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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:
weight of evidence
Study period:
13.02. - 28.08.1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian Albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Asta Werke, Bielefeld
- Age at study initiation: about 5 - 6 month
- Weight at study initiation: 2,1 - 2,3 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Observation period (in vivo):
1, 24, 48 and 72 hours after administration
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: DRAIZE

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of animal #1 and #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Remarks:
of animal #1 and #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Slight conjunctivae (score 1) was observed in 1/3 rabbits at the 1-h reading time point, which persisted until 24 h after installation. The conjunctivae had cleared completely within 48 h. Swelling (score 2) was observed in 1/rabbits at the 1-h reading time point, but cleared completely within 24 h. The iris in 1/3 rabbits showed congestion, swelling and moderate circumcorneal hyperaemia of score 1 at the 24-h reading time point. This effect was totally reversible within 48 h. In 2/3 rabbits the corneas showed scattered or diffuse areas of opacity of score 1 at the 1-h reading time point which was fully reversible within 24 h and 48 h, respevtively. In 1/3 rabbits a score of 2 was obtained for the cornea at the 1-h reading time point, which persisted until 24 h after installation. In this animal, a score of 1 was observed at the 48-h and 72-h reading time point.

Any other information on results incl. tables

Table 1: Results of the in vivo eye irritation study

Rabbit # Time [h] conjunctivae   iris cornea
redness swelling
1 1 0 0 0 1
24 0 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0,0 0,0 0,0 0,0
2 1 0 0 0 1
24 0 0 0 1
48 0 0 0 0
72 0 0 0 0
average 0,0 0,0 0,0 0,3
3 1 1 2 0 2
24 1 0 1 2
48 0 0 0 1
72 0 0 0 1
average 0,3 0,0 0,3 1,3

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: not classified