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EC number: 950-484-0 | 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
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 09-01-2019 to 15-02-2019
- 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:
- yes
- Remarks:
- None of the deviations were considered to have impacted the overall integrity of the study or the interpretation of the study results and conclusions.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- isopropyl (1s,3s)-3-(methylamino)cyclobutane-1-carboxylate succinate
- EC Number:
- 950-484-0
- Molecular formula:
- C9H17NO2*C4H6O4
- IUPAC Name:
- isopropyl (1s,3s)-3-(methylamino)cyclobutane-1-carboxylate succinate
- Test material form:
- solid
- Details on test material:
- Batch (Lot) Number: GR13335
Expiry date: 31 January 2020 (expiry date)
Physical Description: White solid
Purity/Composition: 97.1%
Storage Conditions: At room temperature
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- The batch of PF-07097547-24 tested was a white solid with a purity of 97.1%. No correction
was made for the purity/composition of the test item.
A stock solution of 10 g/L was prepared by adding the test item into Milli-RO water (tap
water purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA).
Test organisms
- Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- The batch of PF-07097547-24 tested was a white solid with a purity of 97.1%. No correction
was made for the purity/composition of the test item.
A stock solution of 10 g/L was prepared by adding the test item into Milli-RO water (tap
water purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA).
Study design
- Test type:
- static
- Water media type:
- freshwater
- Total exposure duration:
- 3 h
- Post exposure observation period:
- 10 minutes
Test conditions
- Test temperature:
- 19.2-22.5 C
- pH:
- 5.1 to 7.6 before sludge addition; 7.8 to 8.4 following 3 hours exposure
- Dissolved oxygen:
- 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. - Salinity:
- N/A
- Conductivity:
- N/A
- Nominal and measured concentrations:
- Nominal concentrations: 100, 180, 320, 560 and 1000 mg/L
- Details on test conditions:
- see below
- Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol
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 (23 mg oxygen per gram of activated
sludge per hour, in the final test).
The coefficient of variation of oxygen uptake in control replicates did not exceed 30%
at the end of the definitive test (6%). - 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 (7.9 mg/L in the final test) - Reported statistics and error estimates:
- ECx
For the reference item, calculation of the EC50 value was based on a 3-parameter logistic
cumulative distribution function (CDF) using non-linear regression analysis, with the
percentages of respiration inhibition versus the logarithms of the corresponding
concentrations of the reference item.
For PF-07097547-24, no EC50 value could be calculated because the test item proved to be
non-toxic (EC50 > 1000 mg/L).
NOEC determination
An effect was considered to be significant if statistical analysis of the data obtained for the
test concentrations compared with those obtained in the control revealed significant inhibition
of the respiration rate (Williams Multiple Sequential t-test Procedure, α=0.05, one-sided,
smaller).
Calculations were performed with ToxRat Professional v. 3.2.1 (ToxRat Solutions® GmbH, Germany).
Any other information on results incl. tables
Combined Limit/Range-Finding Test
The combined limit/range-finding showed 12%, 8% and 29% inhibition of the respiration rate
at a concentration of 10, 100 and 1000 mg/L, respectively. Therefore, the expected EC50
was above a concentration of 1000 mg/L. Since the effect observed at 1000 mg/L was statistically
significant a final test was performed to determine the NOEC.
There was an oxygen release of 3% from abiotic processes. Since this value was considered to
be unreliable, a second abiotic control was performed . The second abiotic control showed no significant oxygen release or uptake from abiotic processes.
The temperature continuously measured in the temperature control vessels ranged between
20.2 and 23.0°C during the test, and was slightly outside the range prescribed by the Study
Plan (20 ± 2°C).
Except for the temperature, all test conditions and acceptability criteria prescribed by the
Study Plan were met.
Final Test
Inhibition of the Respiration Rate
The effects observed were lower then what was expected based on the results of the combined
limit/range-finding test. The results of final test allowed for reliable determination of a NOEC
and ECx values.
No statistical significant inhibition of the respiration rate was observed at any of the tested
concentrations . Therefore, the NOEC was considered to be the highest concentration tested.
mean respiration rate | ||||
treatment | concentration mg/L | mg O2/L h | mg O2/g h (1) | % inhibition of the respiration rate (mean) |
control | 0 | 35.11 | 23.40 | |
T1 | 100 | 32.81 | 21.87 | 6.55 |
T2 | 180 | 37.45 | 24.97 | -6.69 |
T3 | 320 | 35.35 | 23.57 | -0.7 |
T4 | 560 | 38.74 | 25.83 | -10.35 |
T5 | 1000 | 36.56 | 24.37 | -4.13 |
1) The amount of suspended solids in the final test mixture was 1.5 g/L.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In conclusion, under the conditions of the present test PF-07097547-24 was not toxic to waste
water bacteria (activated sludge) at or below a concentration of 1000 mg/L (NOEC).
The EC50 was above 1000 mg/L - Executive summary:
The objective of the study was to evaluate PF-07097547-24 for its ability to adversely affect
aerobic microbial treatment plants and, if possible, to determine the EC50
and/or the no - observed effect concentration (NOEC).
The influence of PF-07097547-24 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-07097547-24 tested was a white solid with a purity of 97.1%. No correction
was made for the purity/composition of the test item.
The test started with the preparation of a stock solution of 10 g/L. Volumes of the clear and
colourless stock solution corresponding to the test concentration were then added to the test
media. 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.
The final test was performed based on the result of a preceding combined limit/range-finding
test. Five concentrations were tested, ranging from 100 to 1000 mg/L and increasing with a
factor 1.8. Five replicates per concentration and seven replicates for an untreated control
group were tested.
No inhibition of the respiration rate was observed at any of the tested concentrations.
Therefore, the NOEC was considered to be the highest concentration tested.
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.
PF-07097547-24 was not toxic to waste water (activated sludge) bacteria at a concentration of
1000 mg/L (NOEC). The EC50 is >1000 mg/L
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