Registration Dossier
Registration Dossier
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EC number: 204-534-7 | CAS number: 122-32-7
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: Acceptable, well documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
- Principles of method if other than guideline:
- 0.1 mL of the test substance was instilled onto the mucosa of rabbits as single application or washed away after 2 sec. The mucosa was evaluated for up to 7 days to score the irritation potential according to the Draize scoring system.
- GLP compliance:
- no
Test material
- Reference substance name:
- Oleic acid, monoester with glycerol
- EC Number:
- 247-038-6
- EC Name:
- Oleic acid, monoester with glycerol
- Cas Number:
- 25496-72-4
- IUPAC Name:
- 2-hydroxy-1-(hydroxymethyl)ethyl octadec-9-enoate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: approx. 90%
- Impurities (identity and concentrations): propylene glycol, 11%
- Lot/batch No.: 5850
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0 - 2.4 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- a) single application without washing (6 eyes) and
b) washing 2 sec after substance application (3 eyes) - Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48, 72 and 96 h and 7 days - Number of animals or in vitro replicates:
- 1 male and 8 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with water at body temperature.
- 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:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibilty: not applicable
- Remarks on result:
- other: single application without washing
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibilty: not applicable
- Remarks on result:
- other: single application without washing
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibilty: not applicable
- Remarks on result:
- other: single application without washing
- 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
- Remarks on result:
- other: washing 2 sec after substance application
- 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:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: washing 2 sec after substance application
- Irritation parameter:
- conjunctivae 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: reversibilty: not applicable
- Remarks on result:
- other: washing 2 sec after substance application
- Irritant / corrosive response data:
- Animals exposed to a single application without washing did not show any signs of eye irritation. In contrast, 1 out of 3 animals showed a slight conjunctival irritation (conjunctivae score 2 at reading time point 1 h after substance application) when the substance was rinsed away with water. As the effect was reversible already after 24 h and the exposure to the test substance occured for only 2 sec, the effect might be due to the washing procedure.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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