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Toxicological information

Eye irritation

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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:
2010
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
Name:
Unnamed
Type:
Constituent
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

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:
cornea opacity score
Basis:
animal: #1, 2 and 3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not relevant as none effect
Irritation parameter:
iris score
Basis:
animal: #1, 2 and3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not relevant as none effect
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:
other: 24 hours
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and 3
Time point:
other: 1 and 24 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and 3
Time point:
other: 48 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 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.