Registration Dossier
Registration Dossier
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EC number: 903-982-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (A scientific review (peer reviewed). No data on GLP)
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 008
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- A human maximization study was carried out with 5% (3450 µg/cm2) fenchyl acetate in petrolatum on 25 (10 male:15 female) healthy volunteers. The author of the study report is Dr. Klingman - coauthor of the maximization test adopted by OECD.
- GLP compliance:
- not specified
- Type of study:
- other: Human maximization test
Test material
- Reference substance name:
- 3,3-dimethyl-8,9-dinorbornan-2-yl acetate
- EC Number:
- 237-588-5
- EC Name:
- 3,3-dimethyl-8,9-dinorbornan-2-yl acetate
- Cas Number:
- 13851-11-1
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,3,3-trimethylbicyclo[2.2.1]hept-2-yl acetate
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5 % (3450 µg/cm2)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5 % (3450 µg/cm2)
- No. of animals per dose:
- 25 (10 male:15 female) healthy volunteers.
- Details on study design:
- Application was under occlusion to the same site on the forearms of all subjects for five alternate-day 48-hour periods. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion. Challenge sites were read on removal of the patch and 24 h thereafter.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No sensitization reactions (0/25) were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The substance was no sensitizing.
- Executive summary:
A human maximization (Kligman, 1966) study was carried out with 5% (3450 µg/cm2) fenchyl acetate in petrolatum on 25 (10 male:15 female) healthy volunteers. Application was under occlusion to the same site on the forearms of all subjects for five alternate-day 48-hour periods. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion. Challenge sites were read on removal of the patch and 24 h thereafter. No sensitization reactions (0/25) were observed.
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