Registration Dossier
Registration Dossier
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EC number: 226-501-6 | CAS number: 5413-60-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- publication
- Title:
- Report on human maximization studies.
- Author:
- Research Institute for Fragrance Materials
- Year:
- 1 974
- Bibliographic source:
- RIFM (Research Institute for Fragrance Materials, Inc.),RIFM Report Number 1801, August 27 (RIFM, Woodcliff Lake, NJ, USA).
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Maximization Pre-Test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate
- EC Number:
- 226-501-6
- EC Name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate
- Cas Number:
- 5413-60-5
- Molecular formula:
- C12H16O2
- IUPAC Name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- - Name of test material (as cited in study report): 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Test animals
- Species:
- human
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 20% tricyclodecenyl acetate (13,800 lg/cm2) and 8% (5520 lg/cm2) in petrolatum were applied to the backs
- Duration of treatment / exposure:
- 48 h
- Number of animals:
- 35 and 26 healthy subjects
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hr
- Remarks on result:
- other: DOSE : 20% ; No irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48h
- Remarks on result:
- other: DOSE : 8% ; No irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In maximization tests involving 35 and 26 healthy subjects, tested at 20% tricyclodecenyl acetate ( 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate) (13,800 lg/cm2) and 8% (5520 lg/cm2) in petrolatum it produced no irritation after a 48-hr.
- Executive summary:
In maximization tests involving 35 and 26 healthy subjects, tested at 20% tricyclodecenyl acetate ( 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate) (13,800 lg/cm2) and 8% (5520 lg/cm2) in petrolatum it produced no irritation after a 48-hr.
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