Registration Dossier
Registration Dossier
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EC number: 405-490-3 | CAS number: 613-62-7 BENZYL-2-NAPHTHYLETHER; BETA-NAPHTHYLBENZYLETHER (BON); BNE; BON; NIPAFAX BNE; SENSLON-50; ZO-1
Eye irritation
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:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- 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
Constituent 1
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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