reaction mass of 3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one and 1-(2,6,6-trimethylcyclohex-2-en-1-yl)pent-1-en-3-one

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: only abstract available

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Cutaneous safety of fragrance material as measured by the maximization test

Author:

Greif N

Year:

1967

Bibliographic source:

American Perfumer and Cosmetics, 82, 54-57

Reference 2

Reference Type:

secondary source

Title:

No information

Author:

Grif N

Year:

2003

Bibliographic source:

RIFM Database

Reference 3

Reference Type:

publication

Title:

Fragrance material review on methyl ionone (mixture of isomers)

Author:

Lalko J et al.

Year:

2007

Bibliographic source:

Food and Chemical Toxicology 45 (2007) S300–S307

Reference 4

Reference Type:

publication

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

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

(1E)-1-(2,6,6-trimethylcyclohex-2-en-1-yl)pent-1-en-3-one; (3E)-3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one

EC Number:

942-741-0

Cas Number:

1335-46-2

Molecular formula:

C14H22O

IUPAC Name:

(1E)-1-(2,6,6-trimethylcyclohex-2-en-1-yl)pent-1-en-3-one; (3E)-3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one

Specific details on test material used for the study:

- Isomers composition: 50 % gamma-ionone

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 25, healthy
- Age: adult

Controls:

no data

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test; Kligman maximization test)

ADMINISTRATION
- Type of application: occlusive
- Site: to the same site on the forearms; 5 alternate-day 48 hour periods
- Vehicle / solvent: unspecified
- Concentrations: 10 %
- Testing/scoring schedule: pre-treated for 24 hours with 1 ml of 5% aqueous sodium lauryl sulfate under occlusion
- Other: Following a 10 day rest period, a challenge patch of the test material was applied to a fresh site on the scapular back for 48 hours under occlusion. Prior to challenge, 10% sodium lauryl sulfate was applied to the test site for one hour before application of test material.


EXAMINATIONS
- Grading/Scoring system: The challenge site was read at patch removal and again on each of two successive days.
A summation of the scores establishes the sensitization rate. From this a sensitization grade from 1 (weak) to 5 (extreme) for each test substance is established. Scoring method follows:
Sensitization Rate - 0 -2/25 => Grade of 1 (Classification - Weak);
Sensitization Rate - 3 -7/25 => Grade of 2 Classification - Mild);
Sensitization Rate - 8 -13/25 => Grade of 3 (Classification - Moderate);
Sensitization Rate - 14 -20/25 =>Grade of 4 Classification - Strong);
Sensitization Rate - 21-25/25 => Grade of 5 (Classification - Extreme)

Results and discussion

Results of examinations:

no effects in 25/25