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EC number: 253-649-9 | CAS number: 37743-18-3
- 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:
- 2017-01-13 to 2017-02-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- EC Number:
- 253-649-9
- EC Name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- Cas Number:
- 37743-18-3
- Molecular formula:
- C18H20NO.Br
- IUPAC Name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: I16DB2126
- manufacture date: 2016-04-27
- Expiration date of the lot/batch: 2018-04-27 (retest date)
- Purity test date: 2016-05-27
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
OTHER SPECIFICS:
- purity: 98.5% (base titration)
- appearance: white powder
- Water solubility: >500 g/L
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: samples were taken before the start of the test, after 24 hours and after 72 hours from each test medium and from the control. 2.4 mL of volume was taken. At the end of the exposure period, the replicates with algae were pooled at each concentration before sampling.
- Sample storage conditions before analysis: stored in a freezer until analysis. Additionally, reserve samples of 2.4 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 the highest test concentration of 130 mg/L (100 mg base/L). No special treatment other than careful mixing was needed to fully dissolve the test item in test medium. The resulting clear and colourless solution was used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions 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):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Strain: NIVA CHL 1
- Source (laboratory, culture collection): In-house laboratory culture
- Method of cultivation: Algal stock cultures were started by inoculating growth medium with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light in a climate room at a temperature of 21-24°C. M1 medium was used.
- Pre-culture: 3 days before the start of the test, cells from the algal stock culture were inoculated in M2 medium at a cell density of 1E+04 cells/mL. The pre-culture was maintained under the same conditions as used in the test. Cell density was measured before use.
ACCLIMATION
- Acclimation period: not relevant (except pre-culture 3 days before start of the test)
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 24 mg CaCO3/L
- Test temperature:
- 22-24°C
- pH:
- t=0h: 7.9-8.0
t=72h: 7.6-7.8 - Dissolved oxygen:
- not reported
- Salinity:
- not relevant
- Conductivity:
- not applicable
- Nominal and measured concentrations:
- nominal test concentrations final test: 1.04, 3.12, 9.36, 28.6 and 84.5 mg/L (0.80, 2.4, 7.2, 22 and 65 mg base/L)
measured test concentration final test t= 0 h: 0.846; 2.61; 7.60; 23.0; 68.3 (mg base/L)
measured test concentration final test t= 72h: 0.496; 1.51; 4.41; 13.1; 39.2 (mg base/L)
The measured concentrations were in agreement with the nominal concentrations at the study start (105-109% relative to nominal). Measured concentrations decreased to 86-92% of initial after 24 hours and further to 60-63% of initial at the end of the test. Based on these results the TWA exposure concentrations were calculated. The range tested based on TWA concentrations corresponded with 0.66, 2.0, 5.9, 17 and 53 mg base/L. This corresponded with 0.51, 1.5, 4.5, 13 and 41 mg/L based on the whole test item. - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 100 ml, all-glass, containing 50 mL of test solution
- Initial cell density: 1 x 10^4 cells/ml
- No. of vessels per concentration and per control (replicates):
* 3 replicates of each test concentration;
* 6 replicates of the control;
* 1 extra replicate of each test group for sampling purposes;
* 1 or 2 repicates of each test concentration without algae;
GROWTH MEDIUM
- Standard medium used: M1; according to the NPR 6505 (“Nederlandse Praktijk Richtlijn no. 6505”) formulated using Milli-RO water (tap-water purified by reverse osmosis
- Detailed composition if non-standard medium was used:
NaNO3 500 mg/L
K2HPO4.3H2O 52 mg/L
MgSO4.7H2O 75 mg/L
Na2CO3.10H2O 54 mg/L
C6H8O7.H2O 6 mg/L
NH4NO3 330 mg/L
CaCl2.2H2O 35 mg/L
C6H5FeO7.xH2O 6 mg/L
H3BO3 2.9 mg/L
MnCl2.4H2O 1.81 mg/L
ZnCl2 0.11 mg/L
CuSO4.5H2O 0.08 mg/L
(NH4)6Mo7O24.4H2O 0.018 mg/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M2; according to the OECD 201 Guideline, formulated using Milli-RO water
- Culture medium different from test medium: Yes. Three days before the start of the test the algal stock culture were inoculated in the same culture medium (M2) used in the test. The culture was maintained under the same conditions as used in the test.
- Intervals of measurements: pH was measured at the beginning and at the end of the test. Temperature was continuously measured in a control vessel. At the end of the final test microscopic observations were performed on all test concentrations to observe for any abnormal appearance of the algae.
OTHER TEST CONDITIONS
- Photoperiod: continuous illumination
- illumination: TLD-lamps with a light intensity within the range of 82 to 84 µE/m²/s.
- Adjustment of pH: no
- Light intensity and quality: 60 to 120 µE/m2/s when measured in the photosynthetically effective wavelength range of 400 to 700 nm.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : growth inhibition
- Determination of cell concentrations: At the beginning, cells were counted using a microscope and a counting chamber. thereafter, cell densities were determined by spectrophotometric measurement of samples at 680 nm using a spectrophotometer with immersion probe (pathlength = 20mm).
- effect calculated parameters: specific growth rate and yield
TEST CONCENTRATIONS
- Spacing factor for test concentrations: ca. 2.95
- Range finding study: combined limit/range finding study was performed
- range finding concentrations: 0.13, 1.3 and 13 and 130 mg/L (0.10, 1.0 and
10 and 100 mg base/L).
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 6.4 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.5 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Any stimulation of growth found in any treatment: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- 72-h EC50 (yield) = 2.8 mg/L (2.2 mg base/L)
- 72-h EC10 (growth rate) = 4.0 mg/L (3.1 mg base/L)
- 72-h EC10 (yield) < 0.51 mg/L (<0.39 mg base/L)
- 72-h NOEC (yield) < 0.51 mg/L (<0.39 mg base/L) - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50: 72h-ErC50 was 1.3 mg/L (95% confidence interval ranging from 1.2 to 1.4 mg/L)
- Other: the historical ranges for growth rate inhibition lie between 0.82 and 2.6 mg/L. The observed 72h-ErC50 for the algal culture tested corresponds with this range - Reported statistics and error estimates:
- Growth rates were not biologically significantly reduced (<10%) at the two lowest TWA concentrations of 0.51 and 1.5 mg/L (9.0 and 3.6%, respectively), whereas the growth rate of algae exposed to TWA concentrations of 4.5 mg/L and higher were both biologically and statistically significantly reduced. Despite the statistical significant effect at 0.51 mg/L, the NOEC for growth rate was set at 1.5 mg/L based on biological relevance and the absence of a concentration related increase of effects at the two lowest test groups.
Yield was inhibited by 36.0 and 15.7% at the two lowest TWA concentrations of 0.51 and 1.5 mg/L, respectively. Yield inhibition increased with increasing concentration of JNJ-16250351-AAH (T000836) from 4.5 mg/L upwards resulting in 100% inhibition at a TWA concentration of 41 mg/L. Statistically significant inhibition of yield was found at all tested concentrations. Hence, the NOEC for yield was
< 0.51 mg/L.
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:
- A 72-h growth inhibition test with the unicellular algal species Pseudokirchneriella subcapitata was performed with the test substance JNJ-16250351-AAH (T000836) according to the OECD guideline 201 (GLP conditions). The test item reduced growth rate of this fresh water algae species significantly at average measured concentrations of 4.5 mg/L (3.5 mg base/L) and higher. The 72h NOEC for growth rate inhibition was determined to be 1.5 mg/L (1.2 mg base/L). The 72h NOEC for yield inhibition was determined to be <0.51 mg/L (<0.39 mg base/L).
The results of the test can be considered reliable without restrictions.
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