Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 272-823-5 | CAS number: 68916-18-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Are coffee silverskin extracts safe for topical use? An in vitro andin vivo approach.
- Author:
- Rodrigues F et al.,
- Year:
- 2 015
- Bibliographic source:
- Industrial Crops and Products 63 (2015) 167–174
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- not specified
- Remarks:
- Study was performed in a research laboratory, probably not GLP compliant.
Test material
- Reference substance name:
- not applicable - High molecular weight constituents (Mwt > 719 g mol-1) such as polysaccharides, proteins and melanoidin polymers
- Molecular formula:
- not applicable - High molecular weight constituents (Mwt > 719 g mol-1) such as polysaccharides, proteins and melanoidin polymers
- IUPAC Name:
- not applicable - High molecular weight constituents (Mwt > 719 g mol-1) such as polysaccharides, proteins and melanoidin polymers
- Reference substance name:
- Caffeine
- EC Number:
- 200-362-1
- EC Name:
- Caffeine
- Cas Number:
- 58-08-2
- Molecular formula:
- C8H10N4O2
- IUPAC Name:
- 1,3,7-trimethyl-3,7-dihydro-1H-purine-2,6-dione
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: coffee silver skin samples were provided by a national coffee roaster (BICAFÉ, Portugal).
- Expiration date of the lot/batch: not available
- Purity test date: not available
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not available
- Stability under test conditions: not available
- Solubility and stability of the test substance in the solvent/vehicle: not available
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not available
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: coffee silver skin was milled to particle size of approximately 0.1 mm using a A11 basic analysis mill (IKA Wearke, Staufen, Germany) and stored in silicone tubes at room temperature (25–28ºC) until extract preparation. Samples (1 g) were submitted to solvent extraction by maceration with 20 mL of water, ethanol: water (1:1 v/v) or ethanol for 30 min at 40ºC. The three different extracts obtained were filtered through Whatman No. 1 paper filter and the filtrates collected.
- Preliminary purification step (if any): not applicable
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid: not applicable
OTHER SPECIFICS: none
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- The in vitro reconstructed human skin tissue (EpiSkin) method, proposed to replace animal testing for skin corrosivity and skin irritation is based on determining cell viability, and cytokine release (IL-1a) as an additional endpoint. The reconstructed 0.38 cm2 skin inserts were used and the assay was performed according to the manufacturer instructions and protocol.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- After exposing to the extracts and controls for 15 min, the epidermis samples were washed with sterile PBS and then incubated in the maintenance medium. After 42 h, the medium was collected and frozen at -20ºC for further determination of IL-1a.
- Number of replicates:
- 3 replicates per coffee sliverskin extract
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- water extract
- Value:
- 117.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- water/ethanolic extract
- Value:
- 105.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- ethanolic extract
- Value:
- 117.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The results of skin irritability assay. Cell viability was assessed by MTT while the post-exposure basal media was analyzed for IL-1a release (pg/mL)
Coffee silverskin extract |
Viability (%) |
IL-1a (pg/mL) |
Water |
117.7 ± 11.7 |
8.5 ± 0.1 |
Water/ethanol (1:1 v/v) |
105.9 ± 15.9 |
76.4 ± 2.0 |
Ethanol |
117.8 ± 9.8 |
17.6 ± 3.2 |
Positive control (SLS) |
11.6 ± 2.4 |
552.9 ± 32.1 |
Negative control (PBS) |
100 ± 9.7 |
28.4 ± 2.6 |
EpiSkin method distinguishes between irritants and non-irritants. Irritant chemicals are identified by their ability to decrease cell viability below defined threshold levels of 50%. The three coffee silverskin extracts were not considered skin irritants, as the viability in all cases was higher than 50%, with values ranging between 105.9 ± 15.9 and 117.8 ± 9.8.
The low irritating potential was also confirmed by the low release of IL-1a, a highly active and pro-inflammatory cytokine produced by keratinocytes.
Additionally, histological analysis did not reveal any morphological differences between extracts and negative control, in contrast to the positive control, where the adverse effects were observed in all the epidermal layers.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results from the in vitro reconstructed human epidermis test, the coffee silverskin extracts did not meet the classification criteria for skin irritation under the CLP Regulation (EC) No 1272/2008.
- Executive summary:
The reconstructed skin inserts (EpiSkin method) were exposed to three types of coffee silverskin extracts (water, water/ethanol, ethanol) and controls for 15 min. The cell viability was determined by MTT assay, while the post-exposure basal media were analyzed for IL-1a release. Three extracts were not considered skin irritants in this test as the cell viability in all the cases was above 50% with the values ranging between 105 ± 15.9 and 117 ± 9.8 %. This potential was also confirmed by the low release of IL-1a, a highly active and pro-inflammatory cytokine produced by keratinocytes. Additionally, no morphological differences were observed between extracts and negative control (PBS), in contrast to the positive control (SLS) where the adverse effects were observed in all the epidermal layers.
Under the conditions of this assay, the coffee silverskin extracts did not meet the classification criteria for skin irritation under the CLP Regulation (EC) No 1272/2008.
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.