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EC number: 418-420-1 | 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
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Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 June 2015 - 04 March 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Test vessels were incubated in a Sanyo Gallenkamp orbital incubator set to maintain 21-24 °C for up to 72 h. The flasks were provided with continuous lightingin the spectral range of 400-700 nm at an intensity of 5360 lux and gently shaken at ca. 100 rpm.Aliquots of test solutions were removed from test vessels at 24, 48 and 72 h to allow algal cell concetrations to be determined. Aliquots of test solution were placed in an Improved Neabauer counting chamber and the number of alagal cells present visualised under a compound light microscope.The pH of test solutions was determined at test initiation and at 72 h.
- Vehicle:
- no
- Details on test solutions:
- Based on the results of a preliminary study, the definitive test was conducted with test solutions prepared as dilutions from a saturated solution of TBE, producing test concetrations of 1, 3.2, 10, 32 and 100 % saturation.The saturated solution was prepared by adding TBE (100.23 mg) to algal medium (1 L) and ultrasonicating for 60 mins. An aliquot (ca. 600 mL) of this saturated solution wassiphoned from the flask, taking care to exclide undissolved test item, and used directly as the 100 % test solution. The remaining stock was serially diluted (2:6.25 v/v) with algal medium to produce the required test concetrations. The control sampe contained algal medium only.Three replicate flasks at each test concentration (6 for control) contained 100 mL of test solution and were each inoculated with ca. 9800 cells/mL P. subcapitata.
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Freshwater green alag Pseudokirchneriella subcapitata (CCAP 278/4) was initially obtained from the Culture Collection of Algae and Protozoa (CCAP), Scottish Association for Marine Science, Dunstaffnage Marine Laboratory, Oban, Argyll, UK on 06 May 2015.The alga was cultured in-house.
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 22.5-23.2 °C
- pH:
- Freshly prepared solutions: 7.94-8.04Expired solutions at 72 h: 8.21-9.42 pH did not deviate by more than 1.5 units throughout the test period.
- Nominal and measured concentrations:
- Nominal concetrations: 100, 32, 10, 3.2 and 1 % saturationMean measured concentrations (0 and 72 h): 27.6, 6.6, 2.1, 1.2, 0.4 mg/L, respectively.More information available in Table 3.
- Reference substance (positive control):
- no
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.4 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.4 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.4 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 1.2 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 10.5 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.4 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 0.7 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.9 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Details on results:
- Analytical samples taken at 0 h and 72 h indicated that concetrations of TBE were maintained at 81-120 % of their initial value over the test period - with the exception of the 3.2 % saturated solution which increased by 100 % over the 72 h period. The overall mean measured concetration of TBE were 0.4, 1.2, 2.1, 6.6 and 27.6 mg/L for the 1, 3.2 10, 32 and 100 % saturated solutions, respectively. TBE was not detected in the control samples. See Table 3 for individual analyte results.See Tables 4 and 5 for growth and yield data summaries.
- Reported statistics and error estimates:
- See Table 6
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 72 h ErC10, ErC20 and ErC50 values for average specific growth rate were estimated to be 0.4, 1.2 and 10.5 mg/L, respectively, based on mean measured concetrations of TBE under the test conditions.The 72 h EyC10, EyC20 and EyC50 values for yield were estimated to be 0.4, 0.7 and 1.9 mg/L, respectively, based on mean measured concetrations of TBE under the test conditions.The 72 h NOEC for both growth rate and yield was estimated to be 0.4 mg/L based on mean measured concetrations of TBE.
- Executive summary:
This study was designed to determine the effects of TBE on the growth of P. subcapitata, a unicellular freshwater green alga, over a 72 h period. The study was performed to meet the requirements of OECD Guideline 210 (2011).
Based on the results of a preliminary study, the definitive test was conducted with solutions prepared as dilutions of a saturated solution (nominally 100 mg/L). As the test item is only partially soluble, the method of preparation was selected to maximize the solubility of TBE under test conditions.
The 72 h ErC10, ErC20 and ErC50 values for average specific growth rate were estimated to be 0.4, 1.2 and 10.5 mg/L, respectively, based on mean measured concetrations of TBE under the test conditions.
The 72 h EyC10, EyC20 and EyC50 values for yield were estimated to be 0.4, 0.7 and 1.9 mg/L, respectively, based on mean measured concetrations of TBE under the test conditions.
The 72 h NOEC for both growth rate and yield was estimated to be 0.4 mg/L based on mean measured concetrations of TBE.
The test met OECD Guideline 201 validity criteria and was therfore considered to be acceptable.
Reference
Table 3 Mean measured concentrations of TBE during the definitive test
Nominal concentration of TBE (% saturation) | Time (h) | Measured concentration (mg/L) | Mean measured concentration (mg/L) | Deviation of 72 h measured concentration from 0 h (±%) |
Control | 0 | nd | nd | 0 |
72 | nd | |||
1 | 0 | 0.42 | 0.4 | -19 |
72 | 0.34 | |||
72* | 0.43* | 0.43* | n/a | |
3.2 | 0 | 0.78 | 1.2 | +100 |
72 | 1.56 | |||
10 | 0 | 2.04 | 2.1 | +2 |
72 | 2.09 | |||
32 | 0 | 6.87 | 6.6 | -8 |
72 | 6.35 | |||
100 | 0 | 25.0 | 27.6 | +20 |
72 | 30.1 | |||
72* | 27.5* | 27.5* | n/a |
nd: not detected
* flask not inoculated with algae
Table 4 Mean cell concentrations at 0, 24, 48 and 72 h during the definitive test
Mean measured concentration of TBE (mg/L) | Replicate | Mean measured concentration (x105cells/mL) | |||
0 h | 24 h | 48 h | 72 h | ||
Control | I | 0.10 | 0.60 | 2.58 | 10.85 |
II | 0.10 | 0.58 | 2.43 | 10.95 | |
III | 0.10 | 0.70 | 2.48 | 10.10 | |
IV | 0.10 | 0.73 | 2.98 | 11.40 | |
V | 0.10 | 0.60 | 2.65 | 12.10 | |
VI | 0.10 | 0.60 | 2.43 | 10.20 | |
Mean | 0.10 | 0.64 | 2.59 | 10.93 | |
0.4 | I | 0.10 | 0.63 | 2.50 | 12.50 |
II | 0.10 | 0.68 | 2.60 | 10.23 | |
III | 0.10 | 0.63 | 2.58 | 11.50 | |
Mean | 0.10 | 0.65 | 2.56 | 11.41 | |
1.2 | I | 0.10 | 0.55 | 2.13 | 9.18 |
II | 0.10 | 0.60 | 1.85 | 9.38 | |
III | 0.10 | 0.58 | 1.93 | 7.83 | |
Mean | 0.10 | 0.58 | 1.97 | 8.80 | |
2.1 | I | 0.10 | 0.48 | 1.78 | 6.03 |
II | 0.10 | 0.50 | 1.83 | 5.63 | |
III | 0.10 | 0.50 | 1.70 | 4.65 | |
Mean | 0.10 | 0.49 | 1.77 | 5.44 | |
6.6 | I | 0.10 | 0.50 | 0.95 | 2.05 |
II | 0.10 | 0.43 | 0.73 | 1.95 | |
III | 0.10 | 0.48 | 0.78 | 1.85 | |
Mean | 0.10 | 0.47 | 0.82 | 1.95 | |
27.6 | I | 0.10 | 0.13 | 0.40 | 0.75 |
II | 0.10 | 0.18 | 0.40 | 0.70 | |
III | 0.10 | 0.15 | 0.20 | 0.60 | |
Mean | 0.10 | 0.15 | 0.33 | 0.68 |
Table 5 Cell growth group mean values determined from daily cell counts during the definitive test
Growth function | Time (h) | Mean measured concentration of TBE (mg/L) | |||||
Control | 0.4 | 1.2 | 2.1 | 6.6 | 27.6 | ||
Mean cell concentration (x 105cells/mL) | 0-24 | 0.64 | 0.65 | 0.58 | 0.49 | 0.47 | 0.15 |
0-48 | 2.59 | 2.56 | 1.97 | 1.77 | 0.82 | 0.33 | |
0.72 | 10.93 | 11.41 | 8.80 | 5.44 | 1.95 | 0.68 | |
Average specific growth rate (µave/day) | 0-24 | 1.86 | 1.89 | 1.77 | 1.62 | 1.57 | 0.44 |
0-48 | 1.64 | 1.63 | 1.50 | 1.45 | 1.06 | 0.59 | |
0-72 | 1.57 | 1.58 | 1.50 | 1.34 | 1.00 | 0.65 | |
Yield | 0-24 | 1.34 | 1.37 | 1.20 | 0.99 | 0.93 | 0.14 |
0-48 | 6.23 | 6.16 | 4.68 | 4.18 | 1.81 | 0.59 | |
0-72 | 27.09 | 28.28 | 21.75 | 13.35 | 4.63 | 1.46 |
Table 6 EC and NOEC values during the definitve test
Growth function | Time (h) | ErC10/EyC10 (mg/L) | ErC20/EyC20 (mg/L) | ErC50/EyC50 (mg/L) | NOEC (mg/L) |
Average specific growth rate (µave/day) | 0-24 | 5.6 (3.0, 8.2) | 8.3 (5.3, 11.3) | 16.2 (12.7, 19.7) | 1.2 |
0-48 | 0.9 (nr) | 2.4 (0.3, 4.4) | 12.2 (7.3, 17.2) | 0.4 | |
0-72 | 0.4 (nr) | 1.2 (0.3, 2.2) | 10.5 (6.7, 14.2 | 0.4 | |
Yield | 0-24 | 2.9 (0.6, 5.1) | 4.6 (1.9, 7.3) | 10.3 (6.6, 14.1) | 1.2 |
0-48 | 0.4 (0.1, 0.6) | 0.8 (0.3, 1.2) | 2.8 (1.9, 3.7) | 0.4 | |
0-72 | 0.4 (0.1, 0.7) | 0.7 (0.3, 1.1) | 1.9 (1.3, 2.4) | 0.4 |
Values in paranthesis are confidence limits
nr: not reported as confidence limits contained 0
Description of key information
72 h ErC50 = 10.5 mg/L, 72 h ErC10 = 0.4 mg/L; OECD 201, 2011 (GLP); Knight (2016)
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 10.5 mg/L
- EC10 or NOEC for freshwater algae:
- 0.4 mg/L
Additional information
The 72 h ErC50 and ErC10 values were estimated as 10.5 and 0.4 mg/L, respectively, in a GLP study concucted in accordance with OECD Guideline 201. (Knight, 2016)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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