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EC number: 844-009-5 | CAS number: 167173-85-5
- 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
Sediment toxicity
Administrative data
- Endpoint:
- sediment toxicity: long-term
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 218 (Sediment-Water Chironomid Toxicity Test Using Spiked Sediment)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
- Cas Number:
- 167173-85-5
- Molecular formula:
- C26H30N2O9
- IUPAC Name:
- (3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
Constituent 1
- Specific details on test material used for the study:
- Substance name: X642188
Lot #: SYN-FS08353-048 (TSN303567)
Purity: 99%
Sampling and analysis
- Analytical monitoring:
- yes
Test substrate
- Vehicle:
- yes
- Remarks:
- acetone
Test organisms
- Test organisms (species):
- Chironomus riparius
Study design
- Study type:
- laboratory study
- Test type:
- static
- Water media type:
- freshwater
- Type of sediment:
- artificial sediment
- Remarks:
- formulated sediment constituents: 75% fine industrial sand (more than 50% of the particles 50-200 μm), 20% kaolin clay (kaolinite content > 30%), and 4-5% sphagnum peat (particle size ≤ 1 mm).
Exposure duration
- Duration:
- 28 d
- Exposure phase:
- total exposure duration
Test conditions
- Hardness:
- 152 to 270 mg CaCO3/L
- Test temperature:
- 20.1 to 21.2 ºC
- pH:
- 8.0 to 8.5
- Dissolved oxygen:
- 7.6 to 8.8 mg/L (90 to 101% saturation)
- Ammonia:
- Un-ionized Ammonia: 0.00 mg/L
- Nominal and measured concentrations:
- Nominal Sediment Concentrations: 0 (control), 0 (vehicle control), 0.63, 1.3, 2.5, 5.0, and 10 mg/kg
Day 0 Mean Sediment Concentrations:Time-Weighted Mean Sediment Concentrations: - Reference substance (positive control):
- yes
- Remarks:
- Potassium chloride (assessed in a different study)
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 10 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 2.8 mg/kg sediment dw
- Conc. based on:
- test mat.
- Basis for effect:
- other: Survival
- Remarks on result:
- other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
- Remarks:
- >8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
- Duration:
- 28 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 2.8 mg/kg sediment dw
- Conc. based on:
- test mat.
- Basis for effect:
- emergence rate
- Remarks on result:
- other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
- Remarks:
- >8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
- Key result
- Duration:
- 10 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.63 mg/kg sediment dw
- Conc. based on:
- test mat.
- Basis for effect:
- other: Survival
- Remarks on result:
- other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
- Remarks:
- 1.9 mg/kg (Based on Mean Measured Sediment Concentrations)
- Key result
- Duration:
- 10 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 2.8 mg/kg sediment dw
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
- Remarks:
- 8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
- Key result
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.63 mg/kg sediment dw
- Conc. based on:
- test mat.
- Basis for effect:
- emergence rate
- Remarks on result:
- other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
- Remarks:
- 1.9 mg/kg (Based on Mean Measured Sediment Concentrations)
- Key result
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 2.8 mg/kg sediment dw
- Conc. based on:
- test mat.
- Basis for effect:
- other: (Development Rate (Male, female & Total))
- Remarks on result:
- other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
- Remarks:
- 8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
- Duration:
- 10 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 1.2 mg/kg sediment dw
- Conc. based on:
- test mat.
- Basis for effect:
- other: survival
- Remarks on result:
- other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
- Remarks:
- 4.0 mg/kg (Based on Mean Measured Sediment Concentrations)
- Duration:
- 10 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 2.8 mg/kg sediment dw
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
- Remarks:
- >8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
- Duration:
- 28 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 1.2 mg/kg sediment dw
- Conc. based on:
- test mat.
- Basis for effect:
- emergence rate
- Remarks on result:
- other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
- Remarks:
- 4.0 mg/kg (Based on Mean Measured Sediment Concentrations)
- Duration:
- 28 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 2.8 mg/kg sediment dw
- Conc. based on:
- test mat.
- Basis for effect:
- other: (Development Rate (Male, female & Total))
- Remarks on result:
- other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
- Remarks:
- >8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
- Results with reference substance (positive control):
- The calculated 48-hour EC50 value was 2,700 mg/L based on nominal exposure concentrations. These results and the control survival during testing confirmed the health of the organism culture and suitability of the dilution water for use in testing.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- NOEC (Day-10 Survival): 0.63 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
NOEC (Day-10 Adult Biomass)): 2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
NOEC (Emergence)): 0.63 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
NOEC (Development Rate (Male, female & Total)): 2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
LOEC (Day-10 Survival): 1.2 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
LOEC (Day-10 Adult Biomass)): >2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
LOEC (Emergence)): 1.2 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
LOEC (Development Rate (Male, female & Total)): >2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
EC50 (Day-10 Survival): >2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
EC50 (Emergence)): >2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations) - Executive summary:
The midge, Chironomus riparius, was tested in a 28-day exposure period according to OECD guideline 218 to determine the potential effects of the test substance on 10-day survival, adult emergence, and development rate of chironomids exposed during their life cycle.
The testing was performed at nominal sediment concentrations of 0 (control), 0 (vehicle control), 0.63, 1.3, 2.5, 5.0, and 10 mg/kg.
The control organisms met the acceptability criterion for mean percent emergence (i.e., >70%) as specified by the study protocol and the OECD 218 testing guideline. All effects concentrations were based on the day 0 mean measured sediment concentrations and the time-weighted mean measured sediment concentrations. The day 10 survival NOEC and LOEC values, based on the day 0 mean measured sediment concentrations, were 1.9 and 4.0 mg/kg, respectively, with EC10, EC15, and EC50 values of 1.8 mg/kg (95% confidence limits 0.66 – 2.8 mg/kg), 2.5 mg/kg (95% confidence limits 1.2 – 3.7 mg/kg), and >8.2 mg/kg (6.4 – 24 mg/kg), respectively. The day 10 survival NOEC and LOEC values, based on the time-weighted mean measured sediment concentrations, were 0.63 and 1.2 mg/kg, respectively, with EC10, EC15, and EC50 values of 0.58 mg/kg (95% confidence limits 0.24 – 0.90 mg/kg), 0.80 mg/kg (95% confidence limits 0.41 – 1.2 mg/kg), and >2.8 mg/kg (2.1 – 7.9 mg/kg), respectively. The emergence NOEC and LOEC values, based on the day 0 mean measured sediment concentrations, were 1.9 and 4.0 mg/kg, respectively, with EC10, EC15, and EC50 values of 1.9 mg/kg (95% confidence limits 0.86 - 2.7 mg/kg), 2.5 mg/kg (95% confidence limits 1.4 – 3.4 mg/kg), and >8.2 mg/kg (6.6 - 14 mg/kg), respectively. The emergence NOEC and LOEC values, based on the timeweighted mean measured sediment concentrations, were 0.63 and 1.2 mg/kg, respectively, with EC10, EC15, and EC50 values of 0.60 mg/kg (95% confidence limits 0.31 – 0.86 mg/kg), 0.81 mg/kg (95% confidence limits 0.48 – 1.1 mg/kg), and >2.8 mg/kg (2.2 – 4.6 mg/kg), respectively. The day 10 adult biomass and the male, female and total development rate NOEC and LOEC values, based on the day 0 mean measured sediment concentrations (time-weighted mean measured sediment concentrations), were 8.2 and >8.2 mg/kg (2.8 and >2.8 mg/kg), respectively. The EC10, EC15, and EC50 values for adult biomass and the male, female and total development rate data could not be calculated due to the lack of a concentration dependent response trend.
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