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: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics (Association of Food and Drug Officials, U.S., p.49, 1959)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- Analytical purity: no data
- Lot/batch No.: 207

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
male and female rabbits were included in the test

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
single application without washing or washing after 2 sec
Observation period (in vivo):
7 days, reading timepoints: 1 h, 1, 2, 3, and 7 days
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
performed in 3 out of 9 treated eyes
- Washing (if done): with 20 mL of distilled water (at body temperature)
- Time after start of exposure: 2 sec

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals (unwashed)
Time point:
other: mean out of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no data on chemosis was given in the study report
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals (unwashed)
Time point:
other: mean out of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no data on chemosis was given in the study report
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals (unwashed)
Time point:
other: mean out of 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no data on chemosis was given in the study report
Irritant / corrosive response data:
Neither unwashed nor washed eyes exhibited any irritation of any kind at one of the reading time points. No data on chemosis was given in the study report.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified