Registration Dossier
Registration Dossier
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EC number: 202-704-5 | CAS number: 98-82-8
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: Data sheet with overview of several studies, no full test report available. However, all relevant information is given. Therefore, the study can be regarded as valid for assessment.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (only cornea, iris and conjunctivae investigated; different scoring system)
- Principles of method if other than guideline:
- 0.1 ml undiluted liquid was applied to the eye of 6 albino rabbits and irritation was observed after 24, 48 and 72 h.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cumene
- EC Number:
- 202-704-5
- EC Name:
- Cumene
- Cas Number:
- 98-82-8
- Molecular formula:
- C9H12
- IUPAC Name:
- isopropylbenzene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- at 24 h intervals during the 72 h period
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 13
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- other: Draize Score
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 6.5
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- other: Draize Score
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 3.5
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- other: Draize Score
Any other information on results incl. tables
Scores |
|||||||
Time of reading |
Structure |
Rabbit No. |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
||
24 h |
Cornea |
0 |
0 |
0 |
10 |
0 |
10 |
Iris |
5 |
0 |
0 |
10 |
0 |
5 |
|
Conjunctivae |
8 |
2 |
4 |
8 |
8 |
8 |
|
48 h |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
5 |
0 |
0 |
10 |
0 |
0 |
|
Conjunctivae |
6 |
0 |
2 |
6 |
8 |
2 |
|
72 h |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
5 |
0 |
0 |
|
Conjunctivae |
2 |
0 |
2 |
6 |
6 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A maximal score of 13 from 110 was observed after 24 h. Therefore, the substance is not classified as irritating to eyes according to EU criteria.
- Executive summary:
0.1 ml undiluted liquid was applied to the eye of 6 albino rabbits and irritation was observed after 24, 48 and 72 h. Mean score decreased from13.0 over 6.5 to 3.5 with the course of time.
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