Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited but acceptable documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
other: eye irritation study in vivo
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Santoflex 14

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 d
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: 24, 48, 72 h
Score:
3.5
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: slightly erythema, discharge
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
6.6
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: slight erythema, moderate to copious discharge
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
3.6
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: slight erythema, slight discharge

Any other information on results incl. tables

Immediate after application: slight discomfort

1 hour after application: slight erythema, very slight edema, copious discharge

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information