Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD 405 but non-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity:>99.9%

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Amount applied: 0.1 other: gram
Duration of treatment / exposure:
0.5 minute(s)
Observation period (in vivo):
1 h, 24 h, 48 h, 72 h, 96 h, and 168 h
Number of animals or in vitro replicates:
6
Details on study design:
Comment: rinsed after (see exposure time)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
unwashed
Time point:
other: 24 h
Score:
57
Max. score:
57
Reversibility:
not fully reversible within: 168 h
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
unwashed
Time point:
other: 48 h after dosing
Score:
58.3
Max. score:
59
Reversibility:
not fully reversible within: 168 h
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
unwashed
Time point:
other: 72 h
Score:
57.7
Max. score:
59
Reversibility:
not fully reversible within: 168 h
Remarks on result:
other: Unwashed group
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Unwashed group
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
0.44
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Unwashed group
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
3.89
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Unwashed group
Irritant / corrosive response data:
Total Scores                 Hours after dosing                 
1h        24h     48h     72h     96h      168h
Eye washed #1     12        57        57        57        55        55
            #2     12        57        59        57        57        57
            #3     12        57        59        59        59        57
       Average   12.0      57.0      58.3      57.7      57.0      56.3
Eye non-washed #4    12         57         61         46         44         42
#5    12        44         44         44         40        40
#6    12        42         42         40         42        42
   Average    12.0      47.7      49.0      43.3      42.0      41.3
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Eye Irritation test: serious eye damage when non eye-washing after exposure and moderately irritating when eye-washing after exposure
Executive summary:

Eye Irritation test: serious eye damage when non eye-washing after exposure and moderately irritating when eye-washing after exposure