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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Principles of method if other than guideline:
The Guinea pig maximization test. Curr. Probl. Derm. 14, 59-106 (Karger, Basel)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test performance before finalization of OECD guideline for LLNA.

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexanone
EC Number:
203-631-1
EC Name:
Cyclohexanone
Cas Number:
108-94-1
Molecular formula:
C6H10O
IUPAC Name:
cyclohexanone
Details on test material:
TS-Freetext:
Cyclohexanone
CAS No.: 108-94-1
Specific details on test material used for the study:
pure Cyclohexanone (Fluka) as well as two batches of a cyclohexanone resin were tested.

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
intradermal: 8 %, epicutaneous: 25 %
Challenge
Concentration / amount:
Challenge concentrations Cyclohexanone: 5%, 10% and 5%
No. of animals per dose:
20

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20% ; 10% and 5 %
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%, 10% and 5 %
No. with + reactions:
0
Total no. in group:
20

Any other information on results incl. tables

2 sensitization experiments were carried out with 2 batches of Cyclohexanone resin. The 1st batch showed a sensitizing potential, while the 2nd only gave a statistically significant difference at the 24 h reading and at a challenge concentration of 10%. A GPMT with cyclohexanone did not reveal any allergenic potential.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met