Registration Dossier
Registration Dossier
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EC number: 940-417-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- testing starting date 1993-02-03; testing terminating date 1993-03-19: reporting date 1993-04-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well performed study; Guideline study; GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5,8,11,14,17-pentaoxahenicosane; 5,8,11,14-tetraoxaoctadecane
- EC Number:
- 940-417-3
- Molecular formula:
- C14H30O4 C16H34O5
- IUPAC Name:
- 5,8,11,14,17-pentaoxahenicosane; 5,8,11,14-tetraoxaoctadecane
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- - Name of test material :Triethylenglykoldibutylether
- CAS: 63512-36-7
- Molecular formula : C14H30O4
- Molecular weight : 263 g/mol
- Physical state: liquid
- Storage condition of test material: in darkness at room temperature under chemical fume hood
- Solubility: 2g/L in water
- Melting point: -42 °C
- Boiling point: 283 °C
- Density: 0.9169 mg/l at 20 °C
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one eye was treated and the other eye was used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Single appication
- Observation period (in vivo):
- Observation at 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48,72
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No classification is to be assigned to the registration substance with respect to the endpoint eye irritation.
- Executive summary:
The eye irritation property of the registration substance was investigated according to the OECD Guideline 405. Triethylenglycoldibutylether (representative material for the registration substance) was given into one eye of three rabbits each at dose of 0.1 ml. The animals exhibited transient conjuctivae redness, maximal scores being one. No significant eye irritation property was found for the registration substance.
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