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
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study summary report
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
ROBUST SUMMARY OF INFORMATION ON LUBRICATING OIL BASESTOCKS
Author:
American Petroleum Institute
Year:
2003
Bibliographic source:
ROBUST SUMMARY OF INFORMATION ON LUBRICATING OIL BASESTOCKS pag 33

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize test
Deviations:
not specified
Principles of method if other than guideline:
0.1 ml of undiluted test material was applied to the corneal surface of one eye of each of 9 rabbits, the other eye was untreated and served as control. After 20 to 30 seconds, the treated eyes of 3 rabbits were washed with lukewarm water for 1 minute. Eyes of the other 6 rabbits were not washed.
Readings of ocular lesions for all animals were made at 1, 24, 48, 72 hours and 7 days after treatment. Sodium fluorescein was used to aid in revealing possible corneal injury.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Only one eye was exposured, the other eye was untreated and served as control.
Duration of treatment / exposure:
20 to 30 seconds
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
9

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1h
Score:
> 2 - < 2.7
Max. score:
2.7
Reversibility:
not specified
Remarks on result:
other: There was no pain response during instillation of the test material and no corneal or iridial irritation was seen during the study.

Any other information on results incl. tables

There was no pain response during instillation of the test material and no corneal or iridial irritation was seen during the study. Any irritation that occurred had cleared by 48 hours.

The primary eye irritation scores for the first 48 hours of the study were as follows:

 Period  Unwash eyes  Washed eyes
 1 hour  2.7  2
 24 hours  0.3  0
 48 hours  0  0

Applicant's summary and conclusion