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EC number: 287-828-8 | CAS number: 85586-25-0
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP -Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C12-14 (even numbered), methyl ester
- EC Number:
- 629-776-4
- Cas Number:
- 308065-15-8
- Molecular formula:
- C13-15H26-30O2
- IUPAC Name:
- Fatty acids, C12-14 (even numbered), methyl ester
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, C12-14 (even numbered), methyl ester
- Physical state: colourless liquid
- Analytical purity: 98.8%
- Composition of test material, percentage of components:
Fatty acids C12 methyl ester: 74.1%
Fatty acids C14 methyl ester: 23.1%
Fatty acids C16 methyl ester: 1.6%
- Lot/batch No.: 0010108393
- Expiration date of the lot/batch: 18 Jun 2015
- Storage condition of test material: room temperature
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: An appropriate amount of the test item was weighed for each loading level and transferred in a brown glass bettle with an appropriate amount of dilution water. The test item dispersion were shaken for 24 hours with 20 rpm at room temperature. After a separation phase of 24 hours, undissolved particles were removed by membrane filtration (membrane filter 0.45 μm, RC, MACHEREY-NAGEL). During filtration, the filter was always covered. The resulting Water Soluble Fractions (WSF) were used in the test. This procedure was carried out 2 days prior to the start of each exposure interval on study day -2 until day 18 for the daily renewal.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Strain: clone 5
- Source: inhouse culture originally obtained by Institut für Wasser-, Boden- und Lufthygiene (WaBolu)
- Age at study initiation (mean and range, SD): < 24h
- Method of breeding: In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 ± 2°C, in an incubator, 16 h illumination; light intensity of max. 20 μE-m-2 . s-1
- Feeding during test
- Food type/Amount: Pseudokirchneriella subcapitata (0.162 - 0.294 ml) and Desmodesmus subspicatus (0.290 - 0.319 ml) suspension was provided as food corresponding to 0.2 mg C per Daphnia and day.
- Frequency: daily
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
Test conditions
- Hardness:
- 160 - 208 mg/L as CaCO3
- Test temperature:
- 20.6 - 22 °C
- pH:
- 7.09 - 7.93
- Dissolved oxygen:
- 4.82 - 9.06 mg/L
- Nominal and measured concentrations:
- Nominal: 1, 3.16, 10, 31.6 and 100 mg/L as loading rate WSF (water soluble fraction)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers (5 (ID) x 8 (H) cm), 100 ml capacity with 50 mL test media
- Renewal rate of test solution: daily
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4
- Intervals of water quality measurement: The water quality parameters (i.e. pH-values, dissolved oxygen concentration, total hardness and water temperature) were measured once within 7 days, at the start (0 h) and at the end (24 h) of an exposure interval, in one replicate of the highest loading evel and the control. The water quality parameters at the start of the exposure interval were measured in an additional replicate without daphnids of the highest loading level and the control. At the end of the exposure interval, the water quality parameters were measured in a test vessel of the highest loading level and the control, which contained daphnids and food algae. The temperature in the incubator was recorded throughout the exposure period with a thermo hygrograph.
OTHER TEST CONDITIONS
- Photoperiod: 16/8h light/dark cycle
- Light intensity: max. 20 µE/m2/s
EFFECT PARAMETERS MEASURED: Effects on the reproduction capacity and other test item-related effects on parameters such as intrinsic rate of natural increase, occurrence of aborted eggs and stillborn juveniles, time of release of the first brood and adult mortality recorded daily throughout an exposure time of 21 days.
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1, 10, 100 mg/L as loading rate WAF
- Results used to determine the conditions for the definitive study: The preliminary testing (acute immobilisation test) has shown toxic (mortality) and physical effects (daphnids being trapped at the water surface) on Daphnia magna, when tested with Water Accommodated Fractions of the test item Fatty acids, C12-14 (even numbered), methyl ester. Therefore, it was considered to perform a full dose-response tes~ with Water Soluble Fractions of the test item. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WSF)
- Basis for effect:
- reproduction
- Details on results:
- No significant effects on the reproductive output or any other measured endpoint were observed in the control and any treatment after 21 days exposure time.
- Results with reference substance (positive control):
- - Results with reference substance valid: yes
- EC50: 1.65 mg/L
- Other: The ECso-value of the reference item potassium dichromate after 24 h is within the prescribed concentration range of 0.6 - 2.4 mg/L of quality criteria according to AQS P 9/2 (02/2000) for daphnids clone 5 cultured in Elendt M4 medium. The ECso-value of the reference item is also within the recommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202.
Any other information on results incl. tables
Table 1: Results of preliminary test
Nominal loading of the WAF [mg/L] |
Immobilisation [%] |
|||||
24h |
48h |
|||||
Replicates |
Replicates |
|||||
1 |
2 |
3 |
1 |
2 |
3 |
|
100 |
100* |
100* |
100 |
100 |
100 |
100 |
10 |
70* |
70* |
70 |
100* |
100* |
100 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
control |
0 |
0 |
0 |
0 |
0 |
0 |
* = most of the daphnids were trapped on the surface of the test loading. Immobile and dead daphnids were observed. A layer of undissolved test item was observed at the WAFs with nominal loadings of 10 and 100 mg/L.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The long-term toxicity of the substance to aquatic invertebrates is investigated according to OECD guideline 211 and GLP. Based on the 21d-NOELR value of > 100 mg/L (loading rate WSF) the substance is very likely not harmful to aquatic invertebrates at chronic exposure.
- Executive summary:
The long-term toxicity of Fatty acids, C12-14 (even numbered), methyl ester (CAS 308065-15-8) to aquatic invertebrates was investigated according to OECD guideline 211 and GLP using Daphnia magna as test organism. A full dose-response test with Water Soluble Fractions of the test item was performed since preliminary testing (acute immobilisation test) has shown toxic (mortality) and physical effects (daphnids being trapped at the water surface) on Daphnia magna, when tested with Water Accommodated Fractions of the test item. Nominal loading rate WSFs between 1 and 100 mg/L were tested over an exposure time of 21 days. No significant effects on the reproductive output or any other measured endpoint were observed in the control and any treatment after 21 days exposure time. Thus, the 21d-NOELR value is determined to be >= 100 mg/L.
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