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Diss Factsheets
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EC number: 471-510-2 | CAS number: -
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-02-06 to 2008-06-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Version / remarks:
- adopted March 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SCCP/0970/06
- Version / remarks:
- adopted 28 March 2006
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- no
- Type of coverage:
- open
- Vehicle:
- other: Cosmetic formulation
- Duration of exposure:
- 24 hours
- Doses:
- Concentration of test material in Vehicle: 4%
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Key result
- Time point:
- 24 h
- Parameter:
- percentage
- Absorption:
- 0.937 %
- Conclusions:
- Based on the results of this in vitro skin penetration test, the dermal absorption of the test item is 1.44 ± 1.69 μg/cm2 or 0.937 ± 1.16 % (mean value of 8 diffusion cells corresponding to 8 donors).
- Executive summary:
The present study was designed to examine the in vitro percutaneous absorption of the test material through viable porcine skin. The test material was tested as a standard cosmetic formulation (LA-129/07-0-1-1) at 4 %.
Two independent experiments were performed on fresh dermatomed pig skin samples under static conditions with 6 diffusion cells per experiment. The thickness of the skin used was approximately 450 μm. The conductivity across the skin samples of each cell was determined before treatment and after the last sampling as a measure of skin integrity. Five (5) μL of the test item were applied on each skin sample, left on the skin for 24 hours and then washed off using 9 x 1 mL extraction solution (water : methanol, 40 : 60, v/v). The receptor solution used was 5 % BSA (w/v)/ 20 % (v/v) EtOH in PBS. The solubility of the test material in 5 % BSA (w/v) in PBS (containing 20 % organic solvent) was shown under the RCC Cytotest Cell Research GmbH study number 1139801 (non-GLP study) and is given up to 2.5 μg/mL. The dermal absorption was monitored over 24 hours under non-occluded static conditions.
The stratum corneum was separated by tape stripping from the epidermis and dermis. The tape stripes (2 x 5 stripes per sample) were pooled as two batches and each extracted for
analysis, respectively, as well as the remaining skin compartments.
The various sample solutions from the skin dermal absorption assay were analysed by LCMS/MS for the presence of the test material. Not all chambers met the
acceptance criteria for the recovery (100±15% of total amount applied) and, therefore, 8 chambers were used for the analysis of the test material. The LOD in receptor
solution was defined as 8.0 ng/mL and in extraction solution as 2.5 ng/mL. The LLOQ was 10.0 ng/mL in receptor solution and 5.0 ng/mL in extraction solution, respectively.
After the application of a formulation containing 4% test material for 24 hours, the vast majority of the test material was detected in the wash-off samples of any chamber. No test material was detected in the receptor fluid. However, for worst-case considerations the LOD in receptor solution was used for the calculation. Small amounts of the test material were detected in the stratum corneum (< 0.5 %) and the viable layers (< 1 %) of the skin. Details are provided in the following summary table:
Amount of test material in Expressed as μg/cm2 of skin surface mean ± S.D. (n = 8) Expressed as % of dose mean ± S.D. (n = 8)
[μg/cm²] [%]
Amount applied 165 ± 24.6 100
Washing solution (after 24 hours) 152 ± 14.9 92.9 ± 8.54
Receptor fluid 1) (after 24 hours) 0.0336 ± 0.00090 0.0207 ± 0.00306
Stratum corneum (isolated by tape stripping) 0.639 ± 0.969 0.413 ± 0.642
Epidermis + Dermis (after 24 hours) 1.40 ± 1.69 0.917 ± 1.16
Recovery 159 ± 13.6 97.1 ± 8.43
Dermal absorption 2) 1.44 ± 1.69 0.937 ± 1.16
1) Based on the LOD in receptor fluid
2) Dermal absorption is defined as the amount of test item in the receptor fluid, epidermis and dermis excluding tape strips
Under the reported conditions, the dermal absorption of the test item is 1.44 ± 1.69 μg/cm2 or 0.937 ± 1.16 % (mean value of 8 diffusion cells corresponding to
8 donors).
Reference
Description of key information
Based on the results of an in vitro skin penetration test, the dermal absorption of the test item is 1.44 ± 1.69 μg/cm2 or 0.937 ± 1.16 % .
Key value for chemical safety assessment
- Absorption rate - dermal (%):
- 0.937
Additional information
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