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EC number: 940-422-0 | CAS number: -
- 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:
- 2014-05-14 to 2014-05-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.
- EC Number:
- 940-422-0
- Cas Number:
- 1591783-13-9
- Molecular formula:
- C15H31NO6 (C8 derivative) C17H35NO6 (C10 derivative) C19H39NO6 (C12 derivative) C21H43NO6 (C14 derivative) C23H47NO6 (C16 derivative) C25H51NO6 (C18 derivative) C25H49NO6 (C18 unsatd. derivative)
- IUPAC Name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.
- Test material form:
- other: waxy
- Details on test material:
- - Molecular formula: C19H39NO6 (C12-Glucamide) and C21H43NO6 (C14-Glucamide)
- Molecular weight: 377.52 – 405.57 g/mol for C12- and C14-Glucamide
- Substance type: UVCB
- Physical state: waxy solid
- Stability under test conditions: Stable (in water and light at room temperature)
- Storage condition of test material: Room temperature, protected from light, in the tightly closed original container
- Other:
- Solubility (in water at RT): Slightly soluble
- pH value (in aqueous solution): Ca. 8-10 at concentration of 10.000 [mg/L]
- Melting point: 70 – 71 °C
- Boiling point: No boiling point, substance decomposes before boiling
- Vapour pressure: < 0.1 Pa
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- All concentration levels and the control were analytically verified the test item by LC-MS/MS at the start (0 h) and at the end of the exposure (48 h).
At the start of the exposure (0 ), sampling was carried out from the freshly prepared test concentrations.
At the end of the exposure (48 h), samples were taken directly from the test vessels.
The method was validated prior to this study according to SANCO 3029/99 rev.4 (2000-07-11).
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The stock solution (40.0 mg/L) was treated with ultrasound for 30 minutes at 40 °C. Test concentrations were prepared by diluting the stock solution of with dilution water.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: Clone 5
- Source:
Origin: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu)
Breeder: DR.U.NOACK-LABORATORIEN, Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
- Age at study initiation (mean and range, SD): 2 to 24 h old daphnids from a healthy stock were used for the study
- Method of breeding:
Culture: In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 +- 2°C, in an incubator, 16 h illumination; light intensity
of max. 20 µE x m-2 x s-1
Culture medium: Elendt M4, according to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L
Cultur feeding: At least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and
Desmodesmus subspicatus, with an algae cell density of > 106 cells/mL
- Feeding during test: No feeding
ACCLIMATION
- Acclimation period: At least 2 h in dilution water.
- Acclimation conditions (same as test or not): Same as test conditions.
- Health during acclimation (any mortality observed): No mortality observed.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 263 mgCaCO3/L
- Test temperature:
- 18 - 22°C, constant within ± 1°C
- pH:
- pH at the Start of the Exposure (0 h)
(measured in one additional replicate per concentration level and control)
Nominal test item
concentration
[mg/L] pH-value
40.0 6.93
20.0 6.84
10.0 6.81
5.00 6.79
2.50 6.74
Control 7.61
pH at the End of the Exposure (48 h)
(measured in all replicates)
Nominal test item
concentration pH-values
[mg/L] Replicates
1 2 3 4
40.0 7.47 7.48 7.50 7.51
20.0 7.45 7.45 7.47 7.47
10.0 7.36 7.39 7.41 7.42
5.00 7.28 7.30 7.32 7.32
2.50 7.19 7.21 7.25 7.25
Control 7.19 7.14 7.16 7.16 - Dissolved oxygen:
- O2-concentration at the Start of the Exposure (0 h)
(measured in one additional replicate per concentration level and control)
Nominal test item
concentration
[mg/L] O2-concentration [mg/L]
40.0 8.19
20.0 8.51
10.0 8.63
5.00 8.71
2.50 8.75
Control 8.70
O2-concentration at the End of the Exposure (48 h)
(measured in all replicates)
Nominal test item
concentration O2-concentration [mg/L]
[mg/L] Replicates
1 2 3 4
40.0 8.14 8.03 8.25 8.20
20.0 8.14 8.20 8.19 8.06
10.0 8.37 8.44 8.59 8.37
5.00 8.61 8.59 8.65 8.45
2.50 8.75 8.71 8.74 8.72
Control 8.86 8.64 8.69 8.71 - Nominal and measured concentrations:
- 2.50 - 5.00 - 10.0 - 20.0 - 40.0 mg test item/L (factor 2)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers (4 cm ID x 7 cm H), 50 mL capacity, loosely covered with watch glasses
- Test volume: 20 mL
- Aeration: None
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO Test water, according to OECD 202, Annex 3
Component Concentration [mg/L]
KCl 5.76
NaHCO3 64.8
CaCl2 x 2 H2O 294
MgSO4 x 7 H2O 123
- Water Quality Parameters of the Dilution Water prior to the Start of the Exposure (0 h):
pH-value DissolvedO2-concentration[mg/L] Temperature[°C] Conductivity[µS/cm] Total hardness [mg CaCO3/L]
7.61 8.70 21.8 654 263
- Culture medium different from test medium: Elendt M4, according to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L
- Intervals of water quality measurement: test start (0h) and test end (48h)
OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: Diffuse light, light intensity of max. 20 µE x m-2 x s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Immobilisation, 24 h interval
TEST CONCENTRATIONS
- Test concentrations: 2.50 - 5.00 - 10.0 - 20.0 - 40.0 mg test item/L (spacing factor 2 )
- Range finding study:
A non GLP preliminary range finding test was conducted under semi-static conditions with two concentrations of the test item of 1.00 and 10.0 mg/L.
The percentage immobility was determined in all concentrations and control groups after 24 and 48 h of exposure. The biological results are presented in the
following table.
Immobilisation Rates in the non GLP Preliminary Range Finding Test
(n = 20, divided into 2 replicates with 10 daphnids each)
Nominal test item
concentration [mg/L] IMMOBILISATION [%]
24 h 48 h
Replicates Replicates
1 2 MV 1 2 MV
10.0 0 0 0 90 30 60
1.00 0 0 0 0 0 0
Control 0 0 0 0 0 0
MV = mean value - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC10
- Effect conc.:
- 4.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: immobilisation
- Remarks on result:
- other: < 2.50 - 6.92
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 4.05 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: immobilisation
- Remarks on result:
- other: < 2.50 - 5.94
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 20.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: immobilisation
- Remarks on result:
- other: 14.6 - 27.9
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 7.29 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: immobilisation
- Remarks on result:
- other: 5.54 - 9.59
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 40 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: immobilisation
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 40 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: immobilisation
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 2.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: immobilisation
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: immobilisation
- Details on results:
- See below
- Results with reference substance (positive control):
- The percentage immobility for the reference item was determined after 24 h. The EC50-value with 95 % confidence interval (CI) was calculated by
sigmoidal dose-response regression. The EC50-value for the most recent of the monthly performed reference tests was:
EC50: 1.62 mg/L (CI 1.57 - 1.66 mg/L)
The EC50-value of the reference item potassium dichromate after 24 h is within the prescribed concentration range of 0.6 - 2.4 mg/L of quality
criteria according to AQS P 9/2 (02/2000) for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item is also within therecommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202.
Any other information on results incl. tables
Biological Data
The percentage immobility, determined in all concentration levels and the control after 24 and 48 h under static conditions, is given in the table below.
Immobilisation Rates after 24 and 48 h of Exposure in the Definitive Test
(n = 20, divided into 4 replicates with 5 daphnids each)
Nominal concentrations |
IMMOBILISATION [%] |
|||||||||||
test item
[mg/L] |
active components Glucamides [mg/L] |
24 h |
48 h |
|||||||||
Replicates |
Replicates |
|||||||||||
1. |
2. |
3. |
4. |
MV |
1. |
2. |
3. |
4. |
MV |
|
||
40.0 |
32.4 |
100 |
80 |
60 |
60 |
75 |
100 |
100 |
100 |
100 |
100 |
|
20.0 |
16.2 |
60 |
40 |
60 |
40 |
50 |
100 |
60 |
100 |
100 |
90 |
|
10.0 |
8.10 |
40 |
20 |
0 |
40 |
25 |
100 |
60 |
40 |
100 |
75 |
|
5.00 |
4.05 |
0 |
0 |
20 |
40 |
15 |
0 |
0 |
20 |
60 |
20 |
|
2.50 |
2.03 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
MV = mean value
All test item concentrations were visually clear throughout the exposure period. At the end of the exposure (48 h), white flakes were observed at the bottom of the test vessels of the concentration levels 20.0 and 40.0 mg/L.
Measured Exposure Concentrations during the Definitive Test
The concentrations of the main components C12-Glucamide and C14-Glucamide were analytically verified via LC-MS/MS at the start of the exposure (0 h) and at the end of the exposure (48 h) in all concentration levels and the control.
The measured concentrations of the component C12-Glucamide at the start of the exposure (0 h) were in the range of 90 to 109 % of the nominal values and 98 to 106 % of the nominal values at the end of the exposure (48 h). The measured concentrations of the component C14-Glucamide at the start of the exposure (0 h) were in the range of 87 to 110 % of the nominal values and 48 to 91 % of the nominal values at the end of the exposure (48 h).The analytical results are presented in the tables below.
Measured Concentrations of the ComponentC12-Glucamideof theTest ItemGlucamide CCduring the Definitive Test
Sampling date |
2014-05-14 0 h Start of the exposure interval |
2014-05-16 48 h End of the exposure interval |
|||
Nominalconcentrationof the |
C12-Glucamide, Component of the Test Item Glucamide CC |
||||
test item [mg/L] |
component C12-Glucamide [mg/L] |
Meas. conc. [mg/L] |
% |
Meas. conc. [mg/L] |
% |
40.0 |
15.8 |
17.3 |
109 |
16.8 |
106* |
20.0 |
7.92 |
7.96 |
101 |
8.08 |
102* |
10.0 |
3.96 |
3.73 |
94 |
4.12 |
104 |
5.00 |
1.98 |
1.79 |
90 |
2.07 |
105 |
2.50 |
0.990 |
0.907 |
92 |
0.974 |
98* |
Control |
< LOQ |
< LOQ |
Meas.
conc. =
measured concentration of
C12-Glucamide of
the test item Glucamide
CC, mean value
of 2 injections,
dilution
factor taken into account
% = percent of the nominal concentration of the test item
LOQ = limit of quantification (30.0 µg/L of the test item, corresponding to 12.0 µg/L C12-Glucamide)
* = reanalysed on 2014-05-16, mean value of 3 replicates
Measured Concentrations of the ComponentC14-Glucamideof theTest ItemGlucamide CCduring the Definitive Test
Sampling date |
2014-05-14 0 h Start of the exposure interval |
2014-05-16 48 h End of the exposure interval |
|||
Nominalconcentrationof the |
C14-Glucamide, Component of the Test Item Glucamide CC |
||||
test item [mg/L] |
component C14-Glucamide [mg/L] |
Meas. conc. [mg/L] |
% |
Meas. conc. [mg/L] |
% |
40.0 |
5.44 |
5.97 |
110 |
2.61 |
48* |
20.0 |
2.72 |
2.62 |
96 |
1.84 |
68* |
10.0 |
1.36 |
1.19 |
88 |
1.18 |
87 |
5.00 |
0.680 |
0.593 |
87 |
0.617 |
91 |
2.50 |
0.340 |
0.305 |
90 |
0.277 |
81** |
Control |
< LOQ |
< LOQ |
Meas.
conc. =
measured concentration of
C14 -Glucamide of
the test item Glucamide
CC, mean value
of 2 injections,
dilution
factor taken into account
% = percent of the nominal concentration of the test item
LOQ = limit of quantification (30.0 µg/L of the test item corresponding to 4.12 µg/L C12-Glucamide)
* = reanalysed on 2014-05-16, mean value of 3 replicates
** = reanalysed on 2014-05-16, mean value of 2 replicates
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the nominal concentrations of the test item Glucamide CC the 48 h-EC50 for Daphnia magna was 7.29 mg/L
(95 % confidence limits: 5.54 – 9.59 mg/L).
Based on the nominal concentrations of the active components Glucamides the 48 h-EC50 for Daphnia magna was 5.91 mg/L
(95 % confidence limits: 4.49 – 7.77 mg/L).
The NOEC after 48 h was 2.50 mg test item/L, which corresponds to 2.03 mg Glucamides/L.
The LOEC after 48 h was 5.00 mg test item/L, which corresponds to 4.05 mg Glucamides/L. - Executive summary:
In the acute immobilisation test with Daphnia magna (STRAUS), the effects of the test item Glucamide CC (batch number:EK13/177) were determined according to OECD 202 (2004) from 2014-05-14 to 2014-05-16, at Dr.U.Noack-Laboratorien, Käthe-Paulus-Str.1, 31157 Sarstedt, Germany.
The study was conducted under static conditions over a period of 48 h with 5 concentrations of the test item Glucamide CC in the range of 2.50 to 40.0 mg/Lin a geometric series with a separation factor of 2. Twenty daphnids were exposed to each concentration leveland the control. The test item is an UVCB substance (substances of Unknown or Variable composition, Complex reaction products or Biological materials) and is slightly soluble in water at room temperature.
The concentrations of the main components C12 -Glucamide and C14 -Glucamide were analytically verified via LC-MS/MS at the start of the exposure (0 h) and at the end of the exposure (48 h) in all concentration levels and the control.
The measured concentrations of the component C12 -Glucamide at the start of the exposure (0 h) were in the range of 90 to 109 % of the nominal values and 98 to 106 % of the nominal values at the end of the exposure (48 h). The measured concentrations of the component C14 -Glucamide at the start of the exposure (0 h) were in the range of 87 to 110 % of the nominal values and 48 to 91 % of the nominal values at the end of the exposure (48 h).
Nevertheless the effect levels are based on the nominal concentrations of the test item Glucamide CC and the active components Glucamides and presented in the table below.
The water quality parameters (i.e. pH-value and dissolved oxygen concentration), measured at the start (0 h) and at the end of the exposure interval (48 h), were within the acceptable limits. The validity criteria of the test guideline were fulfilled.
EC10-, EC50- (with Confidence Interval), EC100-Values, NOEC and LOEC
(based on the nominal concentrations of the test itemGlucamide CCand the active components Glucamides)
Effect levels
Test
duration [h]
Nominal concentrations
of the test item
Glucamide CC[mg/L]
Nominal concentrations
of the active components Glucamides (81.0 % (w/w)[mg/L]
EC10
(with 95 % confidence limits)
24
4.40 (< 2.50 – 6.92)
3.57 (< 2.03 – 5.60)
48
4.05 (< 2.50 – 5.94)
3.28 (< 2.03 – 4.81)
EC50
(with 95 % confidence limits)
24
20.9 (14.6 – 27.9)
16.9 (11.8 – 22.6)
48
7.29 (5.54 – 9.59)
5.91 ( 4.49 – 7.77)
EC100
24
> 40.0
> 32.4
48
40.0
32.4
NOEC
48
2.50
2.03
LOEC
48
5.00
4.05
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