Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
study GLP compliant performed on a similar substanceThe study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier on analogue substance

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
ca. 1
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
ca. 1.7
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
ca. 0.7
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
ca. 1.3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
ca. 1
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
ca. 1
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
ca. 1
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
ca. 1
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
ca. 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU