Glycerol monomyristate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Data source

Reference

Reference Type:

secondary source

Title:

Final report of the amended safety assessment of Glyceryl Laurate, (…), Glyceryl Isostearate/Myristate, (…)

Author:

Johnson, W.

Year:

2004

Bibliographic source:

Interntional Journal of Toxicology, 23(Suppl. 2):55-94

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

- Principle of test: In a single-blind, repeat-insult patch test, a 50% dilution of the test substance in liquid paraffin oil was applied to the back skin of volunteers for 47 h under occlusive conditions. A total of nine induction applications were made, at unspecified intervals. The skin reaction was assessed prior to application of the new patch and 1 h after patch removal on the last day. Challenge patches were applied to the upper back (distant from induction site) of each subject on day 36. The patches were removed and discarded at the end of the 47-h contact period. Reactions were evaluated at 1 and 49 h after challenge patch removal.
- Parameters analysed / observed: skin reactions following exposure to the test substance.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol monomyristate

EC Number:

248-329-0

EC Name:

Glycerol monomyristate

Cas Number:

27214-38-6

Molecular formula:

C17H34O4

IUPAC Name:

2-hydroxy-1-(hydroxymethyl)ethyl myristate

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 93
- Age: 18 - 65
-Other: 107 subjects were recruited to the study, of which 93 completed

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Finn chamber on Scanpore tape
- Vehicle / solvent: liquid paraffin oil
- Concentrations: 50%
- Volume applied:
- Testing/scoring schedule: A total of nine induction applications were made, at unspecified intervals. Following patch removal, the skin reaction was assessed prior to application of the new patch and 1 h after patch removal on the last day. Challenge patches were applied to the upper back (distant from induction site) of each subject on day 36. The patches were removed and discarded at the end of the 47-h contact period. Reactions were evaluated at 1 and 49 h after challenge patch removal.

EXAMINATIONS
- Grading/Scoring system: scored on a scale from 0 (no visible reaction) to 5 (bullous reaction)

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 93

Applicant's summary and conclusion

Conclusions:

The test substance did not cause skin sensitisation under the relevant test conditions.