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Environmental fate & pathways

Biodegradation in water: screening tests

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Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019-05-10 to 2019-08-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)
Version / remarks:
OECD (2006). Guidelines for the Testing of Chemicals. TG 310: Ready Biodegradability – CO2 in sealed vessels (Headspace Test). OECD, Paris.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Test substance name: P1400
Scymaris reference number: 1027TS012
Physical state and appearance: Clear, oily liquid
CAS number: 1200806-67-2
Lot/batch number: 2661
Purity/strength: 98.6% on Certificate of Quality
Valtris Specialty Chemicals confirmed purity on 22 March 2018 as 98.45% (GC analysis, Appendix 3)
Date of manufacture: 31 August 2017
Expiry date: August 2019
Sample storage: Room temperature
Oxygen conditions:
aerobic
Inoculum or test system:
other: mixture of activated sludge and soil
Details on inoculum:
Activated sludge
Activated sludge was obtained from Buckland Sewage Treatment Works, Newton Abbot, Devon, UK on 24 May 2019. This works treats sewage of predominantly domestic origin. At the laboratory, the activated sludge was kept aerated at room temperature and the pH maintained at 7.0 +/- 1.0. Six days prior to the exposure start the activated sludge was centrifuged, washed and the total suspended solids measured.

Soil
The soil used was provided by LUFA Landwirtschaftliche Untersuchungs- und Forschungsanstalt Speyer, 67346 Speyer, Germany. The soil sample was collected from a depth of up to 20 cm below the soil surface. Stones, plant remains and invertebrates were removed from the soil sample before sieving through a 2 mm sieve. The soil was kept under aerobic conditions and stored in a loosely tied polythene bag at 2-4°C in the bag for 23 days. The pH of the soil was measured before use. The day before pre-conditioning started, approx. 500 g of soil was mixed with 500 mL of mineral medium and shaken overnight. The mixture was then allowed to settle for approx. 5 hours and the supernatant was removed (the mixture was not centrifuged).

Inoculum preparation
Six days prior to exposure start, the washed sludge was re-suspended in mineral medium to give a final concentration of 7.37 mg/L sludge solids and soil supernatant was added to give a concentration of 5 mL supernatant per litre of seeded mineral media. The final inoculum was aerated with CO2 free air at 20 +/- 1°C until day 0. This pre-conditioning procedure was to reduce the blank CO2 evolution.
Duration of test (contact time):
60 d
Initial conc.:
20 mg/L
Based on:
IC (inorganic carbon)
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
Test apparatus
Each individual unit consisted of a 160 mL glass bottle with a sealed septum lid situated on an orbital shaker. Bottles were shaken at 150 - 200 rpm. Carbon dioxide produced by biodegradation was trapped in the headspace of the bottle.

Experimental design
Samples were set up as follows:

- Inoculum blank 31 replicates
- Positive control: 19 replicates at a concentration of 20 mg reference substance/l
- P1400: 28 replicates at a concentration of 20 mg P1400/l
- Abiotic P1400: 13 replicates at a concentration of 20 mg P1400/l plus formaldehyde

All test bottles contained the prepared inoculum in mineral medium. On Day 0, the test bottles were setup for the test according to the experimental design.
Inoculum blanks contained no test or reference substance, in order to correct the test item vessels for any CO2 produced by the inoculum only. Positive control bottles contained sodium benzoate, at 20 mg C/L, to demonstrate the viability of the inoculum. The test substance bottles contained P1400 at 20 mg C/L, to determine the biodegradation of the test substance. Abiotic test substance bottles contained P1400 at 20 mg C/L and 5 mL of 37% w/v formaldehyde to show if any degradation of P1400 had been caused by abiotic processes. All bottles were prepared to give triplicate sacrificial bottles on each sampling day, except day 28 and day 60 when 5 bottles were sacrificed to allow calculation of coefficient of variation.

The P1400 bottles were prepared by directly weighing the required quantity to the relevant test bottles into each bottle on a glass slip. Sodium benzoate was dosed as a 686 mg/L stock solution, prepared by dissolving sodium benzoate in RO water to give a clear and colourless solution, this was prepared on the day of exposure start. Additional RO water was added to all vessels to make the final volume up to 100 mL, and to give a final sludge solids concentration of 7.0 mg/L.

Colony forming units (CFU)
The colony forming units (CFU) were measured using Rose Bengal (RBS) dip slides, these have Trypton Soya (TAS) TTC (total colony count; Red Spot) medium on one side for bacteria isolation and Rose Bengal (RBS) media on the other side for yeast and mould isolation. After immersing the dip slide in fluid for about 10 seconds and allowing excess fluid to drain off for a few seconds the dip slide was replaced in tube, sealed firmly, and incubated at 30°C for 5 days. The CFU of the seeded mineral media was measured, using duplicate dip slides, at the beginning of the pre-conditioning phase and on day 0.
Reference substance:
benzoic acid, sodium salt
Test performance:
The validity requirements of the OECD guideline state:
• the reference substance should achieve > 60% biodegradation by Day 14.
• The mean IC content of blank controls at the end of the test should be < 3 mg C/L.
Sodium benzoate reached a mean 88% biodegradation by Day 7. The mean IC content of the inoculum blanks after 60 days was 2.79 mg/L, therefore below 3 mg/L as required in the OECD guideline. Therefore, this test has satisfied all the validity criteria.
Key result
Parameter:
% degradation (CO2 evolution)
Value:
82.4
Sampling time:
60 d
Parameter:
% degradation (CO2 evolution)
Value:
58.3
Sampling time:
28 d
Details on results:
CFU
The duplicate results for the CFU observed in the inoculum on day 0 are given below:
Time Bacteria result Yeast and mould result
(CFU/mL) (CFU/mL)
Start of pre-conditioning 10^4 0
10^3 0
Day 0 10^4 10^2
10^4 0
The CFU observed was within the expected range 10^2 to 10^5 CFU/mL given in the 310 TG.

P1400
The biodegradation results for P1400 show that it attained a mean level of biodegradation (based on the % ThIC) of 58% after 28 days and 82% after 60 days and the results showed good replication (day 60 CV < 20%). P1400 displayed the potential for rapid biodegradation and reached 82% biodegradation in 60 days and can therefore be classified as inherently biodegradable.
P1400 Day 28 Day 60
Mean biodegradation: 58.3% 82.4%
Coefficient of variance: 6.6% 6.1%
95% confidence interval: 55.0 – 61.7% 78.0 – 86.8%

The following phases (approximate) were observed:
Phase Time period
Lag phase days 0 to 5
Degradation phase days 5 to 50
10-day window days 5 to 15

P1400 abiotic control
The increase of TIC in the abiotic controls was < 10% over 60 days, therefore no abiotic degradation processes occurred.

Temperature measurements
Continuous monitoring of the incubator temperature showed it to have remained within the range 20 ± 1°C throughout the study.
Results with reference substance:
The biodegradation results for the reference substance are summarised in Table 4 show that sodium benzoate attained a mean level of biodegradation (based on % ThIC) of 97% within 28 days, and the results showed good replication (CV < 20%). The maximum biodegradation of a reference substance replicate obtained on day 60 was 98%. More than 60% degradation was achieved by day 14 as expected for a biodegradable substance, thus confirming that the inoculum contained viable organisms.

Sodium benzoate Day 28 Day 60
Mean biodegradation: 96.6% 96.2%
Coefficient of variance: 1.9% 2.5%
95% confidence interval: 94.9 – 98.2% 94.1 – 98.3%

The following phases (approximate) were observed:
Phase Time period
Lag phase days 0 to 1
Degradation phase days 1 to 7
10-day window days 1 to 11
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable, but failing 10-day window
Conclusions:
P1400 attained a mean level of biodegradation (based on % ThIC) of 82% after 60 days, and the results showed good replication. Less than 60% degradation was achieved within the 10-day window, so P1400 cannot be classified as readily biodegradable. However, P1400 exhibited the potential for rapid degradation and can be classified as readily biodegradable but failing the 10-day window.
Executive summary:

The biodegradability of P1400 was studied in an OECD 310: Ready Biodegradability – CO2 in sealed vessels (Headspace Test). P1400 attained a mean level of biodegradation (based on % ThIC) of 82% after 60 days, and the results showed good replication.  Less than 60% degradation was achieved within the 10-day window, so P1400 cannot be classified as readily biodegradable.   However, P1400 exhibited the potential for rapid degradation and can be classified as readily biodegradable but failing the 10 day window.

Endpoint:
biodegradation in water: screening test, other
Remarks:
QSAR calculation
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
QSAR is a widely accepted predictive and diagnostic process used for finding associations between chemicalstructures and biological activity.
Qualifier:
no guideline required
Principles of method if other than guideline:
- Software tool(s) used including version: EpiSuite
- Model(s) used: v4. 11
- Model description: see field 'Justification for non-standard information', 'Attached justification' and/or 'Cross-reference'
GLP compliance:
no
Specific details on test material used for the study:
SMILES : c1ccccc1COC(=O)C2CCCCC2C(=O)OCCCC
CHEM : 1,2-Cyclohexanedicarboxylic Acid, 1-butyl 2-(phenylmethyl) ester
MOL FOR: C19 H26 O4
MOL WT : 318.42
Oxygen conditions:
not specified
Inoculum or test system:
not specified
Key result
Parameter:
probability of ready biodegradability (QSAR/QSPR)
Remarks on result:
readily biodegradable based on QSAR/QSPR prediction
Details on results:
Probability of Rapid Biodegradation (BIOWIN v4.10):
Biowin1 (Linear Model) : 1.1808
Biowin2 (Non-Linear Model) : 1.0000
Expert Survey Biodegradation Results:
Biowin3 (Ultimate Survey Model): 3.0963 (weeks )
Biowin4 (Primary Survey Model) : 4.1202 (days )
MITI Biodegradation Probability:
Biowin5 (MITI Linear Model) : 0.6902
Biowin6 (MITI Non-Linear Model): 0.6675
Anaerobic Biodegradation Probability:
Biowin7 (Anaerobic Linear Model): 0.1930
Ready Biodegradability Prediction: YES
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
The QSAR prediction results indicated that the substance is readily biodegradable.
Executive summary:

The ready biodegradability of the test substance, Platinum P1400 (CAS RN 1200806-67-2), was calculated using the QSAR model v4.10. According to the calculation, the test substance resulted to be readily biodegradable.

Description of key information

There are five biodegradation studies available for P1400 which show that it can be considered readily biodegradable but failing the 10 day window. It is also rapidly biodegradable and meets the criteria for inherent biodegradation.

The key study for P1400 is an OECD 310: Ready Biodegradability – CO2 in sealed vessels (Headspace Test) performed in 2019. During this study P1400 attained a mean level of biodegradation (based on % ThIC) of 82% after 60 days, and the results showed good replication.  Less than 60% degradation was achieved within the 10-day window, but the ECHA guidelines state that the 10 -day window requirement can be waived. P1400 exhibited the potential for rapid degradation and can be classified as readily biodegradable but failing the 10-day window.

In a second key study the biodegradability of P1400 was investigated in accordance with OECD 301F. Averages of the percentage biodegradation of the test item by BOD were 91% on Day 28, and 52% at the end of the 10-day window. The results showed that the test item can be considered readily biodegradable, but failing the 10-day window. The test item can be assumed not to be inhibitory on the activated sludge microorganism at the applied concentration level of 100 mg/L.

In a Manometric Respiratory Test performed in accordance with OECD 301F, P1400 attained a mean level of biodegradation (based on the BOD:COD ratio) of 40% after 28 days and the results showed good replication. The test substance was also studied for biodegradation using the CO2method according to OECD Guideline 301B and U.S. EPA OPPTS 835.3100. The mean percent theoretical CO2 produced by the test substance was 31.6% by Day 29 of the study.

The inherent ultimate and primary biodegradability of the test substance was also studied in a modified MITI (II) test equivalent to an OECD 302C and according to multiple Chinese chemical testing guidelines. The biodegradation of the test substance was calculated on the basis of Biochemical Oxygen Demand (BOD) and supplemented with chemical analysis of residual test concentrations. The test bottles incubated in C.E.S. Respirometer Systems at 25°C ± 2°C in the dark for over 28 days. At the end of the test, the test substance residual concentrations of the abiotic control and test suspensions were determined. Following the experiment, the following calculations were performed: (1) Theoretical Oxygen Demand (ThOD), (2) Biochemical Oxygen Demand (BOD), (3) Percentage biodegradation, (4) Abiotic degradation and (5) Primary degradation.

 

Under the conditions of the test, the percentage of ultimate biodegradation of the test substance, calculated by biochemical oxygen demand (BOD), was 59.5%. The primary biodegradation was determined to be 97.7% and the abiotic degradation rate was 50%. The results therefore show that the test substance was inherently biodegradable.

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable but failing 10-day window

Additional information