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EC number: 810-161-6 | CAS number: 1229654-66-3
- 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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Apr 2014 - 25 Apr 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control, solvent control, 5.00 and 10.00 mg a.i./L
- Sampling method: Water samples were taken daily between day 0 (test initiation) and day 4 (test termination) - Vehicle:
- yes
- Remarks:
- dimethylformamide (DMF)
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test solutions were prepared daily by adding the appropriate amounts of stock solution to synthetic seawater. Stock solutions prepared on study day 0 were utilized to spike new test solutions daily.
- Controls: control, solvent control
- Chemical name of vehicle: DMF
- Concentration of vehicle in test medium: 100 μL/L
- Evidence of undissolved material: Precipitates were observed in the test level with 10.0 mg a.i./L in aged test solutions, no precipitates were observed in the test level with 5.00 mg a.i./L. - Test organisms (species):
- Cyprinodon variegatus
- Details on test organisms:
- TEST ORGANISM
- Common name: Sheepshead Minnow
- Culture Lot No.: ABS040214
- Source: Aquatic Bio Systems, Fort Collins, CO, United States
- Age at study initiation: Juvenile
- Length at study initiation: 22.9 ± 3.2 mm
- Weight at study initiation: 0.20 ± 0.06 g
ACCLIMATION
- Acclimation period: > 14 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: Tetramin Flakes and live Brine Shrimp
- Feeding frequency during acclimation: at least once daily; not fed for 48 h prior to testing
- Health during acclimation: No mortalities during 48 hours prior to testing, no treatments for disease - Test type:
- semi-static
- Water media type:
- saltwater
- Remarks:
- synthetic seawater from artificial sea salts
- Limit test:
- no
- Total exposure duration:
- 96 h
- Test temperature:
- 22.6 - 22.8 °C (0-23 h)
21.9 - 22.3 °C (24 - 47 h)
22.4 - 22.8 °C (48 - 71 h)
22.3 - 22.8 °C (72 - 96 h)
21.9 - 22.8 °C (complete exposure period) - pH:
- 8.2 - 8.3 (control)
8.2 - 8.3 (solvent control)
8.1 - 8.3 (4.52 mg a.i./L, mean measured concentration)
8.2 - 8.3 (9.09 mg a.i./L, mean measured concentration) - Dissolved oxygen:
- 5.9 - 6.7 mg O2/L (control)
5.9 - 6.6 mg O2/L (solvent control)
5.9 - 6.6 mg O2/L (4.52 mg a.i./L, mean measured concentration)
6.0 - 6.7 mg O2/L (9.09 mg a.i./L, mean measured concentration) - Salinity:
- 22‰ (control)
22‰ (solvent control)
22‰ (4.52 mg a.i./L, mean measured concentration)
22‰ (9.09 mg a.i./L, mean measured concentration) - Nominal and measured concentrations:
- control, solvent control, 5.00 and 10.00 mg a.i./L (nominal)
<0.025, <0.025, 4.52 and 9.09 mg a.i./L (mean measured) - Details on test conditions:
- TEST SYSTEM
- Test vessel: aquarium
- Material, size, headspace, fill volume: glass, 38 L (49.5 x 25.4 x 30.5 cm), fill volume: 30 L (49.5 x 25.4 x 23.8 cm)
- Renewal rate of test solution: daily
- No. of organisms per vessel: 30
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.2 g/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Artificial sea salts (Crystal Sea Marinemix) mixed with process water to produce a salinity of 20 ± 5 parts per thousand (‰). Process water is made by blending reverse osmosis water with dechlorinated municipal water and/or spring water.
- Total organic carbon: 0.25 - 0.79 mg/L
- Intervals of water quality measurement: daily, in old and newly prepared test solutions
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark with 30 min transition period
- Light intensity: 604 to 1021 lux (mean: 867 lux)
EFFECT PARAMETERS MEASURED
- Survival (mortality) and sublethal behavioral effects
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2 - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 9.09 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: no mortality
- Abnormal responses: no abnormalities
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: precipitants were noted in the 10 mg a.i./L test level - Results with reference substance (positive control):
- No reference substance was tested.
- Reported statistics and error estimates:
- No statistical calculations were conducted to determine the LC50 for this study. The NOEC and LOEC were empirically determined based upon observation data including lethal and sublethal effects.
- Sublethal observations / clinical signs:
Measured recoveries ranged from 71 to 119% of nominal.
Mean Measured Recovery Range: 90 to 91% of nominal.
Control Recoveries: Acceptable results and no indication of control contamination. All samples were below the LOQ (0.025 mg a.i./L).
- Validity criteria fulfilled:
- yes
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 Dec 2013 - 17 Mar 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- rev. 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- Version / remarks:
- April 1996
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Arbeit, Integration und Soziales des Landes Nordrhein-Westfalen, Düsseldorf, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 10 mg a.i./L
- Sampling method: Samples were taken on Day 0 (2013-12-02), Day 2 (2013-12-04) and Day 4 (2013-12-06)
- Sample storage conditions before analysis: Freezer - Vehicle:
- yes
- Remarks:
- DMF
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test media were prepared by weighing an adequate amount of the test item and dissolving it in DMF and a part of the test water, before pouring it into the test vessels.
- Controls: Control, Solvent Control
- Chemical name of vehicle: Dimethylformamide (DMF)
- Concentration of vehicle in test medium: 0.1 mL/L - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: rainbow trout
- Lot: F19/13
- Source: Hatchery Dr. Rosengarten, Oesede-Georgsmarienhütte; Germany
- Length at study initiation: mean 4.1 cm, SD 0.5 cm
- Weight at study initiation: mean 0.8 g, SD 0.3 g
ACCLIMATION
- Acclimation period: 48 h
- Acclimation conditions: same as test
- Type and amount of food during acclimation: commercial trout food (Inicio, BioMar, Denmark)
- Feeding frequency during acclimation: daily
- Health during acclimation: < 5% mortality
FEEDING DURING TEST
- no feeding - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 40 - 60 mg CaCO3/L
- Test temperature:
- 12.0 - 12.1 °C (control)
12.0 °C (solvent control)
11.8 °C (test concentration) - pH:
- 6.8 - 7.1 (control)
6.8 - 7.2 (solvent control)
6.7 - 7.3 (test concentration) - Dissolved oxygen:
- 89 - 100 % (control)
89 - 101 % (solvent control)
86 - 102 % (test concentration) - Conductivity:
- <0.2 mS/cm
- Nominal and measured concentrations:
- control, solvent control, 11.2 mg/L (test item, nominal), corresponding to control, solvent control, 10.0 mg a.i./L (nominal)
<1.25, <1.25, 10.9 mg a.i./L (mean measured) - Details on test conditions:
- TEST SYSTEM
- Test vessel: aquarium
- Type: open
- Material, size, headspace, fill volume: 38 x 32 x 36 cm (h x w x d); test volume: 40 L
- Aeration: Yes, to ensure oxygen saturation
- No. of organisms per vessel: 30
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.60 g fish / L test medium
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water was used. Addition of salt stock solution to demineralized water according to ISO guideline.
- Chlorine: <0.01 mg/L
- Intervals of water quality measurement: experimental Day 0 (test initiation), Day 2, Day 4 (test termination)
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
EFFECT PARAMETERS MEASURED: Cumulative Mortality and Behavioral Observations; at 4 h, 24 h, and every 24 h following
TEST CONCENTRATIONS
- Range finding study: yes, non-GLP - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 11.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: none
- Mortality of control: There was less than 5% mortality within the 48 hour settling-in period and ≤ 10% mortality in the controls. - Sublethal observations / clinical signs:
Analytical results:
The chemical analysis of the test item revealed recoveries between 107 % and 110 % of nominal. The analytical results of the test solution during the 96 hours exposure period demonstrate the stability of the test item concentration over the entire test period. Therefore the results of this study are presented based on the nominal concentrations.
Biological results:
There were neither any sub-lethal effects nor any mortality in the control group and in the single concentration tested.
- Validity criteria fulfilled:
- yes
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 17 Feb 2014 - 31 Mar 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- Verision: 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- Version / remarks:
- Public draft, 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Arbeit, Integration und Soziales des Landes Nordrhein-Westfalen, Düsseldorf, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 10 mg a.i./L
- Sampling method: Samples were taken on Day 0 (2014-02-17), Day 2 (2014-02-19) and Day 4 (2014-02-21)
- Sample storage conditions before analysis: Freezer - Vehicle:
- yes
- Remarks:
- DMF
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test media were prepared by weighing an adequate amount of the test item and dissolving it in DMF and a part of the test water, before pouring it into the test vessels.
- Controls: Control, Solvent Control
- Chemical name of vehicle: Dimethylformamide (DMF)
- Concentration of vehicle in test medium: 0.1 mL/L - Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- TEST ORGANISM
- Common name: fathead minnow
- Lot: F20/13A
- Source: brood stock cultured in the test facility at Bayer CropScience AG
- Length at study initiation: mean 3.5 cm, SD 0.3 cm
- Weight at study initiation: mean 0.4 g, SD 0.1 g
ACCLIMATION
- Acclimation period: 48 h
- Acclimation conditions: same as test
- Type of food during acclimation: Inicio (formerly Ecostart 17), BioMar, Denmark
- Feeding frequency during acclimation: daily
- Health during acclimation: < 5% mortality
FEEDING DURING TEST
- no feeding - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 40 - 60 mg CaCO3/L
- Test temperature:
- 22.3 - 22.4 °C (control)
22.3 - 22.5 °C (solvent control)
22.4 - 22.5 °C (test concentration) - pH:
- 7.4 - 7.5 (control)
7.3 - 7.5 (solvent control)
7.1 - 7.5 (test concentration) - Dissolved oxygen:
- 83 - 95 % (control)
89 - 94 % (solvent control)
65 - 95 % (test concentration) - Conductivity:
- < 0.2 mS/cm
- Nominal and measured concentrations:
- control, solvent control, 11.2 mg/L (test item, nominal), corresponding to control, solvent control, 10.0 mg a.i./L (nominal)
<0.00625, <0.00500, 10.9 mg a.i./L (measured) - Details on test conditions:
- TEST SYSTEM
- Test vessel: aquarium
- Type: open
- Material, size, headspace, fill volume: 38 x 32 x 36 cm (h x w x d); test volume: 40 L
- Aeration: Yes, to oxygen saturation point
- No. of organisms per vessel: 30
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.30 g fish / L test medium
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water was used. Addition of salt stock solution to demineralized water according to ISO guideline.
- Chlorine: <0.01 mg/L
- Intervals of water quality measurement: Samples taken on experimental Day 0 (test initiation), Day 2 and Day 4 (test termination)
OTHER TEST CONDITIONS
- Photoperiod: 16 hours light / 8 hours dark
EFFECT PARAMETERS MEASURED: Cumulative Mortality and Behavioral Observations; at 4 h, 24 h, and every 24 h following
TEST CONCENTRATIONS
- Range finding study: yes, non-GLP - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 11.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Sublethal observations / clinical signs:
The analytical determination of the test item (in water by HPLC – MS/MS) revealed recoveries of 107% - 110% of nominal over the whole testing period of 96 h at the limit test concentration of 11.2 mg test item/L (corresponding to 10.0 mg a.s./ L). There were neither any sub-lethal effects nor any mortality in the control group.
- Validity criteria fulfilled:
- yes
Referenceopen allclose all
Description of key information
Freshwater:
LC50 (96 h) > 10.0 mg a.s./L (M-486042-01-1, Oncorhynchus mykiss, nominal, OECD 203)
Marine water:
LC50 (96 h) > 9.09 mg a.s./L (M-508088-01-1, Cyprinodon variegatus, measured (not specified), OECD 203)
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 10 mg/L
Marine water fish
Marine water fish
- Effect concentration:
- 9.09 mg/L
Additional information
Three studies are available on the short-term toxicity of the test item to fish (M-486042-01-1, M-489576-01-1, M-508088-01-1). The studies were performed according to OECD guideline 203 and GLP, with analytical monitoring of the test item concentration. The mean recovery rates ranged between 90 to 91% and 107% to 110 %, respectively. Different test species were used in the three studies, one with marine (Cyprinodon variegatus) and two with freshwater species (Oncorhynchus mykiss & Pimephales promelas).
The studies with rainbow trout and fathead minnow were conducted as a limit test with the highest test item concentration of 10 mg a.s./L as functional limit of solubility. Due to a moderate water solubility the test item was dissolved in DMF. Thirty fish were exposed in a limit test for 96 h under static test conditions to a nominal concentration of 10.0 mg a.s./L against a water control and a solvent control (DMF, 0.1 mL/L) with further 30 fish each, for both studies. The analytical determination of the test item (in water by HPLC–MS/MS) revealed a mean recovery of 107% - 110% of nominal over the whole testing period of 96 h. The endpoints were reported based on the nominal concentrations. The endpoints for the rainbow trout study and fathead minnow study for limit test showed that 10 mg a.s./L did not cause any mortality neither to rainbow trout (Oncorhynchus mykiss) nor fathead minnow (Pimephales promelas). Therefore, the LC50 (96 h) was > 10.0 mg a.s./ L (practical limit of solubility). None of the 30 fish at this test level showed any symptom after 96 h. The NOEC (96 h) was ≥ 10.0 mg a.s./L based on nominal concentrations.
For the saltwater species sheepshead minnow (30 fish per treatment level) were exposed in a static-renewal system over a period of 96 h to mean measured concentrations of 4.52 and 9.09 mg a.s./L, respectively. The test item was solved in DMF. While precipitants were noted in the 10 mg a.s./L test level, all samples were centrifuged prior to analysis. Measured recoveries ranged from 71 to 119% of nominal concentrations. Mean measured recoveries ranged from 90 to 91% of nominal concentrations. Results are based on mean measured concentrations. The acute effect of the test item on Sheepshead minnow (Cyprinodon variegatus) can be quantified as a LC50 (96h) of > 9.09 mg a.s./L (mean measured concentration), the highest concentration tested.
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.