Registration Dossier
Registration Dossier
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EC number: 241-640-2 | CAS number: 17661-50-6
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Seconddary literature only and documentation insufficient for assessment. The test substance was applied in a 2.35 or 2.98% concentration in a formulation of unspecified composition, few details of the study protocol were given, no individual scores were given, 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 Butyl Stearate, Cetyl Stearate, Isobutyl Stearate, Isocetyl Stearate, Isopropyl Stearate, Myristyl Stearate, and Octyl Stearate. Cosmetic Ingredient Review.
- Author:
- Elder, R.L.
- Year:
- 1 985
- Bibliographic source:
- J Am Coll Toxicol; 4: 107-146
- Reference Type:
- study report
- Title:
- Unnamed
Materials and methods
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- In a prophetic patch test, a formulation with 2.35 or 2.98% test substance (face cream) was applied to the skin of volunteers, 100 in each group. For each volunteer, the exposure site was either left open or covered with an occlusive dressing. The skin irritation effect was scored.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Tetradecyl stearate
- EC Number:
- 241-640-2
- EC Name:
- Tetradecyl stearate
- Cas Number:
- 17661-50-6
- Molecular formula:
- C32H64O2
- IUPAC Name:
- tetradecyl octadecanoate
- Details on test material:
- - Name of test material (as cited in study report): myristyl stearate
- Analytical purity: no data
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 200
- Ethical approval:
- not specified
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- not specified
- Details on exposure:
- A formulation (face cream) with 2.35 or 2.98% test substance was applied to the skin of volunteers, 100 in each group. In 50 subjects, the exposure site was left open and in 50 subjects the exposure site was covered with an occlusive dressing.
- Examinations:
- - Other: local skin irritation effect
Results and discussion
- Results of examinations:
- - Other: no skin irritation effects 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.
