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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:
From June 20th, 1989 to June 27th, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline and GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Physical properties: yellow liquid, insoluble in water
Storage conditions: room temperature
Validity: May 1992
Test material received; May 18, 1989

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approximately 12-14 weeks
- Weight at study initiation: 2500 to 2700 g
- Housing: individually in metal cages (and identified by individually numbered ear tags)
- Diet: standard rabbit pellet (Nafag No. 814, Gossau, Switzerland) ad libitum
- Water: fresh water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h / 12h

All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer.
The drinking water quality fulfilled the critical parameters in the specification of the "Schweizerisches Lebensmittelbuch" (Edition 1972).

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served for control
Amount / concentration applied:
0.1 mL was instilled into the conjunctival sac of the left eye of each animal. The right eye served as untreated control.
Duration of treatment / exposure:
0.1 mL was instilled into the conjunctival sac of the left eye of each animal, the lids were then held together for about one second in order to prevent loss of the test item. The treated eyes were not rinsed.
Observation period (in vivo):
72 hours, extended to 7 days because reactions were observed within 72 hours after instillation of the test item.
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation according to the OECD scoring system. A slit-lamp was used to facilitate the evaluation. Because reactions were observed within 72 hours after treatment, the observation period was extended to 7 days to determine the reversibility of the eye reactions.
Moreover, the animals were checked daily for systemic symptoms and mortality.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(mean)
Basis:
animal: 1, 2, 3, respectively
Time point:
other: 24-48-72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Corneal opacity was seen in none of the 3 animals
Irritation parameter:
iris score
Remarks:
(mean)
Basis:
animal: 1, 2, 3, respectively
Time point:
other: 24 -48-72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Effect in the iris graded 1 was seen in 1/3 animals at reading time point 1 hour only.
Irritation parameter:
conjunctivae score
Remarks:
(mean)
Basis:
animal #1
Time point:
other: 24 -48-72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Conjunctival redness graded 1 was seen at reading time points 1 and 24 hrs but no more thereafter.
Irritation parameter:
conjunctivae score
Remarks:
(mean)
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Conjunctival redness graded 1 was seen at reading time points 1, 24 and 48 hours, and no more thereafter.
Irritation parameter:
conjunctivae score
Remarks:
(mean)
Basis:
animal #3
Time point:
other: 24 -48-72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Conjunctival redness graded 1 was seen at reading time points 1, 24 and 48 hours, and no more thereafter.
Irritation parameter:
chemosis score
Remarks:
(mean)
Basis:
animal: 1, 2, 3, respectively
Time point:
other: 24- 48-72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Chemosis graded 1 was seen in each of the 3 animals at reading time point 1 h only.
Irritant / corrosive response data:
Under the experimental conditions employed, iritis, conjunctival redness and chemosis, all of them graded 1, were reported for all 3 animals at reading time point 1 hour; no corneal opacity was seen. Almost all findings disappeared within 24 to 48 hours, and complete reversibility was achieved at reading time point 72 hours.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU 67/548/EEC and EC/1271/2008
Conclusions:
Under the experimental conditions employed the test article induced minimal irritation of the iris and conjunctiva well below the threshold of significance when instilled into the conjunctival sac of albino rabbits.
Executive summary:

The substance was instilled into the conjunctival sac of one eye in each of 3 female rabbits according to the OECD TG 405; the eyes were not rinsed. The treatment induced iritis, conjunctival redness and chemosis, all of them graded 1, in each of the 3 animals at reading time point 1 hour; no corneal opacity was seen. Almost all findings disappeared within 24 to 48 hours, and complete reversibility was achieved at reading time point 72 hours. Based on the scoring of the eye findings as recommended by the OECD guideline, the test item was not irritating to the eye of rabbit.