Registration Dossier
Registration Dossier
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EC number: 203-398-6 | CAS number: 106-44-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no information on GLP, strain used
Data source
Reference
- Reference Type:
- publication
- Title:
- Bio-Fax-data sheet: p-cresol
- Author:
- Industrial. Bio-Test Laboratory Inc.
- Year:
- 1 969
- Bibliographic source:
- Industrial Bio-Test Laboratory Inc, Northbrook, Ill/USA, data sheet no. 5-5/69
Materials and methods
- Principles of method if other than guideline:
- 0.1 ml undiluted test substance was applied into the eye of rabbits, time of reading: 24, 48, 72 hrs.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- p-cresol
- EC Number:
- 203-398-6
- EC Name:
- p-cresol
- Cas Number:
- 106-44-5
- Molecular formula:
- C7H8O
- IUPAC Name:
- p-cresol
- Details on test material:
- Test substance: p-cresol, M.P.: 36°C, B.P.: 202°C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the second eye served as control
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- unspecified
- Observation period (in vivo):
- up to 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- no further data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 63.3
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 10
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Score:
- 15.7
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- other: mean score cornea, iris, conjunctivae
- Basis:
- animal: mean score of all animals
- Time point:
- other: 72 hours
- Score:
- ca. 93
- Max. score:
- 110
- Irritation parameter:
- other: mean score cornea, iris, conjunctivae
- Basis:
- animal: mean score of all animals
- Time point:
- other: 48 hours
- Score:
- ca. 89.7
- Max. score:
- 110
- Irritation parameter:
- other: mean score: cornea, iris conjunctivae
- Basis:
- animal: mean score for all animals
- Time point:
- other: 24 hours
- Score:
- ca. 84.7
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- animal: all animals
- Time point:
- other: up to 72 hours
- Score:
- ca. 89
- Max. score:
- 110
- Reversibility:
- not reversible
- Remarks on result:
- other: (mean over total observation period)
Any other information on results incl. tables
mean score for cornea: 60; mean score for iris: 10; mean score for conjunctivae: 14.7 48 hours: cornea, iris, conjunctivae: 89.7/110 (mean score)
mean score for cornea: 63.3, mean score for iris: 10, mean score for conjunctivae: 16.3 72 hours: cornea, iris, conjunctivae: 93.0/110 (mean score)
mean score for cornea: 66.6, mean score for iris: 10; mean score for conjunctivae: 16.3 summary: irritation score: 89.0/110
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Executive summary:
The application of 0.1 ml undiluted p-cresol into the eyes of rabbits followed by an obervation period of upto 72 hours resulted in mean irritation score 89 of max 110. Reversibility is not reported.
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