not induce mutation in the Salmonella typhimurium strain TA100, TA1535, TA98, TA1537 with and without rat and hamster liver S9 mix in both lab 1 and lab 2 study and hence is negative for gene mutation in vitro.
- Executive summary:
Bacterial reverse mutation assay was performed for the test chemical Di(2-ethylhexy1)adipate using Salmonella typhimurium strains TA100, TA1535, TA98, TA1537 with and without rat and hamster liver S9 mix. The test chemical was dissolved in ET95 (lab 1) and DMSO (lab 2). The study was performed using the preincubation protocol at five dose levels of 0, 100, 333, 1000, 3333 or 10000µg/plate (lab 1 and 2) with incubation period of 48 hrs in the presence and absence of S9 mix.The final dose level selection was based on the results of a preliminary range-finding study conducted with TA100 in the presence and absence of S-9. No mutagenic response was noted for the test compound in the preliminary dose range finding study and the main study performed.
Di(2-ethylhexy1)adipate did not induce mutation in the Salmonella typhimurium strain TA100, TA1535, TA98, TA1537 with and without rat and hamster liver S9 mix in both lab 1 and lab 2 study and hence is negative for gene mutation in vitro.
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