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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No guideline available
GLP compliance:
no
Remarks:
study pre-dates the introduction of GLP
Type of study:
open epicutaneous test
Justification for non-LLNA method:
LLNA not available at the time of testing

Test material

Constituent 1
Chemical structure
Reference substance name:
rel-(E)-4-((1R,5R)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one
Cas Number:
599-45-1
Molecular formula:
C14H22O
IUPAC Name:
rel-(E)-4-((1R,5R)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one
Constituent 2
Chemical structure
Reference substance name:
rel-(E)-4-((1R,5S)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one
Cas Number:
472-46-8
Molecular formula:
C14H22O
IUPAC Name:
rel-(E)-4-((1R,5S)-2,5,6,6-tetramethylcyclohex-2-en-1-yl)but-3-en-2-one
impurity 1
Reference substance name:
3-Buten-2-one, 4-(2,5,6,6-tetramethyl-1-cyclohexen-1-yl)-, (3E)-
Cas Number:
72074-84-1
Molecular formula:
C14H22O
IUPAC Name:
3-Buten-2-one, 4-(2,5,6,6-tetramethyl-1-cyclohexen-1-yl)-, (3E)-
impurity 2
Reference substance name:
3-Buten-2-one, 4-(2,2,3,6-tetramethyl-3-cyclohexen-1-yl)-, [1α(E),6α]-
Cas Number:
140632-46-8
Molecular formula:
C14H22O
IUPAC Name:
3-Buten-2-one, 4-(2,2,3,6-tetramethyl-3-cyclohexen-1-yl)-, [1α(E),6α]-
impurity 3
Reference substance name:
4-Penten-2-one, 5-(1,3,4-trimethyl-3-cyclohexen-1-yl)-, (E)-
Cas Number:
162282-94-2
Molecular formula:
C14H22O
IUPAC Name:
4-Penten-2-one, 5-(1,3,4-trimethyl-3-cyclohexen-1-yl)-, (E)-
Specific details on test material used for the study:
Material: α-Irone

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Challenge
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
No. of animals per dose:
One to six experimental groups and one control group of six to eight guinea pigs are used.
Details on study design:
Induction consisted of 21 daily open applications to the shaved flank of 6-8 guinea pigs per group. One to six experimental and one control group of six to eight guinea pigs ware used. Open challenge applications were made on days 21 and 35. Reactions were read at 24, 48 and 72 hours. No further details were provided.

Results and discussion

In vivo (non-LLNA)

Results
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
α-Irone was found to be non-sensitizing in the Open Epicutaneous test (OET) in the Guinea Pig.