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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1981
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: white russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 month
- Weight at study initiation: 2.1-2.2 kg
- Housing: singly in stainless steel cages model: ASTA
- Diet (e.g. ad libitum): sniff (K) Alleindiät für Kaninchen, ad libitum
- Water (e.g. ad libitum): Trinkwasserqualität der Stadtwerke Bielefeld, ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test substance was instilled in the conjunctival sac of the right eye.
Duration of treatment / exposure:
100 mg of the test article (undiluted) was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The eyes were not rinsed.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): There was no washing of the eyes.
- Scoring system: OECD TG 405 / Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: observed petechiae
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Max. score:
2
Remarks on result:
other: could not be evaluated due to corneal opacity
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Max. score:
2
Remarks on result:
other: could not be evaluated due to corneal opacity
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: ulcerous and necrotic areas
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: ulcerous and necrotic areas
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: completely closed eyes
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: completely closed eyes
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Other effects:
- Other observations: Severe reactions after instillation of the substance, adverse effects on the iris could not be detected due to the non-reversible, strong opacity of the cornea.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time

point /

Reversibility

Cornea

Iris

Conjuctivae

Chemosis

 

Max. score: 4

Max. score: 3

Max. score: 3

Max. score: 4

60 min

4/3/3

1/1/1

0/0/0

2/2/2

24 h

3/3/3

**) n.d./n.d./1

3/3/2

3/3/3

48 h

4/4/3

n.d./n.d./1

3/3/2

4/4/3

72 h

4/4/3

n.d./n.d./1

3/3/2

4/4/3

Average 24 h, 48 h, 72 h

3.67/3.67/3

n.d./n.d./1

3/3/2

3.67/3.67/3

Reversibility

n.

n.

n.

n.

Average time (unit) for reversion

n.

n.

n.

n.

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

**) n.d. = not detectable

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test substance was tested for eye irritation in a study according to OECD guideline 405 (Acute Eye Irritation / Corrosion). The substance was instilled into the conjunctival sac of three white russian rabbits. The opacity of the cornea was severe among the animals and the effect was not reversible within 21 days in two of the rabbits. Chemosis and conjunctival effects were also severe and not reversible within 21 days. In this study the test item has irreversible severe effects on the eye and is therefore classified in Category 1.