Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an OECD guideline, but GLP information is missing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
DDH
IUPAC Name:
DDH

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: average 60 min - 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: average 60 min - 72 h
Score:
0
Max. score:
0
Irritation parameter:
other: Redness score
Basis:
mean
Remarks:
3 animals
Time point:
other: average 60 min - 72 h
Score:
0
Max. score:
1
Irritation parameter:
other: Inflammation score
Basis:
mean
Remarks:
3 animals
Time point:
other: average 60 min - 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not important eyes lesion cause