Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 951-622-2 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
Toxicity to microorganisms
Administrative data
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 Jan 2019 to 05 Feb 2019
- Reliability:
- 1 (reliable without restriction)
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:
- cis-N-hydroxy-3-[methyl(1H-pyrrolo[2,3-d]pyrimidin- 4-yl)amino]cyclobutanecarboxamide
- EC Number:
- 951-622-2
- Molecular formula:
- C12H15N5O2
- IUPAC Name:
- cis-N-hydroxy-3-[methyl(1H-pyrrolo[2,3-d]pyrimidin- 4-yl)amino]cyclobutanecarboxamide
Constituent 1
- Specific details on test material used for the study:
- Batch (Lot) Number: GR13449
Expiry date: 29 February 2020
Physical Description: White solid
Purity/Composition: 100%
Storage Conditions: At room temperature
Sampling and analysis
- Analytical monitoring:
- not specified
Test solutions
- Vehicle:
- yes
- Remarks:
- Purified tap water
- Details on test solutions:
- The test item was not sufficiently soluble to allow preparation of an aqueous solution at a concentration of 10 g/L. Therefore, weighed amounts were added to the amber coloured 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. Optimal contact between the test item and test organisms was ensured by applying continuous aeration and stirring.
Test organisms
- Test organisms (species):
- activated sludge, domestic
- Details on inoculum:
- Municipal sewage treatment plant: 'Waterschap Aa en Maas','s -Hertogenbosch, Heeswijk-Dinther, The Netherlands, receiving predominantly domestic sewage. 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 (3.0 g/L, as used for the test). The pH was 6.7 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.
Study design
- Test type:
- static
- Water media type:
- other: Adjusted ISO-medium, formulated using RO water (tap water purified by reverse osmosis; GEON Waterbehandeling, BerkelEnschot, The Netherlands) with the following composition: CaCl2.2H2O 211.5 mg/L MgSO4.7H2O 88.8mg/L NaHCO3 46.7 mg/L KCl 4.2 mg/L
- Limit test:
- no
- Total exposure duration:
- 3 h
Test conditions
- Test temperature:
- Between 20 and 23.3°C
- pH:
- 7.2 on the day of testing
- Nominal and measured concentrations:
- Final test Five concentrations: 100, 180, 320, 560 and 1000 mg/L
- Reference substance (positive control):
- yes
Results and discussion
Effect concentrationsopen allclose all
- Key result
- 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
- Key result
- 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
Any other information on results incl. tables
Range finding test:
The combined limit/range-finding showed no inhibition of the respiration rate at 10 and 100 mg/L. A mean inhibition of the respiration rate of 16% was observed at 1000 mg/L.
Therefore, the expected EC50 was above 1000 mg/L. The inhibition of the respiration rate observed at 1000 mg/L was statistical significant. Therefor a full test was performed to determine the NOEC.
There was no oxygen uptake, but a slight oxygen release from abiotic processes.
Final Test:
The effects observed were slightly lower then what was expected based on the results of the combined limit/range-finding test. The results of this test allowed for reliable determination
of a NOEC and ECx values. 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 of 1000mg
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In conclusion, under the conditions of the present test PF-07085579 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-07085579 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-07085579 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-07085579 tested was a white solid with a purity of 100%. 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, weighed amounts were added to the test bottles containing Milli-RO water. The test item – Milli-RO water mixtures were magnetically stirred for a short period. 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.
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 six 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-07085579 was not toxic to waste water (activated sludge) bacteria at a concentration of 1000 mg/L (NOEC). The study met the acceptability criteria prescribed by the Study Plan and was considered valid. PF-07085579 was not toxic to waste water (activated sludge) bacteria at a concentration of 1000 mg/L (NOEC).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)