Alcohols, C16-18

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:

weight of evidence

Study period:

1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Prevalence and sources of sensitization to emulsifiers: a clinical study.

Author:

Tosti A, Guerra L, Morelli R, Bardazzi F.

Year:

1990

Bibliographic source:

Contact Dermatitis. 1990 Aug;23(2):68-72.

Materials and methods

Study type:

clinical case study

Endpoint addressed:

skin irritation / corrosion

skin sensitisation

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Type: other: skin reaction in man

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C16-18

EC Number:

267-008-6

EC Name:

Alcohols, C16-18

Cas Number:

67762-27-0

Molecular formula:

C16 H34 O

IUPAC Name:

Alcohols, C16-18

Details on test material:

Test substance: cetyl stearyl alcohol 99% pure)
- Name of test material (as cited in study report):6 emulsifier agents: triethanolamine, cetyl stearyl alcohol, sorbitan sesquioleate, polyoxyethylene sorbitan monopalmitate, polyoxyethylene sorbitan monooleate, and Amerchol L 101

Method

Type of population:

general

Subjects:

- Number of subjects exposed:737
- Known diseases: with suspected cosmetic or medicament contact dermatitis.

Ethical approval:

confirmed, but no further information available

Route of exposure:

dermal

Reason of exposure:

intentional

Exposure assessment:

measured

Details on exposure:

In a 1990 study, researchers applied emulsifying agents, including cetyl stearyl alcohol, to real human patients. A total of 54 out of 737 experienced reactions to them—redness, inflammation, and the like.

Results and discussion

Results of examinations:

Cetyl stearyl alcohol (C16-18) did not produce positive responses in any of the test subjects.

Any other information on results incl. tables

737 patients with suspected cosmetic- or medicament-related contact dermatitis were patch tested with 6 emulsifier agents: triethanolamine, cetyl stearyl alcohol, sorbitan sesquioleate, polyoxyethylene sorbitan monopalmitate, polyoxyethylene sorbitan monooleate, and Amerchol L 101. 39 patients (5.3%) gave 1 or more positive patch tests to emulsifiers. A total of 54 positive reactions were found, 23 of which were clinically relevant, triethanolamine being the most frequent sensitizer. Patients with emulsifier sensitivity generally give a high prevalence of positive patch tests to other common ingredients of topical preparations, such as preservatives or active ingredients. Cosmetics and topical medicaments were detected as the source of sensitization in an equal number of patients. Patch tests with patients' own causative preparations were frequently negative. To avoid overlooking emulsifier sensitivity, it is advisable to test these compounds in patients with contact dermatitis that is possibly due to topical preparations, regardless of whether they have other clinically relevant positive reactions or whether patch tests with their own products are negative.

Applicant's summary and conclusion

Conclusions:

Cetyl stearyl alcohol (C16-18) did not produce positive responses in any of the test subjects.

Executive summary:

Results: Cetyl stearyl alcohol (C16-18) did not produce positive responses in any of the test subjects.