Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study used for notification under 67/548. Original study report not available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

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 material form:
not specified
Details on test material:
no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
75 mg
Duration of treatment / exposure:
no data
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
6
Details on study design:
no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Score:
0.27
Max. score:
2
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Score:
0
Max. score:
1
Remarks on result:
other: Max. duration: 1 h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
During the observation period, no chemosis and no effects on cornea and iris was observed.
After instillation, two animals showed diffuse reddening of the conjunctivae,
the other animals showed only light conjunctivae reactions.
All reactions were fully reversible within 24 or 48 hours.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the study, only weak symptoms of eye irritation were observed. The results are conclusive but not sufficient for classification.
Executive summary:

The study was conducted according to Guideline EU B.5.

A single dose of 75 mg of the test substance was administered to the rabbit eye.

Only weak signs of irritation were observed for the duration of the study.

These symptoms were fully reversible within 24 -48 hours.

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