Registration Dossier
Registration Dossier
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EC number: 297-083-0 | CAS number: 93334-10-2
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:
- weight of evidence
- Study period:
- 11 Oct-18 Oct 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
- Principles of method if other than guideline:
- The test substance was instilled into the eyes of 6 animals and ocular reactions were scored periodically over 7 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sorbitan oleate
- EC Number:
- 215-665-4
- EC Name:
- Sorbitan oleate
- Cas Number:
- 1338-43-8
- Molecular formula:
- C24H44O6
- IUPAC Name:
- 1,4-anhydro-6-O-oleoyl-D-glucitol
- Details on test material:
- - Name of test material (as cited in study report): [trade name]
- Physical state: clear, dark yellow liquid
- Analytical purity: no data
- Lot/batch No.: 9072C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48 and 72 hours, Day 4 and 7 - Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of the rabbits were left unwashed after instillation of the test substance.
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- Moderate conjunctivae (grade 1) was observed in 3/6 animals 1 hour after instillation of the test substance. These effects had cleared completely by the 24-hour reading time point and no other irritation effects were observed.
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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