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EC number: 942-655-3 | CAS number: 1802727-84-9
- 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
- Study period:
- 2015-11-25 to 2016-03-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.3110 (Ready Biodegradability)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge: The (controlled) activated sludge was supplied by the sewage plant for domestic sewage in Balatonfüred, Hungary, on 06 January 2016 (7 days before the test).
- Preparation of inoculum for exposure: The activated sludge used for this study was washed by centrifugation and the supernatant liquid phase was decanted. The solid material was re-suspended in isotonic saline solution and again centrifuged. This procedure was repeated twice. 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, corresponding to 5 g dry material per litre was mixed with test water and then aerated under test conditions (for 7 days) until use. The pH of the activated sludge inoculum after preparation was 7.62, just before use: 6.87. A pH adjustment of activated sludge inoculum was not performed.
- Pretreatment: Pre-conditioning (06-13 January 2016) consisted of aerating (2 L/minute) activated sludge (in mineral medium, reconstituted water for 7 days at the test temperature (the actual temperature range was 20.5 - 22.9 °C). During the aeration the cell count of inoculum was checked as follows: the viability of the cultured sludge was determined by plating 0.1 mL of the different, usually 10^-2, 10^-3 and 10^-4 dilutions of cultures on nutrient agar plates. The viable cell number of the cultures was determined by these plating experiments by manual colony counting. The approximately cell count of aerated inoculum fell in the range of 108/L; therefore on the day of the test this inoculum was diluted adequately with reconstituted water to reach the necessary cell concentration (guideline proposal of 104-106 approx. cells/L). After preparation the sludge was filtered through cotton wool. Pre-conditioning improved the precision of the test methods by reducing blank values. The inoculum was not pre-adapted to the test chemical. Nutrient agar: Supplier: MERCK; Batch Number: VM664850, Expiry date: 05 November 2019
- Concentration of sludge: Microbial inoculum (2.0 mL per litre test medium) was added to each preparation bottle. - Duration of test (contact time):
- 28 d
- Initial conc.:
- 3 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: In water (purified deionised) analytical grade salts were added to prepare the following stock solutions:
a) KH2PO4, 8.50 g; K2HPO4, 21.75 g; Na2HPO4 x 12H2O 67.16 g; NH4Cl, 0.50 g; Water ad. 1000 mL
b) CaCl2 x 2H2O 18.20 g; Water ad. 500 mL
c) MgSO4 x 7 H2O 11.25 g; Water ad. 500 mL
d) FeCl3 x 6H2O 0.125 g; Water ad. 500 mL2
(The “d” stock solution was prepared on the day of the reconstituted water preparation and was not further stored).
Ratio of ingredients: 1 x 1 mL of the stock solutions a - d) each, were combined and filled to a final volume of 1000 mL with deionised water (aqua purificata). The test medium was aerated for 20 minutes and allowed to stand for about 20 hours at the test temperature. The dissolved oxygen concentration was checked and found 8.22 mg/L. The pH of the reconstituted water was 7.22.
- Test temperature: During the preparation, aeration and incubation of the reconstituted water and at the activated sludge inoculum preparation and incubation, the temperature was 20.2-20.8 °C. During the incubation (28 days) of the test units the temperature range was the following: 20.0-20.4 °C.
- pH: The pH was checked prior study start and found to be 7.22. pH adjustment was considered as not necessary.
- pH adjusted: no
- Continuous darkness: yes
- Surrounding type: The test was carried out in a controlled environment room (during the formulation and oxygen measuring) at a temperature of 22 ± 2 °C according to the guideline. The test flasks were incubated in a controlled incubator at 22 ± 2°C, in the dark. Temperature was measured continuously using min/max thermometer and noticed daily.
TEST SYSTEM
- Culturing apparatus: Winkler bottles (300 mL, coded) with special neck and glass stoppers.
- Number of culture flasks/concentration:
10 (+2 reserve) bottles containing the test item and inoculum
10 (+2 reserve) bottles containing the reference item and inoculum (procedure control)
10 (+2 reserve) bottles containing only inoculum (inoculum control)
10 (+2 reserve) bottles containing the test item, reference item and inoculum (toxicity control)
- Measuring equipment: Oxygen and pH meter with appropriate O2 and pH electrode, Aeration system, Moisture analyser, Temperature controlled (22 ± 2 °C) environment room and incubator with thermometer with exclusion of light, Balance, Centrifuge.
SAMPLING
- Sampling frequency: Oxygen measurements were performed in duplicate on days 0, 7, 14, 21 and 28
- Sampling method: The oxygen concentration was measured with an O2 electrode [working based on LDO (Luminescent Dissolved Oxygen) method].
CONTROL AND BLANK SYSTEM
- Inoculum blank: Only filtered inoculum (10 mL) was added to the aqueous test medium (5000 mL). More studies run in parallel and the corresponding inoculum control was common.
- Toxicity control: Test and reference item stock solutions (50-50 mL) were mixed into the aqueous test medium (ad. 5000 mL) corresponding to the test item concentration of 3.0 mg/L [chosen based on the calculated ThODNH4 of the test item and the preliminary experiment] and to 3.0 mg/L concentration of the reference item.
- procedure control: Based on the theoretical oxygen demand (ThODNH4) of Sodium benzoate (1.67 mg O2 per mg) (details on calculation are given in the guidelines), at the start of the test a stock solution of Sodium benzoate (50 mL) was mixed into (ad. 5000 mL) the aqueous test medium (corresponding to 3.0 mg/L reference item, respectively a ThODNH4 of about 3.0 x 1.67= 5.01 mg O2/L). More studies run in parallel and the corresponding procedure control was common. - Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- The preliminary experiments on solubility and possible toxicity of the test item were not performed in compliance with the GLP-Regulations and are excluded from the Statement of Compliance (Statement of the Study Director), but the raw data of these tests will be archived under the study code of present study.
- Test performance:
- The preparation of the respective test solutions with the test item was performed according to the following:
The respective amount, 60 mg of the test item was weighed and suspended by mechanical dispersion in 200 mL reconstituted water (extra care was taken for avoiding of air bubbles in the stirred solution). The concentration of the obtained stock solution was: 300 mg/L.
Based on the theoretical oxygen demand (ThODNH4) of 2.44 mg O2/mg test item (calculated according to equation given in the guidelines, assuming that no nitrification occurs) and based on the results of a non-GLP preliminary experiment, at the start of the test a suitable volume (50 mL) of the test item solution was thoroughly mixed into the respective volume (5000 mL) of aqueous test medium corresponding to 3.0 mg/L test item, respectively a ThODNH4 of about 7.32 mg O2/L.
A sufficient number of BOD flasks were cleaned with 5 – 10 mL wash liquid (2.5 g iodine and 12.5 g potassium iodide per litre of 1 % w/v sulphuric acid) by well shaking to coat the bottle walls. After standing for about 15 minutes, the wash liquid was poured off, and the bottles were thoroughly rinsed with tap water and deionised water. After the previously described test solutions were added into the bottles bubble-free until the bottles were completely filled, they were tightly closed (with glass stoppers). The biodegradation was followed by the oxygen uptake of the microorganisms during exposure. - Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 4.7
- Sampling time:
- 28 d
- Details on results:
- Under the test conditions the percentage biodegradation of the test item reached a mean of 4.7 % after 28 days based on its calculated ThODNH4. Minimal biodegradation of the test item occurred in this study therefore a biodegradability plateau was not defined. Any occurred variations, slight changes in the biodegradability values were considered as being within the biological variability range of the applied test system. The test item was considered to be not ready biodegradable.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The test item was considered to be not ready biodegradable. According to the test guidelines the pass level for ready biodegradability is 60 % of ThODNH4. Any correction of the BOD values with the observed nitrite values was considered as not necessary. According to the test guidelines the test item can be assumed as not inhibitory on the activated sludge microorganisms because the degradation in the toxicity control group was higher than 25 % within 14 days. The percentage biodegradation of the reference item confirms the suitability of the used activated sludge inoculum.
- Executive summary:
The purpose of this study was to determine the ready biodegradability of the test item. The test item was exposed to activated sludge from the aeration tank of a domestic waste water treatment plant for 28 days. The biodegradation was followed by the oxygen uptake of the microorganisms during exposure. The test item was investigated at the concentration of 3.0 mg/L. The concentration was chosen based on the preliminary test results and based on the theoretical oxygen demand of 2.44 mg O2/mg test item (ThODNH4, calculated according to equation given in the guidelines, assuming that no nitrification occurs). In parallel (under the same conditions as the test item), positive reference item, sodium benzoate at the concentration of 3.0 mg/L (as procedure control), inoculum control and toxicity control were investigated. All validity criteria of the study were met. Under the test conditions ready biodegradation of this test item was not noticed. The percentage biodegradation of the test item reached a mean of 4.7 % after 28 days based on its ThODNH4. The parallel running analytical determination of a possible nitrite and nitrate development demonstrated that no nitrification occurred, therefore the biodegradability of the test item was calculated based on its ThODNH4; any correction, based on the nitrite and/or nitrate content was not performed. The reference item sodium benzoate was sufficiently degraded to a mean of 72.4 % after 14 days, and to a mean of 83.8 % after 28 days of incubation, based on ThODNH4. In the toxicity control containing both, the test item and the reference item, a mean of 27.2 % biodegradation was noted within 14 days and 31.5 % biodegradation after 28 days of incubation. The test item is considered to be not ready biodegradable, since the pass level for ready biodegradability is removal of 60% ThODNH4 in a 10-day window. The percentage biodegradation of the reference item confirms the suitability of the used activated sludge inoculum. According to the test guidelines the test item can be assumed as not inhibitory at the applied concentration level on the activated sludge microorganisms because the degradation in the toxicity control group was higher than 25 % within 14 days.
Reference
Description of key information
The test item was considered to be not ready biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- under test conditions no biodegradation observed
- Type of water:
- freshwater
Additional information
The test item was considered to be not ready biodegradable. According to the test guidelines the pass level for ready biodegradability is 60 % of ThODNH4. Under the test conditions the percentage biodegradation of the test item reached a mean of 4.7 % after 28 days based on its calculated ThODNH4. Any correction of the BOD values with the observed nitrite values was considered as not necessary. According to the test guidelines the test item can be assumed as not inhibitory on the activated sludge microorganisms because the degradation in the toxicity control group was higher than 25 % within 14 days. The percentage biodegradation of the reference item confirms the suitability of the used activated sludge inoculum.
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