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Diss Factsheets
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EC number: 939-638-8 | CAS number: 90268-37-4
- 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
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Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline compliant GLP study with good documentation.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: The concentrations of the test item Butanedioic acid, sulfo-, 4-C12-14-alkyl esters, disodium salts were analyzed in one of the duplicate test media samples from the nominal concentrations of 25 to 100 mg/L from both sampling times (0 and 48 hours). The samples of the nominal test concentrations of 6.25 and 12.5 mg/L were not analyzed since the concentrations were below the 48 hour NOEC determined in this test and, thus, were not relevant for the interpretation of the biological results. From the control, one of the duplicate samples was analyzed per sampling time, too.
- Sampling method: For the determination of the actual test item concentrations, duplicate samples were taken from each treatment at the start and at the end of the test (after 48 hours). For the 48-hour stability samples, the contents of the respective replicates were combined prior to sampling.
- Sample storage conditions before analysis: All samples were stored deep-frozen (at about -20 °C) immediately after sampling. Based on pre-experiments the test item was found to be stable in the test water under these storage conditions - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test medium of the highest nominal concentration of 100 mg/L was by completely dissolving 0.2012 g of test item in 2000 mL of test water under intense stirring for 15 minutes at room temperature. Adequate volumes of this test medium were diluted with test water to prepare the lower concentrated test media. The test media were prepared just before introduction of the daphnids (i.e., start of the test).
- Controls: dilution water only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): NA
- Concentration of vehicle in test medium (stock solution and final test solution): NA
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No remarkable observations were made concerning the appearance of the test media, except in the highest tested concentration of 100 mg/L, were a slight foaming on the surface could be observed. All test media were clear throughout the entire test duration. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna Straus
- Strain: clone 5
- Source: A clone of this species (defined by the supplier as clone 5) was originally supplied by the University of Sheffield / UK in 1992. Since that time, the clone has been bred at Harlan Laboratories in reconstituted water. The parental daphnids were cultured in test medium and the daphnids used for tesing hatched in the test medium.
- Age at study initiation (mean and range, SD): At the start of the test, the organisms used in the test were 6 - 24 hours old and were not first brood progeny.
- Feeding during test: None
- Food type: NA
- Amount: NA
- Frequency: NA
ACCLIMATION
- Acclimation period: Not needed since the cultures were kept under conditions similar to the testing conditions - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 15 mg/L as CaCO3 (nominal from medium)
- Test temperature:
- 21 °C
- pH:
- 7.0 to 7.1
- Dissolved oxygen:
- dissolved oxygen concentrations in the test media and control were at least 7.8 mg/L
- Nominal and measured concentrations:
- control and 6.25, 12.5, 25, 50 and 100 mg test item/L. The measured concentrations of Butanedioic acid, sulfo-, 4-C12-14-alkyl esters, disodium salts in the test media of the test concentrations of the biological relevant nominal concentraitons of 25 to 100 mg/L were between 96 and 99% of the nominal values at the start of the test and between 95 and 106% at the end of the test Only these three concentrations were relevant for the calculation of the EC50. Therefore, the reported EC50 and EC100 values were based on the nominal concentrations since the correct dosage and stability of the test item was confirmed.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 100-mL glass beakers filled with 80 mL of test medium
- Type (delete if not applicable): The test vessels were covered with glass plates to reduce the loss of water by evaporation and to avoid the entry of dust into the solutions.
- Material, size, headspace, fill volume: 100-mL glass beakers filled with 80 mL of test medium
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 16 mL/daphnia
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The test was conducted in AAP Medium. Reconstituted test water (AAP medium) was prepared according to OECD Test Guideline No 201. This medium was chosen to avoid precipitaiton of the test item. The daphnids reproduced in this medium.
- Culture medium different from test medium: no
- Intervals of water quality measurement: start and end
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light to 8-hour dark cycle with a 30-minute transition period
- Light intensity: approximately between 400 and 540 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
immobilization at 0, 24, and 48 hours
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline: NA
- Range finding study: not reported
- Test concentrations: not reported
- Results used to determine the conditions for the definitive study: not reported - Reference substance (positive control):
- yes
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 40 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: Immobilization
- Remarks on result:
- other: 95% C.I.:35 - 44 mg/L
- Details on results:
- - Behavioural abnormalities: not reported
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No remarkable observations were made concerning the appearance of the test media, except in the highest tested concentration of 100 mg/L, were a slight foaming on the surface could be observed. All test media were clear throughout the entire test duration. Analytics confirmed the correct dosage and the stability of the test item under test conditions
- Effect concentrations exceeding solubility of substance in test medium: none - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Mortality: as expected
- EC50/LC50: 0.94 mg/L
- Other: For evaluation of the quality of the daphnia clone and the experimental conditions, potassium dichromate is tested as a positive control twice a year. The result of the latest positive control test in September 2012 (48-hour EC50: 0.94 mg/L, Harlan Laboratories Study D64333) showed that the sensitivity of the test organisms was within the internal historical range (48-hour EC50 from 2000 to 2012: 0.43 1.1 mg/L). - Reported statistics and error estimates:
- The 24- and 48-hour EC50 and the 95% confidence limits were calculated by Weibull Analysis. The NOEC, EC0 and EC100 were determined directly from the raw data.
- Validity criteria fulfilled:
- yes
- Executive summary:
In the Klimisch 1 GLP study from Kimmel (2013) the acute toxicity of Butanedioic acid, sulfo-, 4-C12-14-alkyl esters, disodium salts on Daphnia magna was determined in an 48 hour static test according to OECD 202 and EU method C.2. The test was performed with concentrations of 6.25, 12.5, 25, 50 and 100 mg test item/L. After 48 hours 0, 0, 0. 0, 90 and 100 % immobilization was observed in the control and at test concentrations of 0.6.25, 12.5, 25, 50 and 100 mg test item/L, respectively. Analytical measurements of the biologically relevant test concentrations of 1.8, and 4 mg sulfosuccinate/L confirmed that the test solutions were correctly dosed and stable throughout the exposure period. Therefore the data were evaluated based on nominal concentrations. The EC50 is 40 mg test item /L.
The results are considered relevant and reliable for the risk assessment.
Reference
Description of key information
48 h EC50: 40 mg/L
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- 40 mg/L
Additional information
In the Klimisch 1 GLP study from Kimmel (2013) the acute toxicity of Butanedioic acid, sulfo-, 4-C12-14-alkyl esters, disodium salts on Daphnia magna was determined in an 48 hour static test according to OECD 202 and EU method C.2. The test was performed with concentrations of 6.25, 12.5, 25, 50 and 100 mg test item/L. After 48 hours 0, 0, 0. 0, 90 and 100 % immobilization was observed in the control and at test concentrations of 0.6.25, 12.5, 25, 50 and 100 mg test item/L, respectively. Analytical measurements of the biologically relevant test concentrations of 1.8, and 4 mg sulfosuccinate/L confirmed that the test solutions were correctly dosed and stable throughout the exposure period. Therefore the data were evaluated based on nominal concentrations. The EC50 is 40 mg test item /L.
The results are considered relevant and reliable for the risk assessment.
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