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EC number: 202-494-5 | CAS number: 96-26-4
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 July 2007 - 20 March 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Version / remarks:
- adopted 13 April 2004
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,3-dihydroxyacetone
- EC Number:
- 202-494-5
- EC Name:
- 1,3-dihydroxyacetone
- Cas Number:
- 96-26-4
- Molecular formula:
- C3H6O3
- IUPAC Name:
- 1,3-dihydroxyacetone
- Details on test material:
- Appearance: white powder
Constituent 1
- Radiolabelling:
- yes
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: O/W emulsion
- Duration of exposure:
- 24h
- Doses:
- Non-radiolabelled and radiolabelled test material was formulated in a typical O/W emulsion (SK-06-base) at 2.5, 5.0, 7.0 and 10%, respectively. Homogeneity and the actual radioactive concentration of each formulation was verified measuring radioactivity in aliquots using LSC.
The formulations were applied to the skin membranes at a target application rate of 2.0 mg/cm2 (actual mean application rate was in the range of 2.2-2.5 mg/cm2) - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Human (4 donors)
- Ethical approval if human skin: Informed consent was provided by all skin donors
- Type of skin: abdominal surgery
- Preparative technique: Upon arrival of the skin at the laboratory, subcutaneous fat was removed, the skin was cleared from blood residues, carefully dried and then stored wrapped in aluminium foil at <-18°C until use. After thawing, the skin was cut to a recorded thickness.
- Thickness of skin (in mm): 0.4 mm
- Membrane integrity check: Yes, permeability coefficient for tritiated water
- Storage conditions:
- Justification of species, anatomical site and preparative technique: common for this type of test as described in the OECD TG
PRINCIPLES OF ASSAY
- Diffusion cell: flow-through automated diffusion cells (PermeGear Inc., Riegelsville, PA, USA)
- Receptor fluid: Phosphate Buffered Saline (PBS), pH 7.06
- Solubility of test substance in receptor fluid: soluble in aqueous phase of the O/W formulation
- Static system: no
- Flow-through system: yes
- Test temperature: skin surface temperature was 31.8°C (exp. 1, Donor 1 and 2) and 31.6°C (exp. 2, Donor 3 and 4)
- Humidity: ambient
- Occlusion: no
Results and discussion
Percutaneous absorptionopen allclose all
- Key result
- Time point:
- 24 h
- Dose:
- 2,56%
- Parameter:
- percentage
- Absorption:
- 27.5 %
- Key result
- Time point:
- 24 h
- Dose:
- 5%
- Parameter:
- percentage
- Absorption:
- 27.7 %
- Key result
- Time point:
- 24 h
- Dose:
- 7%
- Parameter:
- percentage
- Absorption:
- 31 %
- Time point:
- 24 h
- Dose:
- 10%
- Parameter:
- percentage
- Absorption:
- 37.2 %
Any other information on results incl. tables
Total radioactivity recovery rates ranged from 95% (2.5% test item) to 97% (5% test item). Between 37% and 45% of the radioactivity applied was removed by skin washing.
The relative absorption of the test item into the receptor fluid was comparable between groups and ranged from 0.89 (2.5% test item) to 1.46 % (7% test item) of the applied dose. Total relative absorption, defined as the summed amounts in the receptor fluid, the receptor compartment wash and skin membrane (epidermis and dermis, excluding tape strips), slightly increased with test item concentration, i.e. values were 27.5 %, 27.7 %, 31.0 % and 37.2 % of the applied dose at DHA concentrations of 2.5, 5, 7 and 10% respectively.
Total absolute absorption values were 18.0, 34.0, 49.5 and 84.4 µg.cm-2 µg.cm-2 at test item concentrations of 2.5, 5, 7 and 10% respectively.
Most of the amounts of DHA considered to be absorbed (i.e. 87 to 91% of the summed amounts in the receptor fluid, the receptor compartment wash and skin membranes) were actually found within the epidermis. This suggests that considerable amounts of the test material might actually be bound to residual parts of the stratum corneum that could not be removed by the ten tape strips performed.
Applicant's summary and conclusion
- Conclusions:
- In summary, the dermal absorption of the test item contained in typical self tanning formulations was estimated to be 27.5 % (18.0 µg.cm-2), 27.7 %(34.0 µg.cm-2), 31.0 % (49.5 µg.cm-2) and 37.2 % (84.4 µg.cm-2) of the applied dose at test item concentrations of 2.5, 5, 7 and 10% respectively.
- Executive summary:
The test item is a cosmetic ingredient that is added to so-called self tanning products in order to generate a superficial skin tanning. The mechanism of tanning is due to substance binding to amino acid residues in the skin.
The present study was designed to examine the in vitro percutaneous absorption of dihydroxyacetone (DHA) through human skin membranes using [14C]-DHA. DHA was tested as an OIW formulation at four concentrations, i.e. 10 %, 7 %, 5 % and 2.5 % in flow-through diffusion cells. The formulations were applied to the skin at a target application rate of 2.0 mg/cm2 (actual mean application rate was in the range of 2.2 - 2.5 mg/cm2) and the contact time was 24 hours. Overall mean recovery rates ranged from 95.0 % (5 % DHA) to 97.4 % (2.5 % DHA).
The relative transdermal absorption of DHA into the receptor fluid was independent of the DI IA concentration applied and narrowly ranged from 0.89 % to 1.46 % of the applied dose. Accordingly, mean values of the absolute transdermal absorption of DHA into the receptor fluid increased with increasing concentrations of DHA in the applied self-tanning creams from 0.77 µg/cm2 (2.5 % DHA) to 2.99 µg/cm2 (10 % DHA) over the 24-hour exposure period.
The relative amounts of DHA in the skin fractions (stratum corneum, epidermis and dermis) were almost comparable between groups. Consequently, the absolute amounts of DHA in each skin fraction equally increased with increasing concentrations of DHA in the applied formulation.
Total relative DHA absorption, defined as the amount in the receptor fluid, the receptor compartment wash and skin membrane (epidermis and dermis), excluding tape strips slightly increased with the applied DHA concentration, being 27.5 % (18.0 µg/cm2) and 27.7 % (34.0 µg/cm2) of the applied dose for the 2.5 % and 5 % DHA formulations, respectively, and 31.0 % (49.5 µg/cm2) and 37.2 % (84.4 µg/cm2) of the applied dose for the 7.5 % and 10 % DHA formulations, respectively.
Most of the amounts of DHA considered being absorbed (i.e. 87 % to 91 % of the amounts in the receptor fluid, the receptor compartment wash and the skin membranes) were actually found within the epidermis. This suggests that considerable amounts of the test material might actually be bound to residual parts of the stratum corneum that could not be removed by the tape stripping as applied.
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