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Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
July 2001 to June 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: REad-across from an acceptable, well-documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Simultaneous sodium lauryl sulphate testing improves the diagnostic validity of allergic patch tests. Results from a prospective multicentre study of the German Contact Dermatitis Research Group (Deutsche Kontaktallergie Gruppe, DKG)
Author:
Löffler H et al
Year:
2005
Bibliographic source:
British Journal of Dermatology 152, 709-719

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: study with patients
Principles of method if other than guideline:
Collecting human patch test data of patients from 19 centers in Germany and Austria in the Information Network of Department of Dermatology (IVDK).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Method

Type of population:
general
Ethical approval:
no
Subjects:
- Number of subjects exposed: 5971 enrolled by 19 departments of Dermatology in Germany and Austria
- Sex: 38.0 % male, 62 % female
- Age: 3956 (66.3 %) patients were aged >= 40
- Race: no data
- Demographic information:
- Other:
Clinical history:
- History of allergy or casuistics for study subject or populations: Suspected allergic contact dermatitis (occupational dermatitis 872 (14.6%), past or present atopic dermatitis 1024 (17.1%))
Main anatomical sites of skin disease: hands (1672 patients, 28 %), legs (691, 11.6 %), face (821, 13.7 %)
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: in 17 departments (5145 patients): small Finn Chambers, in 2 departments (826 patients) Haye´s test chambers (0.8 x 0.8 cm2 polypropylene chambers mounted on an adhesive plaster)
- Vehicle / solvent: water
- Number of allergens tested: 29
- Concentrations: CAPB 1 % aq
- Volume applied: 25 µl SLS 0.5 % aq. and 0.25 % aq. was applied in addition to the test substances
- Removal of test substance: after 48 h in 4652 patients (14 centers) and 24 h in 1319 patients (5 centers)
- Reading: after 48 and 72 h


EXAMINATIONS
- Grading/Scoring system: according to the Standardisation Group of the European Society of Contact Dermatitis
- Evaluation: positive reaction was interpreted as +, ++, +++ manifested by erythema, infiltration, papules and/or vesicles
- Statistical analysis: Fisher´s exact test, McNemar´s test

Results and discussion

Any other information on results incl. tables

Patients tested negative and positive to SLS, respectively showed mostly doubtful, non-specific erythematous reactions or very weak reactions (+ reactions).

Patients which were tested negative to sodium lauryl sulphate 0.25% + Coco AAPB 1 % aq.:

Erythema: 2.4% (95 % CI 1.8 - 3.0%)

% +:  1.1% (95 % CI 0.7 - 1.5%)

% ++/+++: 0.0 (95 5 CI 0.0 - 0.0)

Patients which were positive to sodium lauryl sulphate 0.25% + Coco AAPB 1 % aq.:

Erythema: 3.7% (95 % CI 2.6 - 4.8%)

% +: 3.8% (95 % CI 2.6 - 5.0%)

% ++/ +++: 0.2% (95 % CI 0.0 - 0.4%)

Patients which were negative to sodium lauryl sulphate 0.5% + Coco AAPB 1 % aq.:

Erythema: 2.2% (95 % CI 1.6 - 2.8%)

% +: 1.2 (95 % CI 0.7 - 1.6 %)

% ++/+++: 0.0 (95 5 CI 0.0 - 0.0)

 

Patients which were positive to sodium lauryl sulphate 0.5% + Coco AAPB 1 % aq:

Erthema: 3.5% (95 % CI 2.6 - 4.5%)

% +:  2.8% (95 % CI 1.9 - 3.6%)

% ++/+++: 0.1% (0.0 - 0.3%)

% + or % ++/+++: reaction index

CI: confidence interval

The authors suggest when skin susceptibility is non-specifically enhanced the intensity of the irritant quality of the contact allergen may be sufficient to induce a visible skin reaction without any sensitization. It can be assumed that the non-specific erythematous reactions are most likely to be of irritant nature due to an increased skin susceptibility. The probability of an irritant reaction seems to be higher when the sodium lauryl sulphate test is positive.

Furthermore, the author suggest, a complicating factor in most of these studies is the fact that sensitizing impurities and by-products from the manufacturing process, such as amidoamine and 3-dimethylaminopropylamine (DMPA) may have been present in the test formulations, resulting in “false positive” reactions for Coco AAPB. This is particularly the case for testing performed before the late 90’s when this issue became evident. Furthermore, the patch test reactions to Coco AAPB (or its impurities)often are irritant in nature, although the morphological picture and crescendo reaction may sometimes suggest a positive allergic reaction (Löffler et al., 2005).

Applicant's summary and conclusion

Executive summary:

In a dermal sensitization study with Coco AAPB (1 % aq., not further specified) in combination with sodium lauryl sulphate (0.25, 0.5 aq. %) 157 to 2866 patients with dermatitis of various types were tested using the patch test method with occlusive dressing for 48 hours.

Patients tested negative and positive to sodium lauryl sulphate, respectively showed mostly doubtful, non-specific erythematous reactions or very weak reactions.

The authors suggest when skin susceptibility is non-specifically enhanced the intensity of the irritant quality of the contact allergen may be sufficient to induce a visible skin reaction without any sensitization. It can be assumed that the non-specific erythematous reactions are most likely to be of irritant nature due to an increased skin susceptibility. The probability of an irritant reaction seems to be higher when the sodium lauryl sulphate test is positive.

Furthermore, the author suggest, a complicating factor in most of these studies is the fact that sensitizing impurities and by-products from the manufacturing process, such as amidoamine and 3-dimethylaminopropylamine (DMPA) may have been present in the test formulations, resulting in “false positive” reactions for Coco AAPB. This is particularly the case for testing performed before the late 90’s when this issue became evident. Furthermore, the patch test reactions to Coco AAPB (or its impurities)often are irritant in nature, although the morphological picture and crescendo reaction may sometimes suggest a positive allergic reaction (Löffler et al., 2005).