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EC number: 212-429-2 | CAS number: 816-19-3
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl 2-ethylhexanoate
- EC Number:
- 212-429-2
- EC Name:
- Methyl 2-ethylhexanoate
- Cas Number:
- 816-19-3
- Molecular formula:
- C9H18O2
- IUPAC Name:
- methyl 2-ethylhexanoate
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Liquid
- Storage condition of test material: Room temperature.
- Other: Clear colourless
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Recognised supplier
- Age at study initiation: Young adult
- Weight at study initiation: Not reported.
- Housing: individually housed in labeled cages with mesh floors conform to the size recommendations in the most recent Guide for the Care
and Use of Laboratory Animals DHEW (NIH)
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): Not reported.
- Air changes (per hr):Not reported.
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
IN-LIFE DATES: From: 22/10/03 To: 22/10/03
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Ocular irritation was evaluated at 1, 24, 48, and 72 hours post-instillation
- Number of animals or in vitro replicates:
- 3. 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system and Draize et al. at 1, 24, 48, and 72 hours post-instillation. The fluorescein dye evaluation procedure was used at 24 hours to verify the absence of corneal damage. Individual scores were recorded for each animal.:
1. Cornea
A. Opacity-degree of density (area most dense taken for reading)
No Opacity 0
Scattered or diffuse area, details of iris clearly visible 1 #
Easily discernible translucent areas, details of iris slightly obscured 2 #
Opalescent areas, no details of iris visible, size of pupil barely discernible 3 #
Opaque, iris invisible 4 #
B. Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
A X B X 5 Total Maximum= 80
2. Iris
A. Values
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive) 1 #
No reaction to light, haemorrhage, gross destruction (any or all of these) 2 #
A X 5 Total Maximum= 10
3. Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2 #
Diffuse beefy red 3 #
B. Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion oflids 2 #
Swelling with lids about half-closed 3 #
Swelling with lids about half-closed to completely closed 4 #
C. Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3
Score (A+ B + C) X 2 Total Maximum= 20
Total Maximum Score: 110 represents the sum of all scores obtained for the cornea, iris and conjunctivae.
# These scores represent a positive response.
TOOL USED TO ASSESS SCORE: ophthalmic examination lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 4
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.55
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no corneal opacity or iritis observed during this study. One hour after test substance instillation, all three treated eyes exhibited conjunctivitis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation by 72 hours. See table 2.
- Other effects:
- There were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
Any other information on results incl. tables
Table 2. Individual Scores for Ocular Irritation
|
Test organism 1 (female) |
Test organism 2 (male) |
Test organism 3 (male) |
|||||||||
|
Hours |
Hours |
Hours |
|||||||||
|
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
Cornea |
|
|
|
|
|
|
|
|
|
|
|
|
A. Opacity |
0 |
0 #2 |
0 |
0 |
0 |
0 #2 |
0 |
0 |
0 |
0 #2 |
0 |
0 |
B. Area |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
AxBx5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
|
|
|
|
|
|
|
|
|
|
|
|
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Ax5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
A. Redness |
2 |
1 |
1 |
0 |
2 |
1 |
1 |
0 |
2 |
1 |
0 |
0 |
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C. Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
(A+B+C)x2 |
2 |
1 |
1 |
0 |
2 |
1 |
1 |
0 |
2 |
1 |
0 |
0 |
Total |
4 |
2 |
2 |
0 |
4 |
2 |
2 |
0 |
4 |
2 |
0 |
0 |
# 2% ophthalmic fluorescein sodium used to verify the absence of corneal opacity.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test substance cannot be considered as eye irritant.
- Executive summary:
The study was performed according to US EPA OPPTS 870.2400 and OECD 405 acute eye irritation in vivo and in accordance with GLP. A volume of 0.1 ml of the test material was placed into the conjunctival sac of one eye of 3 animals. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. There was no corneal opacity or iritis observed during this study. One hour after test substance instillation, all three treated eyes exhibited conjunctivitis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation by 72 hours. All animals appeared active and healthy. There were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour. Under the conditions of this study the test material is mildly irritating. Based on applicant’s calculation of the mean scores following grading at 24, 48 and 72h and the individual scores, the test material is not considered to be irritating to the eye under Regulation (EC) 1272/2008 criteria.
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