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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, data only from secondary source. Due to structural similarities of the registered substance trans-ß-ionone (CAS 79-77-6) and the used test substance ß-ionone (CAS 14901-07-6) the study data could be taken into account for assessment.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Toxicology studies of beta-ionone in the guinea pig
Author:
Takasago International Corporation
Year:
1999
Bibliographic source:
cited in RIFM/FEMA database, location 35056
Report date:
1999
Reference Type:
secondary source
Title:
Fragrance material review on beta-ionone
Author:
Lalko J et al.
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S241–S247
Reference Type:
secondary source
Title:
A toxicologic and dermatologic assessment of ionones when used as fragrance ingredients
Author:
Belsito D et al.
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S130–S167

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
Freund's complete adjuvant test

Test material

Constituent 1
Reference substance name:
4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one
EC Number:
238-969-9
EC Name:
4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one
Cas Number:
14901-07-6
IUPAC Name:
4-(2,6,6-trimethylcyclohex-1-en-1-yl)but-3-en-2-one

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hartley strain albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC, Inc.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Freund's Complete Adjuvant
Concentration / amount:
5, 10, 20, 40, 50%
Challengeopen allclose all
Route:
other: epicutanous, unspecified
Vehicle:
other: Freund's Complete Adjuvant
Concentration / amount:
5, 10, 20, 40, 50%
No. of animals per dose:
together 5 animals for test and 4 animals for control
Details on study design:
- Hair on the back of the animals was cut with an electric clipper and an electric shaver
- Four hours after depilation, based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected.
- For the purpose of this study the test material was freshly prepared as follows:
[Intradermal Induction]: 10% w/v in Complete Adjuvant, 10% w/v in a mixture of Freund's Complete Adjuvant plus physiological saline (1:1);
[Topical Induction]: 10% w/v in Complete Adjuvant;
[Topical Challenge]: 50, 40, 20, 10, 5% w/v in acetone.
- The concentration, homogeneity and stability of the test material formulations were not determined.

SCORING
- The intensity of skin reaction was graded from 0 to 8 scale.
- The criteria and scoring system for assessment of dermal reaction are those of Draize J.H. (1959).
- The scores for erythema and edema at 48-hour reading were totaled for the five test guinea pigs (5 values) and this total was divided by 5 to give the sensitisation index of the test material

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5, 10, 20, 40, 50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5, 10, 20, 40, 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion