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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
1min
Observation period (in vivo):
7d
Number of animals or in vitro replicates:
4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: 4 animals
Time point:
other: 4h,24h, 48h, 72h, 4d, 7d
Score:
1
Max. score:
1
Irritation parameter:
iris score
Basis:
other: 4 animals
Time point:
other: 4h,24h, 48h, 72h, 4d, 7d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 4h,24h, 48h, 72h, 4d, 7d
Score:
0.667
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 4h,24h, 48h, 72h, 4d, 7d
Score:
0.667
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 4h,24h, 48h, 72h, 4d, 7d
Score:
0.333
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 4h,24h, 48h, 72h, 4d, 7d
Score:
0.333
Max. score:
1
Irritation parameter:
other: secretion
Basis:
other: 4 animals
Time point:
other: 4h,24h, 48h, 72h, 4d, 7d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1h, 24h, 48h, 72h, 4d, 7d
Score:
0.167
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1h, 24h, 48h, 72h, 4d, 7d
Score:
0.333
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1h, 24h, 48h, 72h, 4d, 7d
Score:
0.333
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 1h, 24h, 48h, 72h, 4d, 7d
Score:
0.333
Max. score:
1

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information