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EC number: 812-520-2 | CAS number: 1259279-57-6
- 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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-03-09 to 2018-04-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-fluoro-1-(4-methylbenzenesulfonyl)-3-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-1H-pyrrolo[2,3-b]pyridine
- EC Number:
- 812-520-2
- Cas Number:
- 1259279-57-6
- Molecular formula:
- C20H22BFN2O4S
- IUPAC Name:
- 5-fluoro-1-(4-methylbenzenesulfonyl)-3-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-1H-pyrrolo[2,3-b]pyridine
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-63757044-AAA (T003686)
- Physical state: solid (powder)
- Appearance: white powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: I16HD3479
- Expiration date of the lot/batch: 2018-09-03 (retest date)
- Purity test date: 2016-12-05 (certificate of analysis release date)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: not indicated
- Solubility and stability of the test substance in the solvent/vehicle: 0.01 g/L (21.7°C) in water
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: Samples for possible analysis were taken from all test concentrations and the control at t=0 and t=48h. 3.0 mL of volume was taken. At the end of the exposure period, the replicates were pooled at each concentration before sampling.
- Sample storage conditions before analysis: The samples were stored in a freezer. Additionally, reserve samples of 3.0 mL were taken for possible analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The preparation of test solutions started with a loading rate of 100 mg/L applying 3 days of magnetic stirring at room temperature to ensure maximum dissolution of the test item in test medium. This resulted in a hazy dispersion that contained undissolved floating material and precipitate. The obtained mixture was filtered through a 0.45 ìm membrane filter (Whatman; RC55) to remove the undissolved fraction. The filter was pre-conditioned with a small volume of test solution that was discarded. The resulting SS was used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): All final test solutions were clear and colourless
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water-flea
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): < 24 h (from parental daphnids of more than 2 weeks old, maximum age 4 weeks)
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 liters of medium in an all-glass culture vessel. Medium is M7. After 7 days of cultivation half of the medium is renewed twice a week.
- Feeding during cultivation: fresh water algae, daily
- Feeding during test: no
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg/L as CaCO3
- Test temperature:
- 20-21°C
- pH:
- At t=0h: 7.9 - 8.0
At t=48h: 8.1 - 8.2 - Dissolved oxygen:
- At t=0h: 8.5 - 8.6
At t=48h: 8.9 - 9.1 - Salinity:
- not relevant
- Nominal and measured concentrations:
- Final test (final test):
Nominal concentrations: 0, 1.0, 18, 32, 56, 100 % SS prepared at a loading rate of 100 mg/L
Measured concentrations (mg/L) at t=0h: n.d., 0.061, 1.187, 2.113, 3.721, 6.272
Measured concentrations (mg/L) at t=48h: n.d., 0.051, 1.14, 2.02, 3.49, 5.21
n.d. = not detected - Details on test conditions:
- TEST SYSTEM
- Test vessel: vessel
- Material, size, headspace, fill volume: 60 mL, all-glass filled with 50 mL
- Aeration: not during the test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Test medium: adjusted ISO medium
OTHER TEST CONDITIONS
- Photoperiod: 16h light daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobility was defined as those organisms which are not able to swim within 15 seconds after gentle agitation of the test vessel and was monitored after 24 and 48 hours of continuous treatment with the test substance.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: x1.8
- Range finding study
- Test concentrations: 0, 1.0 and 10% of the SS prepared at loading rate of 100 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3.6 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% C.I.: 2.8-4.4 mg/L
- Details on results:
- - Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Mortality: no
- EC50/LC50: 48-h EC50 = 0.33 mg/L. The sensitivity of the daphnids was within the range determined with the historical data collected at Charles River Den Bosch. - Reported statistics and error estimates:
- - The 24 and 48h-EC50-values were calculated from the probits of the percentages of affected daphnids and the logarithms of the corresponding test item concentrations (initially measured) using the maximum likelihood estimation method.
- The calculations were performed with ToxRat Professional v. 3.2.1. (ToxRat Solutions® GmbH, Germany).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of T003686 to Daphnia magna was determined in a 48 hour static test according to OECD guideline 202. Based on initially measured concentrations, the 48-h EC50 was 3.6 mg/L (95% confidence interval between 2.8 and 4.4 mg/L). The results of the test can be considered reliable without restriction.
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.
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