Registration Dossier
Registration Dossier
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EC number: 244-754-0 | CAS number: 22047-49-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (test substance purity not specified, methodological differences, only 0.05 mL test substance evaluated, only 24-h reading, only 24-h observation period).
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:
- test substance purity not specified, methodological differences, only 0.05 mL test substance evaluated, only 24-h reading, only 24-h observation period
- GLP compliance:
- no
Test material
- 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:
- Fatty acids, C16-18, 2-ethylhexyl esters
- Details on test material:
- - Name of test material (as cited in study report): Only trade name given
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated left eye served as control.
- 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
Reading time points: 2, 6 and 24 h after instillation - Number of animals or in vitro replicates:
- 2 (male)
- 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:
- out of all 2 animals
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 2 animals
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 2 animals
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 2 animals
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- One animal showed mild conjunctival erythema 2 hours after instillation, which disapperaed completely within 6 hours.
Applicant's summary and conclusion
- Conclusions:
- The test substance was not irritating in this test, however, observation period was only 24 hours long.
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