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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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Santocure MOR, Lot no. NC 01-001

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
24 h
Observation period (in vivo):
up to 168 h
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
6
Max. score:
110
Reversibility:
fully reversible within: 120 h
Remarks on result:
other: classed as an eye irritant according to F.H.S.A.

Any other information on results incl. tables

Immediate: Slight discomfort

10 min.: moderate to severe erythema, copious discharge

1 h: moderate to severe erythema, copious discharge

24 h: severe erythema, copious discharge containing whitish exudate (mean score 12/110)

48 to 72 h: gradual improvement (mean score 5 and 1 at 48 h and 72 h, respectively)

168 h: all scored zero

168 h mean score: 0

Effects reversible within 168 h

Classed as an eye irritant according to Federal Hazardous substances Act (F.H.S.A.)

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information