Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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:
- 2018
- 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 40875/A TE
Physical Appearance: Dark red powder
Purity as per Certificate of Analysis (Content): 86.4% all organic components
Batch No: BOP 05-17 (BS-ROE 1550 NIM 25+26+27)
Manufactured Date: December 20, 2017
Expiry Date: December 11, 2022
Recommended Storage Condition : Refrigeration (+2 to +8°C)
pH: 4.3 of 2% (w/w) aq. Solution.
Solubility: 499.9 g/L - Analytical monitoring:
- yes
- Details on sampling:
- The prepared test concentration along with the negative control was analyzed for the test item concentration at the beginning and end of test. For analysis, single composite sample was drawn from prepared test concentration and negative control.
- Vehicle:
- yes
- Remarks:
- reconstituted water
- Details on test solutions:
- To prepare test concentrations of 6.25, 12.5, 25, 50 and 100 mg/L, 6.25, 12.5, 25, 50 and 100 mg of test item was added and made up to 1 L in a volumetric flask using test medium separately.
For negative control (G1), 1 L test medium was used. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Age at study initiation (mean and range, SD): Less than 24 hours (Neonates)
- Source: Ecotoxicology lab, Eurofins Advinus Ltd, Bengaluru, India.
- Feeding during test: Chlorella vulgaris.
- Food type: Unicellular green alga.
ACCLIMATION
- Acclimation conditions (same as test or not): Yes
- Health during acclimation (any mortality observed): No - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- Total hardness as Calcium carbonate: 2.35 m moles/L
- Test temperature:
- Range finding : 20.3 to 20.5 °C
Definitive test : 21.1 to 22.2 °C - pH:
- Range finding : 7.69 to 7.81
Definitive test : 7.71 to 7.82 - Dissolved oxygen:
- Range finding : 7.0 to 7.4
Definitive test : 7.0 to 7.3 - Conductivity:
- The conductivity of the de-ionized water used for the preparation of test medium was <5 μS/cm.
- Nominal and measured concentrations:
- Definitive test: 0 (negative control), 6.25, 12.5, 25, 50 and 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: beakers
- Material, size, headspace, fill volume: 250mL, glass,
- Volume of solution: Fill volume - 15 mL in range finding test and 30 mL in definitive test.
- Aeration: No
- No. of organisms per vessel:
Range finding test: Ten daphnia per group divided into two replicates of five daphnia each.
Definitive test: Twenty daphnia per group divided into four replicates of five daphnia each.
- No. of vessels per control / vehicle control (replicates): 150 mL of prepared negative control, test item concentrations and reference substance was dispensed separately into 4 test containers.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Using water deionizing unit - Milli-Q.
- Alkalinity: 0.78 m moles/L
- Ca/mg ratio: 5.3 : 1
- Conductivity: The conductivity of the de-ionized water used for the preparation of test medium was <5 μS/cm.
OTHER TEST CONDITIONS
- Light intensity: complete darkness
VEHICLE CONTROL PERFORMED: yes
RANGE-FINDING STUDY
- Test concentrations: 0.00001, 0.0001, 0.001, 0.01, 0.1, 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No immobility of the daphnia was observed in the negative control. The
observed percent immobilization of daphnia at 48 hour was 10 % at 100 mg/L, no immobilization was observed at any other concentrations at 24 and 48 hours of exposure. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Range finding study : No immobility of daphnia was observed in negative control and the tested concentrations.
- Results with reference substance (positive control):
- At 0.32 mg/L, the immobilization of daphnia was 40 and 50 % at 24 and 48 hours exposure, respectively.
- Reported statistics and error estimates:
- Since, the observed immobilization of daphnia was less than 50% in the highest test concentration used in the study no statistical analysis was
applied. - Validity criteria fulfilled:
- yes
- Conclusions:
- The EC50 value for FAT 40875/A TE at 48 hours was found to be greater than 100 mg/L.
- Executive summary:
The acute immobilization effect of the test item FAT 40875/A TE was studied on Daphnia magna according to OECD test guideline 202, in a GLP certified laboratory.
A range finding test was carried out to determine the test concentrations for the definitive test, where Daphnia magna less than 24 hours old were exposed to the test item concentrations of 0.00001, 0.0001, 0.001, 0.01, 0.1, 1.0, 10 and 100 mg/L along with a negative control in test medium (reconstituted water) at 20.3 to 20.5°C.
The observed percent immobilization of daphnia at 48 hour was 0, 0, 0, 0, 0, 0, 0 and 10 % at 0.00001, 0.0001, 0.001, 0.01, 0.1, 1.0, 10 and 100 mg/L, respectively.
Based on the results of range finding test, in definitive test, Daphnia magna less than 24 hours old were exposed to test concentrations of 6.25, 12.5, 25, 50 and 100 mg/L along with a negative control and a reference substance, potassium dichromate at 0.32 mg/L in test medium (reconstituted water) at 21.1 to 22.2 °C. The number of daphnia immobilized was recorded at 24 and 48 hours exposure.
There was no immobilization of daphnia in the negative control. The observed per cent immobilization of daphnia was 0, 0, 0, 0 and 15 % on at 24h and 0, 0, 0, 0 and 25 % at 48 h exposure at the test concentration of 6.25, 12.5, 25, 50 and 100 mg/L, respectively.
At 0.32 mg/L reference substance, the immobilization of daphnia was 40 and 50 % at 24 and 48 hours exposure, respectively.
In conclusion, the EC50 value for FAT 40875/A TE at 48 hours was established to be greater than 100 mg/L.
Reference
Definitive Test – Results on Daphnia Immobilization
Group | Treatment (mg/L) | No of Daphnia immobilized (5 daphnia per replicate) | % Immobilization | ||||||||
24 h | 48 h | 24 h | 48 h | ||||||||
R1 | R2 | R3 | R4 | R1 | R2 | R3 | R4 | ||||
G1 | Negative control | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
G2 | 6.25 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
G3 | 12.5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
G4 | 25 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
G5 | 50 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
G6 | 100 | 1 | 1 | 0 | 1 | 1 | 1 | 2 | 1 | 15 | 25 |
G7 | Reference Substance 0.32 |
2 | 3 | 2 | 1 | 3 | 3 | 2 | 2 | 40 | 50 |
Description of key information
The EC50 value for FAT 40875/A TE at 48 hours was established to be greater than 100 mg/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
The acute immobilization effect of the test item FAT 40875/A TE was studied onDaphnia magnaaccording to OECD test guideline 202, in a GLP certified laboratory.
A range finding test was carried out to determine the test concentrations for the definitive test, whereDaphnia magnaless than 24 hours old were exposed to the test item concentrations of 0.00001, 0.0001, 0.001, 0.01, 0.1, 1.0, 10 and 100 mg/L along with a negative control in test medium (reconstituted water) at 20.3 to 20.5°C.
The observed percent immobilization ofdaphniaat 48 hour was 0, 0, 0, 0, 0, 0, 0 and 10 % at 0.00001, 0.0001, 0.001, 0.01, 0.1, 1.0, 10 and 100 mg/L, respectively.
Based on the results of range finding test, in definitive test,Daphnia magnaless than 24 hours old were exposed to test concentrations of 6.25, 12.5, 25, 50 and 100 mg/L along with a negative control and a reference substance, potassium dichromate at 0.32 mg/L in test medium (reconstituted water) at 21.1 to 22.2 °C. The number of daphnia immobilized was recorded at 24 and 48 hours exposure.
There was no immobilization of daphnia in the negative control. The observed per cent immobilization of daphnia was 0, 0, 0, 0 and 15 % on at 24h and 0, 0, 0, 0 and 25 % at 48 h exposure at the test concentration of 6.25, 12.5, 25, 50 and 100 mg/L, respectively.
At 0.32 mg/L reference substance, the immobilization of daphnia was 40 and 50 % at 24 and 48 hours exposure, respectively.
In conclusion, the EC50 value for FAT 40875/A TE at 48 hours was established to be greater than 100 mg/L.
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.
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.