Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
other: Data sheet with overview of several studies, no full test report available. However, all relevant information is given. Therefore, the study can be regarded as valid for assessment.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(only cornea, iris and conjunctivae investigated; different scoring system)
Principles of method if other than guideline:
0.1 ml undiluted liquid was applied to the eye of 6 albino rabbits and irritation was observed after 24, 48 and 72 h.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
72 h
Observation period (in vivo):
at 24 h intervals during the 72 h period
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
13
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: Draize Score
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
6.5
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: Draize Score
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
3.5
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: Draize Score

Any other information on results incl. tables

Scores

Time of reading

Structure

Rabbit No.

1

2

3

4

5

6

24 h

Cornea

0

0

0

10

0

10

Iris

5

0

0

10

0

5

Conjunctivae

8

2

4

8

8

8

48 h

Cornea

0

0

0

0

0

0

Iris

5

0

0

10

0

0

Conjunctivae

6

0

2

6

8

2

72  h

Cornea

0

0

0

0

0

0

Iris

0

0

0

5

0

0

Conjunctivae

2

0

2

6

6

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A maximal score of 13 from 110 was observed after 24 h. Therefore, the substance is not classified as irritating to eyes according to EU criteria.
Executive summary:

0.1 ml undiluted liquid was applied to the eye of 6 albino rabbits and irritation was observed after 24, 48 and 72 h. Mean score decreased from13.0 over 6.5 to 3.5 with the course of time.