Registration Dossier

Administrative data

Endpoint:
eye irritation
Remarks:
other: Draize test
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: summary study report
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
ROBUST SUMMARY OF INFORMATION ON Distillate fuel oils
Author:
American Petroleum Institute
Year:
2003
Bibliographic source:
ROBUST SUMMARY OF INFORMATION ON Distillate fuel oils pag 43-44

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Four male and 5 female rabbits were used in this study. 0.1 ml of undiluted test material was placed on the everted lower eyelid of the right eye of each rabbit. The left eyes were not treated and served as controls. 30 seconds after application, the eyes of 3 rabbits (2 females, one male) were flushed for one minute with warm distilled water. Scoring for ocular lesions was done at 24, 48 and 72 hours after treatment using the Draize scale. Fluorescein was used to aid evaluation at the 24 hour reading.
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: The left eyes were not treated and served as controls
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
10

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: All rabbits scored zero at every observation period. Those rabbits that had their eyes rinsed appeared no different to the unrinsed group.

Applicant's summary and conclusion