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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
Study period:
18 September 2006 to 11 November 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
439-910-1
EC Name:
-
Cas Number:
93705-66-9
Molecular formula:
C23H28O4
IUPAC Name:
2,2'-(methylenebis((2,6-dimethyl-4,1-phenylene)oxymethylene))bis oxirane
Test material form:
solid
Details on test material:
- Appearance: white solid
- Storage conditions 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
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: animals were individually housed in suspended cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 23 °C
- Humidity: 30 - 70 %
- Air changes: at least fifteen changes per hour
- Photoperiod: 12 hours light and 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL (57 mg)
Duration of treatment / exposure:
Test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released.
Observation period (in vivo):
Immediately after administration of the test material, an assessment of the initial pain reaction was made. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
3

Initially, a single rabbit was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Details on study design:
- Measurement of pH
The pH of the test material was determined prior to commencement of the study. a 10% w/w aqueous preparation of the test material was found to have a pH of ca 9.

- In vivo study
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
In order to minimise pain on application of the test material, one drop of local anaesthetic (Tetracaine hydrochloride 0.5 %) was instilled into both eyes of these animals 1 to 2 minutes before treatment.

SCORING SYSTEM: Assessment of ocular damage/irritation was made according to the Draize scale.
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
48 hours
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study.
Minimal conjunctival irritation was noted in all treated eyes one and 24 hours after treatment. All treated eyes appeared normal at the 48-hour observation.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to EU criteria
Conclusions:
Under the conditions of the study the test material was found not to be irritating to eyes.
Executive summary:

The potential of the test material to cause irritation to the eye of New Zealand White Rabbits was determined in accordance with the standardised guidelines OECD 405 and EU Method B.5, under GLP conditions.

During the study 0.1 mL (57 mg) test material was instilled in to the right eye of three rabbits. The left eyes remained untreated and served as controls. Immediately after administration of the test material, an assessment of the initial pain reaction was made. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. Assessment of ocular damage/irritation was made according to the Draize scale. Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

No corneal or iridial effects were noted during the study.

Minimal conjunctival irritation was noted in all treated eyes one and 24 hours after treatment. All treated eyes appeared normal at the 48-hour observation.

Therefore, under the conditions of the study the test material was found not to be irritating to eyes.