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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Restriction: No data about the TS; short exposure time.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Draize Test (modified 1964)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
35 d
Number of animals or in vitro replicates:
6
Details on study design:
rinsed after ca. 4 seconds

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Time point:
24 h
Score:
33.6
Max. score:
110
Reversibility:
not specified
Remarks on result:
positive indication of irritation

Any other information on results incl. tables

No vocalization upon dosing. None of the rabbits died at the end of the day 35 observation period. All rabbits showed an increase in body weight gain. The maximum average eye irritation score according to the Draize method was 33.6 at 24 hours (total max. score 110). 1 female showed hair loss around the right eye.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information