Registration Dossier
Registration Dossier
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EC number: 211-309-7 | CAS number: 637-92-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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:
- yes
Test material
- Reference substance name:
- 2-ethoxy-2-methylpropane
- EC Number:
- 211-309-7
- EC Name:
- 2-ethoxy-2-methylpropane
- Cas Number:
- 637-92-3
- Molecular formula:
- C6H14O
- IUPAC Name:
- 2-ethoxy-2-methylpropane
- Details on test material:
- - Name of test material (as cited in study report): ETBE
- Physical state: colourless liquid
- Analytical purity: 95.8%
- Lot/batch No.: 93050601
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ESD
- Age at study initiation: about 3 months old
- Weight at study initiation: 2.0 - 3.0 kg
- Housing: individually
- Diet: 150 g/animal/day
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +- 3
- Humidity (%): >45
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: unexposed eye of each rabbit
- Amount / concentration applied:
- Concentration: 100 %
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- 0.1 ml ETBE was instilled into the conjunctival sac of the right eye, the left eye serving as a control. Ocular examinations were carried out 1 hr after administration, then at 24, 48 and 72 hr post treatment. Readings were continued on days 7 and 14 to determine the reversibility of any lesions present at 72 hr.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24+48+72 hr
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24+48+72 hr
- Score:
- 0.78
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24+48+72 hr
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24+48+72 hr
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- For the observed effects up to 72 hours, see table above. No effects were observed after 7 and 14 days.
Ulceration of the cornea was not observed.
Applicant's summary and conclusion
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