Registration Dossier
Registration Dossier
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EC number: 229-542-8 | CAS number: 6600-31-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and sufficient documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
- Principles of method if other than guideline:
- Ca. 500 mg of the substance was applied on the inner ear of 2 rabbits for 24 hours. The post observation period was 7 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane
- EC Number:
- 229-542-8
- EC Name:
- 3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane
- Cas Number:
- 6600-31-3
- Molecular formula:
- C19H28O4
- IUPAC Name:
- 3,9-bis(cyclohex-3-en-1-yl)-2,4,8,10-tetraoxaspiro[5.5]undecane
- Test material form:
- other: solid
- Details on test material:
- Test substance: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not required
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, (48), (96), 120 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score = 0 at any time point
- Remarks on result:
- other: reading was done in one rabbit at 48 hours and in the other rabbit at 96 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, (48), (96), 120 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score = 0 at any time point
- Remarks on result:
- other: reading was done in one rabbit at 48 hours and in the other rabbit at 96 hours
Any other information on results incl. tables
After the removal of the plaster bandages and during the following observation period of 7 days no erythema, edema or corrsion of the treated skin areas was found.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
Ca. 500 mg of the substance was applied on the inner ear of 2 rabbits for 24 hours. The post observation period was 7 days.
After the removal of the plaster bandages and during the following observation period of 7 days no erythema, edema or corrsion of the treated skin areas was found.Therefore the test substance KAC 4196 has no skin irritation/corrosion effects on rabbits.
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