Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06.03.1995 to 21.03.1995
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
One time treatment
Observation period (in vivo):
Up to 14 days
Number of animals or in vitro replicates:
1 male and 1 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 48 hours
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: unrinsed eye
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 1 hour
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: rinsed with water after application
Irritant / corrosive response data:
The treated unrinsed eye showed markedly deepened rugae of the iris from 2nd to 4th day post administration, as well as a moderate conjunctival reddening and slight chemosis 1 h to 7 days post administration.
In the treasted rinsed eye, the alterations were less severe, so that rinsing with water after an accidental ocular contamination is recommended.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Substance is irritating the eyes.
Executive summary:

The results of this test indicate that severe alterations are to be expected if rabbit eyes were treated with 100 mg of the compound corresponding to OECD Guideline No 405. Therefor, in accordance with the USA - Interagency Regulatory Liason Group Guideline, no further test is considered necessary.

The phrase "irritant to eyes" is recommended on the basis of the results obtained in this test.