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EC number: 410-690-9 | CAS number: 103055-07-8 CGA 184699
- 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
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- 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:
- 23 Jul 2003 to 20 Nov 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Proposal for Updating Guideline 305, Bioconcentration: Flow-through Fish Test
- Version / remarks:
- June 1996; Paris, France.
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- yes
- Details on sampling:
- SAMPLING INTERVALS
- Weight of the fish: The total weight of fish in each tank was determined by bulk weighing (total wet weight) each population at 14 day intervals. After each fish sampling occasion (a maximum of every 7 days), an adjustment was then be made to the quantity of food dispensed.
- Analysis of test solutions: Day -2, -1, 0,1, 2, 7, 14, 21, 28, 35, 42, 49, 56, 60, 61, 120
- Analysis of fish samples: Day 7, 14, 21, 28, 35, 42, 49, 52, 54, 56, 58, 60, 61, 63, 68, 75, 82, 89, 96, 103, 117, 120 (lipid analysis only)
On days 56, 60, 110 and 120 additional fish were sampled and retained should further metabolite analysis be required.
SAMPLING AND PREPARATION
- Test solution: The analytical methods employed to measure the concentrations of [14C]-labelled test substance in the test solutions in this study were based on scintillation counting (LSC) to determine total [14C] residues, and reverse phase liquid chromatography (LC) to characterise the [14C] residues. All results based on LSC are quoted as μg/L equivalents of [14C]-labelled test substance. Water samples for LSC were taken from below the surface film and away from the sides and bottom of the test vessels, by pipetting 10 mL of water directly into scintillation vials. Specific analysis for 14C-lablled test substance was carried out by liquid extraction followed by LSC of the hexane extract and reverse phase LC on exposure days 0, 14, 28, 47 and 60. A sample of approximately 1 L of sub-surface water from each tank was collected in a separating funnel. Due to the expected adsorption of the test substance to glassware, no sub-samples were removed for analysis by LSC at this point. A 25 mL aliquot of hexane was added to the separating funnel which was stoppered and shaken for approximately 2 minutes. The two phases were then left to separate for at least 30 minutes, after which 3 x 1L ml of the aqueous phase was removed for LSC analysis. The remainder of the aqueous layer was discarded after the volume was recorded. 3 x 100 µL of the hexane was analysed by LSC before being blown down to dryness and re—dissolved in methanol (2 mL) for reverse phase LC analysis.
- Fish tissues by combustion: On each sampling occasion, 4 fish were randomly selected from each test vessel. The fish were killed, dissected and frozen until required for analysis. The tissues were then dried for approximately 1 hour at 60 ˚C before being combusted in a sample oxidiser.
- Analysis of fish tissue by TLC: Analysis of fish tissue residues by TLC was performed using solvent extracts of homogenised fish sampled on exposure days 56, 60, 110 and 120. The fish were sampled from the test vessels at the designated time and stored in a deep freeze for subsequent analysis. Each batch of fish sampled (4 fish per vessel per sampling occasion) was removed from the freezer, defrosted and weighed. The fish were then frozen in liquid nitrogen and homogenised to a powder using a pestle and mortar. Duplicate 1 g portions were then extracted twice with 5 mL acetonitrile and twice with 5 mL acetonitrile:water (50:50) using a roller/shaking device After each extraction the mixture was centrifuged (10395 G for 10 minutes). The acetonitrile and acetonitrile:water supernatants were transferred to separate 10 mL volumetric flasks and made up to volume, if required, with deionised water. An 8.2 mL sub-sample from each extract was removed and analysed by LSC. The remaining 1.8 mL was reserved for TLC. After the final solvent extraction, the residual fish tissue was sub-sampled in triplicate for combustion.
- Lipid analysis of the fish tissues: The lipid analysis was carried out on fish sampled on exposure day 0 (8 excess fish from stock supply) and day 120 (4 fish from each treatment vessel). 4 males and 4 females were sampled on day 0, 1 male and 3 females from each of the solvent control and 10 µg/L [14C]- labelled test substance concentration and 2 males and 2 females were taken from the 1.0 µg/L [14C]- labelled test substance on day 120. On each occasion the sacrificed fish were weighed prior to being stored frozen. On 17 February 2004, the fish were defrosted and the total weight of the pooled fish determined. The fish were then frozen in liquid nitrogen and homogenised to a powder using a pestle and mortar. Lipid analysis was then performed between the dates 23 March and 29 April 2004. Depending upon the weight of fish, triplicate 2 - 4 g samples of the homogenate were solvent extracted with 80 mL of chloroform : methanol (50:50) on a roller-shaker overnight. The homogenate was filtered through a filter paper and the filtrate collected in a pre-dried (50°C for 24 hours) and pre-weighed 250 mL round bottomed flask. The extraction vessel and filter were rinsed with a further 80 mL chloroform : methanol (50:50) mixture. The solvent mixture was then removed by rotary evaporation (40°C and under vacuum). The round bottom flask was placed in an oven at 50°C. The flask was removed periodically and weighed until the flask and its lipid contents had reached a constant weight. - Vehicle:
- yes
- Remarks:
- Triethylene Glycol (TEG)
- Details on preparation of test solutions, spiked fish food or sediment:
- - Preparation of stock concentrates and stock solutions: Nominal [14C]-labelled test substance concentrations of 1.0 μg/L, 10 μg/L and a solvent control were used in the study. The [14C]-labelled test substance was continuously dosed into the test vessels from stock solutions made up in triethylene glycol (TEG).
- Nominal 1.0 µg/L concentrate and stocks: The test substance was mixed in 25 mL acetone and the specific activity of the resulting concentrate was measured to be 898 MBq/g. The total radioactivity of this solution was determined to be 59.8 MBq and this is equated to 67 mg of the test substance.
- Nominal 10 µg/L concentrate and stocks: The test substance was mixed in 25 mL acetone and the specific activity of the resulting concentrate was measured to be 90 MBq/g. The total radioactivity of this solution was determined to be 58.1 MBq and this is equated to 646 mg of the test substance. Known volumes of the concentrate were evaporated and re-dissolved in TEG to give 100 mg/L of the test substance stocks. Sub-samples (3 x 0.1 g) of each stock solution were weighed into scintillation vials and analysed by LSC.
- Dosing of stocks: Dosing stocks were replenished every 14 to 17 days. Similarly 1.5 L of TEG were added to a glass jar to act as the solvent control stock solution. A magnetic follower was added to each jar. The jars were then weighed and placed on the test rig and the magnetic stirrers started. The stock solutions were delivered at a nominal flow rate of 0.070 mL/min to the mixing chambers. The flow rates of the stock solutions and of the dilution water were measured on day 0 and thereafter three times per week. The test and control tanks were dosed at 100 µL/L of TEG.
- Preparation of additional stocks: For the nominal 1.0 µg/L concentration a second mixed concentrate was prepared on exposure day 56 (using unlabelled test substance) with a specific activity of 876 MBq/g. The total radioactivity of this solution was determined to be 1.9 MBq and this equated to 2 mg test substance in 25 mL acetone. For the nominal 10 µg/L concentration a second mixed concentrate was also prepared on exposure day 50 (using unlabelled lufenuron) with a specific activity of 91 MBq/g The total radioactivity of this solution was determined to be 10.3 MBq and this equated to 113 mg lufenuron in 21 mL acetone. These mixed concentrates were then dosed following the same procedure as for the original. - Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- TEST ORGANISM
- Common name: Fathead minnow
- Source: Bred stocks from the test facility that had hatched between 14 and 15 October 2003
- Batch No.: Ref 47/02
- Length at study initiation: 41 - 60 mm
- Weight at study initiation: 2.1 - 6.3 g
- Feeding: The proprietary fish food is described by the suppliers as containing 60% protein, 16% fat, 7% ash and 0.5% fibre.
ACCLIMATION
- Acclimation period: From 15 Oct. 2002 until use
- Acclimation conditions: In fibreglass aquaria under artificial lighting. No medication was given to the fish prior to the study.
- Health during acclimation: The fish were considered to be in good condition as no mortalities were observed in the stock population over the 48 hours prior to the start of the test and only 0.2% mortality had occurred during the previous 7 days in the batch of fish used in this study. - Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 60 d
- Total depuration duration:
- 60 d
- Hardness:
- 40.7 – 55.0 mg/L as CaCO3
- Test temperature:
- 25 ± 1°C
- pH:
- 7.0 - 8.0
- Dissolved oxygen:
- 4.8 - 8.2 mg O2/L
- Conductivity:
- 241 ± 22.5 µS/cm at 25 ˚C
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass vessels (external dimensions; 915 mm x 305 mm x 465 mm (length x width x height)), with a maximum capacity of 120 L.
- Fill volume: 105 L
- Type of flow-through: Peristaltic diluter
- Renewal rate of test solution: The test solutions were renewed at a nominal rate of 700 mL to produce 9.6 volume additions per 24 hours
- No. of organisms per vessel: 136
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): 1
- Biomass loading rate: The fish loading at the start of the exposure phase (day 0) was 0.46 g/L/day based on a flow rate of 700 mL/min and the solvent control mean bulk weighing.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The dilution water was dechlorinated tap water, which had been passed through activated carbon, coarsely filtered to remove particulate material and dechlorinated with sodium thiosulphate. Salts were added, as required, to maintain minimum hardness levels, and the treated water was then passed through an ultraviolet steriliser to a second set of 20 and 10 µm filters. The supply was then delivered to a temperature controlled header tank in the test laboratory set to the nominal test temperature of 25 ± 1°C and finally filtered to 5 µm before use. The dechlorinated water supply is also monitored periodically for total ammonia, chemical oxygen demand, total organic carbon, total suspended solids, a range of cations and anions, trace metals, pesticides and other hydrocarbons. It is considered that none of the contaminants were present in sufficient quantity to have adversely affected the quality of the study.
- Test procedure: The test system was prepared on 9 July 2003 when the randomised vessels were filled with dilution water for the first time. [14C]-labelled test substance was first dosed into the test system on exposure day -2 (21 July 2003) to allow time for test solutions to reach equilibrium before fish exposure. The exposure phase started on exposure day 0 (23 July 2003), by placing the required number of fathead minnow into each vessel.
OTHER TEST CONDITIONS
- Photoperiod: 16 hours light:8 hours dark with 20 minute dawn and dusk transition periods
- Light intensity: 610 — 660 lux - Nominal and measured concentrations:
- Nominal concentrations: 0 (solvent control), 1.0, 10 µg/L
Measured concentrations: 0 (solvent control), 0.9, 8.7 µg/L, respectively. (see Table 1 - Table 2 in 'Any other information on results incl. tables') - Reference substance (positive control):
- no
- Details on estimation of bioconcentration:
- The kinetic bioconcentration factor, BCFk, was calculated using the KINETICS program as the ratio of the uptake rate constant to the depuration rate constant. 95%confidence limits for the kinetic bioconcentration factor were calculated using the Bootstrap method.
- Lipid content:
- 10.98 %
- Time point:
- other: throughout study
- Remarks on result:
- other: 1.0 µg/L treatment
- Lipid content:
- 8.3 %
- Time point:
- other: throughout study
- Remarks on result:
- other: 10 µg/L treatment
- Key result
- Conc. / dose:
- 10 µg/L
- Temp.:
- 25 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- 16 265 L/kg
- Basis:
- whole body w.w.
- Time of plateau:
- 120 d
- Calculation basis:
- kinetic
- Remarks on result:
- other: 5% lipid normalised; 10 µg/L treatment
- Conc. / dose:
- 1 µg/L
- Temp.:
- 25 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- 12 756 L/kg
- Basis:
- whole body w.w.
- Time of plateau:
- 120 d
- Calculation basis:
- kinetic
- Remarks on result:
- other: 5% lipid normalised; 1 µg/L treatment
- Conc. / dose:
- 1 µg/L
- Temp.:
- 25 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- 28 000 L/kg
- Basis:
- whole body w.w.
- Time of plateau:
- 120 d
- Calculation basis:
- kinetic
- Remarks on result:
- other: 1 µg/L treatment
- Conc. / dose:
- 10 µg/L
- Temp.:
- 25 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- 27 000 L/kg
- Basis:
- whole body w.w.
- Time of plateau:
- 120 d
- Calculation basis:
- kinetic
- Remarks on result:
- other: 10 µg/L treatment
- Conc. / dose:
- 1 µg/L
- Temp.:
- 25 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- 21 000 L/kg
- Basis:
- whole body w.w.
- Time of plateau:
- 60 d
- Calculation basis:
- steady state
- Remarks on result:
- other: 1 µg/L treatment
- Conc. / dose:
- 10 µg/L
- Temp.:
- 25 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- 19 000 L/kg
- Basis:
- whole body w.w.
- Time of plateau:
- 60 d
- Calculation basis:
- steady state
- Remarks on result:
- other: 10 µg/L treatment
- Remarks on result:
- other: > 25% depuration after 29 days; > 79% depuration within 60 days.
- Rate constant:
- overall uptake rate constant (L kg-1 d-1)
- Value:
- 938
- Remarks on result:
- other: 1.0 µg/L treatment
- Rate constant:
- overall uptake rate constant (L kg-1 d-1)
- Value:
- 644
- Remarks on result:
- other: 10 µg/L treatment
- Rate constant:
- overall depuration rate constant (d-1)
- Value:
- 0.034
- Remarks on result:
- other: 1.0 µg/L treatment
- Rate constant:
- overall depuration rate constant (d-1)
- Value:
- 0.024
- Remarks on result:
- other: 10 µg/L treatment
- Details on kinetic parameters:
- ACCUMULATION PHASE
- 1.0 µg/L treatment: The uptake rate constant, K1, based on the predicted curve from the KINETICS program was calculated be 938/day with 95% confidence limits (736, 1170).
- 10 µg/L treatment: The uptake rate constant, K1, based on the predicted curve from the KINETICS program was calculated to be 644/day with 95% confidence limits (542, 768).
DEPURATION PHASE
The depuration rate constants, K2, based on the predicted curves from the KINETICS program were calculated to be 0.0335/day with 95% confidence limits (0.0256, 0.0440) for the nominal 1.0 µg/L and 0.0239/day with 95% confidence limits (0.0184, 0.0313) for the nominal 10 µg/L treatments. - Metabolites:
- - Analytical results - fish tissues by Thin Layer Chromatography (TLC): Fish extracts analysed by TLC at the end of the accumulation and depuration phases confirmed that the residues in the fish tissues were predominately the test substance, therefore no metabolite characterisation was required. For the 1.0 and 10 µg/L treatments, 92 - 96% and 91 - 96% of the 14C residues respectively were characterised as the parent substance.
- Details on results:
- An overview of the results is provided in Table 1 - Table 7 in 'Any other information on results incl. tables'.
- Analytical results- test solutions: The measured concentrations in the 1.0 µg/L tank during the exposure period ranged from 0.50 to 1.7 µg/L with a time weighted mean of 0.90 µg/L 14C-labelled test substance equivalents, representing 90% of the nominal value. The measured concentration in the 10 µg/L tank similarly ranged from 4.9 to 20 µg/L with a time weighted mean of 8.7 µg/L 14C-labelled test substance equivalents, representing 87% of the nominal value. Time weighted means are used for calculation of the results. Characterisation of the radioactivity in the methanol samples by HPLC confirmed that it was predominately the test substance. The range measured between exposure day 0 and day 60 was 94 - 100% in the 1.0 µg/L test substance treated vessels and 97 - 99% in the 10 µg/L test substance treated vessels.
- Analytical results- fish tissues by combustion: Due to an oversight in the sampling schedule, measurement of radioactivity in the individual tissues as described in the method was not performed on exposure days 56, 60, l 10 and 120. In order to obtain data for these occasions, data from the specific analysis has been used to calculate whole body concentrations.
- Exposure (accumulation) phase: The lipid content in the fish used for calculation of the lipid BCF for [14C]l-labelled test substance was 9.6% (w/w), the mean value of all lipid analyses. The radioactivity expressed as 14C-labelled test substance equivalents was found to accumulate within the tissues. Although a clear plateau is not apparent, measured concentrations do not increase consistently over the last four whole body concentrations. Therefore, BCF at the end of exposure has been calculated to give an effective “plateau” (whole body concentration of 18630 µg 14C-labelled test substance equivalents/kg) for the nominal 1.0 µg/L treatment. The mean concentrations of 14C-labelled test substance equivalents determined in the various tissues and in the whole body during the plateau stage of the exposure phase are summarised with the respective, calculated BCF values for the nominal 1.0 µg/L treatment in the data below. The data below are the means of the individual concentrations recorded at exposure days 54 and 59 viscera, flesh and carcass and 54, 56, 58 and 60 for whole body. Standard deviations are calculated for these means.
1.0 µg/L 14C-labelled test substance
Viscera (wet weight): 26538 ± 12887 µg/kg; BCF = 29000L/kg
Flesh (wet weight): 11988 ± 8786 µg/kg; BCF = 13000L/kg
Carcass (wet weight): 14625 ± 3147 µg/kg; BCF = 16000L/kg
Whole body (wet weight): 18630 ± 8280 µg/kg; BCF = 21000L/kg
Whole body (lipid content): 194063 ± 86250 µg/kg; BCF = 220000L/kg
Similarly, for the nominal 10 µg/L treatment, the radioactivity expressed as 14C- labelled test substance equivalents was found to accumulate within the tissues and reached an effective “plateau” (whole body concentration of 168540 µg 14C- labelled test substance equivalents/kg) at the end of exposure. The values below are the means of the individual concentrations determined at exposure days 54 and 58 for viscera, flesh and carcass and 54, 56, 58 and 60 for whole body. Standard deviations are calculated for these means.
10 µg/L 14C-labelled test substance
Viscera (wet weight): 402713 ± 84552 µg/kg; BCF = 46000L/kg
Flesh (wet weight): 130225 ± 103379 µg/kg; BCF = 15000L/kg
Carcass (wet weight): 129963 ± 3553 µg/kg; BCF = 16000L/kg
Whole body (wet weight): 168540 ± 37271 µg/kg; BCF = 19000L/kg
Whole body (lipid content): 1755625 ± 388240 µg/kg; BCF = 200000L/kg
- Depuration phase: During the 60 days depuration phase the levels of [14C]-labelled test substance equivalents in the whole fish decreased steadily. Within 29 days of transfer to clean water the whole body residues in fish had dropped from the mean plateau phase concentrations by 49 and 25% in the nominal 1.0 and 10 μg/L treatments, respectively. After 60 days, 83 and 79% depuration had been achieved for the nominal 1.0 and 10 μg/L treatments, respectively. After 60 days of depuration > 79% of the [14C]-labelled test substance equivalents had been eliminated from the fish. These values are based on the mean values obtained for the accumulation plateau.
- Kinetic bioconcentration factor: The kinetic bioconcentration factor (BCFk) was calculated as the ratio of the uptake rate constant to the depuration rate constant (K1/K2). For the nominal 1.0 and 10 µg/L treatments, these were 28000 with 95% confidence limits (25000, 31000) and 27000 with 95% confidence limits (24000, 31000), respectively.
- Lipid content of the fish tissues: Samples showed a difference in lipid content between male and female fish and > 25% variation between male fish lipid was observed between the start and end of the study. This is considered to be due to changes in the sexual maturity of the males as the study progressed and is not considered to affect the validity of the study. As the difference was not consistent between the sexes, the mean lipid content was used for lipid normalisation of the BCF. The mean lipid contents on days 0 and at the end of the depuration phase were 8.8 and 9.8% respectively. The overall mean lipid content was 9.6%(w/w).
- Mortalities: Less than 5% mortality was observed in the population tested, which is considered acceptable for this type of study.
- Fish length and weight: The mean weights of the fish sampled as above at day 0 was 4.0 g with a range of weights from 2.1 to 6.3 g. The mean weight of fish sampled on day 120 from the solvent control was 5.0 g with a range of weights 2.4 to 12.1g. - Validity criteria fulfilled:
- yes
- Conclusions:
- In a bioaccumulation study in Fathead minnow, following OECD TG 305 and under GLP, the kinetic bioconcentration factor (BCFk) were calculated to be 28000 and 27000 L/kg for 1.0µg/L and 10µg/L, respectively. After 5% lipid content normalisation, the BCFk values were 12756 and 16265 L/kg for 1.0 and 10 µg/L treatments, respectively.
- Executive summary:
The bioaccumulation potential of the 14C- Dichlorophenyl-ring-labelled test substance was investigated in a flow-through study in accordance with OECD TG 305 and in compliance with GLP criteria. In this study, Fathead minnow (Pimephales promelas) were exposed to the radiolabelled test substance at nominal concentrations of 1 and 10µg/L (measured time weighted concentrations: 0.9 and 8.7µg/L, respectively) for 60-day uptake phase (136 fish per concentration). Afterwards, the fish were transferred to aquaria without the test substance for a 60-day depuration phase. In addition, a solvent control (acetone) was included as well and tested under the same condition. Specific activities were measured and confirmed by using LSC, TLC and HPLC. The test conditions were as following: pH 7.0 – 8.0, 25 ± 1 °C, 16 hours light -8 hours darkness cycle with 20 minute dawn and dusk transition periods (610 – 660 Lux). The water conditions were 40.7 – 55.0 mg/L total hardness (as CaCO3), 241 ± 22.5 µS/cm conductivity (at 25 ˚C) and 4.8 - 8.2 mg O2/L.
The results show that the test substance predominated the radioactivity in the analysed samples. The range measured test substance (between day 0 and day 60) was 94 -100% and 97 - 99% in the 1.0 and 10µg/L treatments, respectively. The radioactivity expressed as 14C-labelled test substance equivalents was found to accumulate within the tissues. Although a clear plateau is not apparent, measured concentrations do not increase consistently over the last four whole body concentrations. Therefore, BCF at the end of exposure has been calculated to give an effective “plateau” (whole body concentration of 18630 µg 14C-labelled test substance equivalents/kg) for the nominal 1.0 µg/L treatment. Similarly, for the nominal 10 µg/L treatment, the radioactivity expressed as 14C- labelled test substance equivalents was found to accumulate within the tissues and reached an effective “plateau” (whole body concentration of 168540 µg 14C- labelled test substance equivalents/kg) at the end of exposure. The mean values of lipid content were 10.98% (w/w) and 8.30% (w/w) for the 1.0 and 10 µg/L treatments, respectively. The depuration of accumulated residues from the whole body was steady with approximately > 25% depuration after 29 days and > 79% depuration within 60 days. Based on these findings, the update rate constants (K1) were calculated to be 938/day for the 1.0µg/L treatment and 644/day for the 10 µg/L treatment. The depuration rate constants (K2) were calculated to be 0.0335/day for the 1.0µg/L treatment and 0.0239/day for the 10 µg/L treatment. The kinetic bioconcentration factor (BCFk) were calculated to be 28000 and 27000 L/kg for 1.0 µg/L and 10 µg/L, respectively. After 5% lipid content normalisation, the BCFk values were 12756 and 16265 L/kg for 1.0 and 10 µg/L treatments, respectively.
Reference
Table 1. Water analysis- LSC results
Study day |
Solvent control |
1.0 µg/L |
10 µg/L |
-1 |
<0.5 |
0.76 |
8.1 |
0 |
<0.5 |
0.86 |
9.6 |
1 |
<0.5 |
0.56 |
5.3 |
2 |
<0.5 |
0.75 |
4.9 |
5 |
<0.5 |
0.50 |
5.0 |
7 |
<0.5 |
0.53 |
5.4 |
14 |
<0.5 |
0.73 |
5.3 |
21 |
<0.5 |
1.1 |
10 |
28 |
<0.5 |
0.84 |
5.4 |
37 |
<0.5 |
1.1 |
11 |
42 |
<0.5 |
0.85 |
20 |
47 |
<0.5 |
0.99 |
17 |
49 |
<0.5 |
1.7 |
13 |
56 |
<0.5 |
1.0 |
11 |
60 |
<0.5 |
1.1 |
7.6 |
61 |
<0.5 |
0.19 |
1.4 |
120 |
<0.5 |
<0.50 |
<0.50 |
Time weighted mean |
<0.5 |
0.90 |
8.7 |
Percentage of nominal |
- |
90 |
87 |
a. Time weighted mean excludes data from days -1, 61 and 120
Table 2. Water analysis- HPLC results
Study day |
Treatment (µg/L) |
Measured conc. of the test substance equivalents by LSC (µg/L) |
Percentage of radioactivity recovered in total procedure |
Percentage of test substance determined in methanol sample by HPLC |
0 |
1.0 |
0.86 |
97 |
100 |
10 |
9.6 |
95 |
99 |
|
14 |
1.0 |
0.73 |
90 |
94 |
10 |
5.3 |
94 |
97 |
|
28 |
1.0 |
0.84 |
95 |
99 |
10 |
5.4 |
90 |
99 |
|
47 |
1.0 |
0.99 |
91 |
97 |
10 |
17 |
96 |
98 |
|
60 |
1.0 |
1.1 |
88 |
98 |
10 |
7.6 |
96 |
98 |
Table 3. Measured concentration of 14C-labelled test substance equivalents in fish tissues (exposed at 1.0 µg/L; expressed as µg/kg)
A) Accumulation phase
Fish no.# |
Exposure days |
7 |
14 |
21 |
28 |
35 |
42 |
49 |
52 |
54 |
56 |
58 |
60 |
1 |
Viscera |
4100 |
10800 |
35600 |
40600 |
36300 |
34800 |
64500 |
30400 |
16800 |
- |
28100 |
- |
Flesh |
500 |
2000 |
3900 |
5200 |
3200 |
2900 |
13100 |
6800 |
29300 |
- |
4000 |
- |
|
Carcass |
1000 |
5400 |
8500 |
14100 |
6300 |
9400 |
28800 |
12200 |
20300 |
- |
7800 |
- |
|
Whole body |
1100 |
6200 |
14400 |
20600 |
8100 |
11200 |
34000 |
14000 |
20700 |
24500 |
8700 |
30200 |
|
2 |
Viscera |
7000 |
16800 |
28700 |
37700 |
62400 |
50700 |
53900 |
91000 |
35300 |
- |
43500 |
- |
Flesh |
2100 |
4200 |
6300 |
2100 |
4500 |
11100 |
10100 |
9000 |
6000 |
- |
5400 |
- |
|
Carcass |
3600 |
9000 |
4500 |
13500 |
16300 |
23100 |
19900 |
18300 |
3200 |
- |
24200 |
- |
|
Whole body |
4100 |
10100 |
8300 |
15500 |
21700 |
30200 |
26700 |
27400 |
7000 |
- |
27000 |
- |
|
3 |
Viscera |
11500 |
11200 |
34500 |
59300 |
34400 |
18000 |
27200 |
52200 |
9500 |
- |
35500 |
- |
Flesh |
2400 |
2600 |
5800 |
3700 |
7200 |
4700 |
8400 |
10600 |
21100 |
- |
7100 |
- |
|
Carcass |
3800 |
5600 |
7100 |
8900 |
18400 |
9700 |
17400 |
16900 |
4600 |
- |
19300 |
- |
|
Whole body |
5100 |
6700 |
13100 |
15500 |
21400 |
11500 |
19500 |
24700 |
7500 |
- |
22000 |
- |
|
4 |
Viscera |
9400 |
19800 |
27200 |
26600 |
33800 |
41500 |
47700 |
65600 |
8100 |
- |
35500 |
- |
Flesh |
1900 |
2000 |
3400 |
5400 |
8400 |
5300 |
5900 |
16300 |
16400 |
- |
6600 |
- |
|
Carcass |
1600 |
5200 |
8800 |
10300 |
16000 |
22100 |
8200 |
20300 |
21500 |
- |
16100 |
- |
|
Whole body |
3200 |
6800 |
12200 |
14400 |
20000 |
26200 |
11100 |
32600 |
17900 |
- |
20800 |
- |
|
Mean |
Viscera |
8000 |
14650 |
31500 |
41050 |
41725 |
36250 |
48325 |
59800 |
17425 |
- |
35650 |
- |
Flesh |
1725 |
2700 |
4850 |
4100 |
5825 |
6000 |
9375 |
10675 |
18200 |
- |
5775 |
- |
|
Carcass |
2500 |
6300 |
7225 |
11700 |
14250 |
16075 |
18575 |
16925 |
12400 |
- |
16850 |
- |
|
Whole body |
3375 |
7450 |
12000 |
16500 |
17800 |
19775 |
22825 |
24675 |
13275 |
24500 |
19625 |
30200 |
|
BCF(min) |
Whole body |
1100 |
6200 |
8300 |
14400 |
8100 |
11200 |
11100 |
14000 |
7000 |
- |
8700 |
- |
BCF(max) |
Whole body |
5100 |
10100 |
14400 |
20600 |
21700 |
30200 |
34000 |
32600 |
20700 |
- |
24000 |
- |
BCF |
Whole body |
3750 |
8278 |
13333 |
18333 |
19778 |
21972 |
25361 |
27417 |
14750 |
27222 |
21806 |
33556 |
Bioaccumulation Plateau Phase Mean BCF* |
20700 |
B) Depuration phase
Fish no. # |
Study days |
61 |
63 |
68 |
75 |
82 |
89 |
96 |
103 |
110 |
117 |
120 |
|
Depuration days |
1 |
3 |
8 |
15 |
22 |
29 |
36 |
43 |
50 |
57 |
60 |
1 |
Viscera |
51600 |
77300 |
47100 |
600 |
29300 |
20900 |
9900 |
NR. |
- |
26800 |
- |
Flesh |
5500 |
9100 |
5900 |
100 |
5700 |
2800 |
1300 |
6400 |
- |
11600 |
- |
|
Carcass |
10500 |
17200 |
20700 |
100 |
8800 |
6400 |
3000 |
5800 |
- |
4600 |
- |
|
Whole body |
19500 |
22000 |
24600 |
100 |
13600 |
9500 |
3300 |
NR |
3700 |
7700 |
3200 |
|
2 |
Viscera |
NR |
68100 |
49700 |
41300 |
11500 |
27400 |
18500 |
18300 |
- |
2000 |
- |
Flesh |
NR |
12000 |
11500 |
12900 |
3200 |
3300 |
4200 |
2700 |
- |
300 |
- |
|
Carcass |
NR |
20900 |
19900 |
12100 |
4500 |
9000 |
5200 |
6700 |
- |
600 |
- |
|
Whole body |
NR |
28300 |
26100 |
19800 |
6400 |
13200 |
8200 |
9300 |
- |
600 |
- |
|
3 |
Viscera |
42600 |
35500 |
38600 |
1600 |
29300 |
NR |
38300 |
4900 |
- |
3900 |
- |
Flesh |
6800 |
8500 |
8000 |
200 |
2600 |
3600 |
1900 |
800 |
- |
1400 |
- |
|
Carcass |
21100 |
18700 |
18100 |
200 |
5800 |
4900 |
5700 |
1600 |
- |
2000 |
- |
|
Whole body |
25000 |
22200 |
22000 |
300 |
7700 |
NR |
9300 |
2200 |
- |
2400 |
- |
|
4 |
Viscera |
69400 |
37500 |
4600 |
4500 |
24100 |
11400 |
5800 |
3400 |
- |
6500 |
- |
Flesh |
7700 |
5700 |
900 |
1100 |
6600 |
2600 |
600 |
500 |
- |
2200 |
- |
|
Carcass |
22000 |
18200 |
900 |
1900 |
10600 |
4100 |
1500 |
1500 |
- |
5600 |
- |
|
Whole body |
31000 |
22100 |
1100 |
2600 |
13700 |
5600 |
1700 |
2000 |
- |
5700 |
- |
|
Mean |
Viscera |
54533 |
54600 |
35000 |
12000 |
23550 |
19900 |
18125 |
8867 |
- |
9800 |
- |
Flesh |
6667 |
8825 |
6575 |
3575 |
4525 |
3075 |
2000 |
2600 |
- |
3875 |
- |
|
Carcass |
17867 |
18750 |
14900 |
3575 |
7425 |
6100 |
3850 |
3900 |
- |
3200 |
- |
|
Whole body |
25167 |
23650 |
18450 |
5700 |
10350 |
9433 |
5625 |
4500 |
3700 |
4100 |
3200 |
|
(min) |
Whole body |
19500 |
22000 |
1100 |
100 |
6400 |
5600 |
1700 |
2000 |
- |
600 |
- |
(max) |
Whole body |
31000 |
28300 |
26100 |
19800 |
13700 |
13200 |
9300 |
9300 |
- |
7700 |
- |
%Depuration from Plateau phase (mean whole body)^ |
-38 |
-27 |
1 |
69 |
44 |
49 |
70 |
76 |
80 |
78 |
83 |
NR: No result, due to incomplete combustion of tissue by sample oxidiser, so replicate data not included in Mean calculations and “whole body” calculations not possible
- Individual tissue measurements not available, mean whole body concentration calculated from specific analysis
* Mean plateau BCF (Whole body) over the period 54 to 60 days was 20700. This figure has been calculated using whole body concentrations during the stable plateau phase (study days 54 to 60) and the time weighted mean measured concentration of 14C-labelled test substance equivalents in water during the exposure period
# Fish number refers to replicate number of each batch of 4 fish sampled at each time point
^ Mean whole body plateau concentration is 18630
Table 4. Measured concentration of 14C-labelled test substance equivalents in fish tissues (exposed at 10 µg/L; expressed as µg/kg)
A) Accumulation phase
Fish no.# |
Study days |
7 |
14 |
21 |
28 |
35 |
42 |
49 |
52 |
54 |
56 |
58 |
60 |
1 |
Viscera |
98500 |
116800 |
251400 |
NR |
444600 |
482400 |
405200 |
241600 |
100000 |
- |
765100 |
- |
Flesh |
12900 |
21900 |
21800 |
21500 |
39300 |
39500 |
45200 |
40300 |
651600 |
- |
55600 |
- |
|
Carcass |
22700 |
60800 |
51100 |
53900 |
77900 |
114900 |
91800 |
88100 |
30200 |
- |
125700 |
- |
|
Whole body |
11900 |
71700 |
62100 |
NR |
106700 |
141200 |
110700 |
98500 |
81100 |
173000 |
192500 |
181000 |
|
2 |
Viscera |
99800 |
151500 |
370300 |
340900 |
380700 |
170300 |
668400 |
603400 |
334300 |
- |
337800 |
- |
Flesh |
17100 |
38900 |
25700 |
74600 |
42000 |
43900 |
84500 |
33500 |
49100 |
- |
84800 |
- |
|
Carcass |
27800 |
43100 |
67600 |
81400 |
95700 |
91500 |
NR. |
119800 |
190800 |
- |
146900 |
- |
|
Whole body |
37500 |
57800 |
100800 |
141600 |
119600 |
104900 |
NR. |
156500 |
221400 |
- |
193600 |
- |
|
3 |
Viscera |
104500 |
191600 |
157500 |
286700 |
348200 |
419100 |
343400 |
419200 |
463600 |
- |
273500 |
- |
Flesh |
17000 |
27400 |
41600 |
30500 |
80500 |
55300 |
85600 |
539400 |
51200 |
- |
43400 |
- |
|
Carcass |
41300 |
70300 |
91800 |
69700 |
150700 |
162100 |
129300 |
135800 |
141200 |
- |
134500 |
- |
|
Whole body |
49300 |
88000 |
102000 |
86400 |
199500 |
216200 |
174200 |
221400 |
162800 |
- |
166200 |
- |
|
4 |
Viscera |
102500 |
124600 |
374500 |
325200 |
287100 |
443500 |
408200 |
451800 |
473800 |
- |
473600 |
- |
Flesh |
13600 |
35500 |
32800 |
56300 |
44500 |
106900 |
49800 |
62300 |
61400 |
- |
44700 |
- |
|
Carcass |
34600 |
55800 |
84500 |
116700 |
89400 |
156300 |
78700 |
176500 |
147600 |
- |
122800 |
- |
|
Whole body |
36100 |
68800 |
104600 |
156800 |
98400 |
207600 |
103800 |
219700 |
170600 |
- |
143200 |
- |
|
Mean |
Viscera |
101325 |
146125 |
288425 |
317600 |
365150 |
378825 |
456300 |
429000 |
342925 |
- |
462500 |
- |
Flesh |
15150 |
30925 |
30475 |
45725 |
51575 |
61400 |
66275 |
168875 |
203325 |
- |
57125 |
- |
|
Carcass |
31600 |
57500 |
73750 |
80425 |
103425 |
131200 |
99933 |
130050 |
127450 |
- |
132475 |
- |
|
Whole body |
33700 |
71575 |
92375 |
128267 |
131050 |
167475 |
129567 |
174025 |
158975 |
17300 |
173875 |
181000 |
|
BCF(min) |
Whole body |
11900 |
57800 |
62100 |
86400 |
98400 |
104900 |
103800 |
98500 |
81100 |
- |
143200 |
- |
BCF(max) |
Whole body |
49300 |
88000 |
104600 |
156800 |
199500 |
216200 |
174200 |
221400 |
221400 |
- |
193600 |
- |
BCF |
Whole body |
3874 |
8227 |
10618 |
14743 |
15063 |
19250 |
14893 |
20003 |
18273 |
19885 |
19986 |
20805 |
Bioaccumulation Plateau Phase Mean BCF* |
19373 |
B) Depuration phase
Fish no.# |
Study days |
61 |
63 |
68 |
75 |
82 |
89 |
96 |
103 |
110 |
117 |
120 |
|
Depuration days |
1 |
3 |
8 |
15 |
22 |
29 |
36 |
43 |
50 |
57 |
60 |
1 |
Viscera |
465100 |
594300 |
311800 |
14700 |
360300 |
100100 |
7700 |
49200 |
- |
70800 |
- |
Flesh |
44600 |
59000 |
31800 |
3500 |
48100 |
25400 |
1400 |
13400 |
- |
8700 |
- |
|
Carcass |
116500 |
134800 |
62300 |
4200 |
75200 |
53800 |
2100 |
25000 |
- |
22500 |
- |
|
Whole body |
142100 |
164000 |
82100 |
4800 |
106100 |
64600 |
2500 |
31100 |
44000 |
25500 |
|
|
2 |
Viscera |
353600 |
433900 |
337200 |
437900 |
272200 |
254600 |
99000 |
158300 |
- |
190800 |
- |
Flesh |
50300 |
103800 |
50700 |
80800 |
NR |
85500 |
28700 |
20800 |
- |
55100 |
- |
|
Carcass |
101500 |
201300 |
122300 |
131600 |
92000 |
116800 |
45500 |
38600 |
- |
43500 |
- |
|
Whole body |
121200 |
248700 |
157900 |
160200 |
NR |
155100 |
58700 |
48500 |
- |
56500 |
- |
|
3 |
Viscera |
641900 |
545300 |
NR |
367000 |
51000 |
548000 |
238800 |
6000 |
- |
248000 |
- |
Flesh |
64700 |
158900 |
30400 |
186900 |
14900 |
39400 |
59700 |
1700 |
- |
62500 |
- |
|
Carcass |
212200 |
136900 |
130400 |
166000 |
27300 |
87100 |
98200 |
2100 |
- |
51200 |
- |
|
Whole body |
286500 |
227700 |
NR |
221400 |
33100 |
125500 |
134200 |
2300 |
- |
86900 |
- |
|
4 |
Viscera |
NR |
761000 |
578600 |
423000 |
58800 |
379400 |
384800 |
13100 |
- |
31920 |
- |
Flesh |
NR |
103900 |
87600 |
112000 |
17100 |
42700 |
26100 |
3900 |
- |
11175 |
- |
|
Carcass |
NR |
142800 |
141600 |
105800 |
22400 |
108100 |
69400 |
6700 |
- |
20950 |
- |
|
Whole body |
NR |
220100 |
199400 |
168400 |
31600 |
162500 |
89400 |
6900 |
- |
22870 |
- |
|
Mean |
Viscera |
486867 |
583625 |
409200 |
310650 |
185575 |
320525 |
182575 |
56650 |
- |
135380 |
- |
Flesh |
53200 |
1 06400 |
50125 |
95800 |
26700 |
48250 |
28975 |
9950 |
- |
34369 |
- |
|
Carcass |
143400 |
153950 |
114150 |
101900 |
54225 |
91450 |
53800 |
18100 |
- |
34538 |
- |
|
Whole body |
183267 |
215125 |
146467 |
138700 |
56933 |
126925 |
71200 |
22200 |
30200 |
47943 |
36000 |
|
(min) |
Whole body |
121200 |
164000 |
82100 |
4800 |
31600 |
64600 |
2500 |
2300 |
- |
22870 |
- |
(max) |
Whole body |
286500 |
248700 |
199400 |
221400 |
106100 |
162500 |
134200 |
48500 |
- |
86900 |
- |
%Depuration from Plateau phase (mean whole body)^ |
-9 |
-28 |
13 |
18 |
66 |
25 |
58 |
87 |
74 |
72 |
79 |
NR: No result, due to incomplete combustion of tissue by sample oxidiser, so replicate data not included in Mean calculations and “whole body” calculations not possible
- Individual tissue measurements not available, mean whole body concentration calculated from specific analysis
* Mean plateau BCF (Whole body) over the period 54 to 60 days was 19373. This figure has been calculated using whole body concentrations during the stable plateau phase (study days 54 to 60) and the time weighted mean measured concentration of 14C-labelled test substance equivalents in water during the exposure period
# Fish number refers to replicate number of each batch of 4 fish sampled at each time point
^ Mean whole body plateau concentration is 168540
Table 5. Analysis of fish tissues expressed as mean concentration in lipid
A) accumulation phase
|
|
1.0µg/L treatment (µg/kg in lipid) |
|||||||||||
|
Study days |
7 |
14 |
21 |
28 |
35 |
42 |
49 |
52 |
54 |
56 |
58 |
60 |
Mean |
Whole body |
35156 |
77604 |
125000 |
171875 |
185417 |
205990 |
237760 |
257031 |
138281 |
255208 |
204427 |
314583 |
BCF^ |
Whole body |
39062 |
86227 |
138889 |
190972 |
206019 |
228878 |
264178 |
285590 |
1 53646 |
283564 |
227141 |
349537 |
Mean plateau BCF (Whole body)* |
215625 |
||||||||||||
|
|
10µg/L treatment (µg/kg in lipid) |
|||||||||||
|
Study days |
7 |
14 |
21 |
28 |
35 |
42 |
49 |
52 |
54 |
56 |
58 |
60 |
Mean |
Whole body |
351042 |
745573 |
962240 |
1336115 |
1365104 |
1744531 |
1349656 |
1813021 |
1655990 |
1802083 |
1811198 |
1885417 |
BCF |
Whole body |
40350 |
85698 |
110602 |
153576 |
156909 |
200521 |
155133 |
208363 |
190344 |
2071 36 |
208 1 84 |
216715 |
Mean plateau BCF (Whole body)* |
201796 |
B) Depuration phase
|
1.0µg/L treatment (µg/kg in lipid) |
|||||||||||
Study days |
61 |
63 |
68 |
75 |
82 |
89 |
96 |
103 |
110 |
117 |
120 |
|
Depuration days |
1 |
3 |
8 |
15 |
22 |
29 |
36 |
43 |
50 |
57 |
60 |
|
Mean^ |
Whole body |
268750 |
246354 |
192188 |
59375 |
107813 |
98260 |
58594 |
46875 |
38542 |
75729 |
33333 |
|
|
10µg/L treatment (µg/kg in lipid) |
||||||||||
Study days |
61 |
63 |
68 |
75 |
82 |
89 |
96 |
103 |
110 |
117 |
120 |
|
Depuration days |
1 |
3 |
8 |
15 |
22 |
29 |
36 |
43 |
50 |
57 |
60 |
|
Mean |
Whole body |
1909031 |
2240885 |
1525698 |
1444792 |
593052 |
1322135 |
741667 |
231250 |
458333 |
499406 |
375000 |
^ Based on mean % lipid content of 9.6% (w/w)
* This figure has been calculated using whole body concentrations during the stable plateau phase (study days 54 to 60 for the 1.0 and 10µg/L) and the mean measured concentration of 14C-labelled test substance equivalents in water during the exposure period
Table 6. TLC analysis- Fish
Study day |
Treatment (µg/L) |
Mean recovery of radioactivity (%) |
% of extractable characterised as the test substance |
56 |
1.0 |
106 |
92 |
56 |
10 |
95 |
91 |
60 |
1.0 |
96 |
94 |
60 |
10 |
101 |
95 |
110 |
1.0 |
82 |
96 |
110 |
10 |
95 |
95 |
120 |
1.0 |
85 |
92 |
120 |
10 |
85 |
96 |
Table 7. Lipid analysis
Sample identity |
replicate |
Lipid content (% w/w) |
Mean lipid content (% w/w) |
SD |
Mean lipid content throughout study (% w/w) |
Study day 0 excess fish at start male fish |
1 2 3 |
5.6 5.7 5.3 |
5.5*^ |
0.21 |
9.6 |
Study day 0 excess fish at start female fish |
1 2 3 |
10.0 - 13.9 |
12.0*^ |
2.76 |
|
Study day 120 solvent control male fish |
1 2 3 |
4.3 4.4 - |
4.4 |
0.07 |
|
Study day 120 solvent control female fish |
1 2 3 |
12.3 12.6 12.6 |
12.5 |
0.17 |
|
Study day 120 1.0µg/L male fish |
1 2 3 |
11.8 11.6 11.2 |
11.5* |
0.15 |
|
Study day 120 1.0µg/L female fish |
1 2 3 |
16.4 13.4 - |
14.9* |
0.62 |
|
Study day 120 10µg/L male fish |
1 2 3 |
3.5 3.3 3.6 |
3.5^ |
0.31 |
|
Study day 120 10µg/L female fish |
1 2 3 |
12.0 12.9 11.7 |
12.2^ |
2.12 |
- Sample lost
a. >25% variation from start to end of test, not considered to affect the validity of the study
* Used in calculating the mean lipid content for 1.0µg/L, = 10.98 % (w/w)
^ Used in calculating the mean lipid content for 10µg/L, = 8.30 % (w/w)
Table 8. kinetic bioconcentration factors (BCFk)
|
1.0µg/L treatment |
10µg/L treatment |
Uptake rate constant (K1) |
938/day |
644/day |
Depuration rate constant (K2) |
0.00335/day |
0.0239/day |
BCFk |
28000 |
27000 |
Description of key information
All available data was assessed and the studies representing the worst-case effects were included as key study. Other studies are included as supporting information.
BCF = 16265 L/kg (5% lipid normalised; 10 µg/L treatment), whole fish, Pimephales promela, aqueous, freshwater, OECD proposal for updating OECD TG 305, Maynard 2004
Key value for chemical safety assessment
- BCF (aquatic species):
- 16 265 dimensionless
Additional information
Five studies are available for this endpoint. Three of them followed standard test guideline and complied with GLP (one Reliability 1 and two Reliability 2 studies). The study representing the worst-case effect (i.e. showed highest BCF value) was included as key study. The effect value (BCF = 16265) from the key study was selected in CSA. In this study (Maynard 2004), Fathead minnow (Pimephales promelas) were exposed to the 14C-Dichlorophenyl-ring-labelled test substance at nominal concentrations of 1 and 10µg/L (measured time weighted concentrations: 0.9 and 8.7µg/L, respectively) for 60-day uptake phase (136 fish per concentration). Afterwards, the fish were transferred to aquaria without the test substance for a 60-day depuration phase. In addition, a solvent control (triethylene glycol) was included as well and tested under the same condition. The test conditions were as following: pH 7.0 – 8.0, 25 ± 1 °C, 16 hours light -8 hours darkness cycle with 20 minute dawn and dusk transition periods (610 – 660 Lux). The water conditions were 40.7 – 55.0 mg/L total hardness (as CaCO3), 241 ± 22.5 µS/cm conductivity (at 25 ˚C) and 4.8 - 8.2 mg O2/L. The kinetic bioconcentration factor (BCFk) were calculated to be 28000 and 27000 L/kg for 1.0µg/L and 10µg/L, respectively. After 5% lipid content normalisation, the BCFk values were 12756 and 16265 L/kg for 1.0 and 10µg/L treatments, respectively.
One of the supporting study is a 190-d water/sediment outdoor microcosm study. The maximum BAFs (on Day 7) of the test substance were determined to be 294 and 360 in whole fish (bluegill sunfish, Lepomis macrochirus) for 0.5 mg/L and 5.0 µg/L treatments, respectively (Volz 2003). One supporting study is a 77-d laboratory study on bluegill sunfish (Lepomis macrochirus). The kinetic bioconcentration factor (BCFk) were calculated to be 5300 L/kg for the whole fish (Forbis 1986). The other two supporting studies did not follow standard test guideline but were well documented, and met generally accepted scientific principles. They were in compliance with GLP criteria. One study spiked via the water phase. Four species of aquatic invertebrate (Daphnia magna, Gammarus pulex, Chironomus riparius and Lumbriculus variegatus) were exposed separately to the 14C-dichlorophenyl-labelled test substance at a nominal concentration of 0.4 μg/L in water-sediment systems. The BAF values were determined to be 12, 32, 56 and 210 L/kg for Lumbriculus variegatus, Daphnia magna, Gammarus pulex and Chironomus riparius, respectively (Thompson 2003a). The last supporting study spiked via the sediment phases and used the same test organisms. These organisms were exposed to the 14C-dichlorophenyl-labelled test substance at a nominal sediment concentration of 10 μg/kg dry weight. The BAF values were determined to be 1.5, < 4.6, 2.6 and 8.0 for Lumbriculus variegatus, Daphnia magna, Gammarus pulex and Chironomus riparius, respectively.
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