Registration Dossier
Registration Dossier
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EC number: 292-951-5 | CAS number: 91031-48-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : 0.05 mL instead of 0.1 mL instilled; observation only 24 h instead of 72 h; lack of details on test substance
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, C16-18(even numbered), 2-ethylhexyl esters
- Cas Number:
- 91031-48-0
- Molecular formula:
- C24H48O2 to C26H52O2
- IUPAC Name:
- Fatty acids, C16-18(even numbered), 2-ethylhexyl esters
- Reference substance name:
- Fatty acids, C16-18, 2-ethylhexyl esters
- EC Number:
- 292-951-5
- EC Name:
- Fatty acids, C16-18, 2-ethylhexyl esters
- Cas Number:
- 91031-48-0
- Molecular formula:
- Not applicable, substance is a UVCB.
- IUPAC Name:
- 91031-48-0
- Details on test material:
- - Name of test material (as cited in study report): Octyl Stearate
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 mL undiluted test substance - Duration of treatment / exposure:
- single eye instillation
- Observation period (in vivo):
- 24 hours, eye examinations at 2, 6 and 24 hours after instillation
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 2 tested animals at
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 2 tested animals at
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 2 tested animals at
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 2 tested animals at
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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