Registration Dossier
Registration Dossier
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EC number: 221-787-9 | CAS number: 3234-85-3
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- 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, occlusive application for 24 hours, 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
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- An 8% formulation of the test substance was applied to the skin of volunteers and covered with an occlusive dressing for 24 hours. The skin irritation was scored according to the Draize scoring system.
- 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
- Ethical approval:
- not specified
- Details on study design:
- An 8% formulation of the test substance (cologne stick) was applied to the skin of 20 volunteers and covered with an occlusive dressing for 24 hours. The skin irritation was scored according to the Draize scoring system.
- Exposure assessment:
- not specified
- Details on exposure:
- TYPE OF EXPOSURE: epidermal
Results and discussion
- Results:
- 1/20 had very slight erythema (grade 1 of 4). No skin irritation was observed in the remaining subjects. The primary irritation index was 0.05. This indicates that the irritation potential at this concentration is low.
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.
