Registration Dossier
Registration Dossier
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EC number: 701-203-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given (no data on test substance purity, 9 animals were treated, individual irritation and chemosis data were not given, observation period of 7 days).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (9 animals were treated, individual irritation and chemosis data were not given, observation period of 7 days)
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics (Association of Food and Drug Officials, U.S., p.49, 1959)
- Qualifier:
- according to guideline
- Guideline:
- other: 21 CFR Part 191
- GLP compliance:
- no
Test material
- Reference substance name:
- Sorbitan monooleate, ethoxylated
- EC Number:
- 500-019-9
- EC Name:
- Sorbitan monooleate, ethoxylated
- Cas Number:
- 9005-65-6
- Molecular formula:
- Not applicable as UVCB
- IUPAC Name:
- Sorbitan, C18-unsat, fatty acid esters, ethoxylated (1 - 6.5 moles ethoxylated)
- Reference substance name:
- Tween 81
- IUPAC Name:
- Tween 81
- Details on test material:
- - Name of test material (as cited in study report): Tween 81
- Analytical purity: no data
- Lot/batch No.: 417
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.2-2.2 kg (males and females)
Test system
- Vehicle:
- other: USP light mineral oil (Marcol 70 Humble)
- Controls:
- other: the untreated eyes served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 10% - Duration of treatment / exposure:
- single application without washing (6 animals) or with washing after 2 sec (3 animals)
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48, 72 h and 7 days - Number of animals or in vitro replicates:
- 9 (4 females and 5 males)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the treated eyes of 3/9 animals were each washed after treatment.
- Time after start of exposure: 2 sec
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals (unwashed)
- Time point:
- other: mean after of 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 6 animals (unwashed)
- Time point:
- other: mean after of 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all 6 animals (unwashed)
- Time point:
- other: mean after of 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: 1 h reading time point: conjunctival redness (score 2) in 3/6 animals with unwashed eyes (fully reversible within 24 h)
- Irritant / corrosive response data:
- After treatment with a 10% dilution of the test substance, the only signs of irritation observed were conjunctival redness (score 2) at the 1 h reading time point in 3/6 animals with unwashed eyes. This erythema was fully reversible in all affected animals at the 24 h reading time point.
- Other effects:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information at 10% dilution Criteria used for interpretation of results: EU
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