Registration Dossier
Registration Dossier
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EC number: 266-006-2 | CAS number: 65996-73-8 The wetted particulate matter recovered by wet collection techniques, including pollution abatement equipment, for the recovery of materials such as iron sinter dust, blast furnace dust, steelmaking dust, and mill scale.
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Slimes and Sludges, blast furnace and steelmaking
- EC Number:
- 266-006-2
- EC Name:
- Slimes and Sludges, blast furnace and steelmaking
- Cas Number:
- 65996-73-8
- Molecular formula:
- not applicable
- IUPAC Name:
- Sludges steelmaking
- Details on test material:
- - Physical state: solid
- Composition of test material, percentage of components: Fe (total) 54.29% (mainly as oxides), CaO 10.17%, Zn 5.25%, MgO 4.32%, C 2.06%, SiO2 1.64%, Mn 0.69%, K2O 0.126%, Na2O 0.239%, Al2O3 0.16%
- Lot/batch No.: 21.10.2009
- Expiration date of the lot/batch: unlimited
- Stability under test conditions: unlimited
- Storage condition of test material: stored in PE container at room temperature
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: In vitro method
- Details on test animals or test system and environmental conditions:
- not applicable
Administration / exposure
- Type of coverage:
- other: In vitro method
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: B+B Agro, Cíneves, Czech Republic
- Type of skin: sheet of pork skin from both sides of the backbone (cca 40 x 70 cm)
- Preparative technique: subcutaneous fat was removed using electrical knife and blunt butcher knife; skin was shaved by electrical shaver, washed with lukewarm water and let to dry
- Membrane integrity check: standard 1% solution of caffeine in ethanol / water (3:7) was applied 20 µl per skin preparation, two skin preparations in each run; determined values (30.9 - 37.0 % penetration) falls into the range of historical data (29.4 - 40.2 %) and thus quality of skin was acceptable
- Storage conditions: skin was divided into disc-shaped pieces (diameter 5 cm), which were stored in vacuum bags with designated date of preparation and frozen (-18°C); prior to testing (2-3 hours) the skin preparations were defrozen on air at laboratory temperature
- Justification of species, anatomical site and preparative technique: according to Council Regulation (EC) No. 440/2008 skin from many mammalian species can be used, the structure and characteristics of porcine skin are similar to human skin
PRINCIPLES OF ASSAY
- Diffusion cell: static Franz diffusion cells consisted of a donor chamber (in the form of a glass cap with an opening in the center) and receptor chamber (double bottom glass cell, diameter cca 2 cm, volume cca 5 ml); the system was placed on a magnetic stirrer set for 310 rpm
- Receptor fluid: 0.9% NaCl, 1% bovine albumin, 0.05% Gentamicin in deionised water
- Static system: yes
- Exposure duration: 24 hours
- Test temperature: 34°C
- Reference substance(s): caffeine
- Negative control: distilled water
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Remarks:
- not applicable
- Dermal irritation:
- not examined
- Remarks:
- not applicable
- Absorption in different matrices:
- see Slimes and Sludges - Dermal Absorpotion - Results.pdf in Attached background material
- Total recovery:
- see Slimes and Sludges - Dermal Absorpotion - Results.pdf in Attached background material
Percutaneous absorption
- Key result
- Remarks on result:
- other: Under the test conditions of the in vitro skin absorption method, the elements contained in the test item do not significantly penetrate into the deeper skin layers and receptor fluid, thus excluding the possibility of systemic exposure.
Any other information on results incl. tables
see Slimes and Sludges - Dermal Absorpotion - Results.pdf in Attached background material
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions of the in vitro skin absorption method, the elements contained in the test item do not significantly penetrate into the deeper skin layers and receptor fluid, thus excluding the possibility of systemic exposure.
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