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)
Rationale for reliability incl. deficiencies:
other: Study submitted in the ELINCS notification dossier.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

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:
2-(phenylmethoxy)naphthalene
EC Number:
405-490-3
EC Name:
2-(phenylmethoxy)naphthalene
Cas Number:
613-62-7
Molecular formula:
C17H14O
IUPAC Name:
2-(benzyloxy)naphthalene

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
3 days
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: 24, 48, 72h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
other: all animals
Time point:
other: before 24 h
Score:
1
Max. score:
1
Remarks on result:
other: max duration 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
0
Irritation parameter:
chemosis score
Basis:
other: all animals
Time point:
other: before 24 h
Score:
1
Max. score:
1
Remarks on result:
other: max duration 24 h
Irritation parameter:
cornea opacity score
Basis:
other: all animals
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
other: all animals
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Slight irritation effects were observed in the eyes of the rabbits but the severity was not high enough to lead to a classification.
Executive summary:

An eye irritation study was performed in vitro in 3 rabbits according to the B5 guideline. The observation period was 72 h. A maximum grade 1 conjunctival reddening and grade 1 conjunctival oedema was observed before the 24 h observation time.

The mean score per animal over 24, 48 and 72 h for conjunctival reddening, conjunctival oedema, iris effects and chemosis were 0 for each of the 3 animals.

The substance is not classified as irritant according to the EU criteria.