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EC number: 618-844-9 | CAS number: 923604-58-4
- 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
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:
- 2015-12-18 to 2015-12-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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
Test material
- Reference substance name:
- (1R,4R,6S,7Z,15R,17R)-17-({7-methoxy-8-methyl-2-[4-(propan-2-yl)-1,3-thiazol-2-yl]quinolin-4-yl}oxy)-13-methyl-2,14-dioxo-3,13-diazatricyclo[13.3.0.0^{4,6}]octadec-7-ene-4-carboxylic acid
- EC Number:
- 618-844-9
- Cas Number:
- 923604-58-4
- Molecular formula:
- C35H42N4O6S
- IUPAC Name:
- (1R,4R,6S,7Z,15R,17R)-17-({7-methoxy-8-methyl-2-[4-(propan-2-yl)-1,3-thiazol-2-yl]quinolin-4-yl}oxy)-13-methyl-2,14-dioxo-3,13-diazatricyclo[13.3.0.0^{4,6}]octadec-7-ene-4-carboxylic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-38940642-AAA (T003010)
- Physical state: solid
- 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: I15AB0295
- Manufacture date: 22/01/2015
- Retest date: 22/1/2017
- Purity: 98.7%
- White powder
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: solubility in water <0.01 g/L
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: samples for possible analysis were taken form all test concentrations and the control at t=0 and t=48h. 2.0 mL of volume was taken from the approximate centre of the test vessels. 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 2.0 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: preparation of test solutions started with a loading rate of 100 mg/L applying 2 days of magnetic stirring at room temperature to ensure the maximum dissolution of the test item in the test medium. This resulted in a hazy dispersion that contained undissolved floating material and precipitate. The dispersion was consequently filtered through a 0.45 µm membrane filter (RC55, Whatman) to remove any non-dissolved material. The filter was preconditioned with a small volume of test solution that was discarded. The resulted SS was used as the highest test concentration. The lower test concentrations were prepared by subsequent dilutions of the SS in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): 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): <24h (from parental daphnids of more than 2 weeks old)
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 litres of medium in an all-glass culture vessel.
- Medium: M7. After 7 days of cultivation half of the medium is renewed twice a week.
- Feeding during test: no
ACCLIMATION
- Acclimation period: max. 4 weeks
- Acclimation conditions (same as test or not): yes
- Type and amount of food: fresh water algae.
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg/L as CaCO3
- Test temperature:
- 20°C
- pH:
- At t= 0h: 7.9
At t= 48h: 8.0-8.1 - Dissolved oxygen:
- At t= 0h: 9.2-9.9
At t= 48h: 9.0-9.1 - Salinity:
- not relevant
- Nominal and measured concentrations:
- Range finder:
Nominal concentrations (mg/L): 1.0, 10 and 100
Final test:
Nominal concentration tested (mg/L): 100
Measured concentrations (mg/L) at t=0h: 0.848
Measured concentrations (mg/L) at t=48h: 0.384 - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 100 mL, glass beaker filled with 80mL
- Aeration: not during the test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): not reported
- No. of vessels per control (replicates): not reported
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 container and was monitored after 24 and 48 hours of continuous treatment with the test substance.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: x10
- Range finding study: combined/range finding study was performed
- Test concentrations: 1.0, 10 and 100% of a SS prepared at a 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.:
- > 100 other: % v/v saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
- Measured 24-h EC50 and 48-h EC50 > 0.57 mg/L. - Results with reference substance (positive control):
- - Results with reference substance valid? yes (should lie between 0.3 and 1.0 mg/L)
- Mortality:
- EC50/LC50: 48-h EC50 = 0.38 mg/L with a 95% C.L. between 0.33 and 0.43 mg/L. The sensitivity of the daphnia was within the range determined with the historical data collected at WIL Research Europe. - Reported statistics and error estimates:
- The average exposure concentrations were calculated as the geometric means of the concentrations of JNJ-38940642-AAA (T003010) measured in the samples taken at the start (t =0h) and the end of the test (t =48h).
The 24-h and 48-h EC50 could not be determined because no effect was observed at any of the tested concentrations.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of T003010 to Daphnia magna was determined in a 48-hour static test according to the OECD guideline 202. The 48h-EC50 was beyond the concentration range tested, i.e. exceeded an average exposure concentration of 0.57 mg/L.
The results were therefore based on nominal concentrations, expressed as % v/v saturated solution (SS). The 48-h EC50 was determined to be > 100 % of the saturated solution at 100 mg/L test item. The NOErC was >= 100% v/v SS. The results of the test can be considered reliable without restriction.
In conclusion, the test item T003010 clearly had no toxic effect to Daphnia magna up to the maximum solubility in medium obtained with a loading rate of 100 mg/L.
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