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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
- 2020-11-17 - 2021-02-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 440/2008, Method C.2. “Daphnia sp. Acute Immobilisation Test”
- Version / remarks:
- adopted 30. May 2008
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- adopted 13. Apr. 2004: ”Daphnia sp., Acute Immobilisation Test“
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 100.7 mg/L nominal concentration of the active substance (limit test).
- Sampling method: Before measurement, 500 μL of the taken samples from the blank control and the concentration 100 mg/L (a. s.) were diluted with 500 μL Acetonitrile (2-fold). 200 μL of the diluted sample of 100 mg/L (a. s.) was filled up to 10 mL with Acetonitrile/ demineralised water (50/50%) (100-fold).
- Sample storage conditions before analysis: the test item was stable in the daphnia immobilization test medium for 2 days (107.6% mean recovery). - Details on test solutions:
- A test solution containing 100.7 mg/L nominal concentration of the test item (active substance (a. s.), corresponding to 124.9 mg/L of the test item (based on a purity of 80.6 % given by the sponsor)) in M4-medium was prepared and used for the test.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Strain/clone: Berlin
- Age at study initiation (mean and range, SD): between 0 and 24 hours
- Source: Umweltbundesamt Berlin
- Feeding during test: green algae (Desmodesmus subspicatus) - Test type:
- static
- Water media type:
- freshwater
- Remarks:
- M4-Medium (recipe of ELENDT)
- Limit test:
- yes
- Total exposure duration:
- 48 h
- pH:
- The pH values were determined at the beginning and at the end of the test.
Blank control: start: pH 7.9; after 48 h: pH 7.5 //
100 mg/mL test solution: start: pH 7.9; after 48h: pH 7.6 - Dissolved oxygen:
- The concentration of dissolved oxygen were determined at the beginning and at the end of the test.
Blank control: start: 9.3 mg/L; after 48 h: 8.8 mg/L //
100 mg/mL test solution: start: 9.1 mg/mL; after 48h: 8.8 mg/L - Nominal and measured concentrations:
- At the beginning and at the end of the test, the content of the test item in the test solution was determined using HPLC-UV-determination. The concentration determined at the start of the test was 97 % of the nominal concentration. At the end of the test the determined concentration was 108 % of the nominal concentration. Therefore, the determination of the biological results was based on the nominal concentration.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: beakers
- Material, size, headspace, fill volume: glass, nominal volume 50 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 vessels, each containing 20 ± 5 mL test solution
- No. of vessels per control (replicates): 4 vessels, each containing 20 ± 5 mL test solution
OTHER TEST CONDITIONS
- Photoperiod: 16/8 hours, using LED’s
- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study (202005R201) to assure that the test conditions are reliable.
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- The 24h-EC50 value was determined as 2.01 mg/L. The value was within the requested range for the 24h-EC50 between 0.6 - 2.1 mg/L of potassium dichromate K2Cr2O7 as specified in the OECD guideline.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The following results were determined for the test item Bayscript Black TP LXS 51134 (species:
Daphnia magna) and based on the active substance of the test item (purity of 80.6 %).
48h-NOEC ≥ 100 mg/L (a. s.)
48h-LOEC > 100 mg/L (a. s.)
24h-EC50 > 100 mg/L (a. s.)
48h-EC50 > 100 mg/L (a. s.) - Executive summary:
This study was performed as a limit test in order to evaluate the toxicity of the test item Bayscript Black TP LXS 51134 in an acute immobilisation test under static conditions towards Daphnia magna. Daphnia magna STRAUS, was chosen in the guideline as a typical species of zoo-plankton.
Young daphnia, aged less than 24 hours at the start of the test, were exposed to the test item for a period of 48 hours. Immobilisation was recorded at 48 hours and compared with control values. Not more than 10 % of the control daphnia should show immobilisation or other signs of disease or stress, for example, discoloration or unusual behaviour such as trapping at surface of water. The results were analysed in order to determine the NOEC, LOEC and EC50 at 24 h and at 48 h and are given in a range.
A positive control was tested in a separate study to assure that the test conditions are reliable.
One valid experiment was performed. The study was performed as a limit test with the concentration of 100 mg/L (active substance).
For the test concentration and the blank control, 20 daphnia were exposed to the
test item for 48 hours in a static test system. After 48 hours, the immobilised daphnia were counted.At the beginning and at the end of the test, the content of the test item in the test solution was determined using HPLC-UV-determination. The concentration determined at the start of the test was 97 % of the nominal concentration. At the end of the test the determined concentration was 108 % of the nominal concentration. Therefore, the determination of the biological results was based on the geometric mean of the measured concentrations (see OECD 202 (§ 23)).
No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met. The result of the test is considered valid.
The following results were determined for the test item Bayscript Black TP LXS 51134 (species:
Daphnia magna) and based on the active substance of the test item (purity of 80.6 %).
48h-NOEC ≥ 100 mg/L (a. s.)
48h-LOEC > 100 mg/L (a. s.)
24h-EC50 > 100 mg/L (a. s.)
48h-EC50 > 100 mg/L (a. s.)
Reference
Immobility
Nominal Concentration in mg/L (a. s.) | Immobility 48 hours | ||||
absolute | in % | ||||
Blank control | 1 | 0 | 0 | 0 | 5 |
100 | 0 | 0 | 0 | 0 | 0 |
One of the animals was immobilised in the blank control, but this can be stated as not significant. None of the animals were immobilised in the tested concentration.
Description of key information
The following results were determined for the test item Bayscript Black TP LXS 51134 (species:
Daphnia magna) and based on the active substance of the test item (purity of 80.6 %).
48h-NOEC ≥ 100 mg/L (a. s.)
48h-LOEC > 100 mg/L (a. s.)
24h-EC50 > 100 mg/L (a. s.)
48h-EC50 > 100 mg/L (a. s.)
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- > 100 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.
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.