Registration Dossier
Registration Dossier
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EC number: 270-315-8 | CAS number: 68424-66-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 0.1 ml. of the test sample instilled into the right eye with no further treatment. as its own control. The untreated left eye of each animal served Both the treated and control eyes were examined every twenty-four hours for four days and then again on the seventh day. The scorings recorded were made according to the Draize scale for scoring ocular lesions.
- GLP compliance:
- no
Test material
- Reference substance name:
- Lanolin, hydroxylated
- EC Number:
- 270-315-8
- EC Name:
- Lanolin, hydroxylated
- Cas Number:
- 68424-66-8
- IUPAC Name:
- Lanolin, hydroxylated
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No information reported.
Test system
- Vehicle:
- other: Mineral oil
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 20 % - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Draize scale for scoring ocular lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation observed.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test substance in 20% mineral oil did not produce irritating effects.
- Executive summary:
Three normal, healthy, albino rabbits were used in this experiment. The method of procedure is that suggested by Dr. Draize.
Each animal had 0.1 ml. of the test sample instilled into the right eye with no further treatment as its own control. The untreated left eye of each animal served Both the treated and control eyes were examined every twenty-four hours for four days and then again on the seventh day. The scorings recorded were made according to the Draize scale for scoring ocular lesions. Exposure to the test substance did not produce any irritation.
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