Registration Dossier
Registration Dossier
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EC number: 221-787-9 | CAS number: 3234-85-3
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature only. Few details on the study protocol were given, no individual scores were given, an 8% formulation of the test substances was used, the analytical purity of the test substance was not specified.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Final Report on the Safety Assessment of Myristyl Myristate and Isopropyl Myristate. Cosmetic Ingredient Review.
- Author:
- CIR Expert Panel
- Year:
- 1 982
- Bibliographic source:
- J Am Coll Toxicol; 1: 55-80
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- An 8% formulation of the test substance (cologne stick) was applied to the skin on one arm of volunteers and covered with an occlusive dressing 3 days a week for a total of 10 induction exposures. After a rest period of 14 days, one challenge was performed and the skin assessed for sensitisation reactions.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3234-85-3 (8% in formulation)
- IUPAC Name:
- 3234-85-3 (8% in formulation)
- Details on test material:
- - Name of test material (as cited in study report): myristyl myristate
- Analytical purity: no data
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 196
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Concentrations: 8% in formulation
- Testing/scoring schedule: The test substance was applied to the skin on one arm of volunteers 3 days a week for a total of 10 induction exposures. After a rest period of 14 days, one challenge was performed and the skin assessed for sensitisation reactions.
Results and discussion
- Results of examinations:
- OTHER RESULTS: no sensitisation reactions were observed
Applicant's summary and conclusion
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