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EC number: 286-475-7 | CAS number: 85251-63-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Malus sylvestris, Rosaceae.
- 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
- Study period:
- October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- yes
Test material
- Reference substance name:
- Apple, Malus sylvestris, ext.
- EC Number:
- 286-475-7
- EC Name:
- Apple, Malus sylvestris, ext.
- Cas Number:
- 85251-63-4
- IUPAC Name:
- Apple, Malus sylvestris, ext.
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: Human reconstructed epidermis SkinEthic
- Cell type:
- other: N/A
- Cell source:
- other: N/A
- Source strain:
- other: N/A
- Details on animal used as source of test system:
- N/A
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Inserts (filter + epidermis) were gently detached from the agar and if necessary the bottom of the insert was wiped on ana absorbent paper in order to avoid leaving agar pieces onto the polycarbonate membrane.
Inserts were placed then into wells (6 wells culture plate) previously filled with 1 ml of growth medium at room temperature. Cultures were incubated overnight at 37°C 5% CO2.
Th epidermis was previously moistened with 10 µl deionised sterile wtare in order to unsure good contact with the test item and then 16 mg+/- 2 mg of test item were applied to the surface of the tissue.
16µL+/- 0.5 of the reference item were deposited with a positive displacement micropipette on the surface of the epidermises and a 7.5 mm diameter nylon mesh is gently applied on the surface of the epidermis using tweezers.
The epidermises were incubated in a 0.3 ml of maintenance medium (24 wells plate) at room temperature for 42 min +/-1 minute.
Nylon mesh were removed and the epidermises were rinsed with 25 ml of PBS by epidermis. the epidermises were incubated in a 2 mlof growth medium in 6 wells plate at 37°C, 5%CO2 for 42 hours +/- 1hour.
At the end of incubation period, the plates were stired approximatively 2 mins at 300 rotations/mins in order to homogenize the released mediators or enzymes in the culture medium.
all epidermises were incubated in a 0.3 ml of maintenance medium at 1 mg/ml MTT in 24 wells plate.
After 3 hours incubation at 37°C 5CO2, outside of inserts was rinsed with 2 ml of PBS.
Extraction was performed by placing the epidermises into wells filled with 0.8 ml of isopropanol then covered with 0.7 ml isopropanol for 2 hours +/- 5 mins under gentle agitation at room agitation at room temperature. The inserts were pierced and removed from wells then extraction solution was homogenized by pipeting. The absorbances were measured in triplicate on 200µl MTT extract in 96 wells plate. Absorbances are measured at 540 nm against isopropanol as blank. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 16 mg +/- 2 mg of the test item pur as well as the reference items were tested on three epidermises
- Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Test animals
- Species:
- other: N/A
- Strain:
- other: N/A
Test system
- Type of coverage:
- other: N/A
- Preparation of test site:
- other: N/A
- Vehicle:
- other: N/A
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- ca. 99.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- ca. 99.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- ca. 96.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the retained experimental conditions and according to CLP regulation, the test item tested pure is classified non irritant.
- Executive summary:
Under the retained experimental conditions and according to CLP regulation, the test item tested pure is classified non irritant.
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