Registration Dossier
Registration Dossier
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EC number: 285-206-0 | CAS number: 85049-36-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 16 - 23 Jan 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- yes
- Remarks:
- no chemosis data available; lack of details on test substance and methodological details
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethyl linoleate
- EC Number:
- 208-868-4
- EC Name:
- Ethyl linoleate
- Cas Number:
- 544-35-4
- Molecular formula:
- C20H36O2
- IUPAC Name:
- ethyl octadeca-9,12-dienoate
- Details on test material:
- - Name of test material (as cited in study report): Linoleate D´Ethyle
- Lot No. 0606 H
- Analytical purity: 70%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Duration of treatment / exposure:
- single eye instillation
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48, 72 h and 7 days - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Reversibility: not applicable
- Irritant / corrosive response data:
- Instillation of the test substance into one eye of each of three rabbits resulted in redness of the conjunctivae, which warranted a conjunctivae score of 3 in the first hour after application. The irritation had completely resolved within 48 or 72 hours in all animals. No iridial irritation or corneal opacity was observed.
Any other information on results incl. tables
Table 1: Results of eye irritation study
Observation time |
Rabbit no. |
||||||||
|
1 |
2 |
3 |
||||||
|
Conjunctiva |
Cornea |
Iris |
Conjunctiva |
Cornea |
Iris |
Conjunctiva |
Cornea |
Iris |
1 h |
3 |
0 |
0 |
3 |
0 |
0 |
3 |
0 |
0 |
24 h |
2 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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