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Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 27 to March 12, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Repeated Insult Patch test according to an internal protocol as outlined in the Fedral Register vol. 46, no. 17, 1981.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
No data

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: initially 114, 107 completed the study
- Sex: male and female
- Age: 6 to 79 years
- Race: not indicated
Clinical history:
- History of allergy or casuistics for study subject or populations: excluded
- Symptoms, onset and progress of the disease: absence of any visible skin desease
- Exposure history: no use of topical or systemic steroids or antihystamines seven days prior to the start of the test
- Aggravating factors both in home and workplace: None defined
- Family history: Not defined
- Medical history (for respiratory hypersensitivity): Not relevant
- Any other allergic or airway disorders: If present, not included
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: 3/4"x 3/4"absorbent pad portion of an adhesive dressing
- Concentrations: 100%
- Volume applied: 0.2 g
- Dermal dosage: 55 mg/cm2
- Induction period: Patches applied three times a week for a total of nine applications
- Challenge phase: Approx. 2 weeks after the final Induction patch application, a challenge patch was applied to a virgin test siteadjecent to the original patch site and after removal scored for reaction after 24 and 72 h.

EXAMINATIONS
- Grading/Scoring system:
0= No visible skin reaction
+= Barely perceptible or spotty erythema
1= Mild erythema
2= Moderate erythema + possible mild edema
3= Marked erythema + possible edema
4= Severe erythema, possible edema, vesiculation, bullae and/or ulceration

Results and discussion

Results of examinations:
RESULT OF CASE REPORT: Observations remained completely negative for all participants throughout the test interval.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, Ceraphyl MTE did not indicate a potential for dermal irritation or allergic contact sensitization at a dermal dose of 55 mg/cm2.