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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Isobornyl acetate was not sensitizing.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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
Species:
human
Sex:
not specified
Concentration / amount:
10% in petroleum
Concentration / amount:
10% in petroleum
No. of animals per dose:
25 volunteers
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

The substance produced no sensitization reactions.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Key study: 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.


Justification for classification or non-classification