Acetic acid, esters with lanolin alcs.

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

publication

Title:

Sensitisations to allergens of TRUE Test® in 864 consecutive eczema patients in Israel.

Author:

Magen E, Mishal J & Schlesinger

Year:

2006

Bibliographic source:

Contact Dermatitis, 2006, 55, 370-371

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A total of 864 patients (63.3% female) with eczema were patch-tested using the True Test®. The test patches were held in contact with skin for 2 days and the reading was performed 30 minutes following removal. The exposure sites were then re-examined 4 days later.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

wool alcohol.

IUPAC Name:

wool alcohol.

Details on test material:

wool alcohol.

Method

Type of population:

other: Selected patients

Ethical approval:

confirmed, but no further information available

Subjects:

- Number of subjects exposed: 864 patients
- Sex: 547 (63.3%) female, 317 (36.7%) male
- Age: not reported

Clinical history:

Patients with eczema

Controls:

none

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: patch-tested using the True Test®

- Testing/scoring schedule: Reading was performed 30 minutes following removal. The exposure sites were then re-examined 4 days later.
- Removal of test substance: Removed after 2 days

Results and discussion

Results of examinations:

The reaction rate among the 864 patients was 0.6% (5 individuals) for wool alcohols. As a reference, 13.2% reacted to nickel sulphate.

Applicant's summary and conclusion

Conclusions:

A relatively low reaction frequency was found in this study population for wool alcohol.

Executive summary:

Lanolin is a wax derived from the sebaceous glands of sheep and it is used in a wide range of applications. The primary human exposure to Lanolin comes from extensive use in skin treatment products and it has been used for centuries for this purpose.

 

A potential skin sensitization was claimed in early studies and it is commonly viewed that Lanolin has an allergenic potential. These observations are primarily based on human patch-testing of Lanolin alcohols and this substance is now included as an allergen in many screening panels for allergenicity. Lanolin alcohol is a fraction of Lanolin derived by alkaline treatment. It consists primarily of sterols but also a complex mixture of aliphathic alcohols and lipid species.

A total of 864 patients (63.3% female) with eczema were patch-tested using the True Test®. The test patches were held in contact with skin for 2 days and the reading was performed 30 minutes following removal. The exposure sites were then re-examined 4 days later. The reaction rate among the 864 patients was 0.6% (5 individuals) for wool alcohols. As a reference, 13.2% reacted to nickel sulphate.

 

Evaluation and conclusion:

A relatively low reaction frequency was found in this study population for wool alcohol.