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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 944-675-8 | 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
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)
- Version / remarks:
- 17-Jul-92
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 10707 Water quality - Evaluation in an aqueous medium of the "ultimate" aerobic biodegradability of organic compounds - Method by analysis of biochemical oxygen demand (closed bottle test)
- Version / remarks:
- 1994
- Deviations:
- no
- Principles of method if other than guideline:
- - Principle of test: To measure the biodegradabilty of the test item over 28 days, with an extension to 60 days to test persistence of the test item.
- Short description of test conditions: Minor deviations from the guidelines of the Closed Bottle test (OECD TG 301) were introduced; a) ammonium chloride was omitted from the medium to prevent oxygen consumption due to nitrification (omission does not result in nitrogen limitation as shown by the biodegradation of the reference compound), and b) river water instead of an effluent/extract/mixture was used as inoculum.
- Parameters analysed / observed: N/A - GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- natural water: freshwater
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Rhine near Heavedrop, The Netherlands (06-10-2016). The nearest sewage treatment plant (Arnhem-Zuid) treating domestic wastewater biologically was 3 km upstream.
- Laboratory culture: N/A
- Method of cultivation: N/A
- Storage conditions: Not reported, assuemd ambient
- Storage length: 8 days
- Preparation of inoculum for exposure: The river water was aerated for 7 days before use to reduce the endogenous respiration. Particles were removed by sedimentation after 1 day while moderately aerating. river water used in the Closed Bottle test was spiked per liter of water with 8.5 mg KH2PO4, 21.75 mg K2HPO4, 33.4 mg Na2HPO4·2H2O, 22.5 mg MgSO4·7H2O, 27.5 mg CaCl2, 0.25 mg FeCl3·6H2O.
- Pretreatment: N/A
- Concentration of sludge: N/A
- Initial cell/biomass concentration: N/A
- Water filtered: no
- Type and size of filter used, if any: N/A - Duration of test (contact time):
- 60 d
- Initial conc.:
- 2 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: River water from the Rhine spiked with with 8.5 mg KH2PO4, 21.75 mg K2HPO4, 33.4 mg Na2HPO4·2H2O, 22.5 mg MgSO4·7H2O, 27.5 mg CaCl2, 0.25 mg FeCl3·6H2O per litre.
- Additional substrate: N/A
- Solubilising agent (type and concentration if used):N/A
- Test temperature: 22 - 24 °C
- pH: 8.0 (starting pH and on day 28)
- pH adjusted: no
- CEC (meq/100 g): not measured
- Aeration of dilution water: 8 days before use
- Suspended solids concentration: N/A
- Continuous darkness: yes
- Other: Ammonium chloride was not added to the river water to prevent nitrification.
TEST SYSTEM
- Culturing apparatus:
- Number of culture flasks/concentration: Use was made of 10 bottles containing only river water, 10 bottles containing river water and silica gel, 10 bottles containing river water and test substance (2.0 mg/L), and 6 bottles containing river water and sodium acetate (6.7 mg/L).
- Method used to create aerobic conditions: 8 days of aeration before use
- Method used to create anaerobic conditions: N/A
- Measuring equipment: The dissolved oxygen concentrations were determined electrochemically using an oxygen electrode (WTW TrioXmatic EO 200) and meter (WTW OXI 530). The pH was measured using a Eutech Cyberscan pH11 pH meter. The temperature was measured and recorded with a sensor connected to a data logger.
- Test performed in closed vessels due to significant volatility of test substance: yes
- Test performed in open system:
- Details of trap for CO2 and volatile organics if used: N/A
- Other: N/A
SAMPLING
- Sampling frequency: 0, 7, 14, 21, 28, 42 and 60 days.
- Sampling method: Two duplicate bottles of all series were withdrawn for analyses of the dissolved oxygen concentration at day 7, 14, 21, and 28. One extension from the protocol of the Closed Bottle test was introduced. The Closed Bottle test was prolonged by measuring the course of the oxygen decrease in the bottles of day 28 using a special funnel. This funnel fitted exactly in the BOD bottle. Subsequently, the oxygen electrode was inserted in the BOD bottle to measure the oxygen concentration. The medium dissipated by the electrode was collected in the funnel. After withdrawal of the oxygen electrode the medium collected flowed back into the BOD bottle, followed by removal of the funnel and closing of the BOD bottle
- Sterility check if applicable: N/A
- Sample storage before analysis: ambient temperature, in the dark
- Other: N/A
CONTROL AND BLANK SYSTEM
- Inoculum blank: river water only and river water and silica gel
- Abiotic sterile control: N/A
- Toxicity control: Sodium acetate
- Other: N/A
STATISTICAL METHODS:
Calculation of the theoretical oxygen demand (ThOD)
The ThODs of the test substance, and sodium acetate were calculated from their molecular formulae and molecular weights as follows.
ThODNH3(mgO2 /mg)= 16(2C+12 (H-Cl-3N)+3S+2(0.5*P)+(0.5*Na-O))/ MW
Oxygen consumptionn (mg/L) by test substance = Mcs - Mt
Oxygen consumptionn (mg/L) by reference compound = Mc - Ma
Mc or cs is the mean oxygen level in the control bottles with and without silica gel n-days after the start of the test.
Mt or a is the mean oxygen concentration in the bottles containing the test substance (t) or the reference compound, sodium acetate (a), n-days after the start of the test.
The BOD mg/mg of the test substance and sodium acetate was calculated by dividing the oxygen consumption by the concentration of the test substance and sodium acetate in the closed bottle, respectively.
Calculation of the biodegradation percentages:
The biodegradation was calculated as the ratio of the BOD to the theoretical oxygen demand (ThOD). - Reference substance:
- other: sodium acetate
- Key result
- Parameter:
- % degradation (DOC removal)
- Value:
- 68
- Sampling time:
- 60 d
- Key result
- Parameter:
- % degradation (DOC removal)
- Value:
- 41
- Sampling time:
- 28 d
- Parameter:
- % degradation (DOC removal)
- Value:
- 18
- Sampling time:
- 14 d
- Details on results:
- The validity of the test is demonstrated by an endogenous respiration of 0.9 mg/L at day 28. Furthermore, the differences of the replicate values at day 28 were less than 20 %. Finally, the validity of the test is shown with oxygen concentrations remaining at >0.5 mg/L in all bottles over the test period.
- Key result
- Parameter:
- ThOD
- Value:
- 2.8 g O2/g test mat.
- Remarks on result:
- other: test item
- Key result
- Parameter:
- ThOD
- Value:
- 0.8 g O2/g test mat.
- Remarks on result:
- other: reference material
- Results with reference substance:
- The biodegradation percentage of the reference compound, sodium acetate, at day 14 was 91.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Remarks:
- but not classified as persistent based on the enhanced biodegradability testing scheme.
- Conclusions:
- The test item was biodegraded by 41% at day 28 in the Closed Bottle test. In the prolonged Closed Bottle test the test substance is biodegraded by 68% at day 60. A biodegradation in excess of 60% within the 60-day test period allows classification of the item as not persistent.
- Executive summary:
In order to assess the biotic degradation, a ready biodegradability test was performed (slightly modified OECD 301D) using spiked river water (spiked with 8.5 mg KH2PO4, 21.75 mg K2HPO4, 33.4 mg Na2HPO4·2H2O, 22.5 mg MgSO4·7H2O, 27.5 mg CaCl2, 0.25 mg FeCl3·6H2O per litre). Dissolved oxygen content was used as the measurand.
The test substance did not cause a reduction in the endogenous respiration. The test substance is therefore considered to be non-inhibitory to the inoculum. The test item biodegraded by 41% at day 28 in the Closed Bottle test. In the prolonged Closed Bottle test, the test item was biodegraded by 68% at day 60 (enhanced biodegradability testing). A biodegradation percentage of >60 within a 60-day time period allows classification of the test item as not persistent.
The results were considered valid.
Reference
Table I. Dissolved oxygen concentrations (mg/L) in the closed bottles.
Time (days) |
Oxygen concentration (mg/L) |
|||
|
Ocs |
Ot |
Oc |
Oa |
0 |
8.7 |
8.7 |
8.7 |
8.7 |
|
8.7 |
8.7 |
8.7 |
8.7 |
Mean (M) |
8.7 |
8.7 |
8.7 |
8.7 |
7 |
8.1 |
7.9 |
8.1 |
3.2 |
|
8.1 |
7.8 |
8.2 |
3.6 |
Mean (M) |
8.1 |
7.9 |
8.2 |
3.4 |
14 |
7.8 |
7.0 |
7.8 |
3.1 |
|
7.8 |
6.6 |
7.9 |
2.9 |
Mean (M) |
7.8 |
6.8 |
7.9 |
3.0 |
21 |
7.6 |
5.5 |
7.6 |
|
|
7.8 |
5.8 |
7.7 |
|
Mean (M) |
7.7 |
5.7 |
7.7 |
|
28 |
7.7 |
5.5 |
7.8 |
|
|
7.7 |
5.2 |
7.8 |
|
Mean (M) |
7.7 |
5.4 |
7.8 |
|
42 |
7.4 |
4.2 |
|
|
|
7.3 |
4.4 |
|
|
Mean (M) |
7.4 |
4.3 |
|
|
60 |
7.1 |
3.3 |
|
|
|
6.9 |
3.0 |
|
|
Mean (M) |
7.0 |
3.2 |
|
|
Oc River water with nutrients
Ocs River water with nutrients with silica gel but without test material.
Ot River water with nutrients, test substance (2.0 mg/L).
Oa River water with nutrients and sodium acetate (6.7 mg/L).
Table II. Oxygen consumption (mg/L) and the percentages biodegradation of the test item, the test substance (BOD/ThOD) and sodium acetate (BOD/ThOD) in the Closed Bottle test.
Time (days) |
Oxygen consumption (mg/L) |
Biodegradation (%) |
||
|
Test substance |
Acetate |
Test substance |
Acetate |
0 |
0.0 |
0.0 |
0 |
0 |
7 |
0.2 |
4.8 |
4 |
89 |
14 |
1.0 |
4.9 |
18 |
91 |
21 |
2.0 |
|
36 |
|
28 |
2.3 |
|
41 |
|
42 |
3.1 |
|
55 |
|
60 |
3.8 |
|
68 |
|
Description of key information
Biodegradation: not readily biodegradable (41% biodegradation at day 28), not persistent (68% biodegradation at day 60), OECD 301D, (Anon, 2017).
Key value for chemical safety assessment
- Biodegradation in water:
- inherently biodegradable, not fulfilling specific criteria
Additional information
In order to assess the biotic degradation, a ready biodegradability test was performed (slightly modified OECD 301D) using spiked river water (spiked with 8.5 mg KH2PO4, 21.75 mg K2HPO4, 33.4 mg Na2HPO4·2H2O, 22.5 mg MgSO4·7H2O, 27.5 mg CaCl2, 0.25 mg FeCl3·6H2O per litre).
The test substance did not cause a reduction in the endogenous respiration. The test substance is therefore considered to be non-inhibitory to the inoculum. The test item biodegraded by 41% at day 28 in the Closed Bottle test. In the prolonged Closed Bottle test, the test item was biodegraded by 68% at day 60 (enhanced biodegradability testing). A biodegradation percentage of >60 within a 60-day time-period allows classification of the test item as not persistent.
The results were considered valid.
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.