Registration Dossier
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EC number: 203-577-9 | CAS number: 108-39-4
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: observation time should be longer to evaluate reversibility
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 969
Materials and methods
- Principles of method if other than guideline:
- 0.1 ml undiluted testsubstance was applied into the eye of rabbits, time of reading: 24, 48 and 72 hours.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- m-cresol
- EC Number:
- 203-577-9
- EC Name:
- m-cresol
- Cas Number:
- 108-39-4
- Molecular formula:
- C7H8O
- IUPAC Name:
- m-cresol
- Details on test material:
- IUCLID4 Test substance: other TS: m-cresol, M.P.: 11-12 C; B.P.: 202.8 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 data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 87.3
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- other: score cornea, iris, conjunctivae
- Basis:
- animal: mean score of all animals
- Time point:
- other: 24 hours
- Score:
- ca. 87.3
- Max. score:
- 110
- Reversibility:
- other: see time point: 48 hours
- Irritation parameter:
- other: mean score: cornea, iris, conjunctivae
- Basis:
- animal: mean score of all animals
- Time point:
- other: 48 hours
- Score:
- ca. 87.3
- Max. score:
- 110
- Reversibility:
- other: see time point: 72 hours
- Irritation parameter:
- other: mean score: cornea, iris, conjunctivae
- Basis:
- animal: mean score of all animals
- Time point:
- other: 72 hours
- Score:
- ca. 87.3
- Max. score:
- 110
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: no data for edema score avaiable. Total irritation score: 87.3/110
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: no data for iris score avaiable. Total irritation score: 91.3/110
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: no data for conjunctivae score avaiable. Total irritation score: 91.3/110
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: no data for chemosis score avaiable. Total irritation score: 91.3/110
- Irritant / corrosive response data:
- From beginning of the observation all animals showed irritational effects in the cornea (score 60), iris (score 10) and concunctivae (score 16-18) of the eye which did not change during the observation period of 72 hours.
- Other effects:
- no data
Any other information on results incl. tables
after 24 hrs: cornea, iris, conjunctivae: 87.3 (mean score): -- mean
score for cornea: 60, mean score for iris: 10, mean score for
conjunctivae: 18)
after 48 hrs: cornea, iris, conjunctivae: 87.3 (mean score):
-- mean score for cornea: 60, mean score for iris: 10, mean score for
conjunctivae: 18)
after 72 hrs: cornea, iris, conjunctivae: 87.3 (mean score)
--mean score for cornea: 60, mean score for iris: 10, mean score for
conjunctivae: 18)
summary: irritation score: 87.3/110
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Executive summary:
Application of 0.1 ml into the eye of rabbits and observation up to 72 hours post application resulted in mean irritation score 87.3 of max 110. Reversibility was not reported.
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