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EC number: 939-017-1 | CAS number: 1469982-94-2
- 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
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Starting Date: 23 May 2012 Experimental Completion Date: 24 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols/ Current OECD Guidelines and to GLP standards, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Isostearamide DEA
- IUPAC Name:
- Isostearamide DEA
- Test material form:
- other: amber coloured liquid
- Details on test material:
- The integrity of the supplied data relating to the identity, purity and stability of the test item is the responsibility of the Sponsor.
Identification: Isostearamide DEA
Description: amber coloured liquid
Batch: OE11124 (6/202593/00)
Expiry / retest date: not given
Storage conditions: room temperature in the dark
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
- Details on sampling:
- Amounts of test item (5, 50 and 500 mg (in triplicate)) were each separately dispersed in approximately 200 mL of deionized reverse osmosis water and subjected to ultrasonication for approximately 15 minutes followed by magnetic stirring for 24 hours in order to maximize the dissolved test
item concentration. All test vessels were shielded from the light during mixing. Synthetic sewage (16 mL), activated sewage sludge (250 mL) and
water were added to a final volume of 500 mL to give the required concentrations of 10, 100 and 1000 mg/L (3 replicates).
The pH of the test item dispersions was measured after stirring using a WTW pH/Oxi 340I pH and dissolved oxygen meter (see attached Table 1) and adjusted to between pH 7.0 and 8.0 if necessary.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Test Species
A mixed population of activated sewage sludge micro-organisms was obtained on 23 May 2012 from the aeration stage of the Severn Trent Water Plc sewage treatment plant at Loughborough, Leicestershire, UK which treats predominantly domestic sewage.
Preparation of Test System
At time "0" 16 mL of synthetic sewage was diluted to 250 mL with water and 250 mL of inoculum added in a 500 mL conical flask (first control). The
mixture was aerated with clean, oil-free compressed air via narrow bore glass tubes at a rate of approximately 0.5 – 1 liter per minute. Thereafter, at 15 minute intervals the procedure was repeated for the second control followed by the reference item vessels with appropriate amounts of the
reference item being added. The test item vessels were prepared as described in Section 3.5.1. Finally two further control vessels were prepared.
As each vessel reached 3 hours contact time an aliquot was removed from the conical flask and poured into the measuring vessel (250 mL darkened glass Biological Oxygen Demand (BOD) bottle) and the rate of respiration measured using a Yellow Springs dissolved oxygen meter fitted with a BOD probe. The contents of the measuring vessel were stirred constantly by magnetic stirrer. The rate of respiration for each flask was measured over
the linear portion of the oxygen consumption trace (where possible between approximately 7.0 mg O2/L and 2.0 mg O2/L). In the case of a rapid
oxygen consumption, measurements may have been outside this range but the oxygen consumption was always within the linear portion of the
respiration curve. In the case of low oxygen consumption, the rate was determined over an approximate 10 minute period.
The test was conducted under normal laboratory lighting in a temperature controlled room at 20±2 ºC.
Test organisms
- Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- Preparation of Inoculum
The activated sewage sludge sample was maintained on continuous aeration in the laboratory at a temperature of approximately 21 ºC overnight
prior to use in the test. On the day of collection the activated sewage sludge (10 liters) was fed synthetic sewage sludge (450 mL). The pH of the
sample on the day of the test was 7.8 measured using a WTW pH/Oxi 340I pH and dissolved oxygen meter. Determination of the suspended solids
level of the activated sewage sludge was carried out by filtering a sample (100 mL) of the activated sewage sludge by suction through a pre-weighed GF/A filter paper* using a Buchner funnel which was then rinsed 3 times with 10 mL of deionized reverse osmosis water and filtration continued for
3 minutes. The filter paper was then dried in an oven at approximately 105 ºC for at least one hour and allowed to cool before weighing.
This process was repeated until a constant weight was attained. The suspended solids concentration was equal to 3.0 g/L prior to use.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- Post exposure observation period:
- Not applicable.
Test conditions
- Hardness:
- Test Water
The test water used for the test was deionized reverse osmosis water containing less than 1 mg/L Dissolved Organic Carbon (DOC). - Test temperature:
- The test was conducted under normal laboratory lighting in a temperature controlled room at 20±2 ºC.
- pH:
- The pH of the synthetic sewage stock used to feed the activated sewage sludge was pH 7.0 and the pH of the synthetic sewage stock used for the test was
pH 6.8 and adjusted to 7.0 using 1.0 M NaOH. The pH values were measured using a WTW pH/Oxi 340I pH and dissolved oxygen meter.
The pH values of the test preparations at the start and end of the exposure period are given in the attached Table 4 - Dissolved oxygen:
- The dissolved oxygen concentrations in all vessels after 30 minutes contact time are given in the attached Table 2. Oxygen consumption rates and
percentage inhibition values for the control, test and reference items are given in the attached Table 3. - Salinity:
- Freshwater used
- Nominal and measured concentrations:
- Synthetic sewage (16 mL), activated sewage sludge (250 mL) and water were added to a final volume of 500 mL to give the required concentrations of 10, 100 and 1000 mg/L (3 replicates).
- Details on test conditions:
- Preparation of Test System
At time "0" 16 mL of synthetic sewage was diluted to 250 mL with water and 250 mL of inoculum added in a 500 mL conical flask (first control). The
mixture was aerated with clean, oil-free compressed air via narrow bore glass tubes at a rate of approximately 0.5 – 1 liter per minute. Thereafter, at 15 minute intervals the procedure was repeated for the second control followed by the reference item vessels with appropriate amounts of the
reference item being added. Finally two further control vessels were prepared. - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 3 h
- Dose descriptor:
- other: EC20
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- 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
- Remarks:
- respiration rate
- Duration:
- 3 h
- Dose descriptor:
- other: EC80
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- 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
- Remarks:
- respiration rate
- Duration:
- 3 h
- Dose descriptor:
- other: EC20
- Effect conc.:
- 4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: Reference item: 3,5-dichlorophenol
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- 11 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: Reference item: 3,5-dichlorophenol
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Remarks on result:
- other: 8.7 - 14 95% confidence limits (mg/L)
- Duration:
- 3 h
- Dose descriptor:
- other: EC80
- Effect conc.:
- 31 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: Reference item: 3,5-dichlorophenol
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Details on results:
- RESULTS
Range-Finding Test
The dissolved oxygen concentrations in all vessels after 30 minutes contact time are given in Table 2. Oxygen consumption rates and percentage
inhibition values for the control, test and reference items are given in Table 3. The pH values of the test preparations at the start and end of the
exposure period are given in Table 4. Observations made on the test preparations throughout the study are given in Table 5.
No statistically significant toxic effects were shown at all of the test concentrations employed. It was therefore considered justifiable not to perform a definitive test.
Percentage inhibition is plotted against concentration for the reference item, 3,5 dichlorophenol (see attached Figure 1).
The following results were derived:
Test Item 3,5-dichlorophenol
ECx (3 Hours)(mg/L) 95% Confidence Limits (mg/L) ECx (3 Hours)(mg/L) 95% Confidence Limits (mg/L)
EC20 >1000 - 4.0 -
EC50 >1000 - 11 8.7-14
EC80 >1000 - 31 -
NOEC 1000 - - -
It was considered unnecessary and unrealistic to test at concentrations in excess of 1000 mg/L.
Validation Criteria
The coefficient of variation of oxygen uptake in the control vessels was 1.8% and the specific respiration rate of the controls was 26.60 mg oxygen
per gram dry weight of sludge per hour at the end of the test. The EC50 for the 3,5-dichlorophenol was between 2 mg/L and 25 mg/L.
The validation criteria have therefore been satisfied.
In some instances, the initial and final dissolved oxygen concentrations were outside those recommended in the test guidelines (7.0 mg O2/L and
2.0 mg O2/L respectively). This was considered to have had no adverse effect on the results of the study given that in all cases the oxygen
consumption rate was determined over the linear portion of the oxygen consumption trace.
The dissolved oxygen concentrations after 30 minutes contact time in all vessels were above 60 to 70% of the dissolved oxygen saturation level of
8.9 mg O2/L with the exception of Control replicate 1 which showed 47% saturation and the 10 mg/L, 100 mg/L, and 1000 mg/L R1 test item vessels showing between 45% to 57% saturation. This deviation was considered to have had no adverse effect on the study given that all oxygen
consumption values were measured/calculated over the linear portion of the traces. - Results with reference substance (positive control):
- None
- Reported statistics and error estimates:
- None
Any other information on results incl. tables
Tables
Table 1 pH Values of the Test Item Preparations after Stirring and Prior to the Addition of Inoculum in the Range-Finding Test
Nominal |
pH* |
||
Prior to Adjustment |
After Adjustment |
||
Test Item |
10 |
7.4 |
- |
|
100 |
6.8 |
8.0 |
|
1000 R1 |
6.9 |
7.4 |
|
1000 R2 |
6.9 |
7.3 |
|
1000 R3 |
6.9 |
7.4 |
* Measured using a WTW pH/Oxi 340I pH and dissolved oxygen meter
R1– R3= Replicates 1 to 3
- no adjustment required
Table 2 Dissolved Oxygen Concentrations of the Test Preparations after 30 Minutes Contact Time in the Range-Finding Test
Nominal |
Dissolved Oxygen Concentration |
|
Control |
R1 |
4.2 |
|
R2 |
5.6 |
|
R3 |
5.4 |
|
R4 |
6.0 |
Test Item |
10 |
4.7 |
|
100 |
4.0 |
|
1000 R1 |
5.1 |
|
1000 R2 |
5.6 |
|
1000 R3 |
5.5 |
3,5-dichlorophenol |
3.2 |
6.5 |
|
10 |
7.4 |
|
32 |
8.4 |
*Measured using a WTW pH/Oxi 340I pH and dissolved oxygen meter
R1– R4= Replicates 1 to 4
Table 3 Oxygen Consumption Rates and Percentage Inhibition Values after 3 Hours Contact Time in the Range-Finding Test
Nominal |
Initial O2 |
Measurement Period |
Final O2Reading |
O2Consumption Rates |
% |
|
Control |
R1 |
4.7 |
4 |
2.0 |
40.50 |
- |
|
R2 |
4.8 |
4 |
2.2 |
39.00 |
- |
|
R3 |
4.8 |
5 |
1.5 |
39.60 |
- |
|
R4 |
4.7 |
4 |
2.0 |
40.50 |
- |
Test Item |
10 |
5.3 |
5 |
2.0 |
39.60 |
1 |
|
100 |
4.5 |
4 |
1.8 |
40.50 |
[2] |
|
1000 R1 |
4.5 |
5 |
1.6 |
34.80 |
13 |
|
1000 R2 |
3.5 |
2 |
2.1 |
42.00 |
[5] |
|
1000 R3 |
5.2 |
4 |
2.6 |
39.00 |
2 |
3,5-dichlorophenol |
3.2 |
6.0 |
7 |
1.9 |
35.14 |
12 |
|
10 |
7.3 |
10 |
4.0 |
19.80 |
50 |
|
32 |
7.9 |
10 |
6.5 |
8.40 |
79 |
[Increase in respiration rate as compared to controls]
R1– R4= Replicates 1 to 4
Table 4 pH Values of the Test Preparations at the Start and End of the Exposure Period in the Range-finding Test
Nominal |
pH |
||
0 Hours |
3 Hours |
||
Control |
R1 |
7.6 |
7.5 |
|
R2 |
7.6 |
7.7 |
|
R3 |
7.4 |
7.7 |
|
R4 |
7.4 |
7.6 |
Test Item |
10 |
7.1 |
7.8 |
|
100 |
7.3 |
7.8 |
|
1000 R1 |
7.3 |
7.8 |
|
1000 R2 |
7.4 |
7.8 |
|
1000 R3 |
7.4 |
7.8 |
3,5-dichlorophenol |
3.2 |
7.6 |
7.7 |
|
10 |
7.6 |
7.8 |
|
32 |
7.6 |
7.9 |
R1– R4= Replicates 1 to 4
Table 5 Observations on the Test Preparations throughout the Test Period in the Range-Finding Test
Nominal Concentration (mg/L) |
Observations on Test Preparations |
|||
0 Hours* |
30 Minutes Contact Time |
3 Hours Contact Time |
||
Control |
R1 |
Pale yellow/brown dispersion |
Dark brown dispersion |
Dark brown dispersion |
|
R2 |
Pale yellow/brown dispersion |
Dark brown dispersion |
Dark brown dispersion |
|
R3 |
Pale yellow/brown dispersion |
Dark brown dispersion |
Dark brown dispersion |
|
R4 |
Pale yellow/brown dispersion |
Dark brown dispersion |
Dark brown dispersion |
Test Item |
10 |
Pale yellow/brown dispersion, no undissolved test item visible |
Dark brown dispersion, no undissolved test item visible |
Dark brown dispersion, no undissolved test item visible |
|
100 |
Pale yellow/brown dispersion, no undissolved test item visible |
Dark brown dispersion, no undissolved test item visible |
Dark brown dispersion, no undissolved test item visible |
|
1000 R1 |
Pale yellow/brown dispersion, few small globules of test item on surface |
Dark brown dispersion, few small globules of test item on surface |
Dark brown dispersion, few small globules of test item on surface |
|
1000 R2 |
Pale yellow/brown dispersion, few small globules of test item on surface |
Dark brown dispersion, few small globules of test item on surface |
Dark brown dispersion, few small globules of test item on surface |
|
1000 R3 |
Pale yellow/brown dispersion, few small globules of test item on surface |
Dark brown dispersion, few small globules of test item on surface |
Dark brown dispersion, few small globules of test item on surface |
3,5-dichlorophenol |
3.2 |
Pale yellow/brown dispersion, no undissolved reference item visible |
Dark brown dispersion, no undissolved reference item visible |
Dark brown dispersion, no undissolved reference item visible |
|
10 |
Pale yellow/brown dispersion, no undissolved reference item visible |
Dark brown dispersion, no undissolved reference item visible |
Dark brown dispersion, no undissolved reference item visible |
|
32 |
Pale yellow/brown dispersion, no undissolved reference item visible |
Dark brown dispersion, no undissolved reference item visible |
Dark brown dispersion, no undissolved reference item visible |
*Observations made prior to the addition of activated sewage sludge
R1– R4= Replicates 1 to 4
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The effect of the test item on the respiration of activated sewage sludge micro-organisms gave a 3-Hour EC50 value of greater than 1000 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 1000 mg/L.
- Executive summary:
Introduction
A study was performed to assess the effect of the test item on the respiration of activated sewage sludge. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2010) No. 209 "Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation) ".
Methods
Activated sewage sludge was exposed to an aqueous dispersion of the test item at concentrations of 10, 100 and 1000 mg/L
(3 replicates of the 1000 mg/L test concentration) for a period of 3 hours at a temperature of 20 ± 2°C with the addition of a synthetic sewage as a respiratory substrate.
The rate of respiration was determined after 3 hours contact time and compared to data for the control and a reference item,
3,5-dichlorophenol.
Results
The effect of the test item on the respiration of activated sewage sludge gave a 3‑Hour EC50value of greater than 1000 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was1000mg/L.
It was considered unnecessary and unrealistic to test at concentrations in excess of 1000 mg/L.
The reference item gave a 3-Hour EC50value of 11 mg/L, 95% confidence limits 8.7 - 14 mg/L.
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