Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-940-1 | CAS number: 112-15-2
- 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:
- key study
- Study period:
- From September 04, 2020 to December 02, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997-07-21, corrected 2020-06-26
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethyl acetate
- EC Number:
- 203-940-1
- EC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Cas Number:
- 112-15-2
- Molecular formula:
- C8H16O4
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Production lot
- Lot/batch number of test material: P230220120
- Expiration date of the lot/batch: 2023-04-29
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool, well ventilated place
- Stability under storage conditions: Stable
- Stability under test conditions: Stable
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : Mitochondrial fraction from liver of male Sprague-Dawley rats treated with Aroclor 1254
- method of preparation of S9 mix: S9 fraction buffered and supplemented with the essential co-factors β-NADP and glucose-6-phosphate to form the S9 mix.
- concentration or volume of S9 mix and S9 in the final culture medium: 5% v/v S9 mix for plate incorporation assay, 10% v/v S9 mix for pre-incubation assay
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): Yes, by supplier. - Test concentrations with justification for top dose:
- Plate incorporation assay: 0.0015 - 5 µLg/plate with and without metabolic activation
Pre-incubation assay: 0.1563 - 5 µLg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Distilled water
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Strain TA1537 in the absence of S9
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Strains TA1535 and TA 100 in the absence of S9
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Strain TA98 in the absence of S9
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Strain TA102 in the absence of S9
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- All strains in the presence of S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Experiment 1: in medium; in agar (plate incorporation); Experiment 2: preincubation
DURATION
- Preincubation period: 30 min at 30 °C (only experiment 2)
- Exposure duration: 96 hours at 37 °C
NUMBER OF REPLICATIONS: triplicates per concentration in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: number of revertants, reduction of background lawn
NUMBER OF REPLICATIONS:
- Number of cultures per concentration: duplicate/triplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): ca 2 x 10E+9 CFU/mL
- Test substance added in medium; in agar (plate incorporation) (1st assay) and pre-incubation (2nd assay)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 minutes
- Exposure duration/duration of treatment: 48 hours
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition (thinning of background lawn) and reduction in number of colonies
METHODS FOR MEASUREMENTS OF GENOTOXICIY
Counting of numbers of revertant colonies - Rationale for test conditions:
- As prescribed by test guidelines
- Evaluation criteria:
- The following criteria were used to determine a valid assay:
Tester Strain Integrity - All tester strain cultures exhibited sensitivity to crystal violet, demonstrating presence of the rfa wall mutation. All tester strains demonstrated a requirement for biotin except strain TA102 which is biotin independent. All tester strains showed sensitivity to UV exposure except TA102 which is wild type. All the tester strains demonstrated a requirement for histidine for their growth. Tester strains TA98, TA100 and TA102 exhibited resistance to ampicillin, demonstrating presence of the pKM101 plasmid. Tester strains TA102 exhibited resistance to tetracycline, demonstrating presence of the pAQ1 plasmid.
The following criteria were used to determine a positive result:
A result was considered positive if a concentration-related increase over the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain, with or without metabolic activation, was seen. - Statistics:
- Mean values and standard deviations were calculated. Simple linear regression analysis was performed fto assess the dose dependent nature of any increase in revertant colonies.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1537
- 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
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- 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
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- 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
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium 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
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- 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
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:TEST-SPECIFIC CONFOUNDING FACTORS
- Possibility of evaporation from medium: No
- Water solubility: Suitable for the assay
- Precipitation: No precipitation occurred up to the limit concentration of 5 µL/plate
STUDY RESULTS
- Concurrent vehicle negative and positive control data : Valid
For all test methods and criteria for data analysis and interpretation:
- Concentration-response relationship where possible : None observed
Ames test:
- Signs of toxicity : Not observed
- Mean number of revertant colonies per plate and standard deviation : See tabulated data
- Positive historical control data: Test data fell within the historical control range
- Negative (solvent/vehicle) historical control data: Test data fell wihin the historical control range
Any other information on results incl. tables
Plate incorporation assay - Mean count of revertant colonies
Concentration (µL/plate) |
His+Revertant Colonies/Plate (Absence of Metabolic Activation) |
|||||||||
TA1537 |
TA1535 |
TA98 |
TA100 |
TA102 |
||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
NC (DW) |
7.00 |
2.83 |
14.00 |
2.83 |
19.00 |
0.00 |
122.00 |
5.66 |
206.00 |
2.83 |
0.0015 |
7.00 |
1.41 |
12.50 |
2.12 |
21.50 |
3.54 |
128.00 |
7.07 |
249.00 |
39.60 |
0.005 |
7.50 |
0.71 |
13.50 |
0.71 |
21.00 |
4.24 |
111.00 |
8.49 |
231.00 |
0.00 |
0.015 |
5.00 |
1.41 |
14.00 |
2.83 |
20.50 |
3.54 |
136.50 |
36.06 |
228.50 |
20.51 |
0.05 |
6.50 |
3.54 |
15.50 |
2.12 |
23.00 |
2.83 |
128.00 |
9.90 |
222.50 |
12.02 |
0.15 |
7.00 |
2.83 |
16.00 |
1.41 |
20.00 |
2.83 |
140.50 |
6.36 |
228.00 |
4.24 |
0.5 |
7.50 |
3.54 |
13.50 |
0.71 |
15.00 |
11.31 |
120.00 |
4.24 |
235.00 |
7.07 |
1.5 |
9.00 |
1.41 |
13.00 |
5.66 |
18.00 |
0.00 |
138.00 |
8.49 |
220.00 |
5.66 |
5 |
6.50 |
0.71 |
13.50 |
0.71 |
14.50 |
7.78 |
126.50 |
2.12 |
219.00 |
19.80 |
PC |
173.00 |
63.64 |
307.00 |
55.15 |
460.00 |
29.70 |
682.50 |
55.86 |
927.50 |
101.12 |
Key: SD = Standard Deviation, NC = Negative Control, DW =Distilled Water, PC = Positive Control {TA1537 = 9-Aminoacridine Hydrochloride Monohydrate (75 µg/plate), TA1535 = Sodium Azide (0.5 µg/plate), TA98 = 2-Nitrofluorene (7.5 µg/plate), TA100 = Sodium Azide (5 µg/plate), TA102 = Mitomycin-C (0.5 µg/plate), 2-Aa = 2-Aminoanthracene (5 µg/plate for TA100)},- = Not Applicable.
Plate incorporation assay - Mean count of revertant colonies
Concentration (µL/plate) |
His+Revertant Colonies/Plate [Presence of Metabolic Activation (5% v/v S9 mix)] |
|||||||||
TA1537 |
TA1535 |
TA98 |
TA100 |
TA102 |
||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
NC (DW) |
8.50 |
0.71 |
16.50 |
4.95 |
25.00 |
4.24 |
137.50 |
3.54 |
225.50 |
21.92 |
0.0015 |
6.50 |
0.71 |
11.00 |
2.83 |
22.50 |
2.12 |
131.50 |
10.61 |
230.00 |
9.90 |
0.005 |
11.50 |
4.95 |
18.00 |
7.07 |
19.00 |
7.07 |
135.00 |
45.25 |
205.50 |
9.19 |
0.015 |
10.50 |
3.54 |
19.00 |
1.41 |
19.50 |
6.36 |
121.50 |
28.99 |
227.50 |
6.36 |
0.05 |
11.00 |
0.00 |
17.00 |
7.07 |
20.00 |
1.41 |
161.50 |
19.09 |
209.50 |
2.12 |
0.15 |
9.50 |
7.78 |
13.50 |
9.19 |
18.00 |
5.66 |
125.00 |
29.70 |
243.50 |
2.12 |
0.5 |
8.00 |
0.00 |
12.50 |
2.12 |
20.00 |
2.83 |
118.00 |
9.90 |
235.50 |
23.33 |
1.5 |
8.50 |
4.95 |
11.00 |
4.24 |
21.00 |
4.24 |
133.00 |
5.66 |
234.50 |
19.09 |
5 |
9.00 |
4.24 |
12.00 |
4.24 |
21.50 |
4.95 |
107.00 |
4.24 |
244.50 |
24.75 |
PC |
242.50 |
3.54 |
270.00 |
12.73 |
676.50 |
94.05 |
688.50 |
78.49 |
947.50 |
99.70 |
Key: SD = Standard Deviation, NC = Negative Control, DW =Distilled Water, PC = Positive control {2Aa = 2-Aminoanthracene (10 µg/plate for TA1537, TA1535, TA102 and 5 µg/plate for TA98 and TA100)}.
Pre-incubation assay - Mean count of revertant colonies
Concentration (µL/plate) |
His+Revertant Colonies/Plate [Absence of Metabolic Activation] |
|||||||||
TA1537 |
TA1535 |
TA98 |
TA100 |
TA102 |
||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
NC (DW) |
8.33 |
3.21 |
16.00 |
1.73 |
23.33 |
1.53 |
125.00 |
17.69 |
235.33 |
17.10 |
0.15625 |
8.67 |
1.15 |
15.33 |
3.06 |
26.33 |
3.06 |
134.33 |
13.05 |
234.33 |
7.37 |
0.3125 |
8.33 |
3.21 |
15.33 |
2.08 |
27.33 |
4.51 |
137.33 |
21.03 |
230.00 |
24.43 |
0.625 |
8.67 |
2.08 |
16.67 |
2.08 |
25.33 |
2.52 |
129.00 |
10.82 |
236.00 |
12.49 |
1.25 |
8.33 |
2.08 |
15.00 |
1.73 |
26.67 |
2.89 |
137.33 |
6.11 |
233.67 |
9.71 |
2.5 |
9.00 |
1.73 |
16.67 |
2.08 |
24.33 |
1.53 |
130.33 |
15.95 |
229.67 |
11.24 |
5 |
8.33 |
1.53 |
15.33 |
1.53 |
26.00 |
3.61 |
135.33 |
11.06 |
241.33 |
11.37 |
PC |
188.33 |
16.01 |
282.00 |
11.36 |
570.67 |
72.60 |
695.33 |
17.79 |
1009.33 |
69.51 |
2Aa |
- |
- |
- |
- |
- |
- |
122.33 |
11.06 |
- |
- |
Key: SD = Standard Deviation, NC = Negative Control, DW =Distilled Water,PC = Positive Control {TA1537 = 9-Aminoacridine Hydrochloride Monohydrate (75 µg/plate), TA1535 = Sodium Azide (0.5 µg/plate), TA98 = 2-Nitrofluorene (7.5 µg/plate), TA100 = Sodium Azide (5 µg/plate), TA102 = Mitomycin-C (0.5 µg/plate)}, 2-Aa = 2-Aminoanthracene (5 µg/plate for TA100),- = Not Applicable.
Pre-incubation assay - Mean count of revertant colonies
Concentration (µL/plate) |
His+Revertant Colonies/Plate [Presence of Metabolic Activation (10% v/v S9 mix)] |
|||||||||
TA1537 |
TA1535 |
TA98 |
TA100 |
TA102 |
||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
NC (DW) |
9.33 |
2.52 |
16.00 |
2.00 |
27.33 |
2.52 |
127.00 |
8.00 |
228.00 |
20.95 |
0.15625 |
9.00 |
1.73 |
15.00 |
1.00 |
24.67 |
3.79 |
127.33 |
15.37 |
232.67 |
8.08 |
0.3125 |
7.00 |
2.65 |
15.33 |
3.06 |
27.33 |
1.53 |
133.67 |
9.61 |
236.67 |
12.42 |
0.625 |
7.67 |
0.58 |
16.00 |
2.65 |
26.67 |
2.52 |
130.67 |
10.02 |
238.00 |
16.09 |
1.25 |
9.33 |
3.06 |
14.67 |
2.08 |
25.33 |
4.04 |
127.67 |
10.50 |
230.33 |
9.71 |
2.5 |
7.67 |
2.08 |
17.00 |
1.00 |
27.33 |
3.79 |
137.67 |
12.22 |
228.67 |
19.43 |
5 |
8.00 |
1.00 |
15.67 |
2.52 |
25.33 |
2.08 |
134.00 |
13.23 |
237.00 |
14.00 |
PC |
170.33 |
16.77 |
283.33 |
26.95 |
508.00 |
42.53 |
551.00 |
32.51 |
1126.67 |
163.52 |
Key: SD = Standard Deviation, NC = Negative Control,DW =Distilled Water,PC = Positive Control{2Aa = 2-Aminoanthracene (10 µg/plate for TA1537, TA1535, TA102 and 5 µg/plate for TA98 and TA100)}.
Applicant's summary and conclusion
- Conclusions:
- The tested substance is non-mutagenic to any strain of Salmonella typhimurium, viz., TA1537, TA1535, TA98, TA100 and TA102, when tested under the specified conditions.
- Executive summary:
The mutagenic activity of 2 -(2 -ethoxyethoxy)ethyl acetate has been evaluated using the bacterial reverse mutation test, on five histidine deficient mutant tester strains of Salmonella typhimurium (TA1537, TA1535, TA98, TA100, and TA102) using methods described by OECD test guidelines.
The substance did not induce any significant increase in the number of revertants, in trials with and without S9 mix, in any tester strain. Values for the negative control were within the historical control ranges of the laboratory. Positive controls showed an increase in the number of revertant colonies, demonstrating the efficiency of the test system.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.