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Diss Factsheets
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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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- other: patch test for skin irritation
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods 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
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline required
- GLP compliance:
- no
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 ethanol: water (1:1 v/v) for 30 min at 40ºC. The extract obtained was filtered through Whatman No. 1 paper filter and the filtrate 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
Method
- Subjects:
- - Number of subjects exposed: 20
- Sex: 15 women and 5 men
- Age: 30 ± 5 years
- Race: not specified
- Demographic information: not specified
- Known diseases: without known dermatological diseases or allergy to substances in topical products
- Other: none - Ethical approval:
- confirmed and informed consent free of coercion received
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Details on exposure:
- The volunteers were asked to not apply any topical products in the forearms 24 h before the beginning and throughout the test period. Additionally, solar exposure was forbidden.
Along with coffee silverskin extracts (water/ethanol 1:1 v/v), SLS (2%, w/v, aqueous solution) and purified water were also assayed respectively, as positive and negative control. Fifty microlitres of the test solutions were applied on a filter paper disc (12 mm) and occlusion was achieved with aluminum chambers (12 mm). Patches were removed after 48 h, and following a period of 2 h of observation patch test areas were evaluated by non-invasive measuring methods and visual scoring. - Examinations:
- Prior to application, the basal skin values were evaluated by non-invasive measuring methods and post application by visual scoring and non-invasive measuring methods.
The visual assessment of the degree of irritation was graded according to the following scale: 0 – no reaction; 1 – weak, spotty erythema; 2 – well perceptible erythema covering the total exposure area; 3 – moderate erythema or severe erythema that covers the total exposure area. The same scale was used for edema: 0 – no reaction; 1 – weak, spotty edema; 2 – well perceptible edema covering the total exposure area; 3 – moderate or severe edema that covers the total exposure area.
Non-invasive biophysical measurements were performed in controlled temperature of 21–22ºC and relative humidity of 45–55%. Barrier function was evaluated by Transepidermal water loss (TEWL) measurements, carried out with a Tewameter®TM 210, which measures the relative humidity percentage, which diffuses from the dermis to the skin surface (g/cm2h).
Results and discussion
- Clinical signs:
- Results of patch test demonstrated that hydro-alcoholic extract provoked a slight erythema in three volunteers 2 h after the patch test removal; however, the statistical analysis did not reveal any differences from negative control.
Any other information on results incl. tables
No significant differences were observed for trans-epidermal water loss (TEWL) measurements, in comparison with purified water, 2 h after patch removal (p < 0.05), indicating the absence of barrier disruption.
Applicant's summary and conclusion
- Conclusions:
- In the single-blind patch tests in human volunteers, performed with the hydro-alcoholic extract of coffee silverskin no signs of skin irritation were observed.
- Executive summary:
A single-blind study was performed in order to evaluate the in vivo skin irritation potential of hydro-alcoholic extract of coffee silverskin.
Twenty healthy individuals (15 women and 5 men), without known dermatological diseases or allergies to substances in topical products participated in the study.
Sodium lauryl sulfate and purified water served as positive and negative control, respectively.
Patches with the test solutions were applied for 48 hours and following 2-hour observation period, patch test areas were evaluated by visual scoring and trans-epidermal water loss measurement.
Results of patch test demonstrated that hydro-alcoholic extract provoked a slight erythema in three volunteers 2 h after the patch test removal; however, the statistical analysis did not reveal any differences from negative control.
No significant differences were observed for trans-epidermal water loss measurements, in comparison with purified water, indicating the absence of barrier disruption.
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