Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 485-390-4 | 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
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: GLP-study according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Skin was excised from the abdomen from three females aged 30, 43 and 48 years
Administration / exposure
- Type of coverage:
- other: covered
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 h
- Doses:
- - Actual doses: 30 µL
- No. of animals per group:
- not applicable
- Control animals:
- no
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: abdomen of three females
- Type of skin: abdomen
- Preparative technique: full-thickness skin
- Thickness of skin (in mm): 1520 - 2205 µm
- Membrane integrity check: caffeine as benchmark
- Storage conditions: -20°C
PRINCIPLES OF ASSAY
- Diffusion cell: Franz diffusion cells with a diffusion area of approximately 3 cm2
- Receptor fluid: none
- Solubility of test substance in receptor fluid: no
- Test temperature: 32 +/- °C
- Occlusion: covered with Parafilm
- Reference substance(s): caffeine
Results and discussion
- Total recovery:
- mean recovery: 104.5%
Percutaneous absorption
- Dose:
- 30 µl
- Parameter:
- percentage
- Absorption:
- ca. 0.12 %
- Remarks on result:
- other: 24h
- Remarks:
- mean absorption
- Conversion factor human vs. animal skin:
- not applicable
Applicant's summary and conclusion
- Conclusions:
- In a GLP-study according to OECD test guideline 428, the dermal penetration of the registered substance was determined to be about 0.12%.
- Executive summary:
The skin penetration of the registered substances was determined in a GLP-study according to OECD test guideline 428.
The HPLC method was successfully developed and validated with regard to method selectivity, linearity, accuracy and precision in the extraction medium employed for the penetration experiments (methanol). Furthermore, the test item has demonstrated good stability over the period of 24 hours at RT in methanol.
The content of PHC was determined in triplicate in the test solution and mean value was 109.4 %, which complies to the acceptance criteria of 100 ± 10 %.
The results from the extraction method have shown that methanol was suitable for performing the penetration experiments presenting recovery values which has ranged between 85.18 % to 104.43 % for samples with skin contact, which complies to the acceptance limit 100 ± 20 %.
The mass recovery calculations present amounts and percentages of compound which penetrated and remained in the donor compartment. The mean amount of the registered substance removed from the skin surface (skin wash) ranged from 84.55 % to 121.80 % of the dose applied. The mean recovery in the two first tape strips was 0.36 % during all performed experiments. In the further
18 tape strips a mean recovery of 0.46 % was documented. The mean absorbed dose of the substance,sum of the amounts found in the viable epidermis, dermis and filter, was 0.12 %. That means, most of the test substance remains at the skin surface, a small amount migrates into the Stratum corneum and an even smaller amount enters the deeper skin layers.
The mean Papp values measured for Caffeine in the present study for the human skins are in good agreement with Papp values determined for a variety of skin specimens from different donors under comparable conditions.
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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