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Diss Factsheets
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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September-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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guidance document 129
- Version / remarks:
- July 20th, 2010
- Deviations:
- yes
- Remarks:
- This deviation has no impact on the test item result.
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM protocol 139
- Version / remarks:
- DB-ALM 139 protocol and EURL ECVAM Recommendation, April 2013
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- other: 3T3 NRU method
- Limit test:
- no
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
Test animals
- Species:
- other: N/A
- Strain:
- other: N/A
- Details on test animals or test system and environmental conditions:
- N/A
Administration / exposure
- Route of administration:
- other: N/A
- Vehicle:
- other: N/A
Results and discussion
- Preliminary study:
- Range finding test: The IC50 has been estimated to 40.23 mg/ml.
Effect levels
- Key result
- Dose descriptor:
- LD50
- Effect level:
- ca. 5 297 mg/kg bw
- Based on:
- test mat.
- Mortality:
- N/A
- Clinical signs:
- N/A
- Body weight:
- N/A
- Gross pathology:
- N/A
- Other findings:
- The IC50 for test 1 is equal to 42.31 mg/ml, leading to a LD50 equal to 5559 mg/kg.
The IC50 for test 2 is equal to 32.42 mg/ml, leading to a LD50 equal to 5035 mg/kg
Any other information on results incl. tables
Interpretation:
The test has been evaluated in Acute Tox, an integrated in the EU FP6 project on the optimization and prevalidation of anin vitrotest for predicting human acute oral toxicity.
The NICEATM/ICCVAM Peer review panel report (2006) has confirmed that the test do not allow to predict each of the GHS acute oral toxicity categories. However the test may be used to determine the starting doses for acute oral in vivo toxicity. ICCVAM Test method evaluation report (2006) therefore proposed a regression model, based on rat acute oral toxicity data, in order to predict LD50value from the IC50value obtained with the 3T3 NRU method.
The regression models are as follow:
Millimole regression model: log LD50(mmol/kg) = 0.439 log IC50(mM) + 0.621
Weight regression model: log LD50(mg/kg) = 0.372 log IC50(µg/ml) + 2.024
EURL ECVAM Recommendation from April 2013 has confirmed that the 3T3 NRU Cytotoxicity Assay can be used in an integrated strategy to support identification of non-classified substances when using a threshold of > 2000 mg/kg. This threshold was used for non-classification by EU CLP.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the retained experimental conditions, the mean LD50 of the test item is equal to 5297 mg/kg, which is higher than 2000 mg/kg. The test item may be not classified for acute toxicity according to the CLP classification
- Executive summary:
Under the retained experimental conditions, the mean LD50 of the test item is equal to 5297 mg/kg, which is higher than 2000 mg/kg. The test item may be not classified for acute toxicity according to the CLP classification
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.
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