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Diss Factsheets

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:
2008
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1976

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

Constituent 1
Chemical structure
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

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.