Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
Final report on the safety assessment of benzophenones-1, -3, -4, -5, -9, and -11
Author:
Anonymous
Year:
1983
Bibliographic source:
Journal of the American College of Toxicology, Volume 2, Number 5 (1983), page 35-77

Materials and methods

Test guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Draize
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of same animal
Amount / concentration applied:
100 mg of the undiluted substance
Duration of treatment / exposure:
there was no eye wash
Observation period (in vivo):
daily for 7 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 1
Score:
20
Max. score:
110
Remarks on result:
other: In a second identical study the score was 17
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 2
Score:
7
Max. score:
110
Remarks on result:
other: In a second identical study the score was 15
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 3
Score:
0
Max. score:
110
Remarks on result:
other: In a second identical study the score was 10.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 4
Score:
0
Max. score:
110
Remarks on result:
other: In a second identical study the score was 3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 5
Score:
0
Max. score:
110
Remarks on result:
other: In a second identical study the score was 0

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU