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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1982
Bibliographic source:
J Am Coll Toxicol; 1: 55-80
Reference Type:
study report
Title:
Unnamed
Year:
1974
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

Constituent 1
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

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