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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 242-901-3 | CAS number: 19234-20-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 24 April 2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- (Aug 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147 (adopted 2002)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, London, UK
Test material
- Reference substance name:
- 2-(1-methylethoxy)ethyl acetate
- EC Number:
- 242-901-3
- EC Name:
- 2-(1-methylethoxy)ethyl acetate
- Cas Number:
- 19234-20-9
- Molecular formula:
- C7H14O3
- IUPAC Name:
- 2-(propan-2-yloxy)ethyl acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 57033
- Expiration date of the lot/batch: 25 November 2014
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Details on strain: Hsdlf:NZW
- Source: Harlan Laboratories UK Ltd. Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.33-2.66 kg
- Housing: individually in suspended cages
- Diet: 2930C Teklad Global Rabbit diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period:at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the adjacent eye of the same animal served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 1 single application
- Observation period (in vivo):
- 7 days (reading time points: directly after application, 1, 24, 48, and 72 hours and 7 days thereafter)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize Scoring System
Additionally, a modified version of the system (Kay and Calandra (1962), J. Soc. Chem. 13: 281-289) was used to classify the ocular irritancy potential of the test item. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The scores for cornea, iris and conjunctivae were calculated as follows:
Conjunctivae total score = (redness score + chemosis score + discharge score) x 2
Iris score = iris score x 5
Cornea score = (degree of opacity x area of cornea involved) x 5
TOOL USED TO ASSESS SCORE: standard ophthalmoscope
OTHER
Body weights were recorded on day 0 and at the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: revrsibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of animal #1 and #2
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 h after treatment: score = 2 in both animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 h after treatment: score = 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of animal #1 and #2
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 h after treatment: score = 2 in both animals
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 h after treatment: score = 2
- Irritant / corrosive response data:
- No effects on cornea and iris were observed during the study. All animals showed conjunctival redness and swelling (score = 2) at the 1 h reading. The effects were attenuated within 24 to 72 h and were fully reversible within 72 h in animal #1 and within 7 days in animal #2 and #3.
- Other effects:
- All animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 1: Eye irritation – Details on result
Animal # |
Time after treatment |
Cornea |
Iris |
Conjunctival redness |
Chemosis |
Individual total score |
#1 |
1 h |
0 |
0 |
2 |
2 |
17 |
24 h |
0 |
0 |
2 |
2 |
10 |
|
48 h |
0 |
0 |
1 |
1 |
4 |
|
72 h |
0 |
0 |
0 |
0 |
0 |
|
7 days |
- |
- |
- |
- |
- |
|
Mean (24-72 h) |
0.00 |
0.00 |
1.00 |
1.00 |
- |
|
#2 |
1 h |
0 |
0 |
2 |
2 |
17 |
24 h |
0 |
0 |
1 |
1 |
4 |
|
48 h |
0 |
0 |
1 |
1 |
4 |
|
72 h |
0 |
0 |
1 |
1 |
4 |
|
7 days |
0 |
0 |
0 |
0 |
0 |
|
Mean (24-72 h) |
0.00 |
0.00 |
1.00 |
1.00 |
- |
|
#3 |
1 h |
0 |
0 |
2 |
2 |
10 |
24 h |
0 |
0 |
2 |
2 |
8 |
|
48 h |
0 |
0 |
2 |
1 |
6 |
|
72 h |
0 |
0 |
1 |
1 |
4 |
|
7 days |
0 |
0 |
0 |
0 |
0 |
|
Mean (24-72 h) |
0.00 |
0.00 |
1.67 |
1.33 |
- |
|
Group mean score(24-72 h) |
0.00 |
0.00 |
1.22 |
1.11 |
|
|
|
||||||
|
Group mean total score |
1 h |
14.7 |
|||
24 h |
7.3 |
|||||
48 h |
4.7 |
|||||
72 h |
2.7 |
|||||
7 d |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.