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:
guideline study without detailed documentation

Data source

Reference
Reference Type:
other: reference to SNIF-file
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA-Methode (Federal Register Vol. 38, Nr. 187 (27.09.73) 1500.42) und Draize und Kelley- Methode (Drug Cosm. Ind. 71 (1952) 36)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
according to CLP criteria
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
according to CLP criteria
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.25
Max. score:
2
Remarks on result:
no indication of irritation
Remarks:
according to CLP criteria
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
1
Remarks on result:
no indication of irritation
Remarks:
according to CLP criteria

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance caused slight eye irritation effects in a study according to the Draize method. Classification according to CLP criteria is not warrent.