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EC number: 203-291-4 | CAS number: 105-37-3
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-06-10 to 2015-06-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl propionate
- EC Number:
- 203-291-4
- EC Name:
- Ethyl propionate
- Cas Number:
- 105-37-3
- Molecular formula:
- C5H10O2
- IUPAC Name:
- ethyl propanoate
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Slaughterhouse, Germany
- Characteristics of donor animals: at least 9 month old
- Storage, temperature and transport conditions of ocular tissue: transported to the laboratory at ambient temperature
- Time interval prior to initiating testing: corneae were isolated on the same day after delivery of the eyes, corneae were directly used in the BCOP test on the same day
- indication of any existing defects or lesions in ocular tissue samples: eyes presenting defects were discarded
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.75 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Eyes presenting defects such as vascularization, pigmentation, opacity and scratches were discarded.
QUALITY CHECK OF THE ISOLATED CORNEAS
The basal opacity of all corneae was recorded. Each corneae with a value of the basal opacity > 7 was discarded.
NUMBER OF REPLICATES
Sets of three corneae were used for treatment with the test item and the negative and positive controls.
NEGATIVE CONTROL USED
Saline (0.9% NaCl in deionised water) was used as negative control.
POSITIVE CONTROL USED
2-Ethoxyethanol (purity: 99%) was used as positive control.
APPLICATION DOSE AND EXPOSURE TIME
The anterior compartment received a volume of 0.75 mL on the surface of the corneae.
The incubation time lasted ten minutes.
TREATMENT METHOD:
Each isolated cornea was mounted in a specially designed cornea holder according to the description given in OECD guideline 437 with a closed chamber.
REMOVAL OF TEST SUBSTANCE
- POST-EXPOSURE INCUBATION: After the test item or control items, respectively, were rinsed off from the application side with
saline, the corneae were incubated for further two hours in a vertical position.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: changes in light transmission with an opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: according to OECD guideline 437: =3 no category, >3; =55 no prediction can be made; >55 Serious eye damage according to CLP/EPA/GHS (Cat 1)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 3.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No indication of serious eye damage
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control responses result in opacity and permeability values that are less than the established upper limits for background opacity and permeability values for bovine corneae treated with the respective negative control.
- Acceptance criteria met for positive control: The positive control gives an IVIS that falls within two standard deviations of the current historical mean (updated every three months).
Any other information on results incl. tables
Test Group |
Opacity value = Difference (t130-t0) of Opacity |
Permeability at 490 nm (OD490) |
IVIS |
Mean IVIS
|
Proposed in vitro Irritancy Score |
||
|
|
Mean |
|
Mean |
|
|
|
Negative Control |
-1 |
-0.33 |
0.074 |
0.067 |
0.11 |
0.67 |
Not categorized |
0 |
0.061 |
0.92 |
|||||
0 |
0.066 |
0.99 |
|||||
Positive Control |
55.33* |
1.042* |
70.96 |
76.02 |
Category 1 |
||
55.33* |
1.312* |
73.01 |
|||||
67.33* |
1.116* |
84.07 |
|||||
ETHYLPROPIONATE |
0.33* |
0.048* |
1.05 |
3.10 |
No prediction can be made |
||
3.33* |
0.005* |
3.41 |
|||||
4.33* |
0.033* |
4.83 |
*corrected values
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 0.67).
The positive control (2-Ethoxyethanol) was tested undiluted and showed clear opacity and distinctive permeability of the corneae (mean IVIS = 76.02) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)).
Relative to the negative control, the test item caused a slight increase of the corneal opacity. The calculated mean IVIS was 3.10 (threshold for serious eye damage: IVIS >= 55 or <=03). According to OECD 437 no prediction for the damage hazard of the test item to the eye can be made. - Executive summary:
The corneal damage potential of the test item by means of the BCOP assay using fresh bovine corneae was assessed. With the negative control (0.9% (w/v) NaCl solution in deionised water) neither an increase of opacity nor permeability of the corneae could be observed. The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the corneae corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)). The calculated mean in vitro irritancy score was 3.10. According to OECD 437 (see table in chapter 3.10.3) the test item is not classified as causing serious eye damage but relative to the negative control, the test item caused a slight increase of the corneal opacity. Permeability effects did not occur.
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