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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A scientific review (peer reviewed). No data on GLP.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The maximization test was carried out on 25 volunteers; the material was tested at a concentration of 10% in petrolatum. 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: maximization test
Justification for non-LLNA method:
LLNA method was not established at time of study

Test material

Constituent 1
Chemical structure
Reference substance name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
EC Number:
204-727-6
EC Name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
Cas Number:
125-12-2
Molecular formula:
C12H20O2
IUPAC Name:
(1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl acetate (1S,2S,4S)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl acetate

In vivo test system

Test animals

Species:
human
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
10% in petroleum
Challenge
Concentration / amount:
10% in petroleum
No. of animals per dose:
25 volunteers

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: no data
Group:
test chemical
Dose level:
No data
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
no data
Remarks on result:
no indication of skin sensitisation
Reading:
other: no data
Group:
negative control
Dose level:
0
Clinical observations:
no data
Remarks on result:
not measured/tested
Reading:
other: no data
Group:
positive control
Dose level:
no data
Clinical observations:
no data
Remarks on result:
not measured/tested

Any other information on results incl. tables

The substance produced no sensitization reactions.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
The substance was no sensitizing.
Executive summary:

The maximization test of Isobornyl acetate was carried out on 25 volunteers; the material was tested at a concentration of 10% in petrolatum. The substance produced no sensitization reactions.