Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
422-310-9
EC Name:
-
Cas Number:
114772-53-1
Molecular formula:
C14H11N
IUPAC Name:
4'-methyl-[1,1'-biphenyl]-2-carbonitrile

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
100mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72h
Score:
0.33
Reversibility:
fully reversible within: 1d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 1d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72h
Score:
0.33
Reversibility:
fully reversible within: 1d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 1d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 1d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 1d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 1d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 1d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 1d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 1d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 1d
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 1d

Applicant's summary and conclusion

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