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EC number: 244-815-1 | CAS number: 22174-70-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,3'-[methylenebis(oxymethylene)]bisheptane
- EC Number:
- 244-815-1
- EC Name:
- 3,3'-[methylenebis(oxymethylene)]bisheptane
- Cas Number:
- 22174-70-5
- Molecular formula:
- C17H36O2
- IUPAC Name:
- 3,3'-[methylenebis(oxymethylene)]diheptane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-ethylhexylal
- Physical state: colourless liquid
- Analytical purity: 99.82% (w/w)
- Storage condition of test material: stored in a closed brown glass vial at laboratory temperature during the study
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: breeding farm VELAZ s.r.o., Kolec u Kladna, Czech Republic, RCH CZ 21760152
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.3-2.4 kg
- Housing: Conventional animal room – individually in metallic cages
- Diet (e.g. ad libitum): Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs ad libidum (producer: Ing. Mrkvicka Miroslav – Vyroba krmnych smesi, Mlyn Kocanda, 252 42 Jesenice u Prahy)
- Water (e.g. ad libitum): Drinking tap water ad libitum (quality corresponding to the Regulation No.: 252/2004 Czech Coll. Of Law)
- Acclimation period: not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): used in delivered form (undiluted) - Duration of treatment / exposure:
- Duration of exposure corresponds to duration of observation
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after application, then once daily. After recording the observations at 24 hours, the eyes of rabbit were examined with the aid of fluorescinein and the ophthamoscopy. The grades of ocular reaction for single animal (observation of conjunctivae, cornea and iris) were recorded at each examination.
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: Not relevant
SCORING SYSTEM:
CORNEA
0 - No ulceration or opacity
1 - Scattered or diffuse areas of opacity; details of iris clearly visible
2 - Easily discernible translucent area;details of iris slightly obscured
3 – Nacrous area, no details of iris visible, size of pupil barely discernible
4 – Opaque cornea, iris not discernible through the opacy
Maximum possible: 4
IRIS
0 - Normal
1 – Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia ; or injection ; iris reactive to light (a sluggish reaction is considered to be an effect)
2 – Hemorrhage, gross destruction, or no reaction to light
Maximum possible: 2
CONJUNCTIVAE
0 - Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris) normal
1 - Some blood vessels hyperarmic (injected)
2 - Diffuse, crimson color, individual vessels not easily discernible
3 - Diffuse beefy red
Maximum possible: 3
CHEMOSIS
0 - Normal no alterations
1 - Some swelling above normal
2 - Obvious swelling with partial eversion of lids
3- Swelling with lids about half closed
4 - Swelling with lids more than half closed
Maximum possible: 4
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, 2 and 3
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- Please refer to “Overall irritation/corrosion results”
Any other information on results incl. tables
Body weights were recorded in the table below:
Rabbit No. |
Clinical observation |
Body weight (in kg) |
|
prior to application |
at termination |
||
1 |
No changes |
2.40 |
2.60 |
2 |
No changes |
2.40 |
2.70 |
3 |
No changes |
2.30 |
2.50 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Examination of eye irritation after single application demonstrated, that the test substance, 2-ethylhexylal, is not irritating for eye of rabbit.
- Executive summary:
The test substance,2-ethylhexylal, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).
The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The test was performed initially using one animal (No. 7). If the results of this test indicate the substance to be corrosive or a severe irritant to the eye, the response was confirmed using two additional animals (No. 8 and No. 9).
The following changes were observed on eye at 1 hour after application: conjunctivae - diffuse, crimson color, individual vessels not easily discernible; chemosis – some swelling above normal in all rabbits. Conjunctivae – diffuse, crimson color, individual vessels not easily discernible or some blood vessels hyperaemic (injected) were observed in all rabbits at the 24 hours after application. Conjunctivae – some blood vessels hyperaemic (injected) were observed in two rabbits (No. 8 and No. 9) at the 48 hours after application. No changes on the conjunctival sac were observed at the 72 hours after application in all animals.
No clinical signs of systemic intoxication were detected.
Examination of eye irritation after single application demonstrated, thatthe test substance, 2-ethylhexylal, is not irritating for eye of rabbit.
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