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EC number: 203-794-9 | CAS number: 110-71-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Apr - 29 Apr 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline conform GLP study.
- Justification for type of information:
- Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether, which is tested for its sensitising potential, belong to the glycol ether family. These substances have been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. Due to the fact that Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether have nearly the same chemical structure (especialy with reference to the functional groups):
1. Ethylene glycol dimethyl ether: H3C-O-CH2-CH2-O-CH3
2. Diethylene glycol methyl ethyl ether: H3C-O-CH2-CH2-O-CH2-CH2-O-CH2-CH3
the same mode of interaction with living cells and tissue is expected due to their similar metabolism to the toxic metobolite 2-Methoxyethanol. Therefore, a read-across from Ethylene glycol dimethyl ether to data obtained with Diethylene glycol methyl ethyl ether is scientifically justified.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 13 Apr - 29 Apr 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline conform GLP study.
- Justification for type of information:
- Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether, which is tested for its sensitising potential, belong to the glycol ether family. These substances have been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. Due to the fact that Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether have nearly the same chemical structure (especialy with reference to the functional groups):
1. Ethylene glycol dimethyl ether: H3C-O-CH2-CH2-O-CH3
2. Diethylene glycol methyl ethyl ether: H3C-O-CH2-CH2-O-CH2-CH2-O-CH2-CH3
the same mode of interaction with living cells and tissue is expected due to their similar metabolism to the toxic metobolite 2-Methoxyethanol. Therefore, a read-across from Ethylene glycol dimethyl ether to data obtained with Diethylene glycol methyl ethyl ether is scientifically justified. - Reason / purpose for cross-reference:
- assessment report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 - 25 g
- Housing:single caging
- Diet (e.g. ad libitum): pelleted standard diet (Harlan Laboratories GmbH, 33178 Borchen), ad libidum
- Water (e.g. ad libitum): tap water, (Gemeindewerke, 64380 Rossdorf), ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness will be used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): artificial light 6:00 a.m. - 6:00 p.m.
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, and 100%
- No. of animals per dose:
- 4
- Details on study design:
- In order to study a possible allergenic potential of Diethylenglycol EM, three groups each of four female mice were treated with different concentrations of the test item by topical application at the dorsum of each ear (left and right) on three consecutive days. A control group of four mice was treated with the vehicle only. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a -scintillation counter.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
- Positive control results:
- Experiment performend in November 2009, 5, 10, and 25% alpha-Hexylcinnamaldehyde yielded a S.I. of 1.78, 2.54, and 4.88, respectively. The EC3 value calculated was 12.9%
- Parameter:
- SI
- Value:
- 0.73
- Test group / Remarks:
- 25 % test item concentration
- Parameter:
- SI
- Value:
- 1.03
- Test group / Remarks:
- 50 % test item concentration
- Parameter:
- SI
- Value:
- 0.69
- Test group / Remarks:
- 100 % test item concentration
- Interpretation of results:
- not sensitising
- Conclusions:
- The test item Diethylenglycol EM was not a skin sensitiser under the described conditions.
- Executive summary:
Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether, which is tested for its sensitising potential, belong to the glycol ether family. These substances have been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. Due to the fact that Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether have nearly the same chemical structure (especialy with reference to the functional groups):
1. Ethylene glycol dimethyl ether: H3C-O-CH2-CH2-O-CH3
2. Diethylene glycol methyl ethyl ether: H3C-O-CH2-CH2-O-CH2-CH2-O-CH2-CH3
the same mode of interaction with living cells and tissue is expected due to their similar metabolism to the toxic metobolite 2-Methoxyethanol. Therefore, a read-across from Ethylene glycol dimethyl ether to data obtained with Diethylene glycol methyl ethyl ether is scientifically justified.
The present study (Vogel 2010) analyses the sensitising potential of Diethylenglycol EM
Three groups each of four female mice were treated daily with the test item at concentrations of 25, 50, and 100% (w/v) in acetone:olive oil (4+1) by topical application to the dorsum of each ear (left and right) for three consecutive days. A control group of four mice was treated with the vehicle (acetone:olive oil (4+1)) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of3H-methyl thymidine measured in ab-scintillation counter.
All treated animals survived the scheduled study period and no signs of toxicity were observed.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
In this study Stimulation Indices of 0.73, 1.03, and 0.69 were determined with the test item at concentrations of 25, 50, and 100% in acetone:olive oil (4+1). The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
Test item concentration % (w/v) |
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BGa) |
number of lymph nodes |
DPM per lymph nodeb) |
S.I. |
|||
--- |
BG I |
16 |
--- |
--- |
--- |
--- |
--- |
BG II |
15 |
--- |
--- |
--- |
--- |
--- |
1 |
4826 |
4811 |
8 |
601.3 |
|
25 |
2 |
3520 |
3505 |
8 |
438.1 |
0.73 |
50 |
3 |
4984 |
4969 |
8 |
621.1 |
1.03 |
100 |
4 |
3345 |
3330 |
8 |
416.2 |
0.69 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate 1 = Control Group 2-4 = Test Group S.I. = Stimulation Index
a) = The mean value was taken from the figures BG I and BG II b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
The EC3 value could not be calculated, since all S.I.´s are below 3.
Viability / Mortality: No deaths occurred during the study period.
Clinical Signs: No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
Body Weights: The body weight of the animals, recorded prior to the first application and prior to treatment with3HTdR, was within the range commonly recorded for animals of this strain and age.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-ethoxy-2-(2-methoxyethoxy)ethane
- EC Number:
- 213-690-5
- EC Name:
- 1-ethoxy-2-(2-methoxyethoxy)ethane
- Cas Number:
- 1002-67-1
- Molecular formula:
- C7H16O3
- IUPAC Name:
- 1-ethoxy-2-(2-methoxyethoxy)ethane
- Reference substance name:
- Diethylene glycol methyl ethyl ether
- IUPAC Name:
- Diethylene glycol methyl ethyl ether
- Details on test material:
- Purity: 99.8% (m/m)
Stability in solvent: 24 hours in water, propylene glycol, DMSO, DMF, acetone:olive oil (4+1), and methyl ethyl ketone
Storage: At room temperature
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 - 25 g
- Housing:single caging
- Diet (e.g. ad libitum): pelleted standard diet (Harlan Laboratories GmbH, 33178 Borchen), ad libidum
- Water (e.g. ad libitum): tap water, (Gemeindewerke, 64380 Rossdorf), ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness will be used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): artificial light 6:00 a.m. - 6:00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, and 100%
- No. of animals per dose:
- 4
- Details on study design:
- In order to study a possible allergenic potential of Diethylenglycol EM, three groups each of four female mice were treated with different concentrations of the test item by topical application at the dorsum of each ear (left and right) on three consecutive days. A control group of four mice was treated with the vehicle only. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a -scintillation counter.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
Results and discussion
- Positive control results:
- Experiment performend in November 2009, 5, 10, and 25% alpha-Hexylcinnamaldehyde yielded a S.I. of 1.78, 2.54, and 4.88, respectively. The EC3 value calculated was 12.9%
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.73
- Test group / Remarks:
- 25 % test item concentration
- Parameter:
- SI
- Value:
- 1.03
- Test group / Remarks:
- 50 % test item concentration
- Parameter:
- SI
- Value:
- 0.69
- Test group / Remarks:
- 100 % test item concentration
Any other information on results incl. tables
Test item concentration % (w/v) |
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BGa) |
number of lymph nodes |
DPM per lymph nodeb) |
S.I. |
|||
--- |
BG I |
16 |
--- |
--- |
--- |
--- |
--- |
BG II |
15 |
--- |
--- |
--- |
--- |
--- |
1 |
4826 |
4811 |
8 |
601.3 |
|
25 |
2 |
3520 |
3505 |
8 |
438.1 |
0.73 |
50 |
3 |
4984 |
4969 |
8 |
621.1 |
1.03 |
100 |
4 |
3345 |
3330 |
8 |
416.2 |
0.69 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate 1 = Control Group 2-4 = Test Group S.I. = Stimulation Index
a) = The mean value was taken from the figures BG I and BG II b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
The EC3 value could not be calculated, since all S.I.´s are below 3.
Viability / Mortality: No deaths occurred during the study period.
Clinical Signs: No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
Body Weights: The body weight of the animals, recorded prior to the first application and prior to treatment with3HTdR, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- The test item Diethylenglycol EM was not a skin sensitiser under the described conditions.
- Executive summary:
Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether, which is tested for its sensitising potential, belong to the glycol ether family. These substances have been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. Due to the fact that Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether have nearly the same chemical structure (especialy with reference to the functional groups):
1. Ethylene glycol dimethyl ether: H3C-O-CH2-CH2-O-CH3
2. Diethylene glycol methyl ethyl ether: H3C-O-CH2-CH2-O-CH2-CH2-O-CH2-CH3
the same mode of interaction with living cells and tissue is expected due to their similar metabolism to the toxic metobolite 2-Methoxyethanol. Therefore, a read-across from Ethylene glycol dimethyl ether to data obtained with Diethylene glycol methyl ethyl ether is scientifically justified.
The present study (Vogel 2010) analyses the sensitising potential of Diethylenglycol EM
Three groups each of four female mice were treated daily with the test item at concentrations of 25, 50, and 100% (w/v) in acetone:olive oil (4+1) by topical application to the dorsum of each ear (left and right) for three consecutive days. A control group of four mice was treated with the vehicle (acetone:olive oil (4+1)) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of3H-methyl thymidine measured in ab-scintillation counter.
All treated animals survived the scheduled study period and no signs of toxicity were observed.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
In this study Stimulation Indices of 0.73, 1.03, and 0.69 were determined with the test item at concentrations of 25, 50, and 100% in acetone:olive oil (4+1). The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
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