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Diss Factsheets
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EC number: 236-675-5 | CAS number: 13463-67-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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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:
- other: well-conducted and reported study
Data source
Reference
- Reference Type:
- publication
- Title:
- The in vitro absorption of microfine zinc oxide and titanium dioxide through porcine skin.
- Author:
- Gamer, A.O.; et al.
- Year:
- 2 006
- Bibliographic source:
- Toxicology in Vitro 20, 301-307
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Titanium dioxide
- EC Number:
- 236-675-5
- EC Name:
- Titanium dioxide
- Cas Number:
- 13463-67-7
- Molecular formula:
- O2Ti
- IUPAC Name:
- dioxotitanium
- Test material form:
- solid: nanoform
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- pig
- Strain:
- other: Pietrain-Deutsche Landrasse-Hybrid
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not applicable
Administration / exposure
- Type of coverage:
- other: diffusion cell
- Vehicle:
- physiological saline
- Duration of exposure:
- up to 24 hours
- Doses:
- The test formulations were applied to 1cm² exposed skin at nominal doses of 4 mg/cm² for 24 hours corresponding to nominal doses of about 400 µg/cm² of zinc oxide or titanium dioxide or to nominal doses of 360 and 240 µg/cm² of zinc or titanium, respectively.
- No. of animals per group:
- The skin absorption studies were performed with three pigs per formulation, and the test formulations were applied to 8 (ZnO) or 3 (TiO2) skin preparations from each pig in a parallel experimental setup
- Control animals:
- no
- Remarks:
- in vitro testing
- Details on study design:
- no
- Details on in vitro test system (if applicable):
- Full thickness skin samples of visually intact skin from the lateral abdominal region of 5 months old pigs were dermatomed to a thickness of around 500 µm. The samples were mounted in modified Franz static dermal penetration cells consisting of an upper donor compartment and a lower receptor compartment with the external surface of the stratum corneum facing the donor chamber.
The receptor chambers were filled with approx. 4 ml of the receptor fluid and the cells were placed on a magnetic stirrer (32°C). Each skin sample was checked for integrity by measuring its electrical resistance with a LCR bridge prior testing.
Samples of receptor fluid were taken at various time intervals (3, 6, 12 and 24 hours) after application of the test formulation to the skin and retained for analysis. The skin was removed from the diffusion cell and put onto parafilm. Titanium was removed from the skin preparations by washing with sponge pieces dipped into soap solution, and subsequent tape stripping was used to remove titanium together with the superficial layers of the stratum corneum.
The pools of tape strips, the skin remaining after tape stripping, and all retained receptor fluid samples were acid-treated and analysed for titanium by atomic spectroscopy (AS). Depending on the concentration of the samples, inductively coupled plasma-atomic emission spectrometry or - mass spectrometry was applied for Ti analyses.
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Remarks:
- in vitro absorption was investigated
- Dermal irritation:
- not examined
- Remarks:
- in vitro absorption was investigated
- Absorption in different matrices:
- Reported results include full mass-balance (recovery 86-100%), tape stripping and epidermal and receptor medium analysis.
Absorbed dose (receptor ): 0%
Potentially absorbable dose (skin): 0.1-0.5 %
(excl. surface tape strippings) - Total recovery:
- see table
Mean total recoveries of Ti ranged from 98% to 100% (T-Lite SF-S) and 86% to 93% (T-Lite SF) of the total Ti applied, respectively.
Percutaneous absorptionopen allclose all
- Dose:
- 10%
- Parameter:
- percentage
- Absorption:
- 0 %
- Remarks on result:
- other: after 24 hours
- Remarks:
- T-Lite SF-S (TiO2) formulation
- Dose:
- 10%
- Parameter:
- percentage
- Absorption:
- 0 %
- Remarks on result:
- other: after 24 hours
- Remarks:
- T-Lite SF (TiO2) formulation
Applicant's summary and conclusion
- Conclusions:
- Results show that the test substance was not able to penetrate porcine stratum corneum.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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