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EC number: 700-111-0 | CAS number: 148528-05-6
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 January to 16 February 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted to recognised guidelines
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not applicable - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Nominal concentrations: 4.27, 9.39, 20.7, 45.5 and 100 mg/L + controls.
- Sampling method: At the start of the definitive test, two samples (10 mL) were taken from the freshly-prepared control and test media (pH-adjusted and non-adjusted media). After 48 hours, the contents of the test vessels from each group were pooled and further samples were
taken for analysis.
- Sample storage conditions before analysis: On each occasion, one of the samples was analysed and the other was stored in a freezer in case further analysis was required. - Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance (500 mg) was dissolved in dilution medium (5 L) in a volumetric flask. The contents of the flask were mixed and the pH was measured. If the pH was 9 or higher, an aliquot (1 L) of the medium was removed; the pH of this portion was adjusted to 7.6 ± 0.2 (using 0.1 M HCl) and used as the pH-adjusted media. The remaining non-adjusted media was then either used directly at the highest test concentration or diluted to provide the test media at the four lower concentrations. At each concentration where the pH of the medium was 9 or higher, an aliquot of the non-adjusted medium was adjusted as detailed above. pH adjustment was required at 20.7, 45.5 and 100 mg/L. Nominal test levels: contol, 4.27, 9.39, 20.7, 45.5, 100 mg/L
- Eluate: not applicable
- Differential loading: not applicable
- Controls: Dilution medium (Elendt M4)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Concentration of vehicle in test medium (stock solution and final test solution): not applicable ('vehicle' was dilution medium)
- Evidence of undissolved material (e.g. precipitate, surface film, etc): none reported - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Strain: Straus
- Source: the National Institute for Applied Chemical Research (IRCHA), France.
- Age at study initiation (mean and range, SD): <24 h
- Method of breeding: parthenogenesis
- Feeding during test: none
ACCLIMATION
- Acclimation period: none
- Acclimation conditions (same as test or not): as test
- Type and amount of food: unicellular green algae, Pseudokirchneriella subcapitata/0.1 to 0.2 mg carbon per daphnid except during the initial three days when a slightly lower ration was given.
- Feeding frequency: once per day
- Health during acclimation (any mortality observed): not stated
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- None
- Hardness:
- 266 mg/L as calcium carbonate
- Test temperature:
- 19.1 - 20.2 ºC (Allowed range - 20 +/- 2ºC)
- pH:
- At nominal concentrations of 20.7, 45.5 and 100 mg/L, the pH of the media following the addition of the test substance exceeded that
recommended for this type of test (6 – 9). Therefore at these levels an additional set of media was prepared in which the media was adjusted to levels typically used in this type of test. The high pH at these concentrations also caused the pH to vary by more than 1.5 units during the test although this does not invalidate the test as all validity criteria were met. At 48 hours, the pH of the non-adjusted media had decreased to within the range stated in the protocol.
7.65 - 10.01
7.68 - 7.96 (pH adjusted vessels) - Dissolved oxygen:
- As % air saturation value: 101 - 106
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- Nominal: 4.27 9.39 20.7 45.5 100 non pH adjusted media
Measured: 4.41 9.06 21.1 48.6 97.8
Nominal: 20.7 45.5 100 pH adjusted media
Measured: 21.0 47.0 100 - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): glass dishes loosely covered
- Material, size, headspace, fill volume: glass 100 mL. Headspace and fill volume not stated
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): static
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): not applicable as vehicle was test medium
- Biomass loading rate: not stated
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of test/dilution water: The test organisms were maintained and the tests conducted in Elendt M7 medium prepared using deionised, reverse osmosis water
- Total organic carbon: not reported
- Particulate matter: not reported
- Metals: not reported
- Pesticides: not reported
- Chlorine: not reported
- Alkalinity: not reported
- Ca/mg ratio: not reported
- Conductivity: not reported
- Culture medium different from test medium: No
- Intervals of water quality measurement: not reported
OTHER TEST CONDITIONS
- Adjustment of pH: pH of test solutions was maintained below 9
- Photoperiod: 16 hours light : 8 dark
- Light intensity: not stated other than subdued at beginning and end of each light phase
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilisation of daphnids
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study
- Test concentrations: 0.1, 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: The range finding test employed nominal test concentrations of 0.1, 1, 10 and 100 mg/L. At 10 and 100 mg/L, the pH was measured to be 9 or higher. A pH of 9 or higher is outside of the range stated in the protocol (6 – 9) and could significantly affect the survival of Daphnia magna therefore a second batch of media were prepared in which the pH was adjusted. In the non-adjusted media after 48 hours, all of the Daphnia at 100 mg/L were immobile and all Daphnia were mobile at 10 mg/L. In the pH-adjusted media after 48 hours, 80% of the Daphnia at 100 mg/L were immobile and all Daphnia were mobile at 10 mg/L. Based on these results, the definitive test employed nominal concentrations of:
Nominal concentrations: 4.27, 9.39, 20.7, 45.5 and 100 mg/L - Reference substance (positive control):
- no
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 46 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Remarks:
- test material - pH not adjusted
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL 41.1 53.1
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 37.5 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Remarks:
- test material - pH not adjusted
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL 34.0, 48.6
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 21.1 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Remarks:
- test material - pH not adjusted
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 68.9 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Remarks:
- test material - pH adjusted
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL 53.3 95.4
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 62.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Remarks:
- test material - pH adjusted
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL 49.1 84.1
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 21 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Remarks:
- test material - pH adjusted
- Basis for effect:
- mobility
- Details on results:
- - Other biological observations: none
- Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- 48 h EC50 (pH non-adjusted): 37.5 mg/L (95% CL 34.0 - 48.6 mg/L). NOEC: 21.1 mg/L
48 h EC50 (pH adjusted): 62.8 mg/L (95% CL 49.1 - 84.1 mg/L). NOEC: 21.0 mg/L
EC50values and their 95% confidence limits were calculated using the LD50 application of the SAFEStat system, SAS 8.2 (SAS Institute, 1999). - Validity criteria fulfilled:
- yes
- Conclusions:
- The 48-hour EC50 of MODA for the immobilisation of Daphnia magna in non-adjusted media was 37.5 mg/L (95% confidence limits of 34.0 and 48.6 mg/L) and in pH-adjusted media it was 62.8 mg/L (95% confidence limits of 49.1 and 84.1 mg/L).
The ‘no-observed effect concentration’ of MODA with Daphnia magna was 21.1 and 21.0 mg/L respectively, in non-adjusted and pH-adjusted media.
These results suggest that the pH of the test media, increased by the presence of the test substance, was partially responsible for the toxicity
observed.
Reference
Measured Concentrations
Non-adjusted media
Nominal conc. |
Measured MODA concentrations (mg/L) |
Overall |
||||
(mg/L) |
0 hours |
%N |
48 hours |
%N |
% ti |
mean* |
Control |
nd |
- |
nd |
- |
- |
- |
4.27 |
4.70 |
110 |
4.12 |
96 |
88 |
4.41 |
9.39 |
9.59 |
102 |
8.53 |
91 |
89 |
9.06 |
20.7 |
22.6 |
109 |
19.6 |
95 |
87 |
21.1 |
45.5 |
49.8 |
109 |
47.4 |
104 |
95 |
48.6 |
100 |
97.7 |
98 |
97.8 |
98 |
100 |
97.8 |
pH-adjusted media
Nominal conc. |
Measured MODA concentrations (mg/L) |
Overall |
||||
(mg/L) |
0 hours |
%N |
48 hours |
%N |
% ti |
mean* |
20.7 |
22.2 |
107 |
19.7 |
95 |
89 |
21.0 |
45.5 |
51.2 |
113 |
42.8 |
94 |
84 |
47.0 |
100 |
99.8 |
100 |
101 |
101 |
101 |
100 |
nd : none detected (< 0.5 mg/L).
% ti : mean measured concentration after 48 hours expressed as a percentage of the mean starting
concentration.
%N : mean measured concentration expressed as a percentage of the nominal concentration.
* : arithmetic mean.
At all concentrations, the intended exposure levels of MODA were adequately achieved (between 91 and 113% of their nominal values) and maintained during the test (between 84 and 101% of their starting values) irrespective of whether the pH of the media was adjusted. The overall mean measured levels of MODA were 4.41, 9.06, 21.1, 48.6 and 97.8 mg/L in non-adjusted media and 21.0, 47.0 and 100 mg/L in media where the pH had been adjusted.
Immobility:
After 48 hours in the non-adjusted media, the lowest measured concentration resulting in 100% immobility was 97.8 mg/L and the highest concentration at which no immobilisation occurred was 21.1 mg/L. After 48 hours in the pH-adjusted media 70% of the Daphnia were immobile at 100 mg/L and the highest concentration at which no immobilisation occurred was 21.0 mg/L.
Description of key information
The 48-hour EC50 of MODA for the immobilisation of Daphnia magna in non-adjusted media was 37.5 mg/L (95% confidence limits of 34.0 and 48.6 mg/L) and in pH-adjusted media it was 62.8 mg/L (95% confidence limits of 49.1 and 84.1 mg/L).
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- 62.8 mg/L
Additional information
The ‘no-observed effect concentration’ of MODA with Daphnia magna was 21.1 and 21.0 mg/L respectively, in non-adjusted and pH-adjusted media. These results suggest that the pH of the test media, increased by the presence of the test substance, was partially responsible for the toxicity observed.
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