Registration Dossier
Registration Dossier
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EC number: 201-224-3 | CAS number: 79-77-6
Sensitisation data (human)
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:
- 1 967
- 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 substance name:
- (E)-4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one
- EC Number:
- 201-224-3
- EC Name:
- (E)-4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one
- Cas Number:
- 79-77-6
- Molecular formula:
- C13H20O
- IUPAC Name:
- 4-(2,6,6-trimethylcyclohex-1-en-1-yl)but-3-en-2-one
- Reference substance name:
- 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- EC Number:
- 204-841-6
- EC Name:
- 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- Cas Number:
- 127-41-3
- IUPAC Name:
- 4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one
- 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)
Constituent 1
Constituent 2
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
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