Fatty acids, C10-30, 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:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Unsuitable test system or conditions and/or insufficient reporting of methods and/or results data.

Data source

Reference

Reference Type:

review article or handbook

Title:

The lanolin Paradox

Author:

Wolf R

Year:

1996

Bibliographic source:

Dermatology, 1996, 192, 198-202

Materials and methods

Type of sensitisation studied:

skin

Study type:

other: Review/comment

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

This publication is a review/comment on the contemporary knowledge of Lanolin and sensitization. The author briefly described some of the early studies of Lanolin and skin sensitization potential.

GLP compliance:

no

Remarks:

Not relevant

Test material

Test material information

Constituent 1

Reference substance name:

Not relevant

IUPAC Name:

Not relevant

Details on test material:

Not relevant

Method

Type of population:

other: Not applicable

Ethical approval:

not applicable

Subjects:

not applicable

Clinical history:

Not applicable

Controls:

Not applicable

Route of administration:

dermal

Details on study design:

This publication is a review/comment on the contemporary knowledge of Lanolin and sensitization. The author briefly described some of the early studies of Lanolin and skin sensitization potential.

Results and discussion

Results of examinations:

This publication is a review/comment on the contemporary knowledge of Lanolin and sensitization. The author briefly described some of the early studies of Lanolin and skin sensitization potential. Four “Lanolin Paradoxes” are presented: 1) Lanolin in topical therapeutic agents sensitizes a high proportion of patients whereas the same concentration in cosmetics do not, 2) Patients with an allergic contact dermatitis to lanolin in a medication applied to a stasis ulcer can nevertheless use lanolin-containing cosmetics and not experience a reaction, 3) Lanolin-sensitive individuals often show false-negative patch test reactions to unaltered Lanolin, 4) Patch-testing with 30% wool wax alcohols can not be considered a reliable method for testing for Lanolin skin sensitization potential as there are too many false positive and false negatives. Each of these paradoxes is supported by examples.

Applicant's summary and conclusion

Conclusions:

This publication is a review of various observations related to Lanolin and skin sensitization.

Executive summary:

This publication is a review/comment on the contemporary knowledge of Lanolin and sensitization. The author briefly described some of the early studies of Lanolin and skin sensitization potential. Four “Lanolin Paradoxes” are presented: 1) Lanolin in topical therapeutic agents sensitizes a high proportion of patients whereas the same concentration in cosmetics do not, 2) Patients with an allergic contact dermatitis to lanolin in a medication applied to a stasis ulcer can nevertheless use lanolin-containing cosmetics and not experience a reaction, 3) Lanolin-sensitive individuals often show false-negative patch test reactions to unaltered Lanolin, 4) Patch-testing with 30% wool wax alcohols can not be considered a reliable method for testing for Lanolin skin sensitization potential as there are too many false positive and false negatives. Each of these paradoxes is supported by examples.

 

Evaluation and conclusion:

This publication is a review of various observations related to Lanolin and skin sensitization.