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EC number: 404-310-0 | CAS number: 10591-85-2 PERKACIT TBZTD; PERKACIT TBZTD PDR; PERKACIT TBZTD PDR-D; TBZD
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD and GLP guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
- Deviations:
- yes
- Remarks:
- but the deviations did not affect the integrity of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.13 (Bioconcentration: Flow-through fish test)
- Deviations:
- yes
- Remarks:
- but the deviations did not affect the integrity of the study
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Identification: 14C-TBzTD
- Molecular formula: C30H28N2S4
- Molecular weight: 545.54 (at this specific activity)
- Batch: 2999MJG019-1
- Radiochemical purity: 96.5% (HPLC)
- Chemical purity: 98.9% (HPLC)
- Test substance storage: freezer = -15°C in the dark
- Expiry date: 2 October 2009, allocated by Notox, 1 year after receipt of the substance
- Specific activity: 817 MBq/mmol (1.50 MBq/mg)
- Total activity: 195.6 MBq
- Supplier: Selcia Limited, Fyfield Business and Research Park, Fyfield road, Ongar, Essex, CM5 0GS, UK
- Date received: 02 October 2008 - Radiolabelling:
- yes
- Details on sampling:
- - TBzTD conc was determined in samples of the test media taken after 1, 3, 7, 14, 21 and 28 days of exposure.
- Vehicle:
- yes
- Details on preparation of test solutions, spiked fish food or sediment:
- TBzTD: 0.5 and 5 μg/L, these test concentrations were chosen taking the water solubility limit of TBzTD and the limit of detection of the analytical method into account.
Control:: thest medium without test substance including acetone in the same amount as used in the treated solutions.
Stock solutions were prepared in acetone. The concentrations in these stocks were a factor 10 000 higher than the final concentrations in water: 5 and 50 mg/L. - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- ORGANISMS
- Sex: both male and female organisms
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, the Netherlands
- Initial fish length: 3.9 +/- 0.2 cm, based on the measurement of a total of 10 fish from the batch used in this test
- Initial fish weight: 1.90 +/- 0.26g based on weighing of a total of 10 fish from the batch used for this test
- Characteristics: F1 from a single parent-pair bred in UV-treated water
HOLDING
- Quarantine/acclimatisation: at least 12 days after delivery
- Medium: adjusted ISO medium, formulated using RO-water (tap water purified by reverse osmosis, GEON Waterbehandeling, Berkel-Enschot, The netherlands) 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
- Feeding: daily with pelleted fish food (Cyprico Crumble Excellent (300-500 μm), Coppens International bv, Helmond, The Netherlands
- Validity of batch: in the batch of fish used for the test, mortality during seven days prior to the start of the test was less than 5% - Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 28 d
- Total depuration duration:
- 28 d
- Hardness:
- Ranged from 179-196 mg calcium carobonate per litre
- Test temperature:
- Ranged within the ranges described by the protocol (20-25°C, constant within +/- 2°C)
- pH:
- ranged from 7.1 to 7.9
- Dissolved oxygen:
- generally above 5 mg/L (which is 60% saturation)
on the 6th and 20th day of the uptake phase oxygen levels of both target conc had dropped below 5 mg/L for unknown causes, on the sixth day aeration was introduced and maintained for one day, on the 20th day vessels were refreshed - TOC:
- Ranged from 21-37 mg C/L in samples from the acetone control during the uptake phase, except on day 6 when a value of 68 mg/L was obtained. During the depuration phase T(D)OC was low (below 1 mg/L). Based on the acetone conc of 100 mg/L, the T(D)OC was expected to be at a max of 62 mg C/L during the uptake phase. The extra 6 mg C/L on day 6 can therefore not be related to the presence of acetone.
- Salinity:
- na
- Details on test conditions:
- DOSING
During the uptake phase, the stock solutions were dosed via a computer-controlled system (DaVinci) consisting of micro-dispensers (Gilson). Via this system the dosed volume from the stock entered a mixing flask separately from the medium supply. The medium was supplied via a flow meter and the flow rate was 13 L/h, allowing approximately five volume replacements through each aquarium each day. In the mixing flask the dosed stock volume and the medium were mixed under continuous stirring at a ratio of 1 : 10 000. The whole system was checked daily.
During the depuration phase the medium was supplied directly via the same flow meters at a flow rate of 13 L/h. The system was checked daily.
SPECIFIC TEST CONDITIONS
- Test vessels: 64 litres (40x40x40 cm) consisting of stainless steel and covered by a removable Perspex plate.
- Test medium: adjusted ISO medium
- Total number of fish: 150
- Number of fish per test group: 42 for the control, 54 for each test concentration
- Max fish loading: 0.33g fish/litre/day
- Illumination: 16h light
- Aeration: after 6d of exposure, maintained for 1 day
- Feeding: pelleted fish food (2% of body weight per day)
- Euthanasia: with 1.2% ethylene glycol in monophenylether in water
During the bioconcentration test, samples were taken from the test medium and from the fish for several purposes and at several time points:
-Quantitative and or qualitative analysis of water: 24 samples
- Quantitative analysis of fish: 100 fish
- Fish lipid extraction: 40 fish - Nominal and measured concentrations:
- TBzTD: 0.5 and 5 μg/L, these test concentrations were chosen taking the water solubility limit of TBzTD and the limit of detection of the analytical method into account.
Control:: thest medium without test substance including acetone in the same amount as used in the treated solutions. - Reference substance (positive control):
- no
- Lipid content:
- 9 %
- Time point:
- start of exposure
- Remarks on result:
- other: unexposed fish
- Lipid content:
- 8 %
- Time point:
- end of exposure
- Remarks on result:
- other: for controls and lowest concentration
- Lipid content:
- 7 %
- Time point:
- end of exposure
- Remarks on result:
- other: highest concentration
- Type:
- BCF
- Value:
- ca. 118
- Time of plateau:
- 7 d
- Calculation basis:
- steady state
- Remarks on result:
- other: individual BCFs varied within +/- 20% window of the mean BCF
- Remarks:
- Conc.in environment / dose:0.5 μg/L
- Type:
- BCF
- Value:
- ca. 27
- Time of plateau:
- 7 d
- Calculation basis:
- steady state
- Remarks on result:
- other: individual BCFs varied within +/- 20% window of the mean BCF
- Remarks:
- Conc.in environment / dose:5 μg/L
- Type:
- BCF
- Value:
- 131
- Calculation basis:
- kinetic
- Remarks on result:
- other: Conc.in environment / dose:0.5 μg/L
- Type:
- BCF
- Value:
- 29
- Calculation basis:
- kinetic
- Remarks on result:
- other: Conc.in environment / dose:5 μg/L
- Elimination:
- yes
- Parameter:
- other: DT50 (lowest conc)
- Depuration time (DT):
- 3.3 d
- Elimination:
- yes
- Parameter:
- other: DT50 (highest conc)
- Depuration time (DT):
- 3 d
- Details on kinetic parameters:
- The kinetic parameters were estimated with Modelmaker
- Uptake rate constant (k1, Ku): for the 0.5 and 5 microg/L have uptake rate constants of 27 and 6.7 d-1
- Depuration (loss) rate constant (k2: Kd): for the 0.5 and 5 microg/L have depuration rates of 0.21 and 0.23 d-1
- Indication of bi- or multiphasic kinetics: no
- Computation / data analysis: Modelmaker - Metabolites:
- Medium (based on the information from the analytical report),
- organic phase: two relevant degradation products were detected (> 10% of applied) with retention times 19.1 and 25.4 minutes.
- aqueous residues: these were not analysed on HPLC because the conc in these samples were below the detection limit of TBzTD. However, based on the results of the validation of the concentration method, it can be concluded that the aqueous residues do not containt TBzTD, but metabolites thereof. Because these metabolites were not partitioned to the organic phase, they can be characterized as polar metabolites. - Validity criteria fulfilled:
- yes
- Conclusions:
- The bioconcentration study investigated the possible bioconcentration of TBzTD in carp exposed to two different concentrations for a period of 28 days in a flow through system followed by a depuration phase of 28 days. The BCFss values of TBzTD at target concentrations of 0.5 and 5 μg/I were 118 ± 10 and 27 ± 3, respectively. The BCFk values of TBzTD at target concentrations of 0.5 and 5 μg/I were 131 and 29, respectively.
For both target concentrations the BCFk was similar to the BCFss indicating a relatively rapid depuration. The DT50 values for depuration of TBzTD at target concentrations of 0.5 and 5 μg/I were 3.3 and 3.0 days, respectively. Based on these results TBzTD accumulation in fish is low and appears to be concentration related. - Executive summary:
This report describes a flow-through bioconcentration test in carp with [14C]-TBzTD. For this bioconcentration test [14C]-TBzTD was used. Analysis of water and fish samples was based on the radiochemical substance. Stock solutions were prepared in acetone and dosed via a computer-controlled system consisting of micro-dispensers into a mixing flask separately from the medium supply. Medium was supplied via a flow meter at a flow rate of 13 L/h. In the mixing flask the dosed stock volume and the dilution water were mixed under continuous stirring at a ratio of 1 : 10,000. The final target concentrations were 0.5 and 5 μg/1. At the start of the bioconcentration test, 54 fish per concentration were exposed to the target concentrations of 0.5 and 5 μg TBzTD per litre and 42 fish were exposed to a control. The uptake phase lasted for 28 days, during which samples were taken from the test medium for both quantitative and qualitative analysis and from the fish for quantitative analysis. During the subsequent depuration phase, which lasted for 30 days only fish were sampled (for quantitative analysis). The mean concentrations of TBzTD (i.e. total radioactivity) in the test medium were 0.41 ± 0.025 μg/L and 4.7 ± 0.38 μg/L at target concentrations of 0.5 and 5 μg/L, respectively. The measured concentrations varied within the ± 20% window of the mean concentration at both target concentrations. No TBzTD was detected in the test medium samples taken from the 0.5 μg/L target concentration. Based on HPLC analysis the mean concentrations of parental TBzTD were below the limit of detection (i.e. 0.2 μg/L) at the target concentration of 0.5 μg/L and 2.9 ± 0.86 μg/L at the target concentration of 5 μg/L respectively. Two relevant degradation products (>10% of applied total radioactivity) were detected. The steady state concentration in fish was reached after 7 days of exposure for both target concentrations. During steady state the mean concentrations of TBzTD in fish at target concentrations of 0.5 and 5 IJg/1 were 0.050 ± 0.0041 μg/g and 0.13 ± 0.0049 μg/g, respectively. The measured concentrations varied within the ± 20% window of the mean concentration in fish at both target concentrations. After 28 days of depuration TBzTD concentrations in the fish were reduced to 6% of the concentrations at the start of the depuration phase. The BCFss values of TBzTD at target concentrations of 0.5 and 5 μg/L were 118 ± 10 and 27 ± 3, respectively. The BCFk values of TBzTD at target concentrations of 0.5 and 5 μg/L were 131 and 29, respectively. For both target concentrations the BCFk was similar to the BCFss indicating a relatively rapid depuration. The DTso values for depuration of TBzTD at target concentrations of 0.5 and 5 μg/L were 3.3 and 3.0 days, respectively. Based on these results TBzTD accumulation in fish is low and appears to be concentration related.
Reference
Results on quantitative and qualitative analysis of the test medium
QUANTITATIVE
- although the test was performed with the radioactive version of the substance, all conc were expressed as TBzTD
- mean conc were 0.41 +/- 0.025 microg/L and 4.7 +/- 0.38 microg/L at respectively the low and high test concentration
- the measured conc varied within the 20% window of the mean conc
QUALITATIVE
- measurements in stock solutions indicated 99 -100% recovery
- no TBzTD was detected in the test medium samples taken from the lowest target test concentration. Based on HPLC analysis the mean conc of parental TBzTD were below the limit of detection (0.2 microg/L) at the lowest target conc of 0.5 microg/L and 2.9 +/- 0.86 microg/L at the 5 microg/L respectively. Two relevant degradation products (> 10% of the applied total radioactivity) were detected.
Table: measured conc of TBzTD in fish
Time (days) | Time (days) | Target conc 0.5 µg/L | Target conc 5 µg/L | ||
Uptake phase | Conc (µg/g fish) | BCF | Conc (µg/g fish) | BCF | |
1 | 0.017 | 42 | 0.044 | 9 | |
3 | 0.035 | 96 | 0.090 | 22 | |
7 | 0.056 | 133 | 0.13 | 30 | |
14 | 0.048 | 111 | 0.12 | 24 | |
21 | 0.048 | 114 | 0.13 | 28 | |
28 | 0.049 | 114 | 0.12 | 24 | |
Depuration phase | 30 | 0.026 | 0.064 | ||
35 | 0.013 | 0.028 | |||
42 | 0.0064 | 0.018 | |||
56 | 0.0031 | 0.0070 |
Table: Effect parameters
Target concentration (μg/L) | BCFss | Kd (d-1) | Ku (d-1) | BCFk | DT50 (d) |
0.5 | 118 | 0.21 | 27 | 131 | 3.3 |
5 | 27 | 0.23 | 6.7 | 29 | 3.0 |
Description of key information
The bioconcentration study investigated the possible bioconcentration of TBzTD in carp exposed to two different concentrations for a period of 28 days in a flow through system followed by a depuration phase of 28 days. The BCFss values of TBzTD at target concentrations of 0.5 and 5 μg/L were 118 ± 10 and 27 ± 3, respectively. The BCF values of TBzTD at target concentrations of 0.5 and 5 μg/L were 131 and 29, respectively.
For both target concentrations the BCFk was similar to the BCFss indicating a relatively rapid depuration. The DT50 values for depuration of TBzTD at target concentrations of 0.5 and 5 μg/L were 3.3 and 3.0 days, respectively. Based on these results TBzTD accumulation in fish is low and appears to be concentration related.
Key value for chemical safety assessment
- BCF (aquatic species):
- 131
Additional information
This report describes a flow-through bioconcentration test in carp with [14C]-TBzTD. For this bioconcentration test [14C]-TBzTD was used. Analysis of water and fish samples was based on the radiochemical substance. Stock solutions were prepared in acetone and dosed via a computer-controlled system consisting of micro-dispensers into a mixing flask separately from the medium supply. Medium was supplied via a flow meter at a flow rate of 13 L/h. In the mixing flask the dosed stock volume and the dilution water were mixed under continuous stirring at a ratio of 1 : 10,000. The final target concentrations were 0.5 and 5 μg/1. At the start of the bioconcentration test, 54 fish per concentration were exposed to the target concentrations of 0.5 and 5 μg TBzTD per litre and 42 fish were exposed to a control. The uptake phase lasted for 28 days, during which samples were taken from the test medium for both quantitative and qualitative analysis and from the fish for quantitative analysis. During the subsequent depuration phase, which lasted for 30 days only fish were sampled (for quantitative analysis). The mean concentrations of TBzTD (i.e. total radioactivity) in the test medium were 0.41 ± 0.025 μg/L and 4.7 ± 0.38 μg/L at target concentrations of 0.5 and 5 μg/L, respectively. The measured concentrations varied within the ± 20% window of the mean concentration at both target concentrations. No TBzTD was detected in the test medium samples taken from the 0.5 μg/L target concentration. Based on HPLC analysis the mean concentrations of parental TBzTD were below the limit of detection (i.e. 0.2 μg/L) at the target concentration of 0.5 μg/L and 2.9 ± 0.86 μg/L at the target concentration of 5 μg/L respectively. Two relevant degradation products (>10% of applied total radioactivity) were detected. The steady state concentration in fish was reached after 7 days of exposure for both target concentrations. During steady state the mean concentrations of TBzTD in fish at target concentrations of 0.5 and 5 IJg/1 were 0.050 ± 0.0041 μg/g and 0.13 ± 0.0049 μg/g, respectively. The measured concentrations varied within the ± 20% window of the mean concentration in fish at both target concentrations. After 28 days of depuration TBzTD concentrations in the fish were reduced to 6% of the concentrations at the start of the depuration phase. The BCFss values of TBzTD at target concentrations of 0.5 and 5 μg/L were 118 ± 10 and 27 ± 3, respectively. The BCFkvalues of TBzTD at target concentrations of 0.5 and 5 μg/L were 131 and 29, respectively. For both target concentrations the BCFkwas similar to the BCFss indicating a relatively rapid depuration. The DTso values for depuration of TBzTD at target concentrations of 0.5 and 5 μg/L were 3.3 and 3.0 days, respectively. Based on these results TBzTD accumulation in fish is low and appears to be concentration related.
The highest value has been used for the chemical safety assessment.
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