Registration Dossier
Registration Dossier
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EC number: 211-902-0 | CAS number: 708-06-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-hydroxy-1-naphthaldehyde
- EC Number:
- 211-902-0
- EC Name:
- 2-hydroxy-1-naphthaldehyde
- Cas Number:
- 708-06-5
- Molecular formula:
- C11H8O2
- IUPAC Name:
- 2-hydroxynaphthalene-1-carbaldehyde
- Details on test material:
- Purity: 94%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: in completely air conditioned rooms in single cages
- Diet: Altromin 2123 Haltungsdiat - Kaninchen ( ad libitum)
- Water: deionized and chlorinated water from automatic suspensors (ad libitum):
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%):50+-20
- Photoperiod: 12 hours daily
Test system
- Vehicle:
- other: Polyethyleneglycol 400
- Controls:
- other: the untreated right eye was the control
- Amount / concentration applied:
- 100 mg test item suspended in 0.05 ml Polyethyleneglycol 400
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing:saline
SCORING SYSTEM:
cornea: 0 - 3
iris: 0- 2
conjunctivae: 0 - 3
chemosis: 0 - 4
TOOL USED TO ASSESS SCORE: UV lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritating to the eyes.
- Executive summary:
The substance was tested for eye irritation according to OECD guideline 405. 3 albino Newzealand rabbits were administered 100 mg of the test item suspended in 0.05 ml Polyethyleneglycol 400 in the conjunctivae sac of the left eye. The observation period was 7 days.
Initial findings were fully reversible after 7 days. Therefore there is no need to classify the substance as irritant to the eye.
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