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EC number: 839-734-9 | CAS number: 2290526-77-9
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2019-08-28 to 2019-09-13, with the definitive exposure phase from 2019 09-11 to 2019-09-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- anhydro-D-glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- EC Number:
- 839-734-9
- Cas Number:
- 2290526-77-9
- Molecular formula:
- C15H29NO5 C17H33NO5
- IUPAC Name:
- anhydro-D-glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- Test material form:
- liquid: viscous
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Determination of the test item
All concentration levels and the control were analytically verified via LC-MS/MS in the fresh media at the start of the exposure (0 hours) as well as in the old media at the end of the exposure (48 hours).
The samples were analysed with an LC-MS/MS method, implemented under non-GLP and documented finally in the GLP raw data.
Sampling for the analytical monitoring
At the start of the exposure (0 hours), samples were taken from the freshly prepared concentration levels and the control for analysis.
At the end of the exposure (48 hours), samples for the analyses of the old media were taken from test replicates containing daphnids.
The samples were immediately stabilized with the solvent methanol (dilution factor 2). They were analyzed on the day of sampling. The samples were stored with the stabilizing solvent at room temperature until analysis, if necessary.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Test item concentrations
Five concentration levels prepared from the stock solution 160 mg/L in a geometric series with a separation factor of 2 by dilution of the stock solution with dilution water, were tested as follows:
10.0 - 20.0 - 40.0 - 80.0 - 160 mg/L.
The test item concentrations were selected based on the results of the first definitive test and a non-GLP preliminary range finding test.
Preparation of the stock solution
The stock solution (160 mg/L of the test item were weighed out) was freshly prepared with dilution water prior to start of the exposure.
The test item solution was mixed thoroughly by manual agitation until it was visually clear.
Control
Dilution water without test item incubated under the same conditions as the test groups
Test organisms
- 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.
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, in an incubator, 16 hours illumination; light intensity of max. 1500 lx
Culture medium
Elendt M4, according to OECD 202, Annex 3 (2004), is used. The composition of the culture medium is presented in the table below.
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 are cultured at the test facility
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 to 0.8
Study design
- Test type:
- static
- Water media type:
- freshwater
- Remarks:
- Elendt M4, according to OECD 202, Annex 3 (2004)
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- see any other information on materials and methods incl. tables
- Test temperature:
- see any other information on materials and methods incl. tables
- pH:
- see any other information on materials and methods incl. tables
- Dissolved oxygen:
- see any other information on materials and methods incl. tables
- Salinity:
- Not applicable, freshwater
- Conductivity:
- see any other information on materials and methods incl. tables
- Nominal and measured concentrations:
- 10.0 - 20.0 - 40.0 - 80.0 - 160 mg/L
- Details on test conditions:
- Test method
The study was performed under static conditions.
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
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 of the daphnids was not necessary, because the composition of the dilution water was 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 by a 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. - Reference substance (positive control):
- yes
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC10
- Effect conc.:
- 147 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: 80.0 - >160
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 85.7 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: CI: 80.0 - >160
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 156 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: 80.0 - >160
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 113 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: 80.0 - 160
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 160 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 160 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- The percentage of immobility for the reference item potassium dichromate (SIGMA-ALDRICH, batch number MKBV0900V, purity 99.0%, CAS RN 7778-50-9) was determined after 24 hours from 2019 08-07 to 2019-08-08.
EC50-Value (with Confidence Limits) of the Reference Item Potassium dichromate
based on nominal concentrations mg/L, (0 - 24 hours)
Current Study Valid Range
EC50 2.00 mg/L
0.6 - 2.4 mg/L, acc. to AQS P 9/2 (02/2000)
Confidence limits 1.00 - 4.00 mg/L
The respective confidence limits were empirically derived from the observation data as follows: The highest concentration level without any effect (EC0) and the lowest concentration level causing 100% immobilization (EC100) were used as confidence limits. - Reported statistics and error estimates:
- Methods of evaluation
The EC100-values after 24 and 48 hours were empirically derived from the observation data. The effect levels (EC10 / 50 / 100) given are based on the analytically verified nominal concentrations of the test item.
EC-values and statistical analyses
The EC10- and the EC50-value after 24 hours were calculated by sigmoidal dose-response regression. The EC10- and the EC50-value after 48 hours were calculated by straight line between the highest concentration resulting in 0% immobilization (EC0) and the test item concentration with the highest immobilization rate. The respective confidence limits were empirically derived from the observation data as follows: The highest concentration level without any effect (EC0) and the lowest concentration level causing 100% immobilization (EC100) were used as confidence limits. All calculations were carried out from the best-fit values with the software GraphPad Prism. The concentration-effect relationships of the test item are shown graphically.
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
Any other information on results incl. tables
Immobilization Rates after 24 and 48 hours of Exposure in the Definitive Test
(n = 20, divided into 4 replicates with 5 daphnids each)
Nominal test item concentration
[mg/L] IMMOBILIZATION [%]
24 hours 48 hours
Replicates Replicates
1 2 3 4 MV 1 2 3 4 MV
160 80 80 80 80 80 100 100 100 100 100
80.0 0 0 0 0 0 0 0 0 0 0
40.0 0 0 0 0 0 0 0 0 0 0
20.0 0 0 0 0 0 0 0 0 0 0
10.0 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 in the Definitive Test
(n = 20, divided into 4 replicates with 5 daphnids each)
Nominal test item concentration
[mg/L] NUMBER OF IMMOBILE DAPHNIDS / TOTAL NUMBER OF DAPHNIDS
24 hours 48 hours
Replicates Replicates
1 2 3 4 Sum 1 2 3 4 Sum
100 4 / 5 4 / 5 4 / 5 4 / 5 16 / 20 5 / 5 5 / 5 5 / 5 5 / 5 20 / 20
50.0 0 / 5 0 / 5 0 / 5 0 / 5 0 / 20 0 / 5 0 / 5 0 / 5 0 / 5 0 / 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
Additional Observations during the Definitive Test
All test item concentrations and the control were colorless and visually clear throughout the exposure period.
Water Quality Parameters
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 test period, the temperature in the incubator was 21 °C.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the analytically verified nominal concentrations of the test item cyclic Glucamide C8-C10, the 48-hour EC50 for Daphnia magna was 113 mg/L (confidence limits: 80.0 – 160 mg/L).
- Executive summary:
In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item cyclic Glucamide C8-C10 (batch number: BP 1c (reactor mix)) were determined at the test facility according to OECD 202 (2004) from 2019-08-28 to 2019-09-13, with the definitive exposure phase from 2019 09-11 to 2019-09-13.
The study was conducted under static conditions over a period of 48 hours with five nominal concentrations of the test item cyclic Glucamide C8-C10 prepared in a geometric series with a separation factor of 2 (nominal concentrations of 10 to 160 mg/L).
All test item concentrations and the control were colorless and visually clear throughout the exposure period.
Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration level and the control.
The concentrations of the test item cyclic Glucamide C8-C10 were analytically verified via LC-MS/MS in the fresh media at the start of the exposure (0 hours) and in the old media at the end of the exposure (48 hours) in all concentration levels and in the control.
The measured concentrations of the test item cyclic Glucamide C8 in the fresh media were in the range of 98 to 104% of the nominal values. At the end of exposure after 48 hours, the measured concentrations were in the range of 97 to 101% of the nominal test item concentrations.
The measured concentrations of the test item cyclic Glucamide C10 in the fresh media were in the range of 96 to 104% of the nominal values. At the end of exposure after 48 hours, the measured concentrations were in the range of 94 to 98% of the nominal test item concentrations.
The measured test item concentrations remained stable within ± 20% of the nominal concentrations over the test period. This indicates that the test item concentrations were successfully maintained for the duration of the test. The effect concentrations are based on the analytically verified nominal concentrations of the test item cyclic Glucamide C8-C10.
The validity criteria of the test guideline were fulfilled.
EC10-, EC50- (with Confidence Limits) and EC100-Values
(based on the nominal concentrations of the test item)
Effect levels Test duration [hours] cyclic Glucamide C8-C10 Nominal test item concentrations [mg/L]
EC10 (with confidence limits) 24 147 (Cl: 80.0 – > 160)
48 85.7 (Cl: 80.0 – 160)
EC50 (with confidence limits) 24 156 (Cl: 80.0 – > 160)
48 113 (Cl: 80.0 – 160)
EC100 24 > 160
48 160
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