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EC number: - | CAS number: -
- 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
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: short-term
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to analogue justification document provided in IUCLID section 13.
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: source, RA-A, CAS 91052-28-7, BASF, 2012, Eisenia fetida, 14d
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth, morphology and behaviour
- Remarks on result:
- other: source, RA-A, CAS 91052-28-7, BASF, 2012, Eisenia fetida, 14d
- Conclusions:
- No effects were observed up to the limit of water solubility.
- Endpoint:
- toxicity to soil macroorganisms except arthropods: short-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Aug - 29 Aug 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
- Deviations:
- yes
- Remarks:
- At four days the measured soil temperature increased up to 23.1 °C at maximum for limited time intervals. However, test results have not been impacted.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Analytical monitoring:
- no
- Vehicle:
- yes
- Details on preparation and application of test substrate:
- - Method of mixing into soil: The test item is poorly soluble in water, therefore a volatile organic solvent was used. The stock solution was prepared in acetone. The test item was dissolved in an amount of acetone sufficient to prepare a stock solution. An appropriate amount of the stock solution was used to soak a portion of quartz sand of the artificial soil. After evaporation of the solvent by placing under a fume hood, the quartz sand was coated with the test item. The test item coated fraction of the quartz sand was then incorporated into the remainder of the artificial soil by thouroughly mixing for approximately 5 minutes. The respective batches of treated test substrate were mixed by a portable drilling machine equipped with a stirring staff thoroughly to obtain homogeneous distribution of the test item
- Controls: blank and solvent control
- Evaporation of vehicle before use: yes, under fume hood - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Earthworm
- Source: The earthworms used in this test are kept at ECT Oekotoxicologie GmbH since February 1994. They were originally delivered by Co. Landenberger (D-72355, Schoemberg)
- Age at test initiation and weight at test initiation: Only adult earthworms (with clitellum) with a fresh weight between 300 and 600 mg were used.
ACCLIMATION
- Acclimation period: Adult earthworms were selected out of the culture and acclimatised for at least 24 hours in non-treated artificial soil - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- yes
- Total exposure duration:
- 14 d
- Test temperature:
- 20.0 - 23.1 °C
- pH:
- 5.8-6.0
- Moisture:
- 49.5-51.3% of Water Holding Capacity (WHC)
41.1-42.6% of dry mass - Details on test conditions:
- TEST SYSTEM
- Test container (material, size): Test vessels were 1.7 L preservation jars, covered by perforated twist-off tops
- Amount of soil: 500 grams dry weight per test vessel
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- No. of replicates per vehicle control: 4
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (artificial substrate): The composition of the artificial soil was based on OECD Guideline 207 (percentages refer to dry weight):
10% Sphagnum peat (no visible plant remains; finely groun and air-dried)
20% Kaolin-clay (kaolinite content > 30%)
69-70% Quartz sand (fine sand content with particles between 50 and 200 microns higher than 50%)
0.3-1% Calcium carbonate (CaCO3)
- Maximum water holding capacity (in % dry weigth): 40-60%
- Pretreatment of soil: The air dried peat wa shredded in a chaff-cutter. Afterwards, all parts of the artificial soil were mixed homogeneously. The pH value was adjusted to 6 ± 0.5 using calcium carbonate. The moisture content was adjusted to 40-60% of WHCmax using deionised water. The water content of the artificial soil was determined by drying a small sample at 105 °C
OTHER TEST CONDITIONS
- Photoperiod: Permanent
- Light intensity: 523-604 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Number of dead adult earthworms after 7 and 14 days, body weight at the start of the test and after 14 days, morphology and behaviour after 7 and 14 days
VEHICLE CONTROL PERFORMED: yes
TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Limit test - Nominal and measured concentrations:
- 1000 mg test item/kg artificial soil dry weight (nominal, limit test)
- Reference substance (positive control):
- yes
- Remarks:
- Chloroacetamide
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil ww
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth, morphology and behaviour
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth, morphology and behaviour
- Details on results:
- - No mortality was observed at the solvent control, blank control and the tested limit concentration of 1000 mg/kg dw
- The biomass of individual adults after 14 days amounted to 90.4% of the initial weight in the solvent control, 91.7% in the control and 96.4% at 1000 mg test item/kg artificial soil dry weight
- No other symptoms (morphological, behavioural) were observed - Results with reference substance (positive control):
- LC50 (14 d) = 42.7 mg/kg (within the validity range given in the ISO Guideline 11268-1 (1997))
- Reported statistics and error estimates:
- Mortality was not evaluated statistically since no mortality was observed at the limit concentration tested. Biomass was not evaluated statistically since difference in biomass development between control and the limit concentration was 0.9% only.
Referenceopen allclose all
Description of key information
Key value for chemical safety assessment
Additional information
There is no study available in which the toxicity of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers to soil macroorganisms was assessed. Therefore, read-across to the structurally and chemically closely related source substance Glycerides, C14-18 and C16-18 unsaturated, mono-, di- and tri- (CAS No. 91052-28-7) was performed in accordance with Regulation (EC) No 1907/2006 Annex XI, section 1.5 in order to fulfill the data requirements for this substance. The source substance is characterized by similar chemical structure and is therefore considered as suitable representative for the assessment of the toxicity of the target substance to microorganism.A detailed read-across justification in provided in IUCLID section 13.
The toxicity of the source substance Glycerides, C14-18 and C16-18 unsaturated, mono-, di- and tri- (CAS No. 91052-28-7) to earthworms was exposed for 14 days at a concentration of 1000 mg/kg dw (limit test) according to OECD 207. Due to the poor solubility of the substance in water, test solutions were prepared using a solvent.No effects on survival or biomass during the exposure period were reported, leading to a NOEC (14 d) ≥ 1000 mg/kg dw.
In addition, according to ECHA guidance (Chapter R.7c: Endpoint specific guidance, 2017) new long-term testing only needs to be conducted where the data on aquatic effects are insufficient to complete the Chemical Safety Assessment. Since acute aquatic toxicity data are available for the target substance and structurally and chemically closely related source substances for all three trophic levels and chronic toxicity data are available for aquatic invertebrates and algae the Chemical Safety Assessment can be evaluated completely. All reliable aquatic acute and chronic data show no effects up to the water solubility limit. As all acute toxicity effects range above 10 mg/L and no chronic or long-term effects in aquatic organisms up to the water solubility limit were observed, this can be used to waive the data requirements of Annex IX (Chapter R.7c: Endpoint specific guidance, 2017, page 148).
As the substance is considered readily biodegradable (94% biodegradation after 28 days; read-across) confirmed with QSAR calculations for representative constituents (VEGA (1.1.4); Ready Biodegradability Model (v1.0.9)), it is expected that an extensive elimination of the substance in sewage treatment plants will occur. According to the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7b (ECHA, 2017), the ready biodegradability of a substance can be considered indicative of rapid and ultimate degradation in most environments, including biological sewage treatment plants (STP) where the substance will be extensively removed in the primary settling tank and fat trap. As a result of the high adsorption potential of the substance (log Koc = 1.31 – 12.67, KOCWIN v2.00; MCI method), a removal from the water column to a significant degree by adsorption to sewage sludge can be expected (Guidance on information requirements and chemical safety assessment, Chapter R.7b, (ECHA, 2017)). Thus, only limited amounts will get in contact with activated sludge organisms in STPs and the concentration of the substance in effluents of conventional STPs is presumably marginal. Therefore, discharged concentrations of these substances into the soil compartment are likely to be negligible.Considering this, one can assume that the availability of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers in the soil environment is very low, which reduces the probability of exposure, in particular long-term exposure, of soil organisms in general.
Moreover, the bioaccumulation potential is low. Based on the physico/chemical properties such as poor water solubility and high potential for adsorption a reduced availability in water is expected. In addition, the available literature data showed that soil microorganisms are capable to break-up ester bonds and degrade fatty acids in significant amounts. Moreover, the data indicated the non-toxic properties of fatty acids since they can be used as energy source. It can be concluded that the bioaccumulation potential of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers is negligible. This is supported by a low calculated BCF value ranged from 0.94 - 18.58L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic).With VEGA 1.1.3 BCF values of 0.74 - 2 L/kg were determined (Caesar v2.1.14) for the main components of the substance.
In conclusion, the available results in an earthworm study from a structurally related read-across substance (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile and comparable structure, show no effects on survival or biomass.Furthermore, no chronic or long-term effects in aquatic organisms up to the water solubility limit and no acute effects for aquatic organisms above 10 mg/L were determined. In addition, an extensive elimination of the substance in sewage treatment plants, a low bioavailability and a low bioaccumulation potential is expected for the target substance. Thus, it can be concluded that the target substance Fatty acids, C16-18 (even numbered), esters with glycerol oligomers is not expected to show long-term toxicity to soil macroorganisms up to the limit of its water solubility (91.9 µg/L).
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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