Registration Dossier
Registration Dossier
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EC number: 204-001-9 | CAS number: 112-73-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-02-06 to 2002-04-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well performed study; Guideline study; GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(2-butoxyethyl) ether
- EC Number:
- 204-001-9
- EC Name:
- Bis(2-butoxyethyl) ether
- Cas Number:
- 112-73-2
- Molecular formula:
- C12H26O3
- IUPAC Name:
- 1-[2-(2-butoxyethoxy)ethoxy]butane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 7 days
- 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: 1d,2d,3d
- Score:
- 0.11
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1d,2d,3d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1d,2d,3d
- Score:
- 0.56
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1d,2d,3d
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DEGDBE was investigated for its eye irritation potential according to OECD 405. DEGDBE is not irritating to eyes.
- Executive summary:
DEGDBE was investigated for its eye irritation potential according to OECD 405.
One hour after administration the conjuctivae of all animals showed definitely injected blood vessels. Furthermore, one animal showed definitely injected blood vessels up to a crimson red color and slight swellings 24 hours up to 72 hours after adiminstration. Diffuse areas of opacity of the cornea were observed 24 hours after adiminstration. In the fluoresceine test 24 hours after administration staining areas were observe in this animal. In addition ot these observations, clear-colorless serous eye discharge was noted in all animals. 7 days after administration all signs of irriation had disappeared.
DEGDBE is not irritating to eyes.
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