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Biodegradation in water and sediment: simulation tests

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Endpoint:
biodegradation in water: simulation testing on ultimate degradation in surface water
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study was requested by ECHA (CCH-D-2114440056-58-01/F) and is currently ongoing (remeasurement of some samples, identification of metabolites). We entered as much information as currently available. Although the test analytics is not yet finished (see attachment ), the high degree of parent substance and the low degree of CO2 formation found after 100d clearly indicate that the substance must be considered persistent in the environment. The RSS will be completed and the dossier updated as soon as the final report is available.
Qualifier:
according to guideline
Guideline:
OECD Guideline 308 (Aerobic and Anaerobic Transformation in Aquatic Sediment Systems)
Version / remarks:
adopted in 2002
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 1281-1012
- Purity, including information on contaminants, isomers, etc.: 100%

RADIOLABELLING INFORMATION
- Radiochemical purity: 100%
- Specific activity (a.i.): 2.57 MBq/mg
- Locations of the label: phenyl-ring-U-C14
Radiolabelling:
yes
Oxygen conditions:
aerobic
Inoculum or test system:
natural water / sediment
Details on source and properties of surface water:
Two different water/sediments combinations were tested:
1) Stream named “Ranschgraben” west from the city of Schifferstadt, near the federal road L 532 surrounded by a forest (GPS coordinate 49.4040036/8.4021280). The water was clear and colourless and without any specific odour.
2)Side arm of the river Rhein named “Berghäuser Altrhein” south from the city of Speyer, near the industrial park south surrounded by a forest (GPS coordinate 49.2861252/8.4710159. The water was clear and colourless and without any particular odour.
Details on source and properties of sediment:
Two different water/sediments combinations were tested:
1) Stream named “Ranschgraben” west from the city of Schifferstadt, near the federal road L 532 surrounded by a forest (GPS coordinate 49.4040036/8.4021280). The sediment smelled earthy and appeared brownish grey. The TOC was determined to be 0.2 g/100 g corresponding to 0.2% TOC. The sediment has a coarse texture with a clay and silt content of 0.81% (< 50 μm fraction).
2) Side arm of the river Rhein named “Berghäuser Altrhein” south from the city of Speyer, near the industrial park south surrounded by a forest (GPS coordinate 49.2861252/8.4710159. The sediment smelled earthy-mouldy and appeared grey. The TOC was determined to be 3.4 g/100g corresponding to 3.4% TOC. The sediment has a fine texture with a clay and silt content of 51.2%
Duration of test (contact time):
100 d
Initial conc.:
155.5 µg/L
Based on:
test mat.
Remarks:
corresponding to 0.8 MBq in 500 mL water phase
Parameter followed for biodegradation estimation:
CO2 evolution
radiochem. meas.
Details on study design:
TEST CONDITIONS
- Volume of test solution/treatment: 500 mL water with a sediment layer of 2.5 +- 0.5 cm
- Solubilising agent: acetone
- Test temperature: 20 °C
- Aeration of dilution water: yes
- Continuous darkness: yes

TEST SYSTEM
- Culturing apparatus: Standard cylindrical reagent bottles of 1L volume from Schott, narrow necked with standard ground socket (NS 29/32), material: glass soda glass, outer diameter ~ 9.6 cm and 12 cm height.
- Number of culture flasks/concentration: 16 test assays with test item for regular sampling (8 sampling times, in double determinations)
- Method used to create aerobic conditions: After application of the test substance the test vessels were connected back to the air supply. Aeration with a tube pump was adjusted so that the air bubbles were as small as possible and the water layer in the test vessels were lightly moved.
- Test performed in closed vessels due to significant volatility of test substance: no
- Test performed in open system: no
- Details of trap for CO2 and volatile organics if used: After addition of the test substance to the scheduled test vessels 4x 250 mL absorption flasks will be connected with the test vessels. The first and second trap will be filled with 100 mL 1 M sodium hydroxide solution for the adsorption of carbon dioxide from biodegradation processes. Third trap consists of 50 mL ethylene glycol to absorb volatile organic substances, and the last flask will be filled with 50 mL 0.1 M sulphuric acid for volatile alkali substances.

SAMPLING
- Sampling frequency: Samples were taken afer 0 hr, 2d, 8d, 21d, 49d, 65d, 85d and 100d.

DESCRIPTION OF CONTROL AND/OR BLANK TREATMENT PREPARATION
CONTROL AND BLANK SYSTEM
- Inoculum blank: 2 test assays without test item as control. One of these test assays will be used for determine the parameters in the acclimation phase.
- Toxicity control: c.) 2 test assays with test item for checking the toxic or inhibition effects of the test substance on the microbial community.
- Other: 2 additional control units with the solvent (same solvent volume that was used to apply the test substance) to measure adverse effects on the microbial activity of the test system
Compartment:
natural water / sediment
% Total extractable:
>= 61.1 - <= 74
% Non extractable:
>= 9.9 - <= 10
% CO2:
>= 0.2 - <= 0.3
% Other volatiles:
0
% Recovery:
76.8
St. dev.:
10.4
Remarks on result:
other: Ranschgraben, day 100
Remarks:
Remeasurements of some water and sediment samples are ongoing, due to a adsorption issue with HPLC vials resulting in low recoveries. Thus, the % recovery will be higher after remeasurement. The %CO2 values are not affected.
Compartment:
natural water / sediment
% Total extractable:
>= 26.2 - <= 45.9
% Non extractable:
>= 29.6 - <= 46.1
% CO2:
>= 0.1 - <= 0.2
% Other volatiles:
0
% Recovery:
74.1
St. dev.:
25.7
Remarks on result:
other: Berghäuser Altrhein; day 100
Remarks:
Remeasurements of some water and sediment samples are ongoing, due to a adsorption issue with HPLC vials resulting in low recoveries. Thus, the % recovery will be higher after remeasurement. The %CO2 values are not affected.
Parent/product:
parent
Compartment:
total system
Key result
% Degr.:
>= 0.1 - <= 0.3
Parameter:
CO2 evolution
Sampling time:
100 d
Key result
Compartment:
natural water / sediment
DT50:
> 100 d
Type:
(pseudo-)first order (= half-life)
Temp.:
20 °C
Transformation products:
not specified
Remarks:
Identification of transformation products still ongoing.
Evaporation of parent compound:
no
Volatile metabolites:
no
Details on results:
TEST CONDITIONS
- Aerobicity (or anaerobicity), moisture, temperature and other experimental conditions maintained throughout the study: Yes
- Anomalies or problems encountered (if yes): Adsorption issues with HPLC vials in some samples make a remeasurment necessary.

MAJOR TRANSFORMATION PRODUCTS
Analytics is still ongoing; Quantity of transformation products is ~ 10%

MINOR TRANSFORMATION PRODUCTS
Analytics is still ongoing; Quantity of transformation products is ~ 10%

EXTRACTABLE RESIDUES
- % of applied amount at day 0: 98.5 (Ranschgraben); 95.1 (Berghäuser Rheinarm)
- % of applied amount at end of study period: ~ 70% (Ranschgraben); ~ 45% (Berghäuser Rheinarm)
Remeasurements are ongoing.

NON-EXTRACTABLE RESIDUES
- % of applied amount at day 0: 1.2 (Ranschgraben); 2.7 (Berghäuser Rheinarm)
- % of applied amount at end of study period: ~10% (Ranschgraben); ~ 45% (Berghäuser Rheinarm)
Remeasurements are ongoing.

MINERALISATION
- % of applied radioactivity present as CO2 at end of study: 0.1 - 0.3%

VOLATILIZATION
- % of the applied radioactivity present as volatile organics at end of study: 0%
Conclusions:
The substance is considered to be persistent in the environment according to REACh relevant criteria.
Endpoint:
biodegradation in water: sediment simulation testing
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study was requested by ECHA (CCH-D-2114440056-58-01/F) and is currently ongoing (remeasurement of some samples, identification of metabolites). We entered as much information as currently available. Although the test analytics is not yet finished (see attachment ), the high degree of parent substance and the low degree of CO2 formation found after 100d clearly indicate that the substance must be considered persistent in the environment. The RSS will be completed and the dossier updated as soon as the final report is available.
Qualifier:
according to guideline
Guideline:
OECD Guideline 308 (Aerobic and Anaerobic Transformation in Aquatic Sediment Systems)
Version / remarks:
adopted in 2002
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 1281-1012
- Purity, including information on contaminants, isomers, etc.: 100%

RADIOLABELLING INFORMATION
- Radiochemical purity: 100%
- Specific activity (a.i.): 2.57 MBq/mg
- Locations of the label: phenyl-ring-U-C14
Radiolabelling:
yes
Oxygen conditions:
aerobic
Inoculum or test system:
natural water / sediment
Details on source and properties of surface water:
Two different water/sediments combinations were tested:
1) Stream named “Ranschgraben” west from the city of Schifferstadt, near the federal road L 532 surrounded by a forest (GPS coordinate 49.4040036/8.4021280). The water was clear and colourless and without any specific odour.
2)Side arm of the river Rhein named “Berghäuser Altrhein” south from the city of Speyer, near the industrial park south surrounded by a forest (GPS coordinate 49.2861252/8.4710159. The water was clear and colourless and without any particular odour.
Details on source and properties of sediment:
Two different water/sediments combinations were tested:
1) Stream named “Ranschgraben” west from the city of Schifferstadt, near the federal road L 532 surrounded by a forest (GPS coordinate 49.4040036/8.4021280). The sediment smelled earthy and appeared brownish grey. The TOC was determined to be 0.2 g/100 g corresponding to 0.2% TOC. The sediment has a coarse texture with a clay and silt content of 0.81% (< 50 μm fraction).
2) Side arm of the river Rhein named “Berghäuser Altrhein” south from the city of Speyer, near the industrial park south surrounded by a forest (GPS coordinate 49.2861252/8.4710159. The sediment smelled earthy-mouldy and appeared grey. The TOC was determined to be 3.4 g/100g corresponding to 3.4% TOC. The sediment has a fine texture with a clay and silt content of 51.2%
Duration of test (contact time):
100 d
Initial conc.:
155.5 µg/L
Based on:
test mat.
Remarks:
corresponding to 0.8 MBq in 500 mL water phase
Parameter followed for biodegradation estimation:
CO2 evolution
radiochem. meas.
Details on study design:
TEST CONDITIONS
- Volume of test solution/treatment: 500 mL water with a sediment layer of 2.5 +- 0.5 cm
- Solubilising agent: acetone
- Test temperature: 20 °C
- Aeration of dilution water: yes
- Continuous darkness: yes

TEST SYSTEM
- Culturing apparatus: Standard cylindrical reagent bottles of 1L volume from Schott, narrow necked with standard ground socket (NS 29/32), material: glass soda glass, outer diameter ~ 9.6 cm and 12 cm height.
- Number of culture flasks/concentration: 16 test assays with test item for regular sampling (8 sampling times, in double determinations)
- Method used to create aerobic conditions: After application of the test substance the test vessels were connected back to the air supply. Aeration with a tube pump was adjusted so that the air bubbles were as small as possible and the water layer in the test vessels were lightly moved.
- Test performed in closed vessels due to significant volatility of test substance: no
- Test performed in open system: no
- Details of trap for CO2 and volatile organics if used: After addition of the test substance to the scheduled test vessels 4x 250 mL absorption flasks will be connected with the test vessels. The first and second trap will be filled with 100 mL 1 M sodium hydroxide solution for the adsorption of carbon dioxide from biodegradation processes. Third trap consists of 50 mL ethylene glycol to absorb volatile organic substances, and the last flask will be filled with 50 mL 0.1 M sulphuric acid for volatile alkali substances.

SAMPLING
- Sampling frequency: Samples were taken afer 0 hr, 2d, 8d, 21d, 49d, 65d, 85d and 100d.

DESCRIPTION OF CONTROL AND/OR BLANK TREATMENT PREPARATION
CONTROL AND BLANK SYSTEM
- Inoculum blank: 2 test assays without test item as control. One of these test assays will be used for determine the parameters in the acclimation phase.
- Toxicity control: c.) 2 test assays with test item for checking the toxic or inhibition effects of the test substance on the microbial community.
- Other: 2 additional control units with the solvent (same solvent volume that was used to apply the test substance) to measure adverse effects on the microbial activity of the test system
Compartment:
natural water / sediment
% Total extractable:
>= 61.1 - <= 74
% Non extractable:
>= 9.9 - <= 10
% CO2:
>= 0.2 - <= 0.3
% Other volatiles:
0
% Recovery:
76.8
St. dev.:
10.4
Remarks on result:
other: Ranschgraben, day 100
Remarks:
Remeasurements of some water and sediment samples are ongoing, due to a adsorption issue with HPLC vials resulting in low recoveries. Thus, the % recovery will be higher after remeasurement. The %CO2 values are not affected.
Compartment:
natural water / sediment
% Total extractable:
>= 26.2 - <= 45.9
% Non extractable:
>= 29.6 - <= 46.1
% CO2:
>= 0.1 - <= 0.2
% Other volatiles:
0
% Recovery:
74.1
St. dev.:
25.7
Remarks on result:
other: Berghäuser Altrhein; day 100
Remarks:
Remeasurements of some water and sediment samples are ongoing, due to a adsorption issue with HPLC vials resulting in low recoveries. Thus, the % recovery will be higher after remeasurement. The %CO2 values are not affected.
Parent/product:
parent
Compartment:
total system
Key result
% Degr.:
>= 0.1 - <= 0.3
Parameter:
CO2 evolution
Sampling time:
100 d
Key result
Compartment:
natural water / sediment
DT50:
> 100 d
Type:
(pseudo-)first order (= half-life)
Temp.:
20 °C
Transformation products:
not specified
Remarks:
Identification of transformation products still ongoing.
Evaporation of parent compound:
no
Volatile metabolites:
no
Details on results:
TEST CONDITIONS
- Aerobicity (or anaerobicity), moisture, temperature and other experimental conditions maintained throughout the study: Yes
- Anomalies or problems encountered (if yes): Adsorption issues with HPLC vials in some samples make a remeasurment necessary.

MAJOR TRANSFORMATION PRODUCTS
Analytics is still ongoing; Quantity of transformation products is ~ 10%

MINOR TRANSFORMATION PRODUCTS
Analytics is still ongoing; Quantity of transformation products is ~ 10%

EXTRACTABLE RESIDUES
- % of applied amount at day 0: 98.5 (Ranschgraben); 95.1 (Berghäuser Rheinarm)
- % of applied amount at end of study period: ~ 70% (Ranschgraben); ~ 45% (Berghäuser Rheinarm)
Remeasurements are ongoing.

NON-EXTRACTABLE RESIDUES
- % of applied amount at day 0: 1.2 (Ranschgraben); 2.7 (Berghäuser Rheinarm)
- % of applied amount at end of study period: ~10% (Ranschgraben); ~ 45% (Berghäuser Rheinarm)
Remeasurements are ongoing.

MINERALISATION
- % of applied radioactivity present as CO2 at end of study: 0.1 - 0.3%

VOLATILIZATION
- % of the applied radioactivity present as volatile organics at end of study: 0%
Conclusions:
The substance is considered to be persistent in the environment according to REACh relevant criteria.

Description of key information

DT50 > 100d in surface water and sediment (OECD 308)

Key value for chemical safety assessment

Additional information

One study investigating the biodegradability of O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate in the environment is available. In this study, the biodegradation rates of the test substance in a water/sediment system and the identification of its biotransformation products and their distribution into water and sediment was investigated according to OECD guideline 308 under GLP conditions using radiolabeled test material (BASF 2021). Two different natural water/sediment systems were used differing in TOC content of the sediment (Location 1: 0.2% AR and Location 2: 3.4% AR). The test vessels were incubated in dark conditions at a temperature of 20 °C for 100 days. Whole system mineralization of the parent compound to carbon dioxide accounted for 0.2 – 0.3% AR after 100 days incubation. Formation of organic or inorganic volatile were absent during the exposure. At the end of exposure very few radioactivity was found in water (Location 1: 0.5% AR, Location 2: 0.1% AR). The remaining radioactivity was found in sediment. sediment (~ 50 - > ~70% AR). NERs in sediment was dependent upon the TOC content of the sediment: ~ 10% AR in Location 1 and ~ 45% AR in Location 2. Remeasurements of some water and sediment samples are ongoing, due to an adsorption issue of samples on HPLC vials and thus a poor recovery observed in these samples. Three metabolites are identified which together account for 10% AR. The rest of the activity can be attributed to the parent compound. Analysis to identify the metabolites are still ongoing. The biomass and the other physico-chemical parameters indicated that the condition inside the test systems were stable and the microbiology was active during the exposure time. No inhibition effect of test substance to microorganisms were found. Based on the fact that a) most (~ 90%) of the radioactivity after 100 days can be attributed to the parent compound and b) the degree of mineralization is very low (0.2-0.3%), the substance can be considered persistent in the environment.