(E)-4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one

Skin sensitisation

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

Reference

Reference 1

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 2

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 3

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

Test material information

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)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: Freund's Complete Adjuvant

Induction 2

Concentration / amount:

5, 10, 20, 40, 50%

Challenge

Challenge 1

Route:

other: epicutanous, unspecified

Vehicle:

other: Freund's Complete Adjuvant

Challenge 2

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.