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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:
12.-22.07.1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Register Vol 38, no 187, S. 27019, 1973
GLP compliance:
no
Remarks:
pre-guideline study

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- SPF-Albino-Himalayan
- Source: Hoechst AG, breeding colony
- Housing: single caged
- Diet: standard diet ERKA 8300, ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye served as control respectively
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
Application of the substance to the conjunctival sac of the left eye of each animal, the right eye served as control respectively

- Washing: Washing with physiological saline 24 h after administration

- Tool to assess score after 48 and 72 h: 0.01 % solution of fluorescein sodium, under UV light

The eyes are examined and the grade of ocular reaction is recorded at 1, 24, 48, and 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: after 24, 48 and 72 h
Score:
0.39
Max. score:
4
Reversibility:
other: Grade 1 opacity observed was fully reversible in 5 animals after 72 h.
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: after 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects occured at any time
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: after 24, 48 and 72 h
Score:
0.94
Max. score:
4
Reversibility:
other: Chemosis was fully reversible in 5 animals after 72 h .
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: after 24, 48 and 72 h
Score:
1.17
Max. score:
3
Reversibility:
other: Redness was fully reversible in 2 animals after 72 h.
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 7 h
Score:
22
Max. score:
110
Reversibility:
other: A maximal eye irritation index of 5 was observed after 72 h
Remarks on result:
other: slightly irritant
Other effects:
Discharge was observed after 1 h until 72 h.

Any other information on results incl. tables

Table 1: Individual scores

Animal no

Evaluation Interval

Cornea

Conjunctiva

Iris

Eye Irritation Index (mean)

 

 

Opacity

Redness

Chemosis

Discharge

 

51

 

 

1 h

1

1

2

1

0

 

 

13

52

0

1

2

1

0

53

1

1

2

1

0

54

0

1

2

1

0

56

1

1

1

1

0

58

0

1

2

1

0

51

 

 

7 h

1

2

2

2

0

 

 

22

52

1

2

3

2

0

53

1

1

3

2

0

54

0

1

2

2

0

56

1

2

3

2

0

58

1

2

2

2

0

51

 

 

24 h

1

2

2

2

0

 

 

18

52

1

2

2

2

0

53

1

2

2

2

0

54

0

1

1

0

0

56

1

2

1

2

0

58

1

1

2

1

0

51

 

 

48 h

1

2

2

1

0

 

 

7

52

0

1

0

1

0

53

0

1

1

1

0

54

0

0

0

0

0

56

0

1

1

1

0

58

0

1

1

1

0

51

 

 

72 h

1

2

2

2

0

 

 

5

52

0

0

0

0

0

53

0

1

0

0

0

54

0

0

0

0

0

56

0

1

0

0

0

58

0

1

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
According to the classification criteria of the FDA guideline the test item is slightly irritatnt to eyes.
According to Regulation (EC) no 1272/2008 the test substance has to be regarded as non irritating to eyes. This conclusion is legitimate although the testing regime differs slightly from today's standard methods (scoring system is identical to the currently used system)
Executive summary:

Test material was subject to an acute eye irritation/corrosion test in 6 Himalayan White rabbits according to FDA guideline. 100 mg test substance were placed into the conjunctival sac of one eye each of 6 rabbits. The effects were observed for 72 h. The test item caused grade 1 corneal opacity after 1 h, grade 3 chemosis after 7 h and grade 2 conjunctival reddening grade after 7 h until 48 h. All effects for all irritation parameter during the study were not fully reversible in all animals after 72 h. The determined mean values after 24, 48 and 72 h of the irritation parameter were < 1 (for corneal opacity and iris) and < 2 for conjunctival redness and chemosis.

Therefore, the test item has not to be classified for eye irritation according to Regulation (EC) No 1272/2008.