Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
