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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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 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:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- 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
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- In order to verify the initial concentrations and maintenance of the exposure concentrations of the test item during the ecotoxicological testing, chemical analyses in daphnids test solutions were performed according to the Analytical Protocol FCBA Chimie No.380-e version 2: Method for the chemical analysis of Total Carbon (TC) in samples containing the test item from daphnids ecotoxicology solutions by a Total Organic Carbon Analyzer (described in the study 17/1200F/e and the following protocol:
- In Fresh solutions (at the beginning of the test:T0h and for the renewal at T24h), these solutions were analysed taken directly from the starting solutions without daphnids
- in Old solutions (before renewal T24h and at the end of the test T48h), two test tubes were pooled and analyzed
- for the Control (i.e. daphnids test medium filtered), and the concentration 100 mg/L
Schedule analysis at initial time:
Control Fresh T0h
100 mg/L Fresh T0h
These solutions were analysed taken directly from the starting solutions without daphnids.
Schedule analysis at T24h:
Control Old T24h
100 mg/L Old T24h
Control Fresh T24h
100 mg/L Fresh T24h
Schedule analysis at final time T48h:
Control Old T48h
100 mg/L Old T48h
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test item was soluble in the test medium.
At the request of the sponsor, the test medium and the solution (100 mg test item/L) were filtered through a membrane filter (cellulose acetate) with a mesh size of 0.22 μm to sterilizing and all the manipulations were done under sterile conditions to prevent contamination
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia magna Straus, clone number 5, from at least the third generation (i.e. the third brood) obtained with a non-cyclic parthenogenesis reproduction.
The daphnids breeding was carried out in closed bottles placed in a climatic chamber free from any toxic vapour and in medium M4.
Daphnids used in this experimentation were previously filtered in order to obtain animals from a size between 560 µm and 800 µm (corresponding to daphnids less than 24 hours old).
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- none
Test conditions
- Hardness:
- 260 mg/L of CaCO3
- Test temperature:
- 19.8 – 20.0°C
- pH:
- pH (Dilution water M4) = 8.0
- Dissolved oxygen:
- 9.2 mg/L
- Salinity:
- no data
- Conductivity:
- no data
- Nominal and measured concentrations:
- Nominal concentration: 100 mg/L
Measured concentration: 101.87 mg/L (at initial time), 98.24 mg/L (after 24 hours of exposure) and 100.46 mg/L (after 48h of exposure) - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass test tube
- Type: closed
- Each glass test tube (sterilized by autoclave) contained 10 mL of test solution and five daphnids; they were covered in order to avoid evaporation and dust deposition.
- Renewal rate of test solution: Renewal of test solutions at 24h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
OTHER TEST CONDITIONS
- Light intensity: Darkness
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Observations of the daphnid's immobility and behaviour were carried out after 24 and 48 h in control and exposed groups.
- Any sign of stress observed on the daphnids after 48 hours of exposure to the test item were reported.
- pH and dissolved oxygen were measured before and after renewal of solutions (including the controls).
RANGE-FINDING STUDY
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No immobilization was observed at any of the concentration tested. Based on the results of the preliminary test, it has been proposed to perform a limit test at 100 mg/L for the study. This study was conducted on one concentration levels: 100 mg/L - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: highest tested concentration
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: highest tested concentration
- Details on results:
- - No immobilization was observed at 24 h and 48 h (including controls).
- No sign of stress was observed on the mobile daphnids after 48 h of exposure - Results with reference substance (positive control):
- The last toxic response obtained on the reference item K2Cr2O7 (November 29, 2017) indicates an EC50-24h of 1.53 mg/L (1.39 – 1.68), indicating that the daphnids sensitivity is correct (within the accepted interval of 0.6–2.1 mg/L fixed by the International Standard ISO 6341 December 2012 as mentioned in the OECD 202 Guideline) and in accordance with historical data obtained by the laboratory.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- No ecotoxicity was observed after 24 hours and 48 hours of exposure during the testing at 100 mg/L of the test item.
- Executive summary:
The aim of this study was to assess the effects of the test item on the daphnidsDaphnia magna, according to the OECD 202 guideline, at 100 mg/L, limit test, in semi-static conditions.
This study was carried out in accordance with the study plan no.17/1200F/b dated November 30, 2017.
There was no deviation and no amendment during this study.
The concentrations which immobilise 50% of the daphnids exposed to the test item after 24 and 48 hours, reported as EC50-24h and EC50-48h were evaluated, relative to the tested concentration : 100 mg/L.
The results obtained for the test item on the toxicological endpoint “immobilisation” give an EC50-24h and an EC50-48h higher than the highest tested concentration,i.e. 100 mg/L, based on nominal test item concentration.
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