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EC number: 950-576-0 | 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:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 may 2019 to 10 May 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation))
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test item was not sufficiently soluble to allow preparation of an aqueous solution at a
concentration of 10 g/L. Therefore, the test item was added by direct pipetting into the amber
test bottles containing 200 mL Milli-RO water. The test item – Milli-RO water mixtures were
magnetically stirred for a short period (5-9 minutes). Subsequently, 16 mL synthetic medium,
made up to 50 mL with Milli-RO water, and 250 mL sludge were added, resulting in the
required concentrations (see 'Any other information on materials and methods' for details). Optimal contact between the test item and test
organisms was ensured by applying continuous aeration and stirring.
- Controls: Test medium without test item, treated in the same way as the test item solutions. - Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- - Laboratory culture:
- Name and location of sewage treatment plant where inoculum was collected: Municipal sewage treatment plant: 'Waterschap Aa en Maas',
's-Hertogenbosch, The Netherlands.
- Preparation of inoculum for exposure: The sludge was coarsely sieved (1 mm) and allowed to settle. The supernatant was removed and ISO-medium was added.
The concentration of the suspended solids was determined (3 g/L, as used for the test). The pH was 7.5 on the day of testing. The batch of sludge was used one day after collection.
Therefore, 50 mL of synthetic medium (=sewage feed) was added per litre of activated sludge at the end of the collection day. The sludge was kept aerated at test temperature until use.
- Medium: Adjusted ISO-medium, formulated using tap water purified by reverse osmosis, with the following composition: CaCl2.2H2O: 211.5 mg/L; MgSO4.7H2O: 88.8 mg/L; NaHCO3: 46.7 mg/L; KCl: 4.2 mg/L. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 3 h
- Test temperature:
- Between 20 and 21°C
- pH:
- At start (T=0h): 7.2 - 7.3
At end (t=3h): 7.1 - 8.2 - Nominal and measured concentrations:
- Nominal concentration:1.0, 10, 100 and 1000 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: All glass open bottles/vessels, 500 mL fill volume
- Aeration: Clean, oil-free air. The aeration was adjusted in such a way that the dissolved oxygen concentration at the start was above 60-70% saturation (60% of air saturation is > 5 mg/L at 20°C) and to maintain the
sludge flocs in suspension.
- No. of vessels per concentration (replicates): one replicate for the concetration of 1.0, 10 and 100 mg/L. Three replicates of the 1000 mg/L
- No. of vessels per control (replicates): 6
- No. of vessels per abiotic control (replicates): 1
- Sludge concentration (weight of dry solids per volume): 1.5 g/L suspended solids in the final test mixture.
- Nitrification inhibitor used: none
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water purified by reverse osmosis.
- Synthetic medium: Synthetic sewage feed, according to OECD 209.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: not specified
EFFECT PARAMETERS MEASURED
- Method: fter the 3-hour contact time the oxygen consumption was recorded for a period of approximately 10 minutes. During measurement, the sample was not aerated but continuously stirred on a magnetic stirrer. The pH was determined in the remaining part of the reaction mixture. This procedure was repeated for all test/reference item concentrations and controls.
- Oxygen reading: determination of oxygen was performed with multiple oxygen sensors connected to a BlueBox (GO-Systemelektronik GmbH, Germany), a multichannel measuring and controlling system.
-Temperature:The medium temperature was recorded continuously in temperature control vessels. The temperature control vessels were identically prepared compared to the control vessels. A temperature control vessel with a REES sensor was placed in each fume cupboard of the climate room.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Combined limit/range-finding study: 1.0, 10, 100 and 1000 mg/L - Key result
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Key result
- Duration:
- 3 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Details on results:
- - The combined limit/range-finding test showed no inhibition at 10 and 100 mg/l and an average of 9% inhibition of the respiration rate at 1000 mg/L. Therefore, the EC50 was above
the highest concentration tested (1000 mg/L). See Table 1 in 'Any other information on results' for details on %inhibition.
-The inhibition of the respiration rate of the sludge recorded at a concentration of 1000 mg SHR 1396 per litre was not statistically significant (see also Appendix 3). Therefore, the
NOEC was considered to be at the highest test concentration.
-There was no significant oxygen uptake from abiotic processes. - Results with reference substance (positive control):
- The EC50 of 3,5-dichlorophenol was in the accepted range of 2 to 25 mg/L for total respiration (3.2 mg/L with a 95% confidence interval:2.0 - 4.4 mg/L )
- Reported statistics and error estimates:
- ECx
- reference item: a 3-parameter logistic cumulative distribution function (CDF) using non-linear regression analysis.
- Test item: for SHR 1396, no EC50-value could be calculated because the test item proved to be non-toxic (EC50 > 1000 mg/L).
NOEC determination: (Two-sample t-test Procedure, α=0.05, one-sided, smaller).
Calculations were performed with ToxRat Professional v. 3.2.1. (ToxRat Solutions® GmbH, Germany). - Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of this present test SHR 1396 was not toxic to waste water bacteria (activated sludge) at 1000 mg/L (NOEC).
The EC50 was above 1000 mg/L. - Executive summary:
In a 3 -h activated sludge respiration inhibition study conducted according to OECD Guideline 209 and according to GLP Principles, microorganisms in activated sludge were exposed to the test item at nominal concentrations of 1.0, 10, 100 and 1000 mg/L. The combined limit/range-finding test showed no inhibition at 10 and 100 mg/l and an average of 9% inhibition of the respiration rate at 1000 mg/L.
the EC50 was above the highest concentration tested (1000 mg/L). The inhibition of the respiration rate of the sludge recorded at a concentration of 1000 mg SHR 1396 per litre was not statistically significant. Therefore, the NOEC was considered to be at the highest test concentration (1000 mg/L)
The study met all validity criteria and is considered reliable without restriction.
Reference
Table3
Results - Respiration Rate/Inhibition, pH Values
Replicate |
Concentration (mg/L) |
pH |
Respiration rate |
% Inhibition respiration rate (mean value) |
||
Start |
End |
(mg O2/L.h) |
(mg O2/g.h)¹ |
|||
C 1 |
0 |
7.3 |
7.9 |
40.65 |
27.10 |
|
C 2 |
0 |
7.3 |
8.0 |
34.60 |
23.07 |
|
C 3 |
0 |
7.3 |
8.0 |
41.84 |
27.89 |
|
C 4 |
0 |
7.3 |
8.0 |
38.60 |
25.73 |
|
C 5 |
0 |
7.3 |
7.9 |
40.01 |
26.67 |
|
C 6 |
0 |
7.2 |
7.9 |
40.92 |
27.28 |
|
C Mean |
|
|
|
39.44 |
26.29 (RC) |
|
SD |
|
|
|
2.60 |
1.74 |
|
CV (%) |
|
|
|
7 |
7 |
|
|
|
|
|
|
|
|
R 1 |
1.0 |
7.3 |
8.2 |
28.19 |
18.79 |
28.52 |
R 2 |
3.2 |
7.3 |
8.2 |
20.86 |
13.91 |
47.11 |
R 3 |
10 |
7.3 |
8.2 |
10.63 |
7.09 |
73.05 |
R 4 |
32 |
7.3 |
8.2 |
3.18 |
2.12 |
91.94 |
|
|
|
|
|
|
|
T 1 |
10 |
7.3 |
8.0 |
37.71 |
25.14 |
4.38 |
T 2 |
100 |
7.3 |
7.9 |
41.42 |
27.61 |
-5.03 |
T 3a |
1000 |
7.3 |
7.9 |
33.95 |
22.63 |
13.91 |
T 3b |
1000 |
7.3 |
7.7 |
44.70 |
29.80 |
-13.35 |
T 3c |
1000 |
7.2 |
7.9 |
29.00 |
19.33 |
26.46 |
T3 Mean |
|
|
35.88 |
23.92 (RT) |
9.01 (IT) |
|
|
|
|
|
|
|
|
TA |
1000 |
7.3 |
7.1 |
0.12 |
0.08 |
|
C: Control
R: Reference item, 3,5-dichlorophenol
T: Test item, SHR 1396
TA: Abiotic control of SHR 1396
SD: Standard deviation
CV: Coefficient of variation
RT: Total respiration with SHR 1396
RC: Total respiration in the control
IT: % inhibition of total respiration relative to RC
¹ The amount of suspended solids in the final test mixture was 1.5 g/L.
Description of key information
The EC50 is > 1000 mg/L and the NOEC is 1000 mg/L.
Key value for chemical safety assessment
- EC10 or NOEC for microorganisms:
- 1 000 mg/L
Additional information
In a 3 -h activated sludge respiration inhibition study conducted according to OECD Guideline 209 and according to GLP Principles, microorganisms in activated sludge were exposed to the test item at nominal concentrations of 1.0, 10, 100 and 1000 mg/L. The combined limit/range-finding test showed no inhibition at 10 and 100 mg/l and an average of 9% inhibition of the respiration rate at 1000 mg/L.
the EC50 was above the highest concentration tested (1000 mg/L). The inhibition of the respiration rate of the sludge recorded at a concentration of 1000 mg SHR 1396 per litre was not statistically significant. Therefore, the NOEC was considered to be at the highest test concentration (1000 mg/L)
The study met all validity criteria and is considered reliable without restriction.
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