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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-396-4 | 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
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to microorganisms, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data based on the inhibition control of a ready biodegradability study. This approach is in accordance with the Guidance on information requirements and chemical safety assessment (Chapter R.7b: Endpoint specific guidance, ECHA 2016).
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 310: Ready Biodegradability - CO2 in sealed vessels (Headspace Test)
- Version / remarks:
- 26 Sep 2014
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 14593, Water quality - Evaluation of ultimate aerobic biodegradability of organic compounds in aqueous medium - Method by analysis of inorganic carbon in sealed vessels (CO2 headspace test)
- Version / remarks:
- 15 Mar 1999
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OPPTS 835.3140, Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test), US EPA
- Version / remarks:
- Oct 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution of the test item in acetone was prepared (250.6 mg test item in 50 mL acetone). Appropriate amounts of this stock solution were dosed into the test vessels of the test item (0.5 mL, Ft) and the toxicity control (0.25 mL, Fl) and allowed to evaporate completely overnight before proceeding with the dosing of test water and activated sludge. For the preparation of the test item (Ft), activated sludge (2.5 mL of a stock solution 4 g/L suspended solids) was added to appropriate amounts of the test water (2500 mL) to achieve a sludge concentration of 4 mg/L. The mixture was stirred intensively and appropriate amounts were weighed into each test vessel, containing the evaporated test item and sealed with gas-tight septum caps.
- Inoculum controls (Fb): As the control vessels have to be treated in the same way as the test item vessels, 0.5 mL acetone was added and allowed to evaporate completely overnight before proceeding with the dosing of test water and activated sludge. Activated sludge (2.5 mL of the stock solution of 4 g suspended solids/L) was added to the test water (2500 mL) to achieve a sludge concentration of 4 mg/L. The mixture was stirred intensively and appropriate amounts were dispensed into the test vessels and sealed with gas-tight septum caps.
- Toxicity control (Fl): The toxicity control contains both, the test item and the reference item. The reference item was weighed into a total volume of test water (1500 mL) and activated sludge (1.5 mL of a stock solution of 4 g/L suspended solids) was added. The mixture was stirred intensively and appropriate amounts were weighed into the test vessels, containing the evaporated test item and sealed with gas-tight septum caps.
- Chemical name of vehicle: acetone
- Concentration of vehicle in test medium: As the procedure control (Fc) vessels have to be treated in the same way as the test item vessles, 0.5 mL acetone was added and allowed to evaporate completely overnight before proceeding with the dosing of test water and activated sludge. Appropriate amounts of the reference item sodium benzoate were weighed into a total volume of test water (1500 mL) and activated sludge (1.5 mL of the stock solution of 4 g suspended solids/L) was added to achieve a sludge concentration of 4 mg/L. The mixture was stirred intensively and approprate amounts were dispensed into the test vessels and sealed with gas-tight septum caps.
LOADING RATES
- Test item: 19.8 mg C/L (= 29.5 mg/L test item)
- Reference item: 19.8 mg C/L (= 34.0 mg/L reference item)
- Toxicity control: 19.8 mg C/L (= 14.7 mg/L test item and 17.0 mg/L of reference item) - Test organisms (species):
- activated sludge, domestic
- Details on inoculum:
- - Source of inoculum/activated sludge: aeration tank of a municipal sewage treatment plant, Rossdorf, Germany
- Storage conditions: The washed sludge suspension was adjusted to 4 g dry material per litre and aerated overnight.
- Storage length: overnight
- Preparation of inoculum for exposure: The activated sludge was washed by centrifugation and the supernatant liquid phase was decanted. The solid material was re-suspended in tap water and centrifuged again. This procedure was done three times. An aliquot of the final sludge suspension was weighed, dried and the ratio of wet sludge to its dry weight was determined. Based on this ratio, calculated aliquots of washed sludge suspension were mixed with test water corresponding to 4 g dry material per litre and aerated overnight.
- Concentration of sludge: 4 mg/L (final concentration) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 14 d
- Details on test conditions:
- TEST CONDITIONS
- Composition of medium: Reconstituted water composed of analytical grade salts in pure water.
- Solubilising agent: acetone
- Test temperature: 20 ± 2 °C
- pH: 7.6
- pH adjusted: no
- Aeration of dilution water: Yes, the test water was aerated with CO2-free air prior to test start.
- Suspended solids concentration: 4 mg/L dw
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: Glass bottles with screw-caps and Teflon-coated septa.
- Number of culture flasks/concentration: 3 replicates per treatment and per sampling
- Method used to create aerobic conditions: Aeration of the activated sludge and the test water with CO2-free air prior to test start.
- Measuring equipment: TOC-Analzyer, TOC-V CPH, Shimadzu
- Test performed in closed vessels due to significant volatility of test substance: The test vessel was sealed with gas-tight septum caps.
- Details of trap for CO2 and volatile organics if used:
- Other: The headspace to liquid ratio was 1:2.
SAMPLING
- Sampling frequency: Test item and Inoculum Control (blank): Days 0, 3, 6, 10, 14, 17, 20, 28; Procedure Control and Toxicity Control: Days 0, 6, 14, 28
- Sampling method: The produced CO2 was converted into carbonate using 7 M NaOH solution (0.8 mL to 85 mL test medium) injected into the test vessels at each sampling. The alkalised medium was shaken for 1 h and subjected to total inorganic carbon (TIC) analysis. TIC consists of the carbon contained in carbonates and in carbon dioxide dissolved in water. By acidification all carbonates are converted to carbon dioxide. Carbon dioxide and dissolved carbon dioxide in the sample are volatilized by bubbling CO2-free air through the sample. The TIC-content was analyzed automatically by the TOC-Analyzer using the sealed test vessels as sampling vials.
- Sample storage before analysis: The analysis was done immediately after sampling or the alkalised samples were stored in the refrigerator (4 ± 4°C) for a maximum of 4 d. Samples of Day 0 were stored deep frozen at < -20 °C for 4 d before analysis.
CONTROL AND BLANK SYSTEM
- Inoculum blank: Yes, consisting of 0.5 mL acetone (evaporated overnight), activated sludge (4 mg/L) in test water (2500 mL).
- Toxicity control: Yes, consisting of the test item and the reference item in test water (1500 mL).
- Procedure Control: Yes, consisting of 0.5 mL acetone (evaporated overnight), reference item, activated sludge (4 mg/L) and test water (1500 mL). - Reference substance (positive control):
- yes
- Remarks:
- sodium benzoate
- Key result
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 14.7 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Results of toxicity control from ready biodegradability test
- Results with reference substance (positive control):
- The reference item (sodium benzoate) was sufficiently degraded to 84.3% after 14 d and to 66.0% after 28 d of incubation (Table 1). The percentage of the reference item confirms the suitability of the used aerobic activated sludge inoculum.
- Validity criteria fulfilled:
- yes
Reference
In the toxicity control containing both the test item and the reference item sodium benzoate, 77.8% biodegradation was noted within 14 d and 65.6% biodegradation after 28 d of incubation. Therefore, the test item is not inhibitory to the inoculum.
Description of key information
NOEC (14 d) ≥ 14.7 mg/L (nominal, OECD 310)
Key value for chemical safety assessment
Additional information
Since no studies on the toxicity of the target substance Polyaldo 2-1-IS (CAS 73296-86-3) to aquatic microorganisms are available, a ready biodegradability study is used to derive a NOEC for the toxicity to aquatic microorganisms. If a compound degrades well in a ready biodegradability test, or does not inhibit the degradation of a positive control at a certain concentration, this concentration can be used as a NOEC value. This approach is in accordance with the Guidance on information requirements and chemical safety assessment (Chapter R.7b: Endpoint specific guidance, ECHA 2016).
A substance can be assumed to be not inhibitory to aquatic microorganisms, if in the toxicity control of a ready biodegradation test, more than 25% degradation based on CO2 evolution (CO2/ThCO2)] occurred within 14 d (OECD guideline 301). For the present substance a biodegradation test according to OECD guideline 310 is available. The test includes a toxicity control, which contains 14.7 mg/L of test substance and 17.0 mg/L of the reference material (sodium benzoate).
The toxicity control attained 77.8% degradation after 14 d of incubation. Hence, the substance is not toxic to aquatic microorganisms in the toxicity control and the test item concentration of 14.7 mg/L can be used as NOEC (NOEC (14 d) ≥ 14.7 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.