Registration Dossier
Registration Dossier
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EC number: 250-001-7 | CAS number: 30007-47-7
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP and non-guideline compliant study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
- Reference Type:
- publication
- Title:
- Bronidox, a new preserving agent for the cosmetics: properties and toxicological-dermatological assays
- Author:
- M. Potokar, et al.
- Year:
- 1 976
- Bibliographic source:
- Fette, Seifen, Anstrichmittel, Jahrgang 78, Nr. 7, 269-276
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- 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
Constituent 1
Test animals
- Species:
- human
- Sex:
- male
Administration / exposure
- Vehicle:
- other: oil in water cream
- Duration of exposure:
- 4 hours
- Doses:
- 0.05%
- Details on study design:
- - Number of probands: 5 probands per dose, no clinical treatment, normal food.
- Age: 27 - 34 years
- Weight: 63 - 83 kg
APPLICATION OF DOSE: 2 g oil/water cream= 1 mg test substance
TEST SITE
- Preparation of test site: on the back
- Area of exposure: 20 x 30 cm
- Control: only vehicle (oil in water cream), next to the treated area
REMOVAL OF TEST SUBSTANCE
- Washing procedures and type of cleansing agent: After 4 hours with alcohol
SAMPLE COLLECTION
- Collection of urine: 1, 2, 3, 4, 8 and 24 hours
ANALYSIS
- Method type(s) for identification: GC of the washed test substance
Results and discussion
Percutaneous absorption
- Key result
- Time point:
- 24 h
- Dose:
- 0.05%
- Parameter:
- percentage
- Absorption:
- ca. 50 %
Applicant's summary and conclusion
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