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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
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
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.
Elder, R.L.
Bibliographic source:
J Am Coll Toxicol; 4: 107-146
Reference Type:
study report

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

Constituent 1
Chemical structure
Reference substance name:
Tetradecyl stearate
EC Number:
EC Name:
Tetradecyl stearate
Cas Number:
Molecular formula:
tetradecyl octadecanoate
Details on test material:
- Name of test material (as cited in study report): myristyl stearate
- Analytical purity: no data


Type of population:
- Number of subjects exposed: 200
Ethical approval:
not specified
Route of exposure:
Reason of exposure:
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.
- Other: local skin irritation effect

Results and discussion

Results of examinations:
- Other: no skin irritation effects were observed

Applicant's summary and conclusion