Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Study meets the requirements of OECD Guideline 405 and EU Method B.5, though the observation period was limited to 3 days.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Observation only for 3 days in spite of persisting findings
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
directive 83/467/EEC
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 3 months to 5 months
- Weight at study initiation: 3.2 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Albtromin 2123) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
One administration 24 hours
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
1
Details on study design:
Application of the substance to the conjunctival sac of the left eye of the animal, the right eye served as control.

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place
- Time after start of exposure: see above

TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: after 24, 48 and 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: score after 1 hour: 2.0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: after 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: score after 1 hour: 1.0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: after 24, 48 and 72 hours
Score:
2.7
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: score after 1 hour: 3.0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: after 24, 48 and 72 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: score after 1 hour: 3.0
Irritant / corrosive response data:
One hour after administration slight opacity of cornea, iris redness, swollen, blanched and crimson red coloured conjunctiva were recorded. The eyelids of the animal were about half closed.
After 1 to 3 days all signs of irritation increased. In addition, the nictating membrane was blanched, conjunctiva hemorrhages and definitely injected blood vessels, cornea exfoliation were observed. The eyelids were more than half closed.
Other effects:
Colourless to mucous-yellowish eye discharge was observed at all observation time-points.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
the test substance caused grade 4 cornea lesions and therefore has to be classified as "serious eye damage, category 1".
Executive summary:

A study with the test item according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the eye with one New Zealand White rabbit.

One hour after administration slight opacity of cornea, iris redness, swollen, blanched and crimson red coloured conjunctiva were recorded. The eyelids of the animal were about half closed.

After 1 to 3 days all signs of irritation increased. In addition, the nictitating membrane was blanched, conjunctiva hemorrhages and definitely injected blood vessels, cornea exfoliation were observed.

Due to the severe effects observed - cornea opacity score 4.0 (mean after 24, 48 and 72 hours) - the test substance has to be classified as category 1 (irreversible effects on the eye), H318.