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EC number: 918-045-8 | 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:
- key study
- Study period:
- 2005-06-03 to 2005-12-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.11 (Biodegradation: Activated Sludge Respiration Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-4H-pyrazolo[4,3-d]pyrimidin-7-one;2-hydroxypropane-1,2,3-tricarboxylic acid
- Cas Number:
- 171599-83-0
- Molecular formula:
- C28H38N6O11S
- IUPAC Name:
- 5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-4H-pyrazolo[4,3-d]pyrimidin-7-one;2-hydroxypropane-1,2,3-tricarboxylic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch: November 1, 2005
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient
- Stability under test conditions: Stable
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The contents of the first control vessel were transferred to a BOD bottle and dissolved oxygen concentrations were measured every 10 seconds over a 10 minute period, or until dissolved oxygen concentrations fell below 1.0 mg/L, using a YSI Model 50B Dissolved Oxygen Meter. The respiration rate in subsequent vessels was determined in an identical manner at 15 minute intervals.
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct weight addition
- Controls: A positive control with a known respiration inhibitor was used.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Water
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)):
The reference group was dosed with 3,5-dichlorophenol, a known inhibitor of respiration, at concentrations of 3, 15 and 50 mg/L.
The test substance was tested at nominal concentrations of 1, 3, 10, 30, 100, 300, and 1000 mg/L.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): The test substance dissolved poorly in the water.
Test organisms
- Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- - Name and location of sewage treatment plant where inoculum was collected: Denton Wastewater Treatment Plant, Denton, Maryland on June 27, 2005.
- Preparation of inoculum for exposure: The sludge was sieved using a 2 mm screen and allowed to settle for approximately 30 minutes. The supernatant above the settled solids was removed.
- Pretreatment: Total suspended solids in the settled sludge were adjusted to by dilution with municipal water. 50 mL of synthetic sewage was added to each liter of adjusted sludge.
- Initial biomass concentration: A nominal concentration of approximately 4000 mg/L
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- Remarks on exposure duration:
- Control, reference, and treatment test mixtures were incubated at 20 ± 2ºC and aerated for three hours at a rate sufficient to provide aerobic conditions and maintain solids in suspension.
- Post exposure observation period:
- No post exposure observation period was conducted.
Test conditions
- Test temperature:
- 20 ± 2ºC
- pH:
- The measured initial pH of the sludge on the day of testing was 8.3 and was adjusted to 7.6 prior to use in the test system.
- Nominal and measured concentrations:
- Nominal concentrations:
- Concentration of Inncoulum: 4000 mg/L
- Concentrations of Positive Control: 3, 15 and 50 mg/L
- Concentrations of Test Substance: 1, 3, 10, 30, 100, 300, and 1000 mg/L
Measured concentrations:
- Concentration of Inncoulum: 4393 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 500 ml plastic Erlenmeyer flask
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 300 mL was filed
- Aeration: Yes, at a rate sufficient to provide aerobic conditions and maintain solids in suspension.
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 2
- Sludge concentration (weight of dry solids per volume): 4393 mg/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Municipal water
OTHER TEST CONDITIONS
- Adjustment of pH: The measured initial pH of the sludge on the day of testing was 8.3 and was adjusted to 7.6 prior to use in the test system
- Details on termination of incubation: Upon terminitation, smaples weretransferred into 300 mL biochemical oxygen demand (BOD) bottles to conduct dissolved oxygen (DO) measurements
EFFECT PARAMETERS MEASURED:
DO measurements were measured every 10 seconds over a 10 minute period for the first control vessel.
The respiration rate in subsequent vessels was determined in an identical manner at 15 minute intervals.
TEST CONCENTRATIONS
- Concentrations of Positive Control: 3, 15 and 50 mg/L
- Concentrations of Test Substance: 1, 3, 10, 30, 100, 300, and 1000 mg/L - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol at 99.1% purity at concentration of 3, 15 and 50 mg/L.
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth inhibition
- Key result
- Duration:
- 3 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth inhibition
- Details on results:
- The observed percent inhibitions for sildenafil citrate ranged from –53.6 to 15.7% and were not concentration dependent.
- Results with reference substance (positive control):
- The positive control EC50 had 95 percent confidence limits of 23 and 29 and was within the 5 to 30 mg/L range considered acceptable for the test. This makes the result of this test valid.
- Reported statistics and error estimates:
- The EC50 was calculated using the moving average method.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- This study accurately assesed the EC50 and NOEC for respiration inhibition in activated sludge per guidelines.
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