Registration Dossier
Registration Dossier
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EC number: 202-046-9 | CAS number: 91-17-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-09-05 to 1989-09-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Decahydronaphthalene
- EC Number:
- 202-046-9
- EC Name:
- Decahydronaphthalene
- Cas Number:
- 91-17-8
- Molecular formula:
- C10H18
- IUPAC Name:
- decahydronaphthalene
- Details on test material:
- decahydronaphthalene of Hüls AG, purity 99 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Weight at study initiation: 2.2 - 2.5 kg
- Controls: untreated eye
- Housing: individually in stainless steel cages
- Diet (ad libitum): K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest
- Water (ad libitum): tap water
ENVIRONMENTAL CONDITIONS:
- Temperature: 20°C +/- 1°C
- Humidity: 60 % +/- 5 %
- Air change: 15/ h
- Photoperiods: 12 h dark/ 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hour(s)
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Vehicle: none
- tested for cornea damage with sodium flourescein solution and eye lamp
- rinsed after 72 h with saline solution
- Postexposure observation period: 10 days
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6, 8, and 10 days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- other: conjunctivae redness
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.78
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 0-8 days
- Score:
- 3.5
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjunctivae (Redness): 0.78
- Conjunctivae (Chemosis): 0.44
- Overall irritation score: 3.5/110
DESCRIPTION OF LESIONS: redness, swelling, and slight incrustation of eyelids
REVERSIBILITY: complete within 8 days except for slight redness of eyelids in one animal
Applicant's summary and conclusion
- Conclusions:
- In a primary eye irritation study decahydronaphthalene is considered to be not irritating to eyes.
- Executive summary:
In a primary eye irritation study 0.1 mL decahydronaphthalene were administered into the conjunctival sac of three male rabbits.
Slight reversible irritation was noted.
Eye irritation index was assessed using Draize scale.
The test was evaluated as follows (average of evaluation at 24, 48 and 72 hours respectively): cornea: 0, iris: 0, conjunctivae: redness: 0.78 and chemosis: 0.44 (mean scores on Draize scale). Therefore, decahydronaphthalene is considered to be not irritating to eyes with an overall irritation index of 3.5/110 (0 - 10 = not irritating).
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