Registration Dossier
Registration Dossier
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EC number: 226-501-6 | CAS number: 5413-60-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
Data source
Referenceopen allclose all
- 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).
- Reference Type:
- publication
- Title:
- Report on human maximization studies.
- Author:
- Research Institute for Fragrance Materials
- Year:
- 1 977
- Bibliographic source:
- RIFM (Research Institute for Fragrance Materials, Inc.),RIFM Report Number 1691, May 16 (RIFM, Woodcliff Lake, NJ, USA).
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Maximization tests
- GLP compliance:
- not specified
- Type of study:
- other: Maximization tests
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
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- 20% (13,800 lg/cm2) tricyclodecenyl acetate and 8% (5520 micro.gm./cm2) tricyclodecenyl acetate
Challengeopen allclose all
- Route:
- other: occlusion
- Vehicle:
- petrolatum
- Concentration / amount:
- 20% (13,800 lg/cm2) tricyclodecenyl acetate and 8% (5520 micro.gm./cm2) tricyclodecenyl acetate
- No. of animals per dose:
- 26 volunteers and 21 volunteers
- Details on study design:
- Test material was applied in petrolatum under occlusion to the forearms for a total of five alternate-day 48-h periods. Each application was preceded by a 24-h occlusive treatment of the patch sites with 5% aqueous sodium lauryl sulfate (SLS). Following a 10- to 14-day rest period, challenge patches were applied under occlusion to fresh sites for 48 h.Challenge applications were preceded by 30 min applications of 2–5% SLS under occlusion on the left side and no pretreatment on the right side.
- Challenge controls:
- Following a 10- to 14-day rest period, challenge patches were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded
by 30 min applications of 2–5% SLS under occlusion on the left side and no pretreatment on the right side. Challenge sites were evaluated at removal of the patches and 24 h later.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20
- No. with + reactions:
- 0
- Total no. in group:
- 26
- Clinical observations:
- There was no evidence of contact sensitization
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20. No with. + reactions: 0.0. Total no. in groups: 26.0. Clinical observations: There was no evidence of contact sensitization.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 8
- No. with + reactions:
- 0
- Total no. in group:
- 21
- Clinical observations:
- There was no evidence of contact sensitization
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 8. No with. + reactions: 0.0. Total no. in groups: 21.0. Clinical observations: There was no evidence of contact sensitization.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In two separate maximization tests involving 26 and 21 volunteers, there was no evidence of contact sensitization to 20% (13,800 lg/cm2)or 8% (5520 lg/cm2) tricyclodecenyl acetate(3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate), respectively.
- Executive summary:
In two separate maximization tests involving 26 and 21 volunteers, there was no evidence of contact sensitization to 20% (13,800 lg/cm2)or 8% (5520 lg/cm2) tricyclodecenyl acetate(3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate), respectively.
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