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Registration Dossier
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EC number: 203-377-1 | CAS number: 106-24-1
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: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Geraniol
- EC Number:
- 203-377-1
- EC Name:
- Geraniol
- Cas Number:
- 106-24-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-2,6-dien-1-ol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: female
- Weight at study initiation: 2.3 - 2.4 kg
- Housing: individually in PPO cages with perforated floor.
- Diet (e.g. ad libitum): ad libitum, pelleted complete rabbit diet
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with 20 ml 0.9% sodium chloride solution
- Time after start of exposure: 24 h
SCORING
- time schedule: 1, 24, 48, 72 h; 7, 14 and 21 days after treatment
TOOL USED TO ASSESS SCORE: fluorescein
- After the first 24 hour reading Fluorescein was instilled. After rinsing with 20 ml 0.9% sodium chloride solution the eyes were examined again using UV-light to detect possible corneal damage
Results and discussion
In vivo
Results
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- Results:
- Well defined signs of irritation were observed on the treated eyes, including cornea opacity, iris lesion, crimson red conjunctiva and swelling of the conjuctiva.
- The changes were not reversible in two out of four animals after an observation period of 21 days.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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