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EC number: 620-539-0 | CAS number: 1218787-30-4
- 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
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:
- from 2021-05-31 to 2022-03-23 with the definitive exposure phase from 2022-03-16 to 2022-03-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- (2004)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test item 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4)
Batch number 20192048
CAS No. 1218787-30-4
Purity (certified) 100% UVCB
Water content: 0.07 w/w%
Appearance Yellowish to light brown, solid
Water Solubility Slightly soluble
Stability under test conditions
Not specified
Expiry date 2022-10-25
Recommended storage
Store container tightly closed in a dry, well-ventilated place. Avoid elevated temperatures. - Analytical monitoring:
- yes
- Remarks:
- via LC-MS/MS method
- Details on sampling:
- Sampling schedule
All loading rates and the control were analytically verified via LC-MS/MS method in the fresh media at the start of exposure and at the renewal of the test solutions (0 and 24 hours) as well as in the 24-hours old media at the renewal and at the end of the exposure (24 and 48 hours).
Sampling and pre-treatment
At the start of the exposure and at the renewal (0 and 24 hours), samples were taken after preparation of the loading rates and analyzed. At the renewal and at the end of the exposure (24 and 48 hours), samples of the 24-hours old media were taken from the test vessels. - Vehicle:
- no
- Details on test solutions:
- Water Accommodated Fraction
Water accommodated fractions (WAF) were prepared because the test item is an UVCB substance with compounds of different water solubility. This procedure is in accordance with the OECD guidance document No. 23 (2019).
Using this approach, aqueous media was prepared by mixing the test item with water for a prolonged period sufficient to ensure equilibration between the test item and the water phase.
Preparation of the water accommodated fractions
Five water accommodated fractions (WAF) were prepared separately with nominal loading rates of the test item in the range of 6.25 to 100 mg/L set up in a geometric series with a factor of 2:
6.25 – 12.5 – 25.0 – 50.0 – 100 mg/L, corresponding to the geometric mean measured test item concentrations of 12.5 – 23.5 – 52.0 – 70.3 – 103 µg/L.
For each loading rate an appropriate amount of stock solution containing the test item with methanol was placed on a curved glass slide. The methanol was evaporated. The glass slide with the test item was inserted in a glass flask with an appropriate amount of dilution water. A slow stirring procedure was applied for 24 ± 1 hour at room temperature. For the preparation of the water accommodated fractions a stirring phase of 24 hours was found to be suitable. Longer stirring phases led to a decrease of the loading in the WAFs (< LCL). Therefore, a stirring phase of 24 hours is chosen for the definitive test. The magnetic stirrer bar was placed with a fish-clip® system a few centimeters above the bottom of the flask to prevent direct contact with the test item on the bottom. After a separation phase of 1 hour, the aqueous phase of the WAF was removed by siphoning (from the approximate middle of the glass flask). The first 25 mL were discarded. The WAF were checked via laser beam (Tyndall effect) for undissolved test item. No presence of undissolved test item during the test was observed. The resulting water accommodated fractions (WAF) were used in the test. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test system
Daphnia magna STRAUS, obtained from continuous laboratory cultures.
Reason for the selection of the test system
Daphnia magna is the preferred species in accordance with the test guideline and is bred at the test facility.
Origin
Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), 14195 Berlin, Germany
Breeder
Noack Laboratorien GmbH, Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
Culture
In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 2 °C, 16 hours illumination, light intensity of max. 1500 lx
Culture medium
Elendt M4, according to OECD 202, Annex 3 (2004), is used.
Feeding of the culture stocks
The daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus. The algae were cultured at the test facility. - Test type:
- semi-static
- Water media type:
- freshwater
- Remarks:
- Culture Medium Elendt M4 according to OECD 202, Annex 3 (2004)
- Limit test:
- no
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- A coating phase (saturation of the test container) was carried out. The test containers were pre-treated with the appropriate test solution for at least 12 hours under test conditions. Before the start of the exposure and the renewal.
- Hardness:
- For details see section "Any other information on results incl. tables" below.
- Test temperature:
- During the test period, the temperature in the incubator was 19.5 – 20 °C.
For details see section "Any other information on results incl. tables" below. - pH:
- For details see section "Any other information on results incl. tables" below.
- Dissolved oxygen:
- For details see section "Any other information on results incl. tables" below.
- Conductivity:
- For details see section "Any other information on results incl. tables" below.
- Nominal and measured concentrations:
- Five water accommodated fractions (WAF) were prepared separately with nominal loading rates of the test item in the range of 6.25 to 100 mg/L set up in a geometric series with a factor of 2:
6.25 – 12.5 – 25.0 – 50.0 – 100 mg/L, corresponding to the geometric mean measured test item concentrations of 12.5 – 23.5 – 52.0 – 70.3 – 103 µg/L. - Details on test conditions:
- Control
Dilution water without test item incubated under the same conditions as the test groups.
Reference Test
A reference test with potassium dichromate was conducted as an acute immobilization test (acc. to AQS P 9/2 and OECD 202) in Elendt M4 medium under static conditions with a test duration of 24 hours once per month in order to prove the validity of the test system and test conditions at the test facility.
Test method
The study was performed under semi-static conditions with a renewal of the test solutions after 24 hours.
Test duration 48 hours
Test vessels
Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses
Test volume 20 mL
Dilution water Same composition as the culture medium (see Table 2)
Number of daphnids and replicates
20 daphnids, divided into 4 replicates, each with 5 daphnids, were used for each concentration level and the control.
Age of the daphnids at the start of the exposure
Less than 24 hours old daphnids from a healthy stock were used for the study. To achieve this, juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period were used for the test. No first brood progeny was used for the test.
Acclimatization
Acclimatization is not necessary, because the composition of the dilution water is equivalent to the culture medium.
Application
20 g test solution per replicate were weighed out into each test vessel. This corresponds to 20 mL per test vessel. The daphnids were inserted with a small amount of dilution water (start of the exposure) or test solution (water renewal) by pipette.
Renewal of the test solutions
The test solutions were renewed after 24 hours. For this purpose, a second coated set of test vessels was filled with the freshly prepared test solutions and the daphnids were transferred by pipette.
Test temperature (target) 18 - 22 °C, constant within ± 1 °C
Illumination (target) Diffuse light, light intensity of max. 1500 lx
Photoperiod (target) 16/8 hours light/dark cycle
Feeding The daphnids were not fed during the study.
Pre-treatment
A coating phase (saturation of the test container) was carried out. The test containers were pre-treated with the appropriate test solution for at least 12 hours under test conditions. Before the start of the exposure and the renewal, the test containers were emptied and refilled with freshly prepared test solution.
Type and Frequency of Measurements
Biological Parameters
Immobilization and other observations
Immobilization was determined in all groups after 24 and 48 hours. A daphnid was considered immobile, if it was not able to swim in the water phase within 15 seconds after gentle agitation of the test vessel. Observation of other adverse, sub-lethal effects (e.g. discoloration, abnormal behavior etc.) was done, but none occurred during the course of the study.
Water Quality Parameters
Dilution water
Prior to the start of the exposure and at the renewal of the test solutions (0 and 24 hours), the water quality parameters (i.e. pH-value, dissolved oxygen concentration, total hardness, conductivity and temperature) of the dilution water (control) were measured.
Test media
At the start of the exposure and at the renewal (0 and 24 hours), the water quality parameters of the fresh media (i.e. pH-value, dissolved oxygen concentration) were measured in one additional replicate (without daphnids) of each loading rate and the control.
At the renewal and at the end of the exposure (24 and 48 hours), the water quality parameters of the old media were measured in one appropriate replicate (containing daphnids) of each loading rate and the control. The replicate with the highest immobilization rate per loading level and the control were measured.
Temperature
The incubator temperature (measurement in air with a thermo-hygrograph) was recorded throughout the period of the test. - Reference substance (positive control):
- yes
- Remarks:
- The percentage of immobility for the reference item potassium dichromate (SIGMA-ALDRICH, batch number BCCC1619, purity 100%, CAS RN 7778-50-9) was determined after 24 hours from 2022-01-19 to 2022-01-20.
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 103 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 103 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EL100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 70.9 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- 51.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 103 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 68.8 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL10
- Effect conc.:
- 47.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 24 h
- Dose descriptor:
- EC10
- Effect conc.:
- 103 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EL10
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
The test item contains 0.07% water.
Additional Observations during the Definitive Test:
The tested WAF’s and the control were colorless and visually clear throughout the exposure period.
The measured water quality parameters (i.e. pH-value, dissolved oxygen concentration, total water hardness and water temperature) were within the acceptable limits during the study. During the test period, the temperature in the incubator was 19.5 – 20 °C.
The concentrations of the test item 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) and the control were determined in fresh media (0 hours and 24 hours) and old media (24 hours and 48 hours) of all tested concentration levels and the control via LC MS/MS.
The measured concentrations of the test item 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) at the end of exposure after 24 and 48 hours were in the range of 14 to 82% of the initially measured test item concentrations.- Results with reference substance (positive control):
- The percentage of immobility for the reference item potassium dichromate (SIGMA-ALDRICH, batch number BCCC1619, purity 100%, CAS RN 7778-50-9) was determined after 24 hours from 2022-01-19 to 2022-01-20.
- Reported statistics and error estimates:
- Methods of evaluation
The EC/EL100 – values after 24 and 48 hours and the EC/EL50- value after 24 hours were estimated empirically from the observed immobilization rates.
All effect levels (EL10 / 50 / 100) are given based on the nominal loading rates of the test item, since the test item is an UVCB substance. Per definition of the WAF, all terms related to the concentration were given as loading rate because partly dissolved compounds and mixtures cannot be related to concentrations.
The effect levels (EC10 / 50 / 100) given are based on the geometric mean measured concentrations of the test item.
ECx-values and statistical analyses
The EC/EL10- values after 24 and 48 hours and the EC/EL50- values after 48 hours were calculated by sigmoidal dose-response regression with the software GraphPad Prism. The respective 95% confidence limits were calculated from the standard error and the t distribution. In the case that the confidence limits could not be calculated by the software, the respective confidence limits were empirically derived from the observation data. All calculations were carried out from the best-fit values with the software GraphPad Prism.
Software
All data were computer-processed and rounded for presentation. Consequently, minor variations may occur from the original figures if manual calculations based on the original figures are made subsequently. Calculations were made using the following software:
- GraphPad Prism, GRAPHPAD SOFTWARE, INC.
- Excel, MICROSOFT CORPORATION
Geometric mean measured concentrations
The geometric mean measured concentrations were determined by the sumproduct function of excel, referring to the recoveries and purities of the two lead components of the samples. This procedure takes into account the mean measured concentration of main constituent as well as their content in the product. - Validity criteria fulfilled:
- yes
- Remarks:
- The study was performed according to OECD Guideline 202 (2004). The validity criteria were fulfilled.
- Conclusions:
- Based on the nominal loading rates, the 48 hours-EL50 for Daphnia magna was 51.1 mg/L (confidence limits: 26.3 – 97.3 mg/L) for the test item 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4).
Based on the geometric mean measured concentrations, the 48 hours-EC50 for Daphnia magna was 70.9 µg/L (confidence limits: 53.1 – 94.8 µg/L) for the test item 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4). - Executive summary:
In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) (batch number: 20192048) were determined at the test facility according to OECD 202 (2004) from 2021-05-31 to 2022-03-23 with the definitive exposure phase from 2022-03-16 to 2022-03-18 at the test facility.
The study was conducted under semi-static conditions over a period of 48 hours with five water accommodated fractions (WAF). The WAFs were prepared separately with nominal loading rates of the test item in the range of 6.25 to 100 mg/L set up in a geometric series with a factor of 2. The test containers were pre-treated with the appropriate test solution for at least 12 hours under test conditions. Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each loading rate and the control.
The concentrations of the test item 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) was quantified by measurement of the C16 and C18 amine + 2EO constituents. The concentrations of the test item were determined in fresh media (0 hours and 24 hours) and old media (24 hours and 48 hours) of all tested concentration levels and the control via LC MS/MS.
The measured concentrations of the test item 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) at the end of exposure after 24 and 48 hours were in the range of 14 to 82% of the initially measured test item concentrations.
The geometric mean measured test item concentrations were calculated to be: 12.5 – 23.5 – 52.0 – 70.3 – 103 µg/L.
The EL10/50/100- values given in the table below are based on the nominal loading rates of the test item. Additionally, EC10/50/100-values based on the calculated geometric mean measured test item concentrations are given in the table below.
The validity criteria of the test guideline were fulfilled.EC / EL10-, EC / EL50- and EC / EL100-Values
Effect values Test Nominal loading rates Geometric mean measured test item concentrations duration of the test item [µg/L] [hours] [mg/L] EC / EL10 24 100 (Cl: 25.8 – > 100) 103 (Cl: 51.7 – > 103) (with confidence limits) 48 47.5 (Cl: 25.0 – 95.9) 68.8 (Cl: 52.0 – 93.9) EC / EL50 24 > 100 > 103 (with confidence limits) 48 51.1 (Cl: 26.3 – 97.3) 70.9 (Cl: 53.1 – 94.8) EC / EL100 24 > 100 > 103 48 > 100 > 103
Reference
Composition of the Culture Medium Elendt M4
according to OECD 202, Annex 3 (2004)
Component | Concentration [mg/L] |
CaCl2 x 2 H2O | 294 |
MgSO4 x 7 H2O | 123 |
KCl | 5.80 |
NaHCO3 | 64.8 |
Na2SiO3 x 5 H2O | 7.47 |
NaNO3 | 0.274 |
KH2PO4 | 0.143 |
K2HPO4 | 0.184 |
Na2EDTA x 2 H2O | 2.50 |
FeSO4 x 7 H2O | 0.996 |
H3BO3 | 2.86 |
MnCl2 x 4 H2O | 0.361 |
LiCl | 0.306 |
SrCl2 x 6 H2O | 0.152 |
RbCl | 0.0710 |
NaBr | 0.0160 |
Na2MoO4 x 2 H2O | 0.0615 |
CuCl x 2 H2O | 0.0168 |
ZnCl2 | 0.0130 |
CoCl2 x 6 H2O | 0.0100 |
KI | 0.00325 |
Na2SeO3 | 0.00219 |
NH4VO3 | 0.000575 |
Thiaminhydrochloride | 0.075 |
Cyanocobalamin | 0.0010 |
Biotin | 0.00075 |
pH | 8.2 ± 0.8 |
Preparation of the WAFs in the Definitive Test
SL 1 | |||||
Stock solution | 200 | ||||
[g/L in MeOH] | |||||
Weighing out [g] | 2 | ||||
Volume of the stock solution [mL] | 10 | ||||
Volume of the stock solution placed on a curved glass slide [µL/L] | 500 | 250 | 125 | 62.5 | 31.25 |
Final test item | 100 | 50.0 | 25.0 | 12.5 | 6.25 |
Loading rate [mg/L] |
Immobilization Rates after 24 and 48 hours of Exposure
(n = 20, divided into 4 replicates with 5 daphnids each)
Nominal loading rate | IMMOBILIZATION [%] | |||||||||
of the test item | 24 hours | 48 hours | ||||||||
[mg/L] | Replicates | Replicates | ||||||||
1 | 2 | 3 | 4 | MV | 1 | 2 | 3 | 4 | MV | |
100 | 0 | 20 | 20 | 0 | 10 | 100 | 100 | 80 | 100 | 95 |
50.0 | 0 | 0 | 0 | 0 | 0 | 60 | 40 | 20 | 20 | 35 |
25.0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
12.5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6.25 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Control | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Absolute Numbers of immobile Daphnids after 24 and 48 hours of Exposure
(n = 20, divided into 4 replicates with 5 daphnids each)
Nominal loading rate | Number of immobile Daphnids / Total number of Daphnids | |||||||||
of the test item | 24 hours | 48 hours | ||||||||
[mg/L] | Replicates | Replicates | ||||||||
1 | 2 | 3 | 4 | Sum | 1 | 2 | 3 | 4 | Sum | |
100 | 0 / 5 | 1 / 5 | 1 / 5 | 0 / 5 | 2 / 20 | 5 / 5 | 5 / 5 | 4 / 5 | 5 / 5 | 19 / 20 |
50.0 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 20 | 3 / 5 | 2 / 5 | 1 / 5 | 1 / 5 | 7 / 20 |
25.0 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 20 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 20 |
12.5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 20 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 20 |
6.25 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 20 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 20 |
Control | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 20 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 20 |
Measured Concentrations of the compound C16 Amine + 2EO of the test item 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) during the Definitive Test
Sampling date | Fresh medium, | Old medium, | Fresh medium, | Old medium, | |||
0 hours | 24 hours | 24 hours | 48 hours | ||||
Nominal | 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) | ||||||
loading rate of the | C16 Amine + 2EO | ||||||
test item | active substance | Meas. | Meas. | % | Meas. | Meas. | % |
[mg/L] | [mg a.s./L] | conc. | conc. | conc. | conc. | ||
[mg a.s./L] | [mg a.s./L] | [mg a.s./L] | [mg a.s./L] | ||||
100 | 32.8 | 0.113 | 0.0783 | 69 | 0.0850 | 0.0432 | 51 |
50.0 | 16.4 | 0.0625 | 0.0383 | 61 | 0.0704 | 0.0363 | 52 |
25.0 | 8.20 | 0.0682 | 0.0241 | 35 | 0.0579 | 0.0217 | 37 |
12.5 | 4.10 | 0.0231 | 0.0191 | 82 | 0.0196 | 0.0139 | 71 |
6.25 | 2.05 | 0.0179 | 0.00345 | 19 | 0.0203 | 0.00864 | 43 |
Control | < LOQ | < LOQ | < LOQ | < LOQ |
Meas. conc. = measured concentration of the compound C16 Amine + 2EO of the test item,
dilution factors taken into account
a.s. = active substance
% = percent of the initially measured concentration of the active substance
LOQ = limit of quantification (0.200 µg/L of the test item, corresponding to 0.0656 µg a.s./L)
Measured Concentrations of the compound C18 Amine + 2EO of the test item 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) during the Definitive Test
Sampling date | Fresh medium, | Old medium, | Fresh medium, | Old medium, | |||
0 hours | 24 hours | 24 hours | 48 hours | ||||
Nominal | 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) | ||||||
loading rate of the | C18 Amine + 2EO | ||||||
test item | active substance | Meas. | Meas. | % | Meas. | Meas. | % |
[mg/L] | [mg a.s./L] | conc. | conc. | conc. | conc. | ||
[mg a.s./L] | [mg a.s./L] | [mg a.s./L] | [mg a.s./L] | ||||
100 | 60.8 | 0.0374 | 0.0233 | 62 | 0.0273 | 0.00831 | 30 |
50.0 | 30.4 | 0.0337 | 0.0103 | 30 | 0.0371 | 0.00518 | 14 |
25.0 | 15.2 | 0.0194 | 0.0102 | 53 | 0.00979 | 0.00682 | 70 |
12.5 | 7.60 | 0.00852 | 0.00123 | 14 | 0.00447 | 0.00277 | 62 |
6.25 | 3.80 | 0.00223 | 0.000657 | 30 | 0.00279 | 0.00119 | 43 |
Control | < LOQ | < LOQ | < LOQ | < LOQ |
Meas. conc. = measured concentration of the compound C18 Amine + 2EO of the test item,
dilution factors taken into account
a.s. = active substance
% = percent of the initially measured concentration of the active substance
LOQ = limit of quantification (0.200 µg/L of the test item, corresponding to 0.122 µg a.s./L)
Validity Criteria
The study was performed according to OECD Guideline 202 (2004). The validity criteria were fulfilled:
Validity criteria (target) | Result | Valid |
≤ 10% of the daphnids in the control immobile or showing signs of disease or stress, e.g. discoloration or unusual behavior such as trapping on the surface of the water, during the 48-hour test period | No daphnid | ü (= yes) |
≥ 3 mg O2 /L in the 24-hours old media at the renewal of the test solutions and at the end of the exposure in all concentration levels and in the control | ≥ 7.34 mg/L | ü |
Water Quality Parameters in the fresh Media at the Start of the Exposure and at the Renewal
(0 and 24 hours)
(measured in one additional replicate (without daphnids) per loading level and control)
Nominal loading rate | 0 hours | 24 hours | ||
of the test item | ||||
[mg/L] | pH-value | Dissolved | pH-value | Dissolved |
O2 concentration | O2 concentration [mg/L] | |||
[mg/L] | ||||
100 | 7.38 | 8.11 | 7.72 | 7.37 |
50.0 | 7.37 | 8.40 | 7.74 | 7.42 |
25.0 | 7.33 | 8.42 | 7.74 | 7.34 |
12.5 | 7.29 | 8.41 | 7.77 | 8.27 |
6.25 | 7.26 | 8.37 | 7.77 | 8.35 |
Control | 7.20 | 8.37 | 7.93 | 8.25 |
Water Quality Parameters in the 24-hours old Media at the Renewal and at the End of the Exposure (24 and 48 hours)
(measured in one replicate (containing daphnids) per per loading level and control)
Nominal loading rate | 24 hours | 48 hours | ||||
of the test item | ||||||
[mg/L] | pH-value | Dissolved | Replicate number | pH-value | Dissolved | Replicate number |
O2 concentration | O2 concentration | |||||
[mg/L] | [mg/L] | |||||
100 | 7.75 | 7.98 | 2 | 7.98 | 7.54 | 1 |
50.0 | 7.82 | 8.07 | 2 | 8.03 | 8.41 | 1 |
25.0 | 7.82 | 8.00 | 2 | 8.06 | 8.13 | 1 |
12.5 | 7.83 | 8.21 | 2 | 8.07 | 8.09 | 1 |
6.25 | 7.81 | 8.18 | 2 | 8.10 | 8.13 | 1 |
Control | 7.83 | 8.12 | 2 | 8.12 | 8.24 | 1 |
Water Quality Parameters of the Dilution Water at the Start of the Exposure and at the Renewal (0 and 24 hours)
Dilution water | pH-Value | Dissolved | Temperature | Conductivity | Total hardness |
O2 concentration | |||||
[mg/L] | [°C] | [µS/cm] | [mg CaCO3/L] | ||
0 hours | 7.20 | 8.30 | 21.5 | 612 | 249 |
24 hours | 7.93 | 8.25 | 21.9 | 608 | 256 |
Gradient Table
Time [min] | A [%] | B [%] |
0.00 | 80 | 20 |
0.30 | 80 | 20 |
1.30 | 5 | 95 |
2.00 | 5 | 95 |
2.10 | 80 | 20 |
2.50 | 80 | 20 |
Dilution steps
loading rate | [mL] | [mL] | |
[mg/L] | |||
100 | 800 | 0.11) | 101) |
0.252) | 1.02) | ||
100 | 200 | 0.1 | 10 |
100 | 100 | 0.1 | 5.0 |
50.0 | 800 | 0.11) | 101) |
0.252) | 1.02) | ||
50.0 | 400 | 0.11) | 101) |
0.52) | 1.02) | ||
50.0 | 200 | 0.1 | 10 |
50.0 | 100 | 0.1 | 5.0 |
50.0 | 50 | 0.2 | 5.0 |
25.0 | 400 | 0.11) | 101) |
0.52) | 1.02) | ||
25.0 | 250 | 0.21) | 5.01) |
0.22) | 1.02) | ||
25.0 | 100 | 0.1 | 5.0 |
25.0 | 50 | 0.2 | 5.0 |
12.5 | 250 | 0.21) | 5.01) |
0.22) | 1.02) | ||
12.5 | 100 | 0.1 | 5.0 |
12.5 | 10 | 0.2 | 1.0 |
6.25 | 100 | 0.1 | 5.0 |
6.25 | 50 | 0.2 | 5.0 |
6.25 | 20 | 0.1 | 1.0 |
6.25 | 10 | 0.2 | 1.0 |
*including factor 2
1) first dilution step
2) second dilution step
Requirements of the According to SANCO 3029/99 rev.4 (2000) and SANTE2020/12830
method validation Rev. 1 (24/02/2021) using the following criteria:
Parameter, Acceptance Criteria and Results of the Method Validation
Parameter | Acceptance criteria | Result | |
Linearity | ≥ 5 standard concentrations, | 0.05 to 0.8 µg test item/L (n = 7), | ü (=yes) |
r ≥ 0.99 (R2 ≥ 0.9801 for 2nd order regression) | r ≥ 0.99 | ||
Calibration range from ≤ 30% LOQ to 20% above highest concentration level after sample preparation | |||
Lowest calibration level (LCL) | S/N ≥ 9 for quantifier ion trace | S/N for 0.05 µg test item/L | ü |
S/N ≥ 3 for qualifier ion trace | C16 Amine + 2 EO | ||
159 (Quantifier), 109 (Qualifier) | |||
C18 Amine + 2 EO | |||
406 (Quantifier), 259 (Qualifier) | |||
Limit of Detection (LOD) | Determination only necessary when S/N LCL ≤ 30. | Not necessary | - |
S/N of 3-5 for the signal which is used for the identification. If significant blank values are observable, LOD has to be 3-5 times higher as the mean value plus standard deviation of 5 to 10 blank measurements. | |||
Limit of Quantification (LOQ) | Should be at or below lowest test concentration | 0.200 µg test item/L (1 x LOQ) | ü |
200 µg test item/L (1000 x LOQ) | |||
Accuracy1) | Mean recovery rate of 70-120% | C16 Amine + 2 EO | ü |
(Fortified samples) | per fortification level (2 levels) | 1 x LOQ: 107% (n = 5) | |
1000 x LOQ: 89% (n = 5) | |||
C18 Amine + 2 EO | |||
1 x LOQ: 106% (n = 5) | |||
1000 x LOQ: 88% (n = 5) |
Precision1) | Relative standard deviation ≤ 20% per fortification level | C16 Amine + 2 EO | ü |
1 x LOQ: 8.4% | |||
1000 x LOQ: 6.8% | |||
C18 Amine + 2 EO | |||
1 x LOQ: 6.1% | |||
1000 x LOQ: 6.1% | |||
Specificity1): | Measurement of two transitions of the same precursor ion - one quantifier (used for evaluation) and one qualifier (for confirmation of the analyte identity). | C16 Amine + 2 EO | ü |
LC-MS/(MS) | (Compounds: C16 Component + 2EO; C18 Component + 2EO) | quantifier [m/z]: 330.30 > 88.06 | |
qualifier [m/z]: 330.30 > 70.22 | |||
C18 Amine + 2 EO | |||
quantifier [m/z]: 358.33 > 88.12 | |||
qualifier [m/z]: 358.33 > 70.16 | |||
Blank values < 30% of the LOQ | Blank values < 30% of LOQ | ü | |
Procedural recovery | Procedural recoveries with experimental samples. The recovery has to be 70-120% of the nominal value. | See section 17.2 | ü |
= criterion fulfilled
- = not determined
Preparation of Fortified Samples of the Test Item
LOQ Level | Control | 1 | 1000 |
Stock solution | - | 1000 mg test item/L in acetonitrile | |
Spiking solution | - | 20.0 | 20 000 |
[µg test item/L] | (Dilution medium) | (Daphnia dilution medium) | |
(Medium) | |||
Replicates | 2 | 5 | 5 |
Concentration of the LOQ | - | 0.200 | 200 |
[µg test item/L] | |||
Medium for preparation | Daphnia dilution medium | ||
Volume of spiking solution [mL] | - | 0.05 | 0.05 |
Volume of medium [mL] | 5.0 | 4.95 | 4.95 |
Dilution factor | 2 | 2 | 400 |
Dilution medium | Acetonitrile containing 0.2% fomic acid1) | ||
Dilution medium2) | |||
Sample volume [mL] | 5.01) | 5.01) | 5.01) |
0.052) | |||
Finale volume [mL] | 101) | 101) | 101) |
102) |
1) First dilution step
2) Second dilution step
Dilution medium = acetonitrile : daphnia dilution medium (50 : 50 v/v) containing 0.1% formic acid
Nominal Concentrations of the Fortified Samples of the active ingredients of 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4)
Fortified concentrations*: 0.202 µg test item/L (1 x LOQ) and 200 µg test item/L (1000 x LOQ).
Active ingredient | 1 x LOQ | 1000 x LOQ |
[µg a.s./L] | [µg a.s./L] | |
C16 Amine + 2 EO | 0.0663 | 65.6 |
C18 Amine + 2 EO | 0.123 | 122 |
* = weighing factor taken into account
a.s. = active substance
Measured Concentrations and Percent of Nominal Concentrations of the Fortified Samples of 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4)
Replicate | 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) | |||||||
C16 Amine + 2 EO | C18 Amine + 2 EO | |||||||
1 x LOQ | 1000 x LOQ | 1 x LOQ | 1000 x LOQ | |||||
Meas. | % | Meas. | % | Meas. | % | Meas. | % | |
conc. | conc. | conc. | conc. | |||||
[µg a.s./L] | [µg a.s./L] | [µg a.s./L] | [µg a.s./L] | |||||
1 | 0.0709 | 107 | 52.6 | 80 | 0.131 | 107 | 105 | 86 |
2 | 0.0802 | 121 | 56.2 | 86 | 0.142 | 116 | 109 | 90 |
3 | 0.0729 | 110 | 63.2 | 96 | 0.126 | 103 | 114 | 94 |
4 | 0.0676 | 102 | 59.7 | 91 | 0.126 | 103 | 108 | 89 |
5 | 0.0643 | 97 | 58.8 | 90 | 0.122 | 99 | 97.0 | 80 |
Mean | 0.071 | 107 | 58 | 89 | 0.130 | 106 | 107 | 88 |
SD ± | 0.006 | 4 | 0.008 | 6 | ||||
CV [%] | 8.4 | 6.8 | 6.1 | 6.1 |
Meas. conc. = measured concentration of the active substance, dilution factor taken into account
a.s. = active substance
% = percent concentration of the fortified sample
SD = standard deviation
CV = coefficient of variation
Stability
The stability of the standard stock solution (1000 mg test item/L in acetonitrile) was checked after 15 days and was between 90 and 92% of the nominal concentration for each component.
The stability of the fortified samples at the 1xLOQ was checked after 2 days. The recovery to the nominal concentrations was 92% (C16 Amine + 2 EO) and 100% (C18 Amine + 2 EO).
Procedural Recovery
A procedural recovery (Quality Control) on 1x LOQ Level was freshly prepared on each day of analysis. It was treated in parallel to the test samples.
Measured Concentrations and Percent of Nominal Concentration of the Quality Control during the Definitive Test
Component | C16 Amine + 2 EO | C18 Amine + 2 EO | ||
Analysis date | Meas. conc. | % | Meas. conc. | % |
[µg a.s.L] | [µg a.s.L] | |||
16.03.2023 | 0.0115 | 1721) | 0.126 | 102 |
17.03.2023 | 0.0525 | 79 | - | - |
0.0596 | 89 | 0.128 | 104 | |
0.0559 | 84 | 0.128 | 104 | |
18.03.2023 | 0.0532 | 80 | - | - |
0.0542 | 81 | 0.108 | 87 | |
23.03.2023 | 0.0716 | 107 | 0.133 | 107 |
Meas. conc. = measured concentration of the test item, dilution factors taken into account
% = percent of the nominal concentration
a.s. = active substance
Quality Control = 0.200 µg test item/L, weighing factor taken into account
1) = reanalyzed on 2023-03-17
Preliminary Range Finding Tests (non-GLP)
Solubility Test (non GLP)
WAFs with a nominal loading of 100 and 1000 µg/L were prepared as described. After 24, 48 and 72 hours of stirring samples were taken and analyzed via LC-MS.
A stirring phase of 24 hours was found to be suitable for the preparation of the WAFs. Longer stirring phases led to a decrease of the loading in the WAFs. Therefore, a stirring phase of 24 hours is chosen for the definitive test.
Measured Concentrations of of C16 Component of the Test Item during the Stability Test (non-GLP)
Analytical system: LC-MS
2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) | |||
(C16 Component + 2EO) | |||
Measured concentration [µg a.s./L] | |||
Nominal test item loading | 24 hours | 48 hours | 72 hours |
[µg/L] | |||
100 | 20.4 | 16.6 | 17.2 |
1000 | 164 | Not determined |
Measured Concentrations of of C18 Component of the Test Item during the Stability Test (non-GLP)
Analytical system: LC-MS
2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) | |||
(C18 Component + 2EO) | |||
Measured concentration [µg a.s./L] | |||
Nominal test item loading | 24 hours | 48 hours | 72 hours |
[µg/L] | |||
100 | 2.17 | 1.58 | 2.29 |
1000 | 13.9 | Not determined |
Range Finding Test (non GLP)
A non-GLP preliminary range finding test under semi-static conditions over a period of 48 hours was conducted at the test facility with three WAFs at nominal loading rates of the test item of 1.00, 10.0 and 100 mg/L. The test vessels were pre-treated with the appropriate test solution for at least 12 hours under test conditions. For each loading rate an appropriate amount of stock solution containing the test item with methanol was placed on a curved glass slide. The methanol was evaporated. The glass slide with the test item will be inserted in a glass flask with an appropriate amount of dilution water. All WAFs and the control were visually clear and colorless throughout the exposure. The test item was analytically verified via LC-MS/MS in the WAFs and in the control in the fresh media at the start of the exposure (0 hours) and on the renewal of the test solutions (24 hours) and in the old media (24 and 48 hours).
In the range finding test, two replicates per loading rate and control, each with five daphnids, were tested.
Results of the Range Finding Test (0 - 48 hours)
Nominal loading of the | IMMOBILIZATION [%] | |||||
test item | 24 hours | 48 hours | ||||
[mg/L] | Replicates | Replicates | ||||
1 | 2 | MV | 1 | 2 | MV | |
100 | 100 | 100 | 100 | 100 | 100 | 100 |
10.0 | 0 | 0 | 0 | 0 | 0 | 0 |
1.00 | 0 | 0 | 0 | 0 | 0 | 0 |
Control | 0 | 0 | 0 | 0 | 0 | 0 |
Measured Exposure Concentrations of C16 Component of the Test Item during the non-GLP Preliminary Range Finding Test
Determination of the test item via LC-MS
Sampling date | Fresh media, | Old media, | Fresh media, | Old media, | |||
0 hours | 24 hours | 24 hours | 48 hours | ||||
Nominal test item loading rates | 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) | ||||||
(C16 Component + 2EO) | |||||||
[mg/L] | [mg a.s./L] | Meas. conc. | Meas. conc. | % | Meas. conc. | Meas. conc. | % |
[µg a.s./L] | [µg a.s./L] | [µg a.s./L] | [µg a.s./L] | ||||
100 | 32.8 | 43.8 | 3.25 | 7 | not determined | ||
10.0 | 3.28 | 1.84 | 0.151 | 8 | 1.79 | 2.17 | 121 |
1.00 | 0.328 | 1.29 | < LCL | 0.0532 | 0.399 | 749 | |
Control | < LCL | < LCL | < LCL | < LCL |
% = Percent of the initially measured concentrations
a.s. = active substance
LCL = lowest calibration standard = 0.05 µg/L (0.0164 µg a.s./L)
Meas. Conc. = measured concentration of the test item, dilution factors taken into account
Measured Exposure Concentrations of C18 Component of the Test Item during the non-GLP Preliminary Range Finding Test
Determination of the test item via LC-MS
Sampling date | Fresh media, | Old media, | Fresh media, | Old media, | |||
0 hours | 24 hours | 24 hours | 48 hours | ||||
Nominal test item loading rates | 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) | ||||||
(C18 Component + 2EO) | |||||||
[mg/L] | [mg a.s./L] | Meas. conc. | Meas. conc. | % | Meas. conc. | Meas. conc. | % |
[mg a.s./L] | [mg a.s./L] | [mg a.s./L] | [mg a.s./L] | ||||
100 | 60.8 | 0.0266 | 0.000436 | 2 | not determined | ||
10.0 | 6.08 | 0.0448 | < LCL | 0.00104 | 0.000515 | 80 | |
1.00 | 0.608 | < LCL | < LCL | < LCL | 0.000362 | - | |
Control | < LCL | < LCL | < LCL | < LCL |
% = Percent of the initially measured concentrations
a.s. = active substance
LCL = lowest calibration standard = 0.05 µg/L (0.0304 µg a.s./L)
- = no intial measured concentration
Meas. Conc. = measured concentration of the test item, dilution factors taken into account
Fingerprint
The peak distribution of the test item was analyzed in fresh prepared medium in the highest test item concentration 100 mg/L (WAF approach) from the main study and the control. An analytical standard of the test item was prepared in acetonitrile and diluted to 10.0 mg/L with dilution medium. The highest test item concentration and the control were diluted factor 2 with acetonitrile containing 0.2% formic acid to avoid an inhomogeneous sample. The standard dilution and the test item dilution were analytical verified via MS and evaluated by the software. The detected signals of the analytical standard and of the test item solution were compared. The concentrations of the analytes C16 Amine + 2EO (330.30 Da ± 0.5 Da) and C18 Amine + 2EO (358.33 Da ± 0.5 Da) in the highest test item concentration are too low for significant signals. Both masses were found in the spectrum of the standard.
For analyses, the C16 and C18 amine + 2EO were chosen, because they were both found in the standard solution. During analysis of the test item solutions of the study, another detection mode (MRM) was chosen, because this is more specific and sensitive for concentration control analysis. This modus was suitable to detect both analytes. However, the MRM mode is not suitable for the scan of masses in the fingerprint.
Description of key information
There is one short term toxicity test available performed with the substance.
In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item 2,2’-(C16-18(even numbered) alkyl imino) diethanol (CAS: 1218787-30-4) were determined according to OECD 202 (2004) under GLP conditions.
2,2’-(C16-18(even numbered) alkyl imino) diethanol (PFAEO-HT) is a multicomponent mixture (UVCB) of cationic surface-active constituents with different water solubilities. The fate of cationic surfactants in general deviates from standard chemicals. These substances are therefore considered as difficult substances for which the results of standard guideline studies are very difficult to interpret when considering them in a standard way. The reasons are the intrinsic properties like the relatively low water solubility and strong sorption to equipment and organisms. Classical ecotoxicity testing with these substances using reconstituted water often leads to test results which are poorly reproducible and are associated with high uncertainty. Because of the complex sorption mechanisms (van der Waals and Ionic mechanisms) the actual dissolved exposure concentration cannot reliably be estimated.
The acute daphnia test was therefore performed following the Water Accommodated Fraction (WAF) approach as described in “OECD guidance document on aqueous-phase aquatic toxicity testing of difficult test chemicals” (No. 23 Feb. 2019) with a daily refreshment of the test solutions.
The test solutions for the WAF approach were prepared separately by gentle mixing the test item with test medium for a prolonged period sufficient to ensure equilibration between the test item and the water phase with nominal loading rates of the test item in the range of 6.25 to 100 mg/L set up in a geometric series with a factor of 2. At the completion of mixing and following a settlement period, the WAF was separated by siphoning. This procedure was followed for each renewal of the test solutions.
Five WAFs were prepared and tested at nominal loading rates 6.25 – 12.5 – 25.0 – 50.0 – 100 mg/L (separation factor 2). No undissolved or emulsified material was observed in the WAF solutions based on the Tyndall effect check. The test vessels were pre-saturated with the appropriate test solution for at least 12 hours under test conditions. Before the start of the exposure and the renewal, the test containers were emptied and refilled with freshly prepared test solution.
Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each loading rate and the control. The concentration of PFAEO-HT was quantified by measurement of the C16 and C18 amine + 2EO constituents (representing 96% of the actives). The concentration of the test item was determined in fresh media (0 hours and 24 hours) and old media (24 hours and 48 hours) of all tested concentration levels and the control via LC‑MS/MS. The measured concentrations of PFAEO-HT at the end of exposure after 24 and 48 hours were in the range of 14 to 82% of the initially measured test item concentrations. The geometric mean measured test item concentrations were calculated to be: 12.5 – 23.5 – 52.0 – 70.3 – 103 µg/L.
It should be noted that the geometric mean concentrations are given here even though per definition of the WAF, all terms related to concentration level should be given as “loading rates” because partly dissolved compounds and mixtures cannot be related to concentrations and considering the stability of the test substance and the daily renewal of the test solutions, it is considered justified to use the results based on nominal loading rates for Classification and Labeling purposes.
In Table 1 the results are presented based on nominal Test Loadings and on geometric mean measured concentrations based on quantification of the concentration of 2 main constituents representing 96% of the active ingredient. The observed EL50 and EC50 for mobility after 48 hours are respectively 70.9 µg/L and 51.1 mg/L.
Table 1: EC / EL10-, EC / EL50- and EC / EL100-Values
Effect values | Test duration [hours] | Nominal loading rates of the test item [mg/L] | Geometric mean measured test item concentrations [µg/L] |
EC / EL10 (with confidence limits) | 24 | 100 (Cl: 25.8 – > 100) | 103 (Cl: 51.7 – > 103) |
48 | 47.5 (Cl: 25.0 – 95.9) | 68.8 (Cl: 52.0 – 93.9) | |
EC / EL50 (with confidence limits) | 24 | > 100 | > 103 |
48 | 51.1 (Cl: 26.3 – 97.3) | 70.9 (Cl: 53.1 – 94.8) | |
EC / EL100 | 24 | > 100 | > 103 |
48 | > 100 | > 103 |
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Remarks:
- The effect concentration is based on nominal loading rate and not based on geometric mean measured concentration.
- Effect concentration:
- 51.1 µg/L
Additional information
There is one short term toxicity test with the substance available. This study was conducted reliably according to the OECD 202 test guideline. Chemical analysis was conducted and a detailed Certificate of Analysis is included. Critical validity criteria were met. Some small but non critical discrepancies. Toxicity may be considered an overestimation for risk assesment purposes and sufficient for classification and labelling.
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