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EC number: 807-111-0 | CAS number: 1211441-98-3
- 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 aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb - Aug 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Qualifier:
- according to guideline
- Guideline:
- ISO 8692 (Water Quality - Fresh Water Algal Growth Inhibition Test with Scenedesmus subspicatus and Selenastrum capricornutum)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide
- EC Number:
- 807-111-0
- Cas Number:
- 1211441-98-3
- Molecular formula:
- C23H30N8O
- IUPAC Name:
- 7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide
- Test material form:
- solid: bulk
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Singular samples for possible analysis were taken from all test concentrations and the control according to the schedule below. In addition, the filter containing
the undissolved fraction was retained for possible analysis.
Frequency at t=0 h, t=24 h and t=72 h
Volume 2.0 ml
Storage
Samples were stored in a freezer until analysis.
At the end of the exposure period, the replicates with algae were pooled at each concentration before sampling.
Compliance with the Quality criteria regarding maintenance of actual concentrations was demonstrated by running a test vessel at an intermediate substance concentration but without algae and samples for analysis were taken at the start, after 24 hours of exposure and at the end of the test period.
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- Preparation of test solutions started with an aqueous mixture of 100 mg/l that was magnetically stirred for two days to achieve maximum dissolution in test medium. The resulting dispersion was filtered through a 0.45 μm membrane filter (Whatman; RC55) to remove the undissolved particles. The lower test concentrations were prepared by subsequent dilutions of the filtrate in test medium. The final test solutions were all clear and colourless.
After preparation, volumes of 50 ml were added to each replicate of the respective test concentration.
Subsequently, 1 ml of an algal suspension was added to each replicate providing a cell density of 104 cells/ml.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Pseudokirchneriella subcapitata, strain: NIVA CHL 1
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- 21-24°C
- pH:
- 6.0-9.0
- Reference substance (positive control):
- no
- Remarks:
- Controls: Test medium without test substance or other additives
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- ca. 3.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- >= 2.6 - <= 4.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- ca. 1.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield inhibition
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 0.76 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- Growth rates were in the range of the controls at the TWA concentrations of 0.21 and 0.76 mg/l during the 72-hour test period, whereas the growth rate of algae exposed to 2.5 mg/l and higher were increasingly reduced. It should be noted that, due to mathematical reasons (lack of normal distribution
and heterogeneity of variance) the differences between control and treatments could not be determined at 72 hour of exposure. Therefore, the NOEC for growth rate inhibition could not be statistically determined. However, as only 1.3% effect was observed at 0.76 mg/l this could be safely set as the NOEC as an effect less than 10% is generally considered not biologically relevant. In addition, the EC10 could be used as an alternative measure.
A slight, biologically irrelevant, inhibition of yield was observed at TWA concentrations of 0.21 and 0.76 mg/l. Significant inhibition of more than 90% was observed at TWA concentrations of 2.5 mg/l and higher. Statistically significant inhibition of yield was found at TWA concentrations of 2.5 mg/l and
higher.
Microscopic observations at the end of the test revealed a normal and healthy appearance of the exposed cells when compared to the control.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the present study with Pseudokirchneriella subcapitata, LEE011-A4 reduced growth rate and inhibited the yield of this fresh water algae species significantly at TWA concentrations of 2.5 mg/l and higher.
The EC50 for growth rate inhibition (72h-ERC50) was 3.4 mg/l with a 95% confidence interval ranging from 2.6 to 4.5 mg/l.
The EC50 for yield inhibition (72h-EYC50) was 1.4 mg/l with a 95% confidence interval ranging from 1.3 to 1.6 mg/l.
The 72h-NOEC for both growth rate inhibition and yield inhibition was 0.76 mg/l.
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