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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
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:
- Study Initiation Date - 27 May 2021; Experiment Start Date - 28 May 2021; Experimental End Date - 10 June 2021; Study completion date - 02 July 2021.
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test Item: FAT 75637/B TE
Physical Appearance: Light yellow powder
Purity: 99.4 % all organic constituents; 95.0 % main constituent
Batch No: AT-0063765400
Manufactured Date: 21st April 2020
Expiry Date: May 27th, 2025 - Analytical monitoring:
- yes
- Details on sampling:
- All the test concentrations along with the negative control were analyzed for the test item concentration at the start and end of first and second renewal. For analysis, duplicate set of composite samples were drawn from prepared test concentrations. Analysis was conducted using a validated analytical method. The criteria for acceptance of analysis results of test concentration were 80 to 120 % of nominal concentration with ≤20 % RSD.
- Vehicle:
- no
- Details on test solutions:
- To prepare test concentration of 50 (G2) mg/L, 50 mg test item was ground using test medium and made up to 500 mL in a volumetric flask using test medium and sonicated for 30 minutes. 1 L of test medium itself without any addition of the test item was used as negative control (G1). 150 mL each of negative control and test item concentration dispensed into respective replicate (4 replicates were maintained for each group).
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Less than 24 hour old neonates of daphnia were exposed to a limit test concentration 50 mg/L of the test item for 48 hours in semi-static mode of test with the renewal of test medium at 24 hour interval. Certain concentrations result in certain percentage of daphnia no longer being capable of swimming at 48 hours. The effects on the organisms were assessed at 24 and 48 hours interval and the EC50 value was calculated. Neonates (Daphnia <24-hour old): One day prior to the start of the treatment, 25 adults were incubated in approximately 2 L of reconstituted water (Acclimatization). The following day, the young ones hatched which were less than 24 hour old (not first brood progeny) were collected and used in the tests.
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 250 mg CaCO3 and 0.8 mg C/L
- Test temperature:
- 19.9 to 20.3 °C
- pH:
- 7.65 to 7.71
- Dissolved oxygen:
- 6.8 to 7.1 mg O2/L
- Nominal and measured concentrations:
- Definitive test: 50 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Beakers
- Type: Loosely covered
- Material, size: 250 mL glass beakers.
- Volume of solution: 30 mL
- Aeration: No
- Renewal rate of test solution: once every 24 hours.
- No. of organisms per vessel: 5 daphnia
- No. of vessels per concentration: four replicates
- No. of vessels per control: 5 daphnia
- No. of vessels per vehicle control: four replicates
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Total organic carbon: 0.8 mg/L
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Photoperiod: 16 hour light & 8 hour dark
- Light intensity: 643 to 648 lux
EFFECT PARAMETERS MEASURED: Immobilization
VEHICLE CONTROL PERFORMED: yes
RANGE-FINDING STUDY
- Test concentrations: 0.01, 0.1, 1, 10 and 50 mg/L
- Results used to determine the conditions for the definitive study: There was no immobilization of daphnia at the tested concentrations of 0.01, 0.1, 1, 10 and 50 mg/L at 48 h post treatment. - Reference substance (positive control):
- no
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 50 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Validity criteria fulfilled:
- yes
- Conclusions:
- The EC50, LOEC and NOEC value for immobilization of daphnia at 24 and 48 hours are higher than 50 mg/L based on the nominal concentration.
- Executive summary:
The acute immobilization effect of the test item FAT 75637/B TE was studied on Daphnia magna for 48 hours. This study was conducted according to OECD test guideline 202 in GLP-certified laboratory. In definitive test, daphnids, less than 24 hours old, were exposed to the limit test concentration of 50 mg/L along with a negative control. The number of daphnids immobilized was recorded at 24 and 48 hours exposure. There was no immobilization of daphnids in the negative control and at the tested concentration of 50 mg/L at 24 and 48 hours of exposure. The stability test results concluded that the test item was stable in the test medium at 48 hour at 1.012 mg/L and 151.000 mg/L nominal concentrations. The active ingredient concentration analysis in all test concentrations showed that the recovery with the nominal concentration was 88.548 % (RSD was 2.121 %) at the start of the first renewal (start of the test – 0 h), 103.290 % (RSD was 13.668 %) at the end of first renewal, 82.953 % (RSD was 4.072) at the start of second renewal and 92.305 % (RSD was 7.059 %) at the end of the second renewal (end of the test - 48 hour) indicating that the results were within the acceptable limit (80 to 120 % of the nominal concentration with an RSD of <20 %). The EC50, LOEC and NOEC value for immobilization of daphnia at 24 and 48 hours are higher than 50 mg/L based on the nominal concentration of the test item.
Reference
Test Item Solubility
FAT 75637/B was tested for its solubility in the test medium and formed semi-transparent cream coloured formulation with visible solid particles in test medium at 50 mg/L.
Definitive Test
There was no immobilization of daphnia in the negative control and at the limit test concentration of 50 mg/L at 24 and 48 hours of exposure. The EC50, LOEC and NOEC value for immobilization of daphnia at 24 and 48 hours are higher than 50 mg/L based on the nominal concentration.
Analysis of Test Concentration
The stability test results concluded that the test item was stable in the test medium at 48 h at 1.012 mg/L and 151.000 mg/L nominal concentrations. The active ingredient concentration analysis in all test concentrations showed that the recovery with the nominal concentration was 88.548% (RSD was 2.121%) at the start of the first renewal (start of the test – 0 hour), 103.290 % (RSD was 13.668 %) at the end of first renewal, 82.953 % (RSD was 4.072) at the start of second renewal and 92.305 % (RSD was 7.059 %) at the end of the second renewal (end of the test - 48 hour) indicating that the results were within the acceptable limit (80 to 120 % of the nominal concentration with an RSD of <20 %).
VALIDITY OF THE TEST
This test was considered valid, because:
• There was no immobilization of daphnia in the negative control during the test period, which is within the allowed 10 percent immobilization of daphnids.
• The dissolved oxygen concentration at the end of the test was more than ≥3 mg/L in negative control and treatment test vessels.
Description of key information
The EC50, LOEC and NOEC value for immobilization of daphnids at 24 and 48 hours are higher than 50 mg/L based on the nominal concentration of the test item.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 50 mg/L
Additional information
The acute immobilization effect of the test item FAT 75637/B TE was studied on Daphnia magna for 48 hours. This study was conducted according to OECD test guideline 202 in GLP-certified laboratory. In definitive test, Daphnia magna, less than 24 hours old, were exposed to the limit test concentration of 50 mg/L along with a negative control. The number of daphnids immobilized was recorded at 24 and 48 hours exposure. There was no immobilization of daphnids in the negative control and at the tested concentration of 50 mg/L at 24 and 48 hours of exposure. The stability test results concluded that the test item was stable in the test medium at 48 hour at 1.012 mg/L and 151.000 mg/L nominal concentrations. The active ingredient concentration analysis in all test concentrations showed that the recovery with the nominal concentration was 88.548 % (RSD was 2.121 %) at the start of the first renewal (start of the test – 0 h), 103.290 % (RSD was 13.668 %) at the end of first renewal, 82.953 % (RSD was 4.072) at the start of second renewal and 92.305 % (RSD was 7.059 %) at the end of the second renewal (end of the test - 48 hour) indicating that the results were within the acceptable limit (80 to 120 % of the nominal concentration with an RSD of <20 %). The EC50, LOEC and NOEC value for immobilization of daphnia at 24 and 48 hours are higher than 50 mg/L based on the nominal concentration of the test item.
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