Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable method

Data source

Reference
Reference Type:
publication
Title:
Cutaneous safety of fragrance material as measured by the Maximization Test
Author:
Greif N
Year:
1967
Bibliographic source:
American Perfumes and Cosmetics, Vol. 82, June, 54-57

Materials and methods

Study type:
study with volunteers
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ionone
- Isomers composition: 97.5% alph-ionone (CAS 127-41-3), 2.5% beta-ionone (CAS 79-77-6)

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 25
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)


ADMINISTRATION
- Site: forearms
- Type of application: occlusive 48h
- Concentrations: 8%
- Testing/scoring schedule: 5 x 48 h in 15 d
- Other: patch site was pretreated with 1.0 ml of 5 % aqueous sodium lauryl sulfate (SLS) solution for 24 h
- Other: Prior to challenge, 10 % sodium lauryl sulfate was applied to the test site for one hour before application of test material
- after 10d: patch for 48 h

EXAMINATIONS
- Grading/Scoring system: immediately after patch removal, and 1st and 2nd day
- Scoring: 1 (weak) - 5 (extreme)

SCORING:
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. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 25

Applicant's summary and conclusion

Conclusions:
not sensitizing