Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: RELIBLE SUMMARY REPORT
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
IUCLID DATASET SUBSTANCE ID:68512-62-9
Author:
EUROPEAN COMMISSION - EUROPEAN CHEMICALS BUREAU
Year:
2000
Bibliographic source:
IUCLID DATASET SUBSTANCE ID:68512-62-9 PG 41

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: DRAIZE TEST
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
other: only one eye was treated
Duration of treatment / exposure:
24H
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hour
Score:
>= 2 - <= 9
Reversibility:
not specified

Any other information on results incl. tables

Conjunctival redness was noted in all animals, but there was no evidence of

corneal or iridial damage. At the 24–hour point, conjunctival scores ranged from 2

to 9 out of a maximum of 110, with an average of 5.0. The scores declined

thereafter and all irritation had subsided within 14 days.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
slightly irritating