Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 227-575-2 | CAS number: 5894-60-0
- 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
- Study period:
- 1991-06-03 to 1991-06-07
- 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:
- yes
- Remarks:
- Methanol and tertiary butanol (TBA) were used as solvents to aid test substance dispersion
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Two stock solutions (nominally 300 g/L) were prepared in methanol and tertiary butanol (TBA). The stock solutions were added to the algal culture medium to produce the desired test concentrations.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): It is likely that all exposure concentrations exceeded the solubility of the test substance in the test medium.
- Controls: Algal culture medium - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Strain: SAG 86.81
- Source: Culture supplied by the Collection of Algal Cultures, Institute of Plant Physiology, University of Göttingen, Germany. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- no data
- Test temperature:
- 23+/-1ºC
- pH:
- Medium prepared using methanol stock solution: 8.3-8.9 over 3 days, 8.8-10.5 over 4 days.
Medium prepared using TBA stock solution: 8.4-8.7 over 3 days, 8.4-9.9 over 4 days. - Dissolved oxygen:
- no data
- Salinity:
- not applicable
- Nominal and measured concentrations:
- Nominal concentrations in media prepared with methanol stock solution: 0(Control), 0.01, 0.032, 0.10, 0.32, 1.0, 3.2, 10.2 and 31.8 mg/L.
Nominal concentrations in media prepared with TBA stock solution: 0(Control), 0.009, 0.029, 0.094, 0.29, 0.94, 2.9, 9.4 and 29.5 mg/L.
It is likely that all exposure concentrations exceeded the solubility of the test substance in the test medium. - Details on test conditions:
- TEST SYSTEM
- Test vessel: Conical flasks
- Type: closed with sponge cap
- Material, size, fill volume: glass, 200 mL containing 100 mL of test medium
- Aeration: no
- Initial cells density: 12000 cells/mL (methanol), 10000 cells/mL (TBA)
- Control end cells density: 2200000 cells/mL (methanol), 3000000 cells/mL (TBA)
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
GROWTH MEDIUM
- Standard medium used: yes except that the medium contained 150 mg/l of NaHCO3 instead of the 50 mg/l specified in the OECD guideline.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Milli-Q filtered water
- Culture medium different from test medium: no
- Intervals of water quality measurement: start and end of test
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous
- Light intensity and quality: 60-120 μm/s/m2
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): cell density at 0, 24, 48, 72 and 96 hours (approx)
- Determination of cell concentrations: Coulter Counter Model TAII
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2 approx - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 31.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- with methanol solvent
- Basis for effect:
- growth rate
- Duration:
- 96 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 29.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- with TBA solvent
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 31.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: solvent methanol / values calculated in retrospect from original cell numbers
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 29.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: solvent TBA
- Remarks:
- values calculated in retrospect from original cell numbers
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- >= 31.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: solvent methanol
- Remarks:
- values calculated in retrospect from original cell numbers
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 20.91 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: solvent TBA
- Remarks:
- values calculated in retrospect from original cell numbers
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Any stimulation of growth found in any treatment: some evidence of stimulation at concentrations >/=0.3 mg/L but it is not certain if it is significant.
- Effect concentrations exceeding solubility of substance in test medium: It is likely that all exposure concentrations exceeded the water solubility of the test substance i(0.0029 mg/L). - Reported statistics and error estimates:
- The area under the growth curve (biomass) and growth rate parameters were calculated from the cell concentration data in accordance with the description of the test method.
ECx values were calculated in accordance with the methods described in the OECD test guideline. The NOEC values were determined by visual comparison of the growth curves for the treated cultures and the Control cultures. - Validity criteria fulfilled:
- yes
- Remarks:
- The validity criteria outlined in the OECD guideline 201 version of 1984 are fulfilled
- Conclusions:
- The study resulted in an ErL50 (72 h) and ErL10 (72 h) of > 30.8 mg/L when methanol was used as a solvent. The ErL50 (72 h) and ErL10 (72 h) when TBA was used as a solvent were > 29.5 mg/L and 20.91 mg/L (nominal), respectively. The 72 h effect values were not presented in the report and therefore the calculations were made in retrospect based on the current OECD guideline 201 calculation criteria and the original cell numbers given in the study report.
A 96-hour EL50 value of >30 mg/L and NOELR of 0.3 mg/L have been determined for the effects of the test substance on growth rate and biomass of Scenedesmus subspicatus when expressed as nominal loading rates. The results were independent of whether the test medium was prepared using methanol or tertiary butanol (TBA) as an aid to preparing the test media. - Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to attached justification for grouping of substances in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 96 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 31.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- with methanol solvent
- Basis for effect:
- growth rate
- Duration:
- 96 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 29.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- with TBA solvent
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 31.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: solvent methaol
- Remarks:
- values calculated in retrospect from original cell numbers
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 29.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: solvent TBA
- Remarks:
- values calculated in retrospect from original cell numbers
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- >= 31.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: solvent methanol
- Remarks:
- values calculated in retrospect from original cell numbers
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 20.91 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: solvent TBA
- Remarks:
- values calculated in retrospect from original cell numbers
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: second test, solvent: TBA
- Remarks:
- values calculated in retrospect from original cell numbers
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 3.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: second test, solvent: TBA
- Remarks:
- values calculated in retrospect from original cell numbers
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1989-07-14 to 1989-11-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study followed a protocol based on the OECD 201 (1984) guideline. It should be noted, that only two parallels were investigated for both control and test series. Thus no thorough statistical assessment of effect values is possible. The study duration was 96 hours which is not in accordance with OECD standards. Thus a recalculation of effect values for 72 h has been performed in order to meet CLP and OECD standards.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 1984
- Deviations:
- yes
- Remarks:
- Tertiary butanol (TBA) was used as solvent to aid test substance dispersion, test duration was 96 hours, only two parallels for both control and test series, respectively.
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solutions (nominally 100 g/L) were prepared in tertiary butanol (TBA). From these stock solutions appropriate dilutions were prepared in solvent to contain 10000 times the final concentrations in the test, so that addition of 10 μL to 100 mL of medium yielded the required test concentrations.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): It is likely that all exposure concentrations exceeded the solubility of the test substance in the test medium.
- Controls: Algal culture medium - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Strain: SAG 86.81
- Source: Culture supplied by the Collection of Algal Cultures, Institute of Plant Physiology, University of Göttingen, Germany.
- Preculture: A preculture of algae in the exponential growth phase was prepared as described in the test guideline using culture medium described in Dutch Standard NPR 6505. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- no data
- Test temperature:
- 23+/-1ºC
- pH:
- Start of test: 8.0-8.4
After 3 days: 9.9-8.7
After 4 days: 9.5-10.5
The high values are associated with good growth of the algae - Dissolved oxygen:
- no data
- Salinity:
- not applicable
- Nominal and measured concentrations:
- Nominal concentrations in media - first test: 0(Control), 0 (solvent control), 0.003, 0.010, 0.032, 0.056, 0.10, 0.32 and 1.0 mg/L.
Nominal concentrations in media - second test: 0 (Control), 0 (solvent control), 0.0032, 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L.
The result of the second test were used as the basis for determining the EL50 and NOELR values.
It is likely that all exposure concentrations exceeded the solubility of the test substance in the test medium. - Details on test conditions:
- TEST SYSTEM
- Test vessel: Conical flasks
- Type: closed with sponge cap
- Material, size, fill volume: glass, 200 mL containing 100 mL of test medium
- Aeration: no
- Initial cells density: 35000 cells/mL (first test), 10500 cells/mL (second test)
- Control end cells density: 3700000 cells/mL (first test), 2900000 cells/mL (second test)
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
GROWTH MEDIUM
- Standard medium used: yes except that the medium contained 150 mg/l of NaHCO3 instead of the 50 mg/l specified in the OECD guideline.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Milli-Q filtered water
- Culture medium different from test medium: no
- Intervals of water quality measurement: start and end of test
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous
- Light intensity and quality: 80-110 μm/s/m2
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): cell density at 0, 24, 48, 72 and 96 hours (approx)
- Determination of cell concentrations: Coulter Counter Model TAII
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2 approx - Reference substance (positive control):
- no
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: second test, solvent: TBA
- Remarks:
- values calculated in retrospect from original cell numbers
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 3.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: second test, solvent: TBA
- Remarks:
- values calculated in retrospect from original cell numbers
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Effect concentrations exceeding solubility of substance in test medium: It is likely that all exposure concentrations exceeded the water solubility of the test substance. - Reported statistics and error estimates:
- The area under the growth curve (biomass) and growth rate parameters were calculated from the cell concentration data in accordance with the description of the test method.
ECx values were calculated in accordance with the methods described in the OECD test guideline. The NOEC values were determined by visual comparison of the growth curves for the treated cultures and the Control cultures. - Validity criteria fulfilled:
- yes
- Remarks:
- The validity criteria outlined in the OECD guideline 201 version of 1984 are fulfilled
- Conclusions:
- The study resulted in an ErL50 (72 h) of > 10 mg/L and an ErL10 (72 h) of 3.4 mg/L (nominal). These results are based on calculations made in retrospect, based on the current OECD guideline 201 criteria and the original cell numbers given by the study report.
Referenceopen allclose all
Table 1. Results of test using methanol as the vehicle (cell concentrations [cells/ml] during the test)
Time (h) | Control | Methanol control | 0.01 mg/L | 0.032 mg/L | 0.10 mg/L | 0.32 mg/L | 1.0 mg/L | 3.2 mg/L | 10.2 mg/L | 31.8 mg/L |
0 | 12000 | 11000 | 13000 | 12000 | 8000 | 10000 | 9000 | 9000 | 9000 | 8000 |
22 | 19000 | 20000 | 21000 | 21000 | 21000 | 20000 | 19000 | 23000 | 17000 | 41000 |
45.5 | 115000 | 110000 | 118000 | 113000 | 117000 | 109000 | 98000 | 95000 | 84000 | 44000 |
68.5 | 766000 | 766000 | 812000 | 821000 | 846000 | 816000 | 683000 | 572000 | 457000 | 474000 |
89.5 | 2323000 | 2193000 | 2369000 | 2341000 | 2454000 | 2258000 | 2172000 | 1841000 | 1438000 | 1718000 |
Table 2. Results of test using TBA as the vehicle (cell concentrations [cells/ml] during the test)
Time (h) | Control | TBA control | 0.009 mg/L | 0.029 mg/L | 0.094 mg/L | 0.29 mg/L | 0.94 mg/L | 2.9 mg/L | 9.4 mg/L | 29.5 mg/L |
0 | 10000 | 10000 | 10000 | 10000 | 8000 | 10000 | 10000 | 10000 | 9000 | 11000 |
23.5 | 31000 | 29000 | 29000 | 32000 | 31000 | 30000 | 28000 | 27000 | 33000 | 45000 |
46.5 | 139000 | 142000 | 141000 | 147000 | 155000 | 151000 | 141000 | 116000 | 100000 | 92000 |
70.0 | 1033000 | 999000 | 1027000 | 1032000 | 1103000 | 1100000 | 939000 | 764000 | 654000 | 600000 |
93.0 | 2945000 | 3140000 | 2913000 | 3212000 | 3053000 | 2734000 | 2960000 | 2745000 | 2022000 | 1718000 |
96 h -EC10 values mentioned in the report were 11 mg/L when TBA was used as a solvent and 7 mg/L when methanol was used as a solvent. No effects causing 50% inhibition of the growth rate were observed. The EC values were calculated by means of a parametric model developed by Kooijman et al. 1983.
Re-evaluation of data:
The 72 -h effect concentrations were calculated in retrospect according to the current OECD 201 (2011) guideline and the original cell numbers given in the report.
No differences were observed between the control and the solvent control. However since only duplicates were used, no statistical analysis could be performed. The solvent control was used as a worst case for the calculation of the growth rate inhibition rates.
1) Results on growth rate inhibition when methanol was used as a solvent:
Table 3: % Inhibition of growth rate at 72 h whenmethanolwas used as a solvent, as calculated in retrospect according to the current OECD 201 standards using the orginal cell densities from the study report.
Nominal concentrations [mg/L] | % Growth Rate Inhibition at 72 h |
0.01 | 1.94 |
0.032 | 0.18 |
0.1 | -8.23 |
0.32 | -3.78 |
1 | -3.36 |
3.2 | 2.23 |
10.2 | 8.51 |
31.8 | 5.26 |
No growth rate inhibition up to 10% was observed after 72 h when methanol was used as a solvent resulting in an ErC10 (72 h) >= 31.8 mg/L.
2) Results on growth rate inhibition when TBA was used as a solvent:
Table 4: % Inhibition of growth rate at 72 h whenTBAwas used as a solvent, as calculated in retrospect according to the current OECD 201 standards using the original cell densities from the study report.
Nominal Concentrations [mg/L] | % Grwoth Rate Inhibition at 72 h |
0.009 | -1.75 |
0.029 | -1.88 |
0.094 | -6.89 |
0.29 | -3.26 |
0.94 | 0.49 |
2.9 | 4.84 |
9.4 | 5.9 |
29.5 | 13.08 |
The EC10 value was calculated based on the dose-response curve. The ErC10 (72 h) was 20.914 mg/L (nominal) when TBA was used as a solvent.
No growth rate inhibition up to 50% was observed after 72 h of exposure when TBA was used as a solvent resulting in an ErC50 (72 h) > 29.5 mg/L (nominal).
Table 1.Cell concentrations [cells/mL] (TBA was used as a solvent)
Conc [mg/L] | 10^4 cells/mL corrected for background | |||||
Replicates | 0 d | 1 d | 2 d | 3 d | 4 d | |
Control | 1.1 | 2.1 | 10.9 | 135.6 | 298.4 | |
1 | 1.8 | 11.3 | 134.5 | 283.4 | ||
Solv. control | 1 | 1.1 | 1.6 | 9.5 | 98.5 | 284.9 |
2 | 1 | 1.6 | 11.5 | 136.9 | 296.9 | |
0.0032 | 1 | - | 2.4 | 14.9 | 184.2 | 311.4 |
2 | - | 1.7 | 10.5 | 105.1 | 300.6 | |
0.01 | 1 | - | 2.1 | 12.0 | 137.1 | 287.5 |
2 | - | 1.5 | 8.5 | 79.9 | 309.2 | |
0.032 | 1 | - | 1.8 | 10.0 | 105.8 | 291.7 |
2 | - | 1.7 | 11.6 | 135.6 | 296.4 | |
0.1 | 1 | - | 2.0 | 9.6 | 130.0 | 318.4 |
2 | - | 1.6 | 10.5 | 193.6 | 283.5 | |
0.32 | 1 | - | 2.1 | 9.8 | 123.2 | 311.3 |
2 | - |
1.6 |
6.9 |
82.0 |
282.0 |
|
1 |
1 |
- |
2.1 |
9.2 |
94.4 |
318.6 |
2 |
- |
1.6 |
7.5 |
78.7 |
327.1 |
|
3.2 |
1 |
- |
2.8 |
8.2 |
80.7 |
294.2 |
2 |
- |
1.5 |
7.9 |
65.3 |
298.9 |
|
10 |
1 |
- |
2.3 |
5.4 |
44.1 |
247.5 |
2 |
- |
5.2 |
6.0 |
37.5 |
234.4 |
A 96 h EC50 value of >10 mg/L and 96 h NOEC of 0.32 mg/L (both nominal) have been determined for both growth rate and biomass effects in the study. The EC50 value were calculated in accordance with the methods described in the OECD test guideline while the NOEC values were determined by visual comparison of the growth curves for the treated cultures and the control cultures.
Re-evaluation of data:
The 72 -h effect concentrations were calculated in retrospect according to the current OECD 201 (2011) guideline and the original cell numbers given in the report.
No differences were observed between the control and the solvent control. However since only duplicates were used, no statistical analysis could be performed. The solvent control was used as a worst case for the calculation of the growth rate inhibition rates.
Since no cell numbers at timepoint 0 were adressed for the test item vessels in the report (see table 1), the mean of the control values being 1.05 x 10^4 cells/mL was used as a starting value.
Table 2: % Inhibition of growth rate at 72 h when TBA was used as a solvent, as calculated in retrospect according to the current OECD 201 standards using the orginal cell densities from the study report.
Nominal Concentrations [mg/L] | % Inhibition of growth rate at 72 h |
0.0032 | -3.82 |
0.01 | 2.23 |
0.032 | -0.64 |
0.1 | -6.63 |
0.32 | 3.06 |
1 | 6.31 |
3.2 | 10.01 |
10 | 22.31 |
The EC10 value was calculated based on the dose-response curve. The ErC10 (72 h) was 3.4 mg/L (nominal).
No growth rate inhibition up to 50% was observed after 72 h of exposure resulting in an ErC50 (72 h) > 10 mg/L (nominal).
Description of key information
72-h EL50 > 31.8 mg/l based on growth rate (OECD 201; Scenedesmus subspicatus, read-across from CAS No. 16415-12-6).
72-h EL10 ≥ 31.8 mg/l based on growth rate (OECD 201; Scenedesmus subspicatus, read-across from CAS No. 16415-12-6).
Key value for chemical safety assessment
- EC10 or NOEC for freshwater algae:
- 31.8 mg/L
Additional information
Measured data on the toxicity towards algae was not available for trichloro(hexadecyl)silane (CAS No. 5894-60-0), therefore data was read-across from the structural analogue substance trimethoxy(hexadecyl)silane (CAS No. 16415-12-6) for the assessment of toxicity towards algae. Both substances hydrolyse in the aquatic environment, but with very different hydrolysis rates (DT50 << 2 min at room temperature and pH 7 (target); DT50 > 14 d at pH 7 (source)). However, both form the same silanol hydrolysis product hexadecylsilanetriol. The second hydrolysis product of the target substance is hydrochloric acid, while the second hydrolysis product of the source compound is methanol. Hydrochloric acid and methanol are both well described substances in the public domain literature and both are not expected to contribute to the overall aquatic toxicity of target and source substances (OECD SIDS, 2002; OECD SIDS 2004). Therefore, hydrochloric acid and methanol can be disregarded in the environmental hazard assessment. Further information can be found in an attached read-across justification in Section 13 of IUCLID.
The toxicity of hexadecyl(trimethoxy)silane (CAS No. 16415-12-6) was studied in two growth inhibition tests. Both studies followed a protocol based on the OECD guideline 201 (1984) and GLP standards. Scenedesmus subspicatus was used as the test organism.
It should be noted, that only two parallels were used for both control and test series. Thus no thorough statistical assessment of effect values is possible. The study duration was 96 hours, which is not in accordance with the guideline standards. Thus a recalculation of the effect values for 72 h has been performed in retrospect in order to meet CLP and OECD standards.
The key study was initiated based on remaining uncertainties of a previous study. There was an uncertainty on the storage stability of the samples tested in the first test. Furthermore, the influence of solvent was investigated more thoroughly in the second test by adding methanol as a second solvent in addition to tertiary butanol (TBA). Therefore the chronologically second study was chosen as the key and the first study was used as supporting information.
In the key study, the test item solutions were prepared with methanol and tertiary butanol as solvents. Two stock solutions (nominally 300 g/L) were initially prepared in methanol and tertiary butanol (TBA) and subsequently added to the algal culture medium to produce the desired test concentrations. Nominal concentrations of 0 (control), 0.01, 0.032, 0.10, 0.32, 1.0, 3.2, 10.2 and 31.8 mg test item/L with methanol as a solvent and 0 (control), 0.009, 0.029, 0.094, 0.29, 0.94, 2.9, 9.4 and 29.5 mg test item/L with TBA as a solvent, were tested. The study resulted in ErC50 (96 h) values of >31.8 mg/L and > 30 mg/L with methanol and TBA as solvents, respectively. Furthermore ErC10 (96 h) values of 7 mg/L and 11 mg/L when methanol or TBA was used as a solvent, respectively, were determined. The 72 h effect values were calculated in retrospect using the original cell numbers addressed in the report. When methanol was used as a solvent the 72 h ErC50 and ErC10 were both ≥ 31.8 mg/L (nominal). When TBA was the solvent, the ErC50 (72 h) was > 29.5 mg/L while the ErC10 (72 h) was calculated to be 20.91 mg/L (nominal).
In the supporting study, the test series comprised the following concentrations: 0.0032, 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg test item/L in addition to a control and solvent control. Tertiary butanol was used as a solvent. The 72 h effect values were calculated in retrospect using the original cell numbers addressed in the report. The ErC50 (72 h) was > 10 mg/L while the ErC10 (72 h) was calculated to be 3.4 mg/L (nominal).
Due to the use of solvents, the tested concentration largely exceeded the water solubility of the silanol hydrolysis product.
Based on the results of the substance is not assumed to cause adverse effects toward algae. Therefore, the registered target compound trichloro(hexadecyl)silane is not expected to have any effects on the toxicity towards algae.
References:
OECD, 2002. Hydrogen Chloride - SIDS Initial Assessment Report for SIAM 15, Boston, USA: UNEP Publications.
OECD SIDS, 2004. Methanol - SIDS Initial Assessment Report For SIAM 19, Berlin, Germany: UNEP Publications.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.