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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is performed in male animals only, with a +- 50% active ingredient formulation, and not under GLP compliance. Similar studies wiht different formulations provided consistent results in terms of active ingredient for the acute oral toxicity studies, therefore this study is also considered to be adequate, reliable and relevant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FHSA procedure
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Not provided
- Age at study initiation: Not provided
- Weight at study initiation: Not provided
- Fasting period before study: Not provided
- Housing: Not provided
- Diet (e.g. ad libitum): Not provided
- Water (e.g. ad libitum): Not provided
- Acclimation period: Not provided

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not provided
- Humidity (%):Not provided
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): Not provided

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of [Trade name]
Duration of treatment / exposure:
FHSA procedure
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): FHSA procedure
- Time after start of exposure: not applicable

SCORING SYSTEM:
The scoring system used is that of Draize, J.H. , Woodward, G., and Calvery, H.O.: J. Pharmacolo. Exptl. Therap., 82:377, 1944

TOOL USED TO ASSESS SCORE: Not provided

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72h
Score:
20.6
Max. score:
80
Reversibility:
not fully reversible within: 72h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72h
Score:
1.9
Max. score:
10
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72h
Score:
4.1
Max. score:
20
Reversibility:
not fully reversible within: 72h
Other effects:
6 of 6 eyes were positive for corneal opacity; 3 of 6 had irritis.

Any other information on results incl. tables

Table 1. Rabbit eye irritation after application of 0.1mL of [Trade name] (FHSA procedure)

Time,

Hours

Reaction

Rabbit Number, Value

Mean Value

1

2

3

4

5

6

24

CORNEA

IRIS

CONJUNCTIVAE

20

0

4

10

5

2

30

0

4

40

5

6

15

0

4

40

5

6

25.8

2.5

4.3

48

CORNEA

IRIS

CONJUNCTIVAE

5

0

4

10

0

2

20

0

4

30

5

6

5

0

4

40

5

6

18.3

1.7

4.3

72

CORNEA

IRIS

CONJUNCTIVAE

5

0

4

5

0

2

5

0

2

30

5

6

5

0

4

40

5

6

15.0

1.6

3.7

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item containing +-50% active ingredient was irritating to the rabbit eye (an irritant by FHSA definition). 6 of 6 eyes were positive for corneal opacity; 3 of 6 had iritis.
Executive summary:

6 Male albino rabbits underwent an eye irritation test with 0.1 mL test item containing +-50% active ingredient. According to FHSA procedure. Scoring according to Draize et al. (1944) demonstrated mean 24 -48h score of 20.6/80 for cornea, 1.9/10 for iris and 4.1/20 for conjuctiva irritation, therefore the substance was concluded to be irritating to the rabbit eye (by FHSA definition), with 6 of 6 eyes positive for corneal opacity and 3 of 6 with iritis.