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EC number: 203-940-1 | CAS number: 112-15-2
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- Endpoint summary
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- 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
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- 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

Endpoint summary
Administrative data
Description of key information
Skin irritation: not irritating
Eye irritation: irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 May - 18 May 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: Small White Russian (Chbb-SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 - 2.7 kg
- Housing: individually in stainless steel cages
- Diet: K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, Soest, Germany; ad libitum
- Water: tap water; ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated sites served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL on an approx. 6 cm² area of the skin - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 10 days
Reading time points: 1, 24, 48, and 72 h and 6, 8, and 10 days after application - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Test site preparation: Approx. 24 h before application, the dorsal and lateral parts of the trunk were clipped (10 x 10 cm).
- Area of exposure: approx. 6 cm² (2.5 x 2.5 cm)
- Type of wrap if used: gauze patch fixed with an elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, substance residues were washed off softly with warm water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize Scoring System - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Only very slight effects (max. score = 1) were observed throughout the study. No edema were seen with the exception of animal #1 at the 1-hour reading. Slight erythema were seen in two animals 1 hour after application which were fully reversible within 72 h and 8 days, respectively.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
Acute dermal irritation has been investigated in the rabbit. Minor irritation was observed which was not of sufficient severity to require classification.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 May - 11 Sep 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1987
- Deviations:
- yes
- Remarks:
- (simultaneous testing of 6 animals, no data on intactness of the eyes before application)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: Small White Russian (Chbb-SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: individually in stainless steel cages
- Diet: K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, Soest, Germany; ad libitum
- Water: tap water; ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye of each animal served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- one single application
- Observation period (in vivo):
- 21 days
Reading time points: 1, 24, 48, and 72 h and 6, 8, 10, 13, 17, and 21 days after application - Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, the treated eyes were instilled with Na-fluorescein solution to assess corneal damage followed by washing with water.
- Time after start of exposure: 72 hours
SCORING SYSTEM: Draize Scoring System
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effects at any reading time point
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: still circumcorneal injections after 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: circumcorneal injections at day 6-8
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: circumcorneal injections at day 6
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The scores were decreasing during the study and lasted until day 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The scores were decreasing during the study and lasted until day 17
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The scores were decreasing during the study and lasted until day 17
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The scores were decreasing during the study and lasted until day 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The scores were decreasing during the study and lasted until day 17
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritant / corrosive response data:
- All effects decribed below were already present at the 1-h scoring. Slight corneal opacity (score 1 - 2) was present in all animals which was reversible within 8 days in 5/6 animals. Slight effects on iris (score = 0 - 1) were observed in 5/6 animals, that were fully reversible within 2-10 days in 4 animals. Conjunctival redness (scores = 3) and swelling (scores = 1 - 2) was seen in all animals and lasted until day 17 and day 10 in 3/6 animals, respectively. Exudate formation at 24 - 72 h after application was observed in 2/6 animals. Thus, at day 21 effects were still seen in only 1/6 animal.
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Eye irrit 2, H319
DSD: Xi, R36 - Executive summary:
Acute eye irritation has been investigated in the rabbit. Irritation was observed of sufficient severity and duration to require classification.
Reference
Table 1 . Results of study.
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
redness |
swelling |
||||
1 |
1 |
3 |
2 |
0 |
1 |
24 |
3 |
1 |
0 |
2 |
|
48 |
3 |
1 |
0 |
1 |
|
72 |
3 |
1 |
0 |
1 |
|
average |
3.0 |
1.0 |
0.0 |
1.3 |
|
2 |
1 |
3 |
2 |
0 |
1 |
24 |
3 |
2 |
1 |
2 |
|
48 |
3 |
2 |
1 |
2 |
|
72 |
3 |
2 |
0 |
2 |
|
average |
3 |
2 |
0.7 |
2 |
|
3 |
1 |
3 |
2 |
0 |
1 |
24 |
3 |
2 |
0 |
2 |
|
48 |
3 |
2 |
1 |
2 |
|
72 |
3 |
2 |
0 |
2 |
|
average |
3 |
2 |
0.3 |
2 |
|
4 |
1 |
3 |
2 |
0 |
1 |
24 |
3 |
2 |
1 |
1 |
|
48 |
3 |
1 |
0 |
1 |
|
72 |
3 |
1 |
0 |
2 |
|
average |
3 |
1.3 |
0.3 |
1.3 |
|
5 |
1 |
3 |
1 |
0 |
1 |
24 |
3 |
1 |
0 |
1 |
|
48 |
3 |
1 |
0 |
1 |
|
72 |
3 |
1 |
0 |
1 |
|
average |
3 |
1 |
0 |
1 |
|
6 |
1 |
3 |
2 |
0 |
1 |
24 |
3 |
2 |
0 |
1 |
|
48 |
3 |
1 |
0 |
1 |
|
72 |
3 |
2 |
0 |
1 |
|
average |
3 |
1.7 |
0 |
1 |
|
|
|
||||
Time [h] |
conjunctivae |
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average |
1 |
3.00 |
1.83 |
0.00 |
1.00 |
24 |
3.00 |
1.67 |
0.33 |
1.50 |
|
48 |
3.00 |
1.33 |
0.33 |
1.33 |
|
72 |
3.00 |
1.50 |
0.00 |
1.50 |
|
24+48+72 |
3.00 |
1.50 |
0.22 |
1.44 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation/corrosion
The skin irritation properties of 2-(2-ethoxyethoxy)ethyl acetate were tested in a study according to OECD guideline 404 (Mürmann, 1990). In the study, 3 male Small White Russian rabbits were exposed to 0.5 mL of the unchanged test substance, applied to the shaved skin for 4 h using a semiocclusive dressing. The treated skin was observed and evaluated at 1, 24, 48 and 72 h post-application.
Very slight erythema was observed in 2/3 animal being reversible within 6 days h (mean erythema score out of all 3 animals over 24, 48 and 72 h: 0.6). Very slight edema was observed in one animal after 1 h, only.
Thus, no skin irritating properties of 2-(2-ethoxyethoxy)ethyl acetate were apparent.
Eye Irritation/corrosion
The eye irritation properties of 2-(2-ethoxyethoxy)ethyl acetate were tested in a study according to OECD guideline 405 (Mürmann, 1990). In a group of 6 rabbits Small White Russian rabbits, 0.1 mL of the test substance was applied into the eye. Observation of the eyes was performed 24, 48 and 72 h and 6, 8, 10, 13, 17 and 21 days after application.
Slight to moderate corneal opacity was observed in 6/6 animals with a mean cornea score of 1.44 over 24, 48 and 72 h out of all animals. Corneal opacity was fully reversible in 5/6 animals within 8 and 10 days. One animal showed opalescent areas after 21 days. Iritis was observed after 24 and 48 h in 2/6 animals and in 3/6 and 2/6 animals after 6 and 8 days, respectively. The resulting mean score over 24, 48 and 72 h. Iritis was fully reversible 5/6 animals within 10 and 13 days. One animal showed circumconreal injections after 21 days. After 1, 24, 48 and 72 h conjunctival redness was observed in 6/6 animals resulting in a mean score of 3 over 24, 48 and 72 h out of all 6 animals. Redness was fully reversible in 5/6 animals within 21 days. In one animal, moderate redness was still persistent after 21 days. Chemosis was observed in 6/6 animals after 24, 4 and 72 h being fully reversible within 72 h in 5/6 animals. Chemosis was still observed in 1 animal, being still apparent after 21 days.
Thus, the results show that only one single animal did not recover. In all other animals effects were fully reversible. The study report did not include a description of a pre-test to exclude potential pre-existing damage to the cornea of the animal. Therefore, the effects seen in this animal were regarded as an outliner. In addition, mean scores out of the remaining five animals as well as out of all six animals did not meet the criteria for classification as corrosive. Thus, under the experimental conditions described, it was concluded, that evidence of eye irritation was seen after treatment with 2-(2-ethoxyethoxy)ethyl acetate (CAS 112-15-2). Thus, the substance does meet the criteria for classification according to Regulation (EC) 1272/2008 and Directive 67/548/EEC, to have the potential to induce reversible eye irritation and is classified in Category 2.
In addition, the eye irritation properties of 2-(2-ethoxyethoxy)ethyl acetate were tested in an in-vivo study applying differing volumes of the undiluted test substance to rabbit eye (Carpenter, 1946). In groups of 5 albino rabbits (no further information given), 0.5 mL of the undiluted test substance were applied in a single application without washing. The eyes were observed and reactions were evaluated 18-24 h after application. The individual numerical scores of each eye treated with a given volume or concentration of a chemical are added together and then divided by the number of eyes to obtain the score of the injury caused by the treatment. The Grade of 5 was selected as representative of severe injury. This figure corresponded to necrosis, visible after staining and covering about 3/4 of the surface of the cornea; or a more severe necrosis covering a smaller area. The injury grade, after application of 0.5 mL of the undiluted test substance resulted in a calculated score of >1 - ≤ 5 out of five eyes after 18-24 h. This corresponds to a Grade 2 out of 10 injury grade levels. Thus, under the experimental conditions described, the authors concluded, that there was no evidence of irreversible effects on the eye after treatment with 2-(2-ethoxyethoxy)ethyl acetate (CAS 112-15-2).
Conclusion for skin and eye irritation
In conclusion, no evidence of skin irritation properties were seen after treatment with 2-(2-ethoxyethoxy)ethyl acetate (CAS 112-15-2).
Under the experimental conditions described, it was concluded, that evidence of reversible eye irritation was seen after treatment with 2-(2-ethoxyethoxy)ethyl acetate (CAS 112-15-2).
Justification for classification or non-classification
The available data on skin irritation properties of 2-(2-ethoxyethoxy)ethyl acetate (CAS 112-15-2) do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and the data are therefore conclusive but not sufficient for classification.
The available data on eye irritation properties of 2-(2-ethoxyethoxy)ethyl acetate (CAS 112-15-2) do meet the classification criteria for Eye irritation Category 2 (H319) according to Regulation (EC) 1272/2008 and for R36 (Irritating to eyes) according to Directive 67/548/EEC.
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