Registration Dossier
Registration Dossier
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EC number: 906-083-8 | CAS number: -
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
Test material
- Reference substance name:
- Geranyl acetate
- EC Number:
- 203-341-5
- EC Name:
- Geranyl acetate
- Cas Number:
- 105-87-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 3,7-dimethylocta-2,6-dien-1-yl acetate (E)-
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 25
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: repeated insult patch test
ADMINISTRATION
- Site: forearms (induction), scapular back (challenge)
- Type of application: occlusive 48h
- Concentrations: 4%
- Testing/scoring schedule: 5 x 48 h for induction, 10 days resting period, 1x48h for challenge
- Readings: at patch removal and again on each of two successive days.
- 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
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
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