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Diss Factsheets

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

Referenceopen allclose all

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 Type:
secondary source
Title:
No information
Author:
Grif N
Year:
2003
Bibliographic source:
RIFM Database
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 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

Constituent 1
Chemical structure
Reference substance name:
Ionone, methyl-
EC Number:
215-635-0
EC Name:
Ionone, methyl-
Cas Number:
1335-46-2
Molecular formula:
C14H22O
IUPAC Name:
Ionone, methyl-
Details on test material:
- 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

Applicant's summary and conclusion