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EC number: 814-233-8 | CAS number: 444649-70-1
- 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:
- From July 12, 2016 to July 19, 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation))
- Deviations:
- yes
- Remarks:
- but uncritical or assessed
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.11 (Biodegradation: Activated Sludge Respiration Inhibition Test)
- Deviations:
- yes
- Remarks:
- but uncritical or assessed
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch no.: JBGJ0045R
Purity: 100% (UVCB)
Appearance: clear yellowish liquid - Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- The sludge was taken from the activation basin of the ESN (Stadtentsorgung Neustadt) sewage treatment plant in D-67435 NW-Lachen-Speyerdorf. Upon arrival in the test facility, the sludge was filtrated, washed with tap water 3 times and re-suspended in tap water. The activated sludge was aerated until usage in the test and fed daily with 50 mL synthetic sewage feed /L.
First experiment. The dry matter was determined as 2.9g suspended solids/L, giving a concentration of 1.45g suspended solids/L in the test.
Second experiment. The dry matter of the inoculum was determined as 2.96 g suspended solids/L, giving a concentration of 1.48g suspended solids/L in the test. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- Hardness:
- -
- Test temperature:
- 20.7 - 22.2°C
- pH:
- 7.5 ± 0.5
- Dissolved oxygen:
- -
- Salinity:
- -
- Conductivity:
- -
- Nominal and measured concentrations:
- 1000, 320, 100, 32, 10 and 1 mg/L nominal concentration
- Details on test conditions:
- cfr "Any other information on materials and methods incl. tables"
- Reference substance (positive control):
- yes
- Remarks:
- 3,5-Dichlorophenol
- Key result
- Duration:
- 3 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 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.:
- 54 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Key result
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1 500 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks on result:
- other: extrapolated
- Details on results:
- - For evaluation of the results the nominal concentrations were used because the difference between real concentration and nominal concentration can be stated as not significant.
- Two valid experiments were performed. In the first experiment (pre-test) the test substance was tested using 4 concentrations: 1000, 100, 10 and 1 mg/L nominal concentration. Because significant inhibition was observed, one additional experiment was performed under the same test conditions. In the second experiment (main test) the test substance was tested using 5 concentrations: 1000, 320, 100, 32 and 10 mg/L nominal concentration. Significant inhibition was observed at all concentration with the exception of the lowest concentrated treatment. EC50 lies outside the tested range of concentrations and was extrapolated using linear regression. In some replicates oxygen concentration in the test solution at the beginning of oxygen measurement was unexpected low. Therefore the measurement period was partly less than 5 minutes. Because linearity of all regression curves was given and the correlation of the inhibition values within the test replicates was very good, this can be stated as uncritical. Inhibition at concentration 1000 mg/L in the pre-test was slightly lower than inhibition at the same concentration in the main test. The apparent difference between the experiments was related to the used sludge. Taking into account the results of the positive control (higher EC50 in the first experiment), the sludge which was used in the first experiment may have been slightly less sensitive than the sludge which was used in the second experiment. Nevertheless, the differences in the inhibition values and oxygen uptake rates in the control replicates were within the normal range of a biological system. All validity criteria were met. For the estimation of the EC50 of the positive control, the fits showed good statistical correspondence of the data with the dose-response-equation. The positive control gave an EC50 of 9.3 mg/L (first experiment) and 8.5 mg/L (second experiment) which lie within the recommended range of 2 – 25 mg/L. The coefficient of variation of oxygen uptake rate in control replicates was below 30% at the end of the test. The oxygen uptake rate of the blank controls was above 20 mg O2 per gram activated sludge in 1 hour. No observations were made which might cause doubts concerning the validity of the study outcome. The result of the test can be considered valid.
Based on the results, the values for the test substance were determined: :
3 h NOEC: 10 mg/L
3 h EC10: 54 mg/L
3 h EC50: 1500 mg/L (extrapolated) - Results with reference substance (positive control):
- The positive control gave an EC50 of 9.3 mg/L (first experiment) and 8.5 mg/L (second experiment) which lie within the recommended range of 2 – 25 mg/L.
- Reported statistics and error estimates:
- - Statistical determination of the NOEC and LOEC:
For the treatments with the test substance concentrations 32 and 10 mg/L, it was tested whether the differences between treatment and control were significant. For this determination, the values of the O2 consumption were used. In order to select a suitable test for significance, it was checked whether equality of variance was given. The difference between treatment 10 mg/L and the control can be considered as not significant as the calculated t-value lay below the significance level and O2 consumption in the treatment was higher than in the control. Therefore, the concentration 10 mg/L was stated as NOEC. As the difference between treatment 32 mg/L and the control can be considered as significant because the calculated t-value lay above the significance level, the concentration 32 mg/L was stated as LOEC.
- EC50 lies outside the tested range of concentrations and was extrapolated using linear regression. As good correlation of the tested concentrations was observed (r2 = 0.874), and EC50 lies above 1000 mg/L, this was considered as uncritical. For the calculation of the EC10 and EC50, the percentage inhibition was plotted versus concentration in a Gauß-logarithmic diagram. EC10 and EC50 were determined from the x-values of the regression line at y = 10% and y = 50%. - Validity criteria fulfilled:
- yes
- Conclusions:
- Under the study conditions, the 3 h NOEC, EC10 and EC50 values were determined to be at 10, 54 and 1500 mg/L (extrapolated using linear regression) (respiration inhibition test).
- Executive summary:
A study was conducted to determine the toxicity of the test substance to microorganisms according to OECD Guideline 209 and EU Method C.11 (respiration inhibition test), in compliance with GLP. In a preliminary test, non-adapted activated sludge was exposed to the test substance at 4 nominal concentrations: 0, 1, 10, 100 and 1000 mg/L for 3 h. Because of significant inhibition at all the tested concentrations, the main test was conducted with the test substance at 5 nominal concentrations: 0, 10, 32, 100, 320 and 1000 mg/L under similar test conditions. In addition, two controls and three different concentrations of the reference substance 3,5-dichlorophenol (5, 16 and 50 mg/L) were tested. The respiration rate (oxygen consumption) of the aerobic activated sludges fed with a standard amount of synthetic wastewater was measured. The inhibitory effect of the test substance at the particular concentrations was expressed as a percentage of the mean respiration rate of the controls. Significant inhibition was observed at all concentrations with the exception of the lowest tested concentration. Exposure to the highest tested concentration lead to about 42% inhibition. Therefore, the EC50 was considered to lie outside the tested range of concentrations and was extrapolated using linear regression. In some replicates oxygen concentration in the test solution at the beginning of oxygen measurement was unexpected low. Therefore the measurement period was partly less than 5 minutes. Because linearity of all regression curves was given and the correlation of the inhibition values within the test replicates was very good, this can be stated as uncritical. Inhibition at concentration 1000 mg/L in the pre-test was slightly lower than inhibition at the same concentration in the main test. The apparent difference between the experiments was related to the used sludge. Taking into account the results of the positive control (higher EC50 in the first experiment), the sludge which was used in the first experiment may have been slightly less sensitive than the sludge which was used in the second experiment. Nevertheless, the differences in the inhibition values and oxygen uptake rates in the control replicates were within the normal range of a biological system. All validity criteria were met. For the estimation of the EC50 of the positive control, the fits showed good statistical correspondence of the data with the dose-response-equation. The positive control gave an EC50 of 9.3 mg/L (first experiment) and 8.5 mg/L (second experiment) which lie within the recommended range of 2 – 25 mg/L. The coefficient of variation of oxygen uptake rate in control replicates was below 30% at the end of the test. The oxygen uptake rate of the blank controls was above 20 mg O2 per gram activated sludge in 1 h. No observations were made which might cause doubts concerning the validity of the study outcome. Therefore, results of the test can be considered valid. The results of the nominal concentrations were used because the difference between real and and nominal concentration were considered not significant. Under the study conditions, the 3 h NOEC, EC10 and EC50 values were determined to be at 10, 54 and 1500 mg/L (extrapolated using linear regression) (Muckle, 2016).
Reference
Deviations from the Study Plan
The following deviations from the study plan were recorded:
- The temperature in the first experiment was in a range of 21.2 – 22.2 °C instead of 20.0 ± 2.0 °C. This deviation was stated as uncritical, as normal respiration activity of the control
could be observed.
- The measurement period was partly less than 5 minutes. Because linearity of all regression curves was given and the correlation of the inhibition values within the test replicates was good, this was stated as uncritical.
- The test item was stored from the date of receipt to last usage for the study at 20 ± 5 °C except of 8 h at 25.8 °C. This is uncritical as the test item was stored only for 8 h above 25 °C. It is assumed that this marginal deviation has no impact on the test item.
Deviations from the Guideline
The following deviations from the guideline were recorded:
- The temperature in the first experiment was in a range of 21.2 – 22.2 °C instead of 20.0 ± 2.0 °C. This deviation was stated as uncritical, as normal respiration activity of the control
could be observed.
- The measurement period was partly less than 5 minutes. Because linearity of all regression curves was given and the correlation of the inhibition values within the test replicates was good, this was stated as uncritical.
Description of key information
The 3 h EC50 and EC10 values were determined to be 1500 and 54 mg/L (nominal) respectively.
Key value for chemical safety assessment
- EC50 for microorganisms:
- 1 500 mg/L
- EC10 or NOEC for microorganisms:
- 54 mg/L
Additional information
A study was conducted to determine the toxicity of the test substance to microorganisms according to OECD Guideline 209 and EU Method C.11 (respiration inhibition test), in compliance with GLP. In a preliminary test, non-adapted activated sludge was exposed to the test substance at 4 nominal concentrations: 0, 1, 10, 100 and 1000 mg/L for 3 h. Because of significant inhibition at all the tested concentrations, the main test was conducted with the test substance at 5 nominal concentrations: 0, 10, 32, 100, 320 and 1000 mg/L under similar test conditions. In addition, two controls and three different concentrations of the reference substance 3,5-dichlorophenol (5, 16 and 50 mg/L) were tested. The respiration rate (oxygen consumption) of the aerobic activated sludges fed with a standard amount of synthetic wastewater was measured. The inhibitory effect of the test substance at the particular concentrations was expressed as a percentage of the mean respiration rate of the controls. Significant inhibition was observed at all concentrations with the exception of the lowest tested concentration. Exposure to the highest tested concentration lead to about 42% inhibition. Therefore, the EC50 was considered to lie outside the tested range of concentrations and was extrapolated using linear regression. In some replicates oxygen concentration in the test solution at the beginning of oxygen measurement was unexpected low. Therefore the measurement period was partly less than 5 minutes. Because linearity of all regression curves was given and the correlation of the inhibition values within the test replicates was very good, this can be stated as uncritical. Inhibition at concentration 1000 mg/L in the pre-test was slightly lower than inhibition at the same concentration in the main test. The apparent difference between the experiments was related to the used sludge. Taking into account the results of the positive control (higher EC50 in the first experiment), the sludge which was used in the first experiment may have been slightly less sensitive than the sludge which was used in the second experiment. Nevertheless, the differences in the inhibition values and oxygen uptake rates in the control replicates were within the normal range of a biological system. All validity criteria were met. For the estimation of the EC50 of the positive control, the fits showed good statistical correspondence of the data with the dose-response-equation. The positive control gave an EC50 of 9.3 mg/L (first experiment) and 8.5 mg/L (second experiment) which lie within the recommended range of 2 – 25 mg/L. The coefficient of variation of oxygen uptake rate in control replicates was below 30% at the end of the test. The oxygen uptake rate of the blank controls was above 20 mg O2 per gram activated sludge in 1 h. No observations were made which might cause doubts concerning the validity of the study outcome. Therefore, results of the test can be considered valid. The results of the nominal concentrations were used because the difference between real and and nominal concentration were considered not significant. Under the study conditions, the 3 h NOEC, EC10 and EC50 values were determined to be at 10, 54 and 1500 mg/L (extrapolated using linear regression) (Muckle, 2016).
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