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EC number: 695-878-0 | CAS number: 1283129-18-9
- 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
Link to relevant study record(s)
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-06-15 to 2016-06-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.11 (Biodegradation: Activated Sludge Respiration Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 8192 (Water quality - Test for inhibition of oxygen consumption by activated sludge for carbonaceous and ammonium oxidation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- see study report
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: I15AB0305
- manufacture date: 2015-01-24
- Expiration date of the lot/batch: 2017-01-23 (retest date)
- Purity test date: 2015-09-22
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
OTHER SPECIFICS:
- purity: 99.7%
- appearance: white powder
- Water solubility: not available - Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was not sufficiently soluble to allow the preparation of a 10 g/L stock solution in water. Therefore, 1-Litre test bottles were filled with 200 mL of test item mixtures in Milli-RO water (tap water purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA) with initial loading rates of
2.5 times the final loading rate. These mixtures were stirred in closed dark brown bottles for approximately 24 hours. Subsequently, 16 mL synthetic medium made up to 50 mL with Milli-RO water and 250 mL sludge were added resulting in the required loading rates (see also paragraph 6.5). Optimal contact between the test item and test organisms was ensured applying continuous aeration and stirring.
- Controls: blank controls: test medium without test item and treated in the same way as the test item solutions. - Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- - Laboratory culture: predominantly domestic sewage treatment plant, "Waterschap Aa en Maas", 's-Hertogenbosch, The Netherlands.
- Preparation of inoculum for exposure: coarsely sieved (1 mm) and allowed to settle. The supernatant was removed and ISO-medium was added. A small amount of the sludge was weighed and dried overnight at ~105°C to determine the amount of suspended solids
- Pretreatment: The batch of sludge was used one day after collection; therefore 50 mL of synthetic medium was added per L of activated sludge at the end of the collection day. The sludge was kept aerated at test temperature until use.
- Initial biomass concentration: 3.0 g/L of sludge - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 3 h
- Post exposure observation period:
- After 3 h of exposure, oxygen consumption was recorded for approximately 10 minutes.
- Test temperature:
- The temperature continuously measured in the temperature control vessels ranged between 18 and 22°C during the test, and complied with the requirements as laid down in the study plan (20 ± 2°C).
- pH:
- The pH in all test vessels, before addition of sludge was between 7.5 and 7.6. After the 3 hour exposure period the pH was between 7.4 and 8.0.
- Dissolved oxygen:
- The aeration was adjusted in such a way that the dissolved oxygen concentration at the start was above 60-70% saturation (60% of air saturation is > 5 mg/L at 20°C) and to maintain the sludge flocs in suspension.
- Salinity:
- not applicable
- Nominal and measured concentrations:
- In a combined limit/range-finding test loading rates of 10, 100 and 1000 mg/L were tested
- Details on test conditions:
- - Test vessel: All glass open bottles/vessels
- Aeration: The aeration was adjusted in such a way that the dissolved oxygen concentration at the start was above 60-70% saturation (60% of air saturation is > 5 mg/L at 20°C) and to maintain the sludge flocs in suspension.
- replicates:
* Highest loading rate: triplicate
* Lower loading rates: 1 replicate
* 1000 mg/L and abiotic control: 1 replicate
* blank control: 6 replicates
- Biomass loading rate: initial loading ca. 3.0 g dw/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: adjusted ISO medium, formulated using RO-water (tap water purified by reverse osmosis) with the following composition:
CaCl2.2H2O 211.5 mg/L
MgSO4.7H2O 88.8 mg/L
NaHCO3 46.7 mg/L
KCl 4.2 mg/L
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Determination of oxygen was performed with multiple oxygen probes connected to a BlueBox (GO-Systemelektronik GmbH, Germany), a multichannel measuring and controlling system.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: x10
- Range finding study: yes
- Test concentrations: loading rates of 10, 100 and 1000 mg/L
- Results used to determine the conditions for the definitive study: combined limit/range-finding test - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol
- Key result
- Duration:
- 3 h
- Dose descriptor:
- other: ELR50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Key result
- Duration:
- 3 h
- Dose descriptor:
- other: NOELR
- Effect conc.:
- 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Details on results:
- - Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no data
- Effect concentrations exceeding solubility of substance in test medium: no data
- Blank controls oxygen uptake rate: 48.90 mg O2/L.h
- Coefficient of variation of oxygen uptake rate in control replicates: 13 - Results with reference substance (positive control):
- - 3h-EC50 (mg/L) value for 3,5-dichlorophenol: 6.3 mg/L
This is within the recommended range of 2-25 mg/L confirming suitability of the activated sludge used. - Reported statistics and error estimates:
- - EC50 value was based on 3 parameter normal CDF non-linear regression analysis with the percentages of respiration inhibition versus the corresponding concentrations of the item.
For JNJ-42808415-AAA (T003422) no ELR50-value could be calculated because the test item proved to be non-toxic (ELR50 > 1000 mg/L)
- NOELR: An effect was considered to be significant if statistical analysis of the data obtained for the test
concentrations compared with those obtained in the blank control revealed significant inhibition of the respiration rate (Two-sample t-test Procedure, α=0.05, one-sided smaller). No inhibition of the respiration rate was observed at any of the tested concentrations. Therefore, the NOELR was considered to be the highest test concentration. The calculations were performed with ToxRat Professional v. 3.2.1. (ToxRat Solutions® GmbH, Germany). - Validity criteria fulfilled:
- yes
- Conclusions:
- An activated sludge respiration inhibition test (according OECD guideline 209) with activated sludge from a predominantly domestic sewage treatment plant resulted in a 3-h ELR50 > 1000 mg/L. In conclusion, JNJ-42808415-AAA (T003422) was not toxic to activated sludge at a loading rate of 1000 mg/L (NOELR). The results of the study can be considered reliable without restriction.
Reference
Description of key information
The study of Desmares-Koopmans (2017), investigating the toxicity of T003422 to microorganisms according to OECD guideline 209, was considered as the key study for endpoint coverage. The 3-h ELR50 was >1000 mg/L.
Key value for chemical safety assessment
Additional information
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