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EC number: 606-384-1 | CAS number: 19797-08-1
- 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:
- 08 Mar 2018 - 13 Apr 2018
- 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))
- Version / remarks:
- 22 Jul 2010
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was pipetted directly into the amber test bottles containing 200 mL Milli-RO water (tap water purified by reverse osmosis). The test item+Milli-RO water mixtures were magnetically stirred for a short period and subsequently, 16 mL synthetic medium made up to 50 mL with Milli-RO water and 250 mL sludge were added.
- Differential loading: Yes
- Controls: Test medium without test item, treated in the same way as the test item solutions (6 replicates) - Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- - Laboratory culture:
No
- Inoculum source: Municipal sewage treatment plant 'Watershap Aa en Maas', 's-Hertogenbosch, The Netherlands
- Preparation of sludge: The sludge was coarsely sieved (1 mm) and allowed to settle. The supernatant was removed and ISO-medium was added.
- Pretreatment: The batch of sludge was used 1 d after collection. Therefore, 50 mL of synthetic medium ( = sewage feed) was added per Liter of activated sludge at the end of the collection day. The sludge was kept aerated at test temperature until use.
- Sludge concentration (suspended solids): 3.0 g/L, as used for the test
- Final concentration of sludge at test start: 1.5 g/L (250 mL sludge in a final volume of 500 mL test solution) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 3 h
- Test temperature:
- 20 - 21 °C
- pH:
- Start: 7.4 - 7.5
End: 8.1 - 8.5 - Nominal and measured concentrations:
- Control, 100, 180, 320, 560, and 1000 mg/L (nominal)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: All glass open bottles
- Aeration: Yes, continuous aeration with clean, oil-free air throughout the test. The aeration was adjusted such that the dissolved oxygen concentration at the start was > 60-70% saturation (60% air saturation is > 5.0 mg/L at 20 °C) and to maintain the sludge flocs in suspension.
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 6
- No. of vessels per abiotic control (replicates): 1 (only in combined limit/range-finding test)
- Sludge concentration (weight of dry solids per volume): 3.0 g/L
- Nutrients provided for bacteria: Synthetic feed
- Performance of the test: The synthetic medium (= 16 mL sewage feed) and an appropriate amount of test item stock were mixed and made up to 250 mL with Milli-RO water (tap water purified by reverse osmosis). Then, 250 mL activated sludge was added and this was the start of the test.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO-medium was prepared with RO water (tap water purified by reverse osmosis)
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Other: The test vessels were constantly aerated and stirred during exposure.
EFFECT PARAMETERS MEASURED:
- Oxygen consumption: After 3 h contact time, the oxygen consumption was recorded for a period of approximately 10 min. During the measurement, the sample was not aerated but continuously sitrred on a magnetic stirrer.
- Oxygen recording: Oxygen measurements were performed with multiple oxygen sensors connected to a BlueBox (GO-Systemelektronik GmbH, Germany), a multi-channel measuring and controlling system.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study : Yes, a combined limit/range-finding test was performed, in which the highest concentration level was tested in triplicate and lower concentration levels only in 1 replicate.
- Test concentrations: 10, 100, and 1000 mg/L
- Results used to determine the conditions for the definitive study: Yes. No inhibition, 4% and 32% inhibition of the respiration rate was observed at 10, 100, and 1000 mg/L treatment levels, respectively. The EC50 was above the highest concentration tested (1000 mg/L). - Reference substance (positive control):
- yes
- Remarks:
- 3,5-Dichlorophenol
- 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
- Duration:
- 3 h
- Dose descriptor:
- EC10
- Effect conc.:
- 446 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks on result:
- other: 95% confidence interval: 263 - 561 mg/L
- Details on results:
- - Adsorption: None
- Blank controls oxygen uptake rate: The mean control oxygen uptake rate was 31 mg oxygen per one gram of activated sludge in the final test and thus was higher than the required 20 mg oxygen/g activated sludge (dw of suspended solids).
- Coefficient of variation of oxygen uptake rate in control replicates: The coefficient of variation of oxygen uptake in control replicates was 8% and thus did not exceed 30%. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50: 7.1 mg/L, 95% confidence interval: 3.9 - 10.3 mg/L - Reported statistics and error estimates:
- Data analysis was performed with ToxRat Professional v3.2.1 (ToxRat Solutions GmbH, Germany).
EC10 and EC20 values were based on Probit analysis using linear maximum likelihood regression, with the percentage of respiration inhibition versus the logarithms of the corresponding concentrations of the test item.
However, no EC50 values could be calculated for the test item because the effects were < 50% (EC50 > 1000 mg/L).
The NOEC was determined with a Williams Multiple Sequential t-test Procedure (alpha = 0.05, one-sided, smaller). An effect was considered significant if the statistical analysis of the data obtained for the test concentrations showed significant inhibition of the respiration rate compared to the control. - Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
Reference
VALIDITY CRITERIA
The study fulfilled the validity criteria of the guideline (Table 1) and is thus valid.
Table 1: Validity criteria for OECD 209.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The blank controls (without the test substance or reference substance) oxygen uptake rate should not be less than 20 mg oxygen per one gram of activated sludge (dry weight of suspended solids) in an hour. |
The mean oxygen uptake of the control was 31 mg oxygen per gram activated sludge. |
Yes |
The coefficient of variation of oxygen uptake rate in control replicates should not be more than 30% at the end of definitive test. |
The coefficient of variation of oxygen uptake in control replicates was 8%. |
Yes |
RESULTS
No statistically significant inhibition of the respiration rate of the sludge was recorded at a test item concentration of 320 mg/L. At higher concentrations, the inhibitory effect of the test item on aerobic waste water (activated sludge) bacteria increased with increasing concentration, resulting in 14% inhibition at 560 mg/L and 31% at 1000 mg/L (Table 2).
However, the inhibitory effect on aerobic waste water bacteria observed at 1000 mg/L was below 50%. Therefore, the NOEC was considered to be the highest concentration tested where no statistically significant effects were observed. The effect values are summarized in Table 3.
Table 2. Results of the final test.
Treatment |
Concentration [mg/L] |
Mean respiration rate |
mean % inhibition of the respiration rate |
|
[mg O2/L h] |
[mg O2/g h]1 |
|||
Control |
0 |
46.87 |
31.25 |
|
1 |
100 |
44.84 |
29.89 |
4.35 |
2 |
180 |
46.06 |
30.70 |
1.74 |
3 |
320 |
46.13 |
30.76 |
1.58 |
4 |
560 |
40.51 |
27.01* |
13.58 |
5 |
1000 |
32.40 |
21.60* |
30.87 |
1The amount of suspended solids in the final test mixture was 1.5 g/L.
* Statistically significantly different compared to control.
Table 3. Effect parameters of final test.
Parameter |
test item concentration [mg/L] |
NOEC |
320 |
EC10 |
446 (263 – 561 mg/L)* |
EC20 |
708 (563 – 846 mg/L)* |
EC50 |
> 1000 |
*The 95% confidence intervals are given in brackets.
Description of key information
No inhibition of STP microorganisms expected. EC50 (3 h) > 1000 mg/L.
Key value for chemical safety assessment
Additional information
One experimental study is available testing the toxicity of the substance to aquatic microorganisms. The study was conducted using activated sludge of a STP treating predominantly domestic sewage. The study procedure followed test guideline OECD 209 (GLP). The respiration of activated sludge in a control without test substance was compared to the oxygen consumed by the inoculum at test concentrations of 100, 180, 320, 560, and 1000 mg/L (nominal). The experimental duration was 3 hours. The determined EC50 (3 h) was > 1000 mg/L. Based on the results N-ethylcaprolactam is not expected to affect the degradation process in STPs.
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