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EC number: 202-319-2 | CAS number: 94-28-0
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- 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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant OECD guideline study, available as unpublished report, no restrictions, adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- 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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2'-ethylenedioxydiethyl bis(2-ethylhexanoate)
- EC Number:
- 202-319-2
- EC Name:
- 2,2'-ethylenedioxydiethyl bis(2-ethylhexanoate)
- Cas Number:
- 94-28-0
- Molecular formula:
- C22H42O6
- IUPAC Name:
- 2-(2-{2-[(2-ethylhexanoyl)oxy]ethoxy}ethoxy)ethyl 2-ethylhexanoate
- Details on test material:
- - Name of test material (as cited in study report): Eastman TEG-EH
- Description: Eastman(TM) TEG-EH (Triethylene Glycol Bis (2-EthylHexanoate)) Plasticizer
- Physical state: clear colourless liquid
- Specific gravity: 0,968 (20/20C)
- Analytical purity: 99,1% (ester by GC)
- Impurities (identity and concentrations): see confidential details on test material
- Composition of test material, percentage of components: see confidential details on test material
- Purity test date: 2007-07-11
- Lot/batch No.: TD-7022702
- Expiration date of the lot/batch : not provided (production date = 2007-07-11)
- Storage condition of test material: room temperature in the dark
Constituent 1
Method
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: uvrB- Salmonella strains
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: WP2uvrA-
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test material was immiscible in water according to the information provided by the Sponsor. However, the test material was fully miscible in dimethyl sulphoxide at 50 mg/ml in solubility checks performed in-house. Dimethyl sulphoxide was therefore selected as the vehicle.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9-mix
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9-mix
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9-mix
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9-mix
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: approximately 10 hours at 37°C
- Exposure duration: approximately 48 hours at 37°C
NUMBER OF REPLICATIONS: triplicate
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A test material will be considered mutagenic (positive) in the test system if a dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation are observed. Biological relevance of the results will be considered first, however, statistical significance will not be the only determining factor for a positive response.
A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: An oily precipitate was observed at 5000 µg/plate, this did not prevent the scoring of revertant colonies.
RANGE-FINDING/SCREENING STUDIES:
In order to select appropriate dose levels for use in the main test, a preliminary test was carried out to determine the toxicity of the test material. The concentrations tested were 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate. The test material was non-toxic to the strains of bacteria used (TA100 and WP2uvrA-). The test material formulation and S9-mix used in this experiment were both shown to be sterile.
COMPARISON WITH HISTORICAL CONTROL DATA:
Yes
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was, therefore, -tested up to the maximum recommended dose level of 5000 µg/plate. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The mean number of revertant colonies and the standard deviations, for the test material, positive and vehicle controls, both with and without metabolic activation, are presented in Table 1 and Table 2 for Experiment 1 and Table 3 and Table 4 for Experiment 2.
Table 1: Test Results: Experiment 1 – Without metabolic activation
Test period |
From:16 August 2007 |
To:19 August 2007 |
|||||||||
With or without S9-mix |
Test substance cc (µg/plate) |
Mean number (M) of revertant colonies and the standard deviations (SD) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||||
M |
SD |
M |
SD |
M |
SD |
M |
SD |
M |
SD |
||
- |
0 |
101 |
9.6 |
18 |
3.5 |
20 |
3.8 |
20 |
2.1 |
16 |
1.2 |
- |
50 |
112 |
58.6 |
18 |
3.2 |
17 |
1.7 |
18 |
4.4 |
15 |
5.0 |
- |
150 |
105 |
10.0 |
25 |
8.4 |
16 |
5.3 |
21 |
5.5 |
14 |
2.9 |
- |
500 |
98 |
1.5 |
22 |
4.2 |
18 |
3.8 |
19 |
7.2 |
15 |
1.7 |
- |
1500 |
96 |
11.5 |
14 |
6.0 |
17 |
1.5 |
14 |
3.0 |
17 |
3.8 |
- |
5000 |
87 |
18.6 |
17 |
4.2 |
21 |
2.0 |
13 |
3.1 |
13 |
4.0 |
Positive controls - |
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||
Cc (µg/plate) |
3 |
5 |
2 |
0.2 |
80 |
||||||
N° colonies per plate |
480 |
88.0 |
79 |
16.5 |
291 |
47.6 |
435 |
43.5 |
566 |
72.3 |
Table 2: Test Results: Experiment 1 – With metabolic activation
Test period |
From:16 August 2007 |
To:19 August 2007 |
|||||||||
With or without S9-mix |
Test substance cc (µg/plate) |
Mean number (M) of revertant colonies and the standard deviations (SD) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||||
M |
SD |
M |
SD |
M |
SD |
M |
SD |
M |
SD |
||
+ |
0 |
98 |
13.6 |
14 |
0.0 |
26 |
6.8 |
30 |
6.1 |
14 |
2.6 |
+ |
50 |
83 |
13.6 |
11 |
1.5 |
19 |
2.5 |
28 |
3.1 |
17 |
3.2 |
+ |
150 |
82 |
12.9 |
11 |
2.3 |
17 |
6.9 |
27 |
3.5 |
16 |
2.3 |
+ |
500 |
91 |
16.3 |
9 |
1.2 |
20 |
8.1 |
29 |
1.5 |
18 |
2.1 |
+ |
1500 |
92 |
7.4 |
11 |
2.5 |
25 |
5.5 |
22 |
4.6 |
13 |
1.7 |
+ |
5000 |
86 |
16.1 |
14 |
0.6 |
26 |
9.0 |
27 |
3.5 |
13 |
7.8 |
Positive controls + |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
|||||
Cc (µg/plate) |
1 |
2 |
10 |
5 |
2 |
||||||
N° colonies per plate |
559 |
42.9 |
206 |
25.2 |
332 |
20.2 |
252 |
28.4 |
331 |
48.0 |
Table 3: Test Results: Experiment 2 – Without metabolic activation
Test period |
From:23 August 2007 |
To:26 August 2007 |
|||||||||
With or without S9-mix |
Test substance cc (µg/plate) |
Mean number (M) of revertant colonies and the standard deviations (SD) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||||
M |
SD |
M |
SD |
M |
SD |
M |
SD |
M |
SD |
||
- |
0 |
100 |
3.2 |
19 |
4.0 |
21 |
4.9 |
22 |
2.5 |
15 |
3.5 |
- |
50 |
91 |
2.3 |
16 |
2.5 |
18 |
4.4 |
22 |
2.3 |
14 |
1.2 |
- |
150 |
88 |
2.6 |
16 |
1.5 |
21 |
4.2 |
22 |
0.6 |
11 |
2.6 |
- |
500 |
97 |
4.0 |
17 |
1.2 |
19 |
3.5 |
23 |
2.5 |
13 |
1.5 |
- |
1500 |
95 |
9.1 |
17 |
4.2 |
24 |
4.9 |
18 |
2.9 |
14 |
0.6 |
- |
5000 |
74 |
3.1 |
17 |
2.6 |
21 |
0.6 |
23 |
3.1 |
14 |
1.5 |
Positive controls - |
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||
Cc (µg/plate) |
3 |
5 |
2 |
0.2 |
80 |
||||||
N° colonies per plate |
662 |
25.7 |
303 |
6.7 |
614 |
25.7 |
367 |
61.5 |
653 |
20.1 |
Table 4: Test Results: Experiment 2 – With metabolic activation
Test period |
From:23 August 2007 |
To:26 August 2007 |
|||||||||
With or without S9-mix |
Test substance cc (µg/plate) |
Mean number (M) of revertant colonies and the standard deviations (SD) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||||
M |
SD |
M |
SD |
M |
SD |
M |
SD |
M |
SD |
||
+ |
0 |
99 |
2.5 |
15 |
0.6 |
27 |
2.5 |
22 |
4.5 |
12 |
5.6 |
+ |
50 |
91 |
14.6 |
12 |
1.5 |
28 |
3.8 |
20 |
2.6 |
13 |
9.2 |
+ |
150 |
87 |
4.2 |
15 |
0.6 |
24 |
4.0 |
22 |
3.0 |
7 |
3.8 |
+ |
500 |
92 |
12.5 |
12 |
3.0 |
23 |
6.8 |
22 |
4.4 |
7 |
3.1 |
+ |
1500 |
88 |
10.1 |
13 |
2.5 |
22 |
5.5 |
21 |
3.5 |
10 |
3.5 |
+ |
5000 |
94 |
11.7 |
12 |
0.6 |
24 |
2.1 |
21 |
2.6 |
8 |
1.5 |
Positive controls + |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
|||||
Cc (µg/plate) |
1 |
2 |
10 |
5 |
2 |
||||||
N° colonies per plate |
684 |
18.0 |
200 |
35.0 |
432 |
26.6 |
230 |
26.1 |
175 |
9.5 |
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO: 4-Nitroquinoline-l-oxide
9AA: 9-Aminoacridine
2AA: 2-Aminoanthracene
BP: Benzo(a)pyrene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material was considered to be non-mutagenic under the conditions of this test. - Executive summary:
Salmonella trphimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA were treated with solutions of the test material using the Ames plate incorporation method at five dose levels, in triplicate, both with and without the addition of a rat
liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range was determined in a preliminary toxicity assay and was 50 to 5000 µg/plate in the first experiment.The experiment was repeated on a separate day using the same dose range as Experiment 1, fresh cultures of the bacterial strains and fresh test material formulations.
The vehicle (dimethyl sulphoxide) and positive controls were valid. The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate. An oily precipitate was observed at 5000 µg/plate, this did not prevent the scoring of revertant colonies. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.
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