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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
