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Diss Factsheets
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EC number: 948-406-5 | 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
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Principles of method if other than guideline:
- In view of the difficulties associated with the evaluation of aquatic toxicity of poorly water soluble test items, a modification of the standard method for the preparation of aqueous media was performed ( OECD 2019). A series of solvent stock solutions was prepared in dimethylformamide in a series of nominal concentrations. An aliquot of each solvent stock solution was separately dispersed in test water with the aid of magnetic stirring fto give the desired nominal testconcentrations.
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: Duplicate samples were taken from the solvent control and each test group from the bulk test preparation at 0 and 24 hours and from the pooled replicates (R1 to R4) at 24 and 48 hours for quantitative analysis.
- Sample storage conditions before analysis: All samples were placed in universal vials containing 5 mL of THF supplied by Chemistry and stored refrigerated prior to analysis. Duplicate samples were taken at 0, 24 and 48 hours and stored refrigerated for further analysis if necessary. - Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Range finder tests were carried out with and without solvent. The method preferred for th e definitive test used Dimethyl formamide as the vehicle as the substance alone could not be suitably solubilised using a water accomodated fraction approach. Aliquots of stock solution were diluted in test medium to give required final test concentrations.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Dimethyl formamide (DMF)
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): 10g/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no. The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0, 24, 48 hours. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Age at study initiation (mean and range, SD): adults
- Stage and instar at study initiation: first instar
- Source: in house breeding. Culture conditions ensured that reproduction was by parthenogenesis.
- Age of parental stock (mean and range, SD):
- Feeding during test : no
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS: Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing.
- Food type: mixture of algal suspension (Pseudokirchneriella subcapitata) and GEMMA Micro 300 fish food suspension
- Frequency: daily - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Test temperature:
- 20-21 °C
- pH:
- 8.0 to 8.1 across all replicates throughout study
- Dissolved oxygen:
- 8.8 - 9.1mg O2/L across all replicates throughout study
- Salinity:
- not applicable
- Conductivity:
- not measured
- Nominal and measured concentrations:
- Nominal: 0.04, 0.09, 0.2, 0.5, 1.2 mg/L
Measured (geometric mean): 0.018, 0.075, 0.15, 0.32, 0.99 mg/L - Details on test conditions:
- TEST SYSTEM
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 150mL, vessel completely filled.
- Volume of solution: 150mL
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): renewed at 24hrs
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4 (100 μL/L of DMF)
- Biomass loading rate:
TEST MEDIUM / WATER PARAMETERS
- diluent water considered not to contain any contaminant that would affect the integrity or outcome of the study.
- Test medium: Reconstituted Water – Elendt M4 Medium, containing salts, trace elements and vitamins.
- Water Hardness: 2.5 mmol/L (= 250 mg/L as CaCO3)
- Alkalinity: 0.9 mmol/L
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16hrs light, 8hr dark with 20min dawn/dusk transitions
- Light intensity: between 200 and 1200 lux)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilization or adverse reactions to exposure were recorded at 24 and 48 hours after the start of exposure. The criterion of effect used was that Daphnia were considered to be immobilized if they were unable to swim within 15 seconds after gentle agitation.
VEHICLE CONTROL PERFORMED: yes
RANGE-FINDING STUDY
- Study 1 using water accomodated fraction with nominal loading of 1.0, 10, 100mg/L. Significant immobilisation at all loadings
- Study 2 using water accomodated fraction with nominal loading of 0.001, 0.01, 0.1, 1.0mg/L. Stability of test substance could not be confirmed.
- Study 2 using water accomodated fraction with stock solution with nominal loading of 1.0mg/L which was diluted to produce test concentrations of 0.1 and 0.01mg/L. Inconsistent results obtained.
- Study 4 using stock solution of substrate in dimethyl formamide (10g/L) diluted to produce test solution strengths as per test 2. This approach was deemed satisfactory (only ~50% substrate loss) and was sufficient to determine test concentrations for definitive study. Substance loss was a reason why a semi-static approach was used. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.88 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.11 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- mobility
- Details on results:
- - Other biological observations:
reduced mobility seen at concentrations below lethality.
- Mortality of control: <10%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no. All solutions observed to be colourless throughout study with no sign of precipitation.
- Effect concentrations exceeding solubility of substance in test medium:no - Results with reference substance (positive control):
- - Results with reference substance valid?
Yes. Last conducted on tes system 7 months previously.
- Relevant effect levels:
- Limit test: no
- Dose-response test: yes (0.32, 0.56, 1.0, 1.8, 3.23 mg/L)
- EC50 (48hr): 0.71 mg/L - Reported statistics and error estimates:
- 95% confidence interval of 48hr EC50: 0.055 - 0.19 mg/L
- Validity criteria fulfilled:
- yes
- Executive summary:
In a guideline GLP study, the 48hr EC50 in daphnia magna of the substance THI-TM was determined to be 0.11mg/L.
Reference
Validation criteria:
• No more than 10% of the control daphnids showed immobilization or other signs of disease or stress (e.g. discoloration or unusual behavior such as trapping at the surface water).
• The dissolved oxygen concentration at the end of the test was greater than 3 mg/L in the control and test vessels.
Description of key information
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.11 mg/L
Additional information
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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