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EC number: 834-970-9 | CAS number: 130111-95-4
- 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:
- supporting study
- Study period:
- 20-12-2018 to 21-12-2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- propan-2-yl 3-oxocyclobutane-1-carboxylate
- EC Number:
- 834-970-9
- Cas Number:
- 130111-95-4
- Molecular formula:
- C8H12O3
- IUPAC Name:
- propan-2-yl 3-oxocyclobutane-1-carboxylate
- Test material form:
- liquid
- Details on test material:
- Batch (Lot) Number: GR13224
Expiry date: 31 January 2020 (expiry date)
Physical Description: Colourless to pale yellow liquid
Purity/Composition: 99.6%
Storage Conditions: At room temperature
1
Sampling and analysis
- Analytical monitoring:
- no
Test solutions
- Vehicle:
- yes
- Remarks:
- milli-RO water
- Details on test solutions:
- The batch of PF-06238566 tested was a colourless to pale yellow liquid with a purity of
99.6%. No correction was made for the purity/composition of the test item.
The test item was not sufficiently soluble to allow preparation of an aqueous solution at a
concentration of 10 g/L. Therefore, aliquots of test item corresponding with the final test
concentration were pipetted directly into the amber test bottles containing 200 mL Milli-RO
water (tap water purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA). The
test item – Milli-RO water mixtures were magnetically stirred for a short period.
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 Table 1). Optimal contact
between the test item and test organisms was ensured by applying continuous aeration and
stirring. Any residual volumes were discarded.
Test organisms
- Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- Test system: Micro-organisms in activated sludge.
Source: Municipal sewage treatment plant: 'Waterschap Aa en Maas',
's-Hertogenbosch, The Netherlands, receiving predominantly
domestic sewage.
Preparation of the sludge:
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 of sludge, as used for the test). The pH was 7.2 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 RO-water (tap water
purified by reverse osmosis; GEON Waterbehandeling, BerkelEnschot,
TheNetherlands)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
Rationale: Recognized by international guidelines as the recommended
test system.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 3 h
Test conditions
- pH:
- The pH was within 7.5 ± 0.5.
- Details on test conditions:
- Test Procedure and Conditions
Contact time: 3 hours, during which aeration and stirring took place.
Vessels: All glass open bottles/vessels.
Milli-RO / Milli-RO water: Tap water purified by reverse osmosis (Millipore Corp., Bedford, Mass., USA).
Synthetic medium (=sewage feed):
16 g peptone
11 g meat extract
3 g urea
0.7 g NaCl
0.4 g CaCl2.2H2O
0.2 g MgSO4.7H2O
2.8 g K2HPO4
Dissolved in Milli-RO water, made up to 1 litre and filtered.
The pH was within 7.5 ± 0.5.
Air supply Clean, oil-free air.
Aeration 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.
Test set up See Table 1
Performance of the test:
The synthetic medium (= sewage feed, 16 mL) and an
appropriate amount of the test item stock were mixed and made
up to 250 mL with Milli-RO water. The pH was determined.
Thereafter, 250 mL activated sludge was added. This was the
start of the test.
After 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.
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.
Oxygen recording:
Determination of oxygen was performed with multiple oxygen
sensors connected to a BlueBox (GO-Systemelektronik GmbH,
Germany), a multichannel measuring and controlling system. - Reference substance (positive control):
- yes
- Remarks:
- 3,5-Dinitrophenol
Results and discussion
Effect concentrationsopen allclose all
- 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:
- 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 mean control oxygen uptake rate exceeded 20 mg oxygen per gram of activated
sludge (dry weight of suspended solids) per hour (21 mg oxygen per gram of activated
sludge).
The coefficient of variation of oxygen uptake in control replicates did not exceed 30%
at the end of the test (15%). - 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 (5.9 mg/L)
Any other information on results incl. tables
Experimental Conditions
The pH in all test vessels, before addition of sludge was 7.1. After the 3 hour exposure period
the pH was between 7.0 and 7.9.
The temperature continuously measured in the temperature control vessels ranged between
20.0 and 23.3°C during the test, and was outside the range prescribed by the study plan (20 ±
2°C).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of this present test PF-06238566 was not toxic to waste water bacteria
(activated sludge) at 1000 mg/L (NOEC).
The EC50 was above 1000 mg/L. - Executive summary:
The objective of the study was to evaluate PF-06238566 for its ability to adversely affect
aerobic microbial treatment plants and, if possible, to determine the no - observed effect
concentration (NOEC).
The influence of PF-06238566 on the respiration rate of activated sludge was investigated
after a contact time of 3 hours.
The study procedures described in this report were based on the OECD guideline No. 209,
2010.
The batch of PF-06238566 tested was a colourless to pale yellow liquid with a purity of
99.6%. No correction was made for the purity/composition of the test item.
The test item was not sufficiently soluble to allow preparation of an aqueous solution at a
concentration of 10 g/L. Therefore, aliquots of test item corresponding with the final test
concentration were pipetted directly into the test-bottles containing Milli-RO water. The test
item – Milli-RO water mixtures were magnetically stirred for a short period and subsequently,
synthetic medium, sludge and Milli-RO water were added resulting in the required
concentrations. Optimal contact between the test item and test medium was ensured by
applying continuous aeration and stirring during the 3 hour exposure period. Thereafter,
oxygen consumption was recorded for approximately 10 minutes.
In a combined limit/range-finding test concentrations of 10, 100 and 1000 mg/L were tested.
The highest concentration was tested in triplicate, lower concentrations consisted of one
replicate. Furthermore, at 1000 mg/L an abiotic control (1 replicate) was tested. Responses
were compared to the controls.
No statistically significant inhibition of the respiration rate of the sludge was recorded at a
concentration of 1000 mg PF-06238566 per litre. Therefore, the EC50 was above the highest
concentration tested (1000 mg/L).
There was no oxygen uptake from abiotic processes.
The batch of activated sludge was tested for sensitivity with the reference item
3,5-dichlorophenol, and showed normal sensitivity.
The study met the acceptability criteria prescribed by the study plan and was considered
valid.
Under the conditions of this present test PF-06238566 was not toxic to waste water (activated
sludge) bacteria at a concentration of 1000 mg/L (NOEC).
The EC50 was above 1000 mg/L.
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