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Toxicological information

Sensitisation data (human)

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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: see 'Remark'
Remarks:
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. The information does not come from a test report, and the minimum fields required cannot be filled in.

Data source

Reference
Reference Type:
publication
Title:
Reproducibility of patch test results: a concurrent right-versus-left study using TRUE Test™
Author:
Ale IS & Maibach IH
Year:
2004
Bibliographic source:
Contact Dermatitis, 2004, 50, 304-312

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:
This study is not focused on skin sensitization potential of Lanolin but rather a study of patch test reproducibility where Lanolin alcohol was included in the panel of substances tested. The reproducibility of the TRUE Test™ was tested in 500 volunteers (58% women, 42% men, mean age 42.4 years) with suspected contact dermatitis (based on history and clinical examination) but with no active dermatitis. Each volunteer was administered a TRUE Test™ panel (strips) on the left and right side of the upper back. After 48 hours the panels were removed and the reaction was assessed. The test area was read after 96 hours in the majority of volunteers.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
other: Volunteers (58% women, 42% men, mean age 42.4 years) with suspected contact dermatitis (based on history and clinical examination) but with no active dermatitis.
Ethical approval:
other: The study was approved by the Ethics Committee of the University Hospital, Montevideo, Uruguay.
Subjects:
- Number of subjects exposed: 500
- Sex: 58% women & 42% men
- Age: mean age 42.4 years
- Race: Not reported
- Demographic information: Uruguay

- Other:

Criteria for inclusion in the study were:
-Contact dermatitis suspected from history and clinical examination
-Over 15 years old
-No active dermatitis (except from mild localized dermatitis)
-No active dermatitis of any degree on or around the test area
-No systemic corticosteroid or immunosuppressive treatment during the previous 30 days
-No topical treatment with corticosteroids during the previous 15 days on or around the test area
-Not pregnant (by history)
Clinical history:
- History of allergy or casuistics for study subject or populations:
Deatils of present dermatitis
- Exposure history: Occupational and non-occupational exposures, including hobbies, topical and systemic therapies, personal skin care, etc.

- Family history: personal & family atopy
- Medical history (for respiratory hypersensitivity): histiry of previous dermatitis
Controls:
Not reported
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: TRUE Test™ panel (strips)

- Testing/scoring schedule:
The test area was read after 96 hours in the majority of volunteers.

- Removal of test substance:
After 48 hours the panels were removed and the reaction was assessed

EXAMINATIONS
- Statistical analysis: The X2 -test and the two-sided Student's t-test were used for statistical comparisons between different subgroups of patients. A P-value of 0.05 or less was considered to indicate statistical significance.
- Other:

Results and discussion

Results of examinations:
Lanolin alcohol was positive concordant (reaction observed on both application areas) in 7 volunteers and positive discordant (reaction observed in only one application area) in 3 volunteers.

Applicant's summary and conclusion

Conclusions:
There was a relatively large degree of discordant observations with Lanolin alcohols
Executive summary:

This study is not focused on skin sensitization potential of Lanolin but rather a study of patch test reproducibility where Lanolin alcohol was included in the panel of substances tested. The reproducibility of theTRUE Test™was tested in 500 volunteers (58% women, 42% men, mean age 42.4 years) with suspected contact dermatitis (based on history and clinical examination) but with no active dermatitis. Each volunteer was administered a TRUE Test™ panel (strips) on the left and right side of the upper back. After 48 hours the panels were removed and the reaction was assessed. The test area was read after 96 hours in the majority of volunteers. Lanolin alcohol was positive concordant (reaction observed on both application areas) in 7 volunteers and positive discordant (reaction observed in only one application area) in 3 volunteers.

There was a relatively large degree of discordant observations with Lanolin alcohols