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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 471-510-2 | 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:
- 2006-09-23 to 2006-11-23
- 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)
- Version / remarks:
- adopted 04 April 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 29 December 1992
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Remarks:
- As the water solubility of the test substance is <0.02 mg/L and no effects on daphnia was observed in a pretest up to the limit concentration (nominal 100 mg/L), no analytical monitoring was performed during this study.
- Details on sampling:
- N/A
- Vehicle:
- no
- Details on test solutions:
- Reconstituted water according to ELENDT (1990):
Macro nutrients (mg/L):
CaCI2 x 7 H20 293.80
MgSO4 x 7 H20 123.30
NaHCO3 64.80
KCI 5.80
Na2SiO3 x 9H20 10.00
NaNO3 0.27
KH2PO4 0.14
K2HPO4 0.18
Trace elements (mg/L):
B 0.5000
Fe 0.2000
Mn 0.1000
Li, Rb and Sr 0.0500
Mo 0.0250
Br 0.0125
Cu and Zn 0.0063
Co and I 0.0025
Se 0.0010
V 0.0003
Macro nutrients (mg/L):
Na2EDTA x 2H20 2.50
Vitamins (µg/L):
Thiamine 75.00
B12 1.00
Biotin 0.75
After preparation, the reconstituded water was aerated for 24 hours.
- Hardness: about 14° dH (about 250 mg/L CaCO3)
- pH: 7.9 ± 0.3, after an aeration for 24 hours.
References:
ELENDT, B.-P. Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus.
Protoplasma 154, 25-33, 1990 - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna (Straus)
- Justification for species: internationally accepted for this type of study
- Age at study initiation (mean and range, SD): not older than 24 hours
- Source: Merck KGaA - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 14 ° dH (about 250 mg/L CaCO3)
- Test temperature:
- 21-22 °C
- pH:
- 7.9 +/- 0.3
- Dissolved oxygen:
- at least 87 %
- Nominal and measured concentrations:
- Nominal 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 25 mL glass beaker
- Type (delete if not applicable): open
- Volume of solution: 10 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light - 8 hours dark
RANGE-FINDING STUDY
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: no immobilization
Further Information:
-- Preparation
The test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test material and vehicle, reconstituted water, was treated in an ultrasonic device for 1 hour. Subsequently the preparation was aerated, and stirred with a magnetic stirrer for further 23 hours. After 24 hours the formulation was given through a nutsch filter (pore size >10 - <16 µm). The filtrate was used for the study.
-- Analysis
The solubility in water was examined. The solubility of the test material could not be determined but was < 0.02 mg/L. Further refinement of the analytical method would be extremely cost- and time consuming. Thus, no further analysis could be performed during this study.
-- Administration
At the start of the experimental phase, 5 Daphnia magna were placed into 10 ml of reconstituted water (control group) or test medium (test material group). The Daphnia magna were not fed, and the control medium and test medium were not aerated during the test.
The test vessels were labeled to assure an unequivocal identification.
-- Dose levels
The solution of a nominal test material concentration of 100 mg/L was tested in an open static system.
-- Observation schedule
The motility was determined by visual control and recorded after 24 and 48 hours. Those animals, not able to swim within 15 seconds after gentle agitation of the test container, are considered to be immobile.
-- pH and oxygen concentration
The pH values and dissolved oxygen concentration (02) were measured in the control and test material concentration at the beginning and at the end of the experimental part.
-- Temperature
During the experimental part, the temperature was registered in a control vessel with an electronic thermometer containing a maximum and minimum memory display. - Reference substance (positive control):
- no
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Clinical findings
The nominal concentration of the preparation of the test substance and the immobilization data are shown in the following table:
--------------------------------------------------------------------
Nominal concentration
[mg/L] Immobilized/exposed Daphnia magna
---------------------------
24 hours 48 hours
--------------------------------------------------------------------
0 0/20 0/20
100 0/20 0/20
--------------------------------------------------------------------
A dose group with nominal 100 mg/L of the test substance, maximal water solubility < 0.02 mg/L, induced no immobilization in this test system.
No remarkable observations were made concerning the appearance of the solution of the test material preparation. The test medium was a clear preparation and stayed unchanged throughout the study.
EC50 value
An aqueous solution of nominal 100 mg/L of the test substance revealed no aquatic toxicity in the test system. The 24 hours and 48 hours EC50 to Daphnia magna exceeded the maximal water solubility (< 0.02 mg/L) of the test material and, thus, was not determined in this test.
Under the given experimental conditions, the test material showed an nominal 48h EC50 value of 100 mg/L and an analytical 48h EC50 value > 0.02 mg/L.
Analysis
pH, oxygen concentrations, and temperature during the study were inconspicuous.
------------------------------------------------------------------------------------------------------------
Nominal concentration
[mg/L] Start of the experiment End of the experiment
---------------------------
0 hour 48 hours
pH O2 [%] pH O2 [%]
---------------------------------------------------------------------------------------------------------------------------
0 7.90 96.4 7.41 90.3
100 7.70 97.3 7.41 87.8
---------------------------------------------------------------------------------------------------------------------------
The temperature in the control vessel was in the range of 21 to 22 °C. - Validity criteria fulfilled:
- yes
- Conclusions:
- An aqueous solution of nominal 100 mg/L of the test item induced no immobilization in the test system Daphnia magna. The 48 hours analytical EC50 to Daphnia magna exceeded the maximal solubility of the test material in reconstituted water (< 0.02 mg/L) and, thus, could not be determined in this test.
- Executive summary:
Purpose
The purpose of this assay was to identify the aquatic toxicity potential of the test substance in Daphnia magna to provide a rational basis for hazard estimation for the test item in aquatic environments
Study Design
For this purpose, juvenile daphnids were exposed to an aqueous test material solution over 48 hours, under defined conditions. The study comprised of four test vessels per concentration and control group containing five daphnids each, i.e. 20 daphnids per concentration (test medium group) and control group.
Daphnids were exposed to a nominal test material concentration of 100 mg/L (limit test) in an open static system. The method followed that described in the OECD Guidelines for Testing of Chemicals (Adopted: 4 April 1984) No 202 Daphnia sp., Acute Immobilisation Test.
Results
After exposure of Daphnia magna to a saturated aqueous solution of nominal 100 mg/L for 48 hours, the following results were obtained:
Nominal concentration Immobilized/exposed daphnids [mg/L] 24 hours 48 hours 0 0/20 0/20 100 0/20 0/20
Daphnia magna exposed to an aqueous preparation of the nominal concentration of 100 mg test item /L were not affected.
The analysis revealed, that the water solubility of the test substance was 0.02 mg/L. Because of this low water solubility and the fact that the study was performed as a limit test, the test material concentration in the aqueous medium at the start and the end of this study was not quantified.
For the test material, the following EC50 values for Daphnia magna were determined:
24 h EC50 > 0.02 mg/L (nominal 100 mg/L)
48 h EC50 > 0.02 mg/L (nominal 100 mg/L)
Conclusion
An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The analytical 48 hours EC50 to Daphnia magna exceeded the maximal solubility of the test material in reconstituted water (< 0.02 mg/L) and, thus, could not be determined in this test.
Reference
Description of key information
An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The analytical 48 hours EC50 to Daphnia magna exceeded the maximal solubility of the test material in reconstituted water (< 0.02 mg/L) and, thus, could not be determined in this test.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- >= 100 mg/L
Additional information
Purpose
The purpose of this assay was to identify the aquatic toxicity potential of the test substance in Daphnia magna to provide a rational basis for hazard estimation for the test item in aquatic environments
Study Design
For this purpose, juvenile daphnids were exposed to an aqueous test material solution over 48 hours, under defined conditions. The study comprised of four test vessels per concentration and control group containing five daphnids each, i.e. 20 daphnids per concentration (test medium group) and control group.
Daphnids were exposed to a nominal test material concentration of 100 mg/L (limit test) in an open static system. The method followed that described in the OECD Guidelines for Testing of Chemicals (Adopted: 4 April 1984) No 202 Daphnia sp., Acute Immobilisation Test.
Results
After exposure of Daphnia magna to a saturated aqueous solution of nominal 100 mg/L for 48 hours, the following results were obtained:
Nominal concentration | Immobilized/exposed daphnids | |
[mg/L] | 24 hours | 48 hours |
0 | 0/20 | 0/20 |
100 | 0/20 | 0/20 |
Daphnia magna exposed to an aqueous preparation of the nominal concentration of 100 mg test item /L were not affected.
The analysis revealed, that the water solubility of the test substance was 0.02 mg/L. Because of this low water solubility and the fact that the study was performed as a limit test, the test material concentration in the aqueous medium at the start and the end of this study was not quantified.
For the test material, the following EC50 values for Daphnia magna were determined:
24 h EC50 > 0.02 mg/L (nominal 100 mg/L)
48 h EC50 > 0.02 mg/L (nominal 100 mg/L)
Conclusion
An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The analytical 48 hours EC50 to Daphnia magna exceeded the maximal solubility of the test material in reconstituted water (< 0.02 mg/L) and, thus, could not be determined in this test.
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.