Registration Dossier
Registration Dossier
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EC number: 263-061-4 | CAS number: 61789-45-5
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:
- weight of evidence
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Regulations for the Enforcement of the Federal Hazardous Substances Act. F.R. Sept. 17, 1964
- GLP compliance:
- no
Test material
- Reference substance name:
- Oleic acid
- EC Number:
- 204-007-1
- EC Name:
- Oleic acid
- Cas Number:
- 112-80-1
- Molecular formula:
- C18H34O2
- IUPAC Name:
- octadec-9-enoic acid
- Details on test material:
- Purity: no data
Physical state: Clear yellow liquid
Batch no.: 1922-69
Carbon chain length distribution: C18:1
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
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): 0.1 mL per eye
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- Reading time points: 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- 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:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- other: in one animals chemosis was observed over all thre reading time points
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- other: fully reversible within 48 h except one animal, in which score 1 persisted over all three reading time points
- 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: not applicable
- Irritant / corrosive response data:
- The test material produced mild conjunctival redness (score of 1) and chemosis (score of 1) in one animal at the 24 hour reading and these symptoms were not reduced by the end of the observation period at 72 hours. Discharge (score of 1) was also observed in this animal at the 48 and 72 hour readings. Minor conjunctival redness (score of 1) was observed in four other animals at the 24 hour reading only. No signs of irritation were observed in one animal. The table below summarizes the results for each animal.
- Other effects:
- No lesions were observed.
Any other information on results incl. tables
Scores for Ocular Lesions
Rabbit No. |
24 hrs |
48 hrs |
72 hrs |
|
31 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 1 1 0 |
0 0 0 1 1 1 |
0 0 0 1 1 1 |
32 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 1 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
33 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 1 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
34 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 1 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
35 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
36 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge |
0 0 0 1 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
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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