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Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1997

Materials and methods

Study type:
study with volunteers
Principles of method if other than guideline:
Method: Patch test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
5-bromo-5-nitro-1,3-dioxane
EC Number:
250-001-7
EC Name:
5-bromo-5-nitro-1,3-dioxane
Cas Number:
30007-47-7
Molecular formula:
C4H6BrNO4
IUPAC Name:
5-bromo-5-nitro-1,3-dioxane

Method

Type of population:
other: dermatitis patients
Ethical approval:
not specified
Subjects:
a) With ethanol
Patients: 1024
- Preparation: Test solution was prepared fresh every week

b) with petrolatum
Patients: 1085

Route of administration:
dermal
Details on study design:
TYPE OF TEST USED: patch test (epicutaneous test)

Range finding study: For detection of contact allergy to a preservative commonly higher concentrations than use concentrations have to be tested. Initially, test substance 1 % in ethanol was tested, but morphologically irritant reactions were noted in some patients. Therefore, the test concentration was lowered to 0.25 %.

ADMINISTRATION
- Type of application: occlusive
- Description of patch: The patch test was performed with the Al test technique (Astra Agency, Södertälje, Sweden).
The Al test was attached to Scanpore tape and the patches were removed from the back after two days.
- Vehicle / solvent: a) ethanol, b) petrolatum
- Concentrations: 0.25%
- Volume applied: 25 µL
- Removal of test substance: After two days
- Testing/scoring schedule: The tests were read one or, occasionally, two days after the removal.

EXAMINATIONS
- Grading/Scoring system: According to ICDRG criteria
- Statistical analysis: Fisher's exact test was used.

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions:
Ethanol: 17/1024 (1.7 %)
Petrolatum: 4/1085 (0.4 %)


Applicant's summary and conclusion

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