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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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

Data source

Reference Type:
study report

Materials and methods

Type of sensitisation studied:
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:

Test material

Test material form:
not specified
Details on test material:
No data


Type of population:
Ethical approval:
confirmed and informed consent free of coercion received
- 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:
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)
- 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.

- 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

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.