Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The study did not meet the criteria of current guidelines for eye irritation testing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Principles of method
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data available.

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 ml

- Concentration (if solution): undiluted


Duration of treatment / exposure:
Single instillation into both eyes, after which one eye was washed and the other was not.
Observation period (in vivo):
The eyes were observed for 1, 2, 24, 48 and 168 hours.
Number of animals or in vitro replicates:
1
Details on study design:
No data available.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: not stated
Score:
0
Max. score:
0
Reversibility:
other: no effects reported
Irritant / corrosive response data:
No eye irritation was observed. The test material was not an eye irritant.
Other effects:
No data available.

Any other information on results incl. tables

Individual irritation scores were not available.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the available information, D3 was not irritant to rabbit eyes.