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EC number: 457-320-2 | CAS number: -
- 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
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-02-12 to 1999-05-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 305 C (Bioaccumulation: Test for the Degree of Bioconcentration in Fish)
- Deviations:
- yes
- Remarks:
- test terminated at 56 days (Guideline - 60 days)
- Qualifier:
- according to guideline
- Guideline:
- other: Method for Testing the Degree of Accumulation of Chemical Substances in Fish Body stipulated in Testing Methods for Chemical Substances (Ministry of International Trade and Industry, Japan)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Water solubility: <0.8 mg/litre - Radiolabelling:
- no
- Details on sampling:
- - Sampling intervals/frequency for test organisms: 2-week intervals
- Sampling intervals/frequency for test medium samples: twice weekly
- Sample storage conditions before analysis: no data
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods):
Test organisms: Homogenised in tetrahydrofuran (THF) and centrifuged; supernatant concentrated and partitioned into CHCl3:NaCl; CHCl3 layer dried and taken up into butyl acetate for atomic absorption spectrophotometry (AA) analysis
Test medium: partitioned between CHCl3: NaCl; CHCl3 layer dried and taken up in THF for HPLC analysis - Vehicle:
- yes
- Details on preparation of test solutions, spiked fish food or sediment:
- PREPARATION OF SPIKED WATER
- Details of spiking: test material plus dispersant were dissolved in tetrahydrofuran (THF). THF was evaporated and deionised water added to make a 1000 mg/litre stock solution.
- Controls: yes
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): dispersant: hydrogenated castor oil and olive oil
- Concentration of vehicle in final test solution: 0.025 g/litre - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Carp
- Strain: no data
- Source: Sugishima fish farm, Kumamoto 866-0024 Japan
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): 9.7 cm
- Weight at study initiation (mean and range, SD): 21.9 g
- Weight at termination (mean and range, SD): no data
- Method of breeding: no data
- Health status: no abnormalities
- Description of housing/holding area: acclimatizing aquarium
- Feeding during test: yes
- Food type: pelleted feed for carp (Nippon Formula Feed Mfg. Co., Ltd)
- Amount: about 2% of total body weight/day
- Frequency: twice/day
ACCLIMATION
- Acclimation period: 104 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: as for study
- Feeding frequency: as for study
- Health during acclimation (any mortality observed): no mortalities reported - Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 8 wk
- Hardness:
- 111 mg/litre (Ca; Mg)
- Test temperature:
- 25 ± 2 ºC
- pH:
- 7.5
- Dissolved oxygen:
- For level 1 concentration: 6.6 - 7.6 mg/litre
For level 2 concentration: 7.6 - 8.1 mg/litre
For control: 6.7 - 7.7 mg/litre - TOC:
- 0.6 mg/litre
- Salinity:
- not applicable
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 100-litre glass tank
- Aeration: no data
- Type of flow-through (e.g. peristaltic or proportional diluter): no data
- Renewal rate of test solution (frequency/flow rate): 2 ml/min stock solution; 400 ml/min dilution water - total flow 579 litre/day
- No. of organisms per vessel: 11 (test); 5 (control)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): 1
- Biomass loading rate: 214.9 g
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: underground source at Kurume Research Laboratories
- Particulate matter: <1 mg/litre
- Metals: Hg, Pb, Cd, Cr, As, Cu, Fe -- all below detection limit
- Pesticides: no data
- Chlorine: <0.01 mg/litre
- Alkalinity: 98.1 mg/litre
- Ca/mg ratio: no data
- Conductance: 384 µs/cm
- Holding medium different from test medium: same
- Intervals of water quality measurement: every 6 months
- Intervals of test medium replacement: continuous flow
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: no data
- Light intensity: no data
RANGE-FINDING / PRELIMINARY STUDY
- Test concentrations: 80 mg/litre
- Results used to determine the conditions for the definitive study: yes - LC50 - Nominal and measured concentrations:
- Nominal: level 1: 0.5 mg/litre (as test material)
Nominal: level 2: 0.05 mg/litre (as test material)
Measured: level 1 at weeks 2, 4, 6 and 8: 0.430, 0.438, 0.439 and 0.445 mg/litre respectively
Measured: level 2 at weeks 2, 4, 6 and 8: 0.0379, 0.0375, 0.0376 and 0.0375 mg/litre respectively - Reference substance (positive control):
- no
- Details on estimation of bioconcentration:
- Bioconcentration factor (BCF) = concentration of test material in fish/average concentration of test material in dilution water
No BCFs calculated because the measured concentrations of the test material in the test fish were below the limit of detection - Lipid content:
- 4.1 %
- Time point:
- start of exposure
- Remarks on result:
- other: average value
- Key result
- Conc. / dose:
- 0.5 mg/L
- Temp.:
- 25 °C
- Type:
- BCF
- Value:
- <= 7.4 dimensionless
- Basis:
- whole body w.w.
- Key result
- Conc. / dose:
- 0.05 mg/L
- Temp.:
- 25 °C
- Type:
- BCF
- Value:
- <= 88 dimensionless
- Basis:
- whole body w.w.
- Details on kinetic parameters:
- No bioaccumulation detected
- Metabolites:
- not done
- Results with reference substance (positive control):
- not done
- Details on results:
- - Mortality of test organisms: none
- Behavioural abnormalities: none
- Observations on body length and weight:
body weight (n=2) at 2, 4, 6 and 8 weeks (0.05 mg/litre nominal dose) - 33.2/40.0; 38.5/41.2; 44.9/50.0 and 51.8/46.8 respectively
body weight (n=2) at 2, 4, 6 and 8 weeks (0.5 mg/litre nominal dose) - 35.6/40.3; 45.1/47.5; 43.1/45.5 and 42.8/56.9 respectively
body weight (n=2) of control fish at termination of study - 52.0/45.1
- Other biological observations: appearance
- Organ specific bioaccumulation: not applicable
- Bound residues forming a plateau: not applicable
- Mortality and/or behavioural abnormalities of control: none
- Loss of test substance during test period: no - Reported statistics:
- none
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a GLP study conducted according to a protocol equivalent to OECD guideline 305C, no bioaccumulation of EC# 434-650-5 was detected in carp following exposure for up to 8 weeks at concentrations of 0.5 and 0.05 mg/litre in a continuous flow apparatus, resulting in bioaccumulation factors of <7.4 and <88 respectively.
- Executive summary:
In a GLP study conducted according to a protocol equivalent to OECD guideline 305C, the bioaccumulation in carp (Cyprinus carpio) of EC#434-320-2 was evaluated in a continuous flow system. Groups of eleven fish were exposed at two concentrations of test material 0.05 and 0.5 mg/litre for a period of 8 weeks, the concentrations of test material in the medium being determined twice weekly and at two-week intervals in the fish. A further group of five fish was exposed to medium only.
No deaths and no abnormalities in behaviour or appearance were seen in the fish during the study. No change in the concentration of test material in the medium was detected over the study period, varying from 0.430 to 0.445 mg/litre at the higher concentration (0.5 mg/litre nominal) and 0.0375 to 0.0379 mg/litre at the lower concentration (0.05 mg/litre nominal). No bioaccumulation of the test material was detected in the exposed fish during the study, the measured concentrations in the whole body being below the limit of quantitation of the assay (3.3 µg/g body weight for a fish weighing 30 g) at all time points.
In conclusion, based on the analytical detection limits of the test material, the bioconcentration factor (BCF) for EC# 434-650-5 in fish exposed at 0.5 and 0.05 mg/litre was <7.4 and <88 respectively. In view of the structural and chemical similarities, it is considered that the results of this study can be used for read-across to EC# 457-320-2.
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Lipid content:
- 4.1 %
- Time point:
- start of exposure
- Key result
- Conc. / dose:
- 0.5 mg/L
- Temp.:
- 25 °C
- Type:
- BCF
- Value:
- <= 7.4 dimensionless
- Basis:
- whole body w.w.
- Key result
- Conc. / dose:
- 0.05 mg/L
- Temp.:
- 25 °C
- Type:
- BCF
- Value:
- <= 88 dimensionless
- Basis:
- whole body w.w.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a GLP study conducted according to a protocol equivalent to OECD guideline 305C, no bioaccumulation of EC# 434-650-5 was detected in carp following exposure for up to 8 weeks at concentrations of 0.5 and 0.05 mg/litre in a continuous flow apparatus, resulting in bioaccumulation factors of <7.4 and <88 respectively.
- Executive summary:
Based on the analytical detection limits of the test material, the bioconcentration factor (BCF) for EC# 434-650-5 in fish exposed at 0.5 and 0.05 mg/litre was <7.4 and <88 respectively. In view of the structural and chemical similarities, it is considered that the results of this study can be used for read-across to EC# 457-320-2.
Referenceopen allclose all
Description of key information
In a GLP study on a structurally similar analogue material conducted according to a protocol equivalent to OECD guideline 305C, no bioaccumulation of EC# 434-650-5 was detected in carp following exposure for up to 8 weeks at concentrations of 0.5 and 0.05 mg/litre in a continuous flow apparatus, resulting in bioaccumulation factors of <7.4 and <88 respectively.
Key value for chemical safety assessment
- BCF (aquatic species):
- 88 dimensionless
Additional information
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