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EC number: 442-480-8 | CAS number: 182893-11-4
- 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
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to protocol. Not all details on chemical analysis are given but enough to validate the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- During the final test samples for analysis were taken in duplicate from all test concentrations and the blank-control.
- Frequency: at t=0 h, t=24 h and t=72 h
- Volume: 6ml
- Storage: Samples were stored in a deep-freeze until analysis.
Compliance with the Quality criteria regarding maintenance of actual concentrations was demonstrated by running a test vessel at the highest substance concentration but without algae and samples for analysis were taken at the start, after 24 hours of exposure and at the end of the test period.
Additionally, reserve samples of 12 ml were taken from all test solutions for possible analysis. If not already used, these samples were stored in a freezer for possible analysis. - Vehicle:
- no
- Details on test solutions:
- Preparation of test solutions started with stock solutions at nominally 100 mg/I (range-finding test) or 10 mg/I (final test). These solutions were magnetically stirred for ca. 20 minutes and additionally treated with ultrasonic waves for 5 minutes during the range-finding test. The resulting, clear and colourless, stock solutions were then used to prepare the lower test concentrations by subsequent dilutions in test medium. After preparation, volumes of 50 ml were added to each replicate of the respective test concentration. Subsequently, adequate volumes of an algal suspension were added to each replicate providing a cell density of 10^4 cells/ml.
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- - Species: Selenastrum capricornutum, strain: NIVA CHL 1.
- Control of sensitivity: The results of the most recent reference test with potassium dichromate (Merck, Art. 4864) are appended to this report.
- Stock culture: Algae stock cultures were started by inoculating growth medium with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light (4000-9000 lux) in a climate room at a temperature of 23 ± 2°C.
- Pre-culture: 3 days before the start of the test, cells from the algal stock culture were inoculated in culture medium at a cell density of 2.10^4 cells/ml. The pre-culture was maintained under the same conditions as used in the test. The cell density was measured immediately before use. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- 24 mg/l as CaCO3
- Test temperature:
- 23.8-24.7 °C
- pH:
- 8.3-9.3
- Nominal and measured concentrations:
- Nominal: 0.46, 1.0, 2.2, 4.6, 10 mg/l
Measured: n.m., 0.2, 0.5, 1.2, 6.0 mg/l
n.m: Not measured
Note from the reviewer: The lowest test concentration was not measured and the second and third lowest were on average below the detection limit. As effects on growth rate were only significant at the second highest test concentration this is not considered to have an impact on the outcome of the test. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 ml, all-glass
- Material, size, headspace, fill volume: 50 ml
- Aeration: no
- Initial cells density: 1*10^4 cells/ml
- Control end cells density: 127.5*10^4 cells/ml
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- No. of vessels per highest concentration without algae: 2
- No. of vessels per concentration with algae for chemical analysis after 24h: 1
GROWTH MEDIUM
- Standard medium used: yes, M2 medium
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M2 medium
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous light
- Light intensity and quality: 70-98 µE/m2/s
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: counting chamber at the beginning of the test; spectrophotometer at 720 nm for all other measurements
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Range finding study
- Test concentrations: 0.1, 1, 10 and 100 mg/l
- Results used to determine the conditions for the definitive study: slight inhibition at 1 mg/l and 100% inhibition at 10 and 100 mg/l. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.61 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% C.I. 0.42-0.90 mg/l
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.7 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% C.I. 1.2-2.5 mg/l
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.28 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% C.I. 0.08-0.93 mg/l
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.98 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% C.I. 0.30-3.2 mg/l
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.5 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- CHEMICAL ANALYSIS
It was known that the analytical method was not sensitive enough to measure the nominal concentration of 0.46 mg/1. Consequently, this concentration was not measured. The results of analysis also indicated that the measured concentration at nominally 1.0 mg/l was below the limit of detection at all measuring times. At 2.2 and 4.6 mg/I the measured concentration decreased below the detection limit after 72 hours of exposure. In conclusion: actual concentrations at the lower test concentrations were difficult to obtain.
The actual range of TRIGONOX R-938 concentrations tested was based on the average exposure concentrations of both main components. As the TWA concentrations of the components did only marginally differ, it was acceptable to base the actual test range on the mean of both TWA concentrations. The actual test concentrations were 0.2, 0.5, 1.2 and 6.0 mg/l at nominally 1.0, 2.2, 4.6 and 10 mg/l, respectively. - Results with reference substance (positive control):
- Results as expected
- Reported statistics and error estimates:
- For determination of the NOEC and the EC50 the approaches recommended in the OECD guideline (201, adopted 7 June 1984) were used. An effect was considered to be significant if statistical analysis of the data obtained for the test concentrations compared with those obtained in the negative control revealed significant reduction of growth or inhibition of growth rate (ANOVA, Tukey test, Bonferroni t-test, TOXSTAT Release 3.5,1996, D.o. Gulley, A.M. Boelter, H.L. Bergman). Additionally, the EC10 was determined to meet the recommendations as put down in "A Review of Statistical Data Analysis and Experimental Design in OECD Aquatic Toxicology Test Guidelines" by S. Pack, August 1993.
Calculation of the EC50 and EC10 values was based on linear regression analysis of the percentages of growth inhibition and the percentages of growth rate reduction versus the logarithms of the corresponding TWA exposure concentrations of the test substance. - Validity criteria fulfilled:
- yes
- Conclusions:
- The EC50 for growth rate reduction (ErC50: 0-72h) was 1.7 mg/I with a 95% confidence interval ranging from 1.2 to 2.5 mg/l.
The EC10 for growth rate reduction (ErC10: 0-72h) was 0.61 mg/I with a 95% confidence intervalranging from 0.42 to 0.90 mg/l.
Based on this study TRIGONOX R-938 is classified as toxic to aquatic organisms. - Executive summary:
Selenastrum capricornutum, Fresh Water Algal Growth Inhibition Test.
The study procedures described in this report were based on the EEC Directive 92/69, Publication No. L383 Part C-3 adopted December, 1992; OECD guideline No. 201, Adopted June 7, 1984; and ISO Standard 8692, First edition, 15 November 1989.
The test substance was completely miscible with test medium at the concentrations tested.
The project started with a range-finding test exposing exponentially growing algal cultures to nominal concentrations of 0.1, 1.0, 10 and 100 mg/l. The results showed that the EC50 for cell growth inhibition and growth rate reduction was between nominally 1 and 10 mg/l.
The range-finding test was followed by a final EC50 test exposing exponentially growing algal cultures to nominal concentrations of 0.46, 1.0, 2.2, 4.6 and 10 mg/l. The study further included a blank-control. The initial cell density was 10^4 cells/ml. The total test period was 72 hours. Samples for determination of actual exposure concentrations were taken from all concentrations at the start, after 24 hours and at the end of the test period.
Analysis of the samples taken during the final test showed that concentrations decreased by more than 20% during the test period. Consequently, Time Weight Average (TWA) exposure concentrations were calculated based on both main components measured.
As the TWA concentrations of the components did only marginally differ, it was acceptable to base the actual test range on the mean of both TWA concentrations. The actual test concentrations were 0.2, 0.5, 1.2 and 6.0 mg/I at nominally 1.0, 2.2, 4.6 and 10 mg/I, respectively.
It was known that the analytical method was not sensitive enough to measure the nominal concentration of 0.46 mg/l. Consequently, this concentration was not measured.
In the controls, cell density increased by an average factor of > 16 within 3 days. Further all test conditions (pH and temperature) remained within the ranges prescribed by the protocol.
The test substance reduced growth rate of this fresh water algae species significantly at nominally 4.6 mg/I and higher, corresponding to a TWA concentration of 1.2 mg/l.
Toxicity parameters based on TWA exposure concentrations were as follows:
The EC50 for cell growth inhibition (EbC50: 0-72h) was 0.98 mg/I with a 95% confidence interval ranging from 0.30 to 3.2 mg/l.
The EC10 for cell growth inhibition (EbC10: 0-72h) was 0.28 mg/I with a 95% confidence interval ranging from 0.08 to 0.93 mg/l.
The EC50 for growth rate reduction (ErC50: 0-72h) was 1.7 mg/I with a 95% confidence interval ranging from 1.2 to 2.5 mg/l.
The EC10 for growth rate reduction (ErC10: 0-72h) was 0.61 mg/I with a 95% confidence intervalranging from 0.42 to 0.90 mg/l.
The NOEC for cell growth inhibition based on nominal concentrations was 1.0 mg/I, corresponding to a TWA concentration of 0.2 mg/l.
The NOEC for growth rate reduction based on nominal concentrations was 2.2 mg/I,corresponding to a TWA concentration of 0.5 mg/l.
Reference
Measured concentrations versus nominal concentrations
Nominal conc. (mg/l) |
Measured conc. (mg/l) Peak 1 / Peak 2 |
Time Weight Average (mg/l) Peak 1 / Peak 2 / Mean |
||
T=0h |
T=24h |
T=72h |
||
1.0 |
0.321/ 0.321 |
0.321/ 0.321 |
0.0642/ 0.0632 |
0.20 / 0.20 0.2 |
2.2 |
1.45 / 1.33 |
0.70 / 0.73 |
0.0642/ 0.0632 |
0.48 / 0.47 0.5 |
4.6 |
3.27 / 3.08 |
2.55 / 2.40 |
0.0642/ 0.0632 |
1.23 / 1.2 1.2 |
10 |
8.05 / 7.66 |
7.42 / 6.67 |
4.39 / 3.47 |
6.38 / 5.59 6.0 |
10 (w.a.) |
8.45 / 8.00 |
7.98 / 7.36 |
6.42 / 5.51 |
7.51 / 6.80 7.2 |
w.a.: without algae
1The final exposure concentration was taken as half the lower limit of quantification
2The final exposure concentration was taken as a factor of 10 below the limit of detection as the substance was not detected
Cell densities calculated from the individual extinction values (*10^4 cells/ml)
Nominal conc. (mg/l) |
Vessel no. |
Exposure time (h) |
|||
0 |
24 |
48 |
72 |
||
Control |
1 2 3 4 5 6 |
1.00 1.00 1.00 1.00 1.00 1.00 |
2.92 3.59 3.17 3.55 4.08 4.46 |
32.62 34.11 32.78 26.40 33.11 32.41 |
130.38 147.40 125.21 119.00 120.57 122.56 |
0.46 |
1 2 3 |
1.00 1.00 1.00 |
5.04 5.57 5.95 |
24.79 28.39 34.40 |
132.33 155.06 133.08 |
1.0 |
1 2 3 |
1.00 1.00 1.00 |
5.16 5.41 6.11 |
30.92 27.23 35.80 |
121.52 109.97 166.58 |
2.2 |
1 2 3 |
1.00 1.00 1.00 |
4.41 4.04 4.79 |
21.89 22.51 25.70 |
93.53 100.94 109.14 |
4.6 |
1 2 3 |
1.00 1.00 1.00 |
3.38 3.67 4.29 |
7.31 6.53 10.42 |
24.21 19.82 42.59 |
10 |
1 2 3 |
1.00 1.00 1.00 |
1.47 1.39 1.31 |
2.47 1.47 1.56 |
1.00 1.00 1.00 |
Description of key information
The EC50 for growth rate reduction (ErC50: 0-72h) was 1.7 mg/I with a 95% confidence interval ranging from 1.2 to 2.5 mg/l.
The EC10 for growth rate reduction (ErC10: 0-72h) was 0.61 mg/I with a 95% confidence intervalranging from 0.42 to 0.90 mg/l.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 1.7 mg/L
- EC10 or NOEC for freshwater algae:
- 0.61 mg/L
Additional information
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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