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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:
1974
Report Date:
1974

Materials and methods

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

Test material

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

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

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: slight erythema and discharge

Any other information on results incl. tables

AVERAGE SCORE: 1.3/110

according to F.H.S.A.: not classed as an eye irritant

immediate: slight discomfort

10 min: slight erythema and discharge

1 h: slight erythema and discharge

24 h: slight erythema and discharge (24 h mean score: 4.0)

48 h: All scored zero

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information