Registration Dossier
Registration Dossier
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EC number: 939-538-4 | CAS number: 1471313-87-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-12-10 to 2012-12-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 1.00 - 3.16 - 10.0 - 31.6 - 100 - 316 mg/L
- Sampling method: The concentrations of the test item were analytically determined from all test concentrations and the control at the start of the exposure (0 h) and at the end of the exposure (72 h). Samples at the start of the exposure were taken from an additional replicate without algae. At the end of the exposure samples were taken directly from the pooled test replicates.
- Sample storage conditions before analysis:
All original samples were stored at room temperature until sample preparation. Prepared samples were stored at room temperature until analysis. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution of 316 mg/L was freshly prepared with dilution water.
- Eluate: DIlution water
- Differential loading: 1.00 - 3.16 - 10.0 - 31.6 - 100 - 316 mg/L
- Controls: Six replicates without test item were tested under the same test conditions as the test replicates. - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Desmodesmus subspicatus Chodat
- Strain: SAG 86.81
- Source (laboratory, culture collection): SAG Pflanzenphysiologisches Institut der Universitaet Goettingen, Nikolausberger Weg 18, D-37073 Goettingen, Germany
- Age of inoculum (at test initiation): 3 days
- Method of cultivation: Fresh stocks were prepared every month on Z-Agar. Light intensity amounted to 35 - 70 µE x m-2 x s-1 for 24 h per day. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
- Hardness:
- 0.24 mmol Ca+Mg/l
- Test temperature:
- min.: 22.0 max.: 23.0, mean value: 22.5 °C
- pH:
- Nominal test item concentration pH-value
Test item [mg/L] Active ingredient [mg/L a.i.] Start; 0 hours End; 72 hours
316 193 7.73 7.90
100 61.0 7.73 8.01
31.6 19.3 7.76 8.14
10.0 6.10 7.79 8.29
3.16 1.93 7.83 8.38
1.00 0.610 7.89 8.54
Control 7.97 8.71 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured, freshwater conditions
- Nominal and measured concentrations:
- See window "Any other information on materials and methods incl. tables"
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL Erlenmeyer flasks
- Type (delete if not applicable): open, cotton wool plugs
- Material, size, headspace, fill volume: sterile 250 mL Erlenmeyer flasks, test volume 100 mL
- Aeration: Test containers were placed on a rotary shaker and oscillated at appr. 70 rpm
- Type of flow-through (e.g. peristaltic or proportional diluter): None
- Renewal rate of test solution (frequency/flow rate): One application at test start
- Initial cells density: Nominal: approximately 2 - 5 x 103 cells/mL, Actual: mean 4332 cells/mL
- Control end cells density: Mean 717179 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Composition of Dilution Water
according to the guideline
Component Concentration [mg/L]
NH4Cl 15
MgCl2 6 H2O 12
CaCl2 2 H2O 18
MgSO4 7 H2O 15
KH2PO4 1.6
FeCl3 6 H2O 0.064
Na2EDTA 2 H2O 0.1
H3BO3 0.185
MnCl2 4 H2O 0.415
ZnCl2 3 x 10-3
Na2MoO4 2 H2O 7 x 10-3
CoCl2 6 H2O 1.5 x 10-3
CuCl2 2 H2O 1 x 10-5
NaHCO3 50
pH 8.1 0.2
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: 24 h
- Light intensity and quality: 60 - 120 µE x m-2 x s-1, mean value: 67.9
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: [counting chamber; electronic particle counter; fluorimeter; spectrophotometer; colorimeter] fluorimeter, Cell density and self fluorescence was measured daily via Chlorophyll-a- fluorescence, excitation at 436 nm, emission at 685 nm. Dilution water was used as background signal.
TEST CONCENTRATIONS
Results of the Range Finding Test (0-72 hours)
Nominal Test Item Concentration
[mg/L] Growth Rate Inhibition [%] Yield Inhibition [%]
100 56 95
10.0 13 48
1.00 2 9
0.1 3 13
0.01 1 8
- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 117 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- is UVCB means 100% act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI 99.7-138 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 11.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- is UVCB means 100% act.ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI 6.75-16.5 mg/L
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test):
- Unusual cell shape: No
- Colour differences: No
- Flocculation: No
- Adherence to test vessels: No
- Aggregation of algal cells: No
- Other: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
Current Study Valid Range (average ± 3 x SD)
Growth Rate Inhibition
ErC50 0.631 0.682 ± 0.452
95 %
confidence
interval 0.583 - 0.687
Yield Inhibition
EyC50 0.256 0.314 ± 0.144
95 %
confidence
interval 0.247 - 0.265
SD = Standard deviation - Reported statistics and error estimates:
- NOEC/LOEC were determined by calculation of statistical significance of growth rate and yield. As standard One Way Analysis of Variance (ANOVA) and DUNNETT’s test were used for NOEC/LOEC calculations. When running a One Way Analysis of Variance a Normality test and an Equal Variance test were done first. The SHAPIRO-WILK-Test was used to test for normally distributed populations. The Levene median test was used for equal variance. P-values for both Normality and Equal Variance tests are 0.05. The -value (acceptable probability of incorrectly concluding that there is a difference) is =0.05.
Detection of statistically significant differences were considered negligible when inhibition values were ≤ 10 %. These findings were marked “biologically not significant”. Following the recommendations of the UBA (HEGER ET AL. 1998), inhibitions > 10 % are significant. - Validity criteria fulfilled:
- yes
- Conclusions:
- In this study Sodium methyl oleyl taurate was found to inhibit the growth of the freshwater green alga Desmodesmus subspicatus after 72 hours. The NOEC-values of the test item for inhibition of growth rate and inhibition of yield after 72 hours were 10.0 mg/L and 1.00 mg/L, respectively. The LOEC-values of the test item for inhibition of growth rate and inhibition of yield after 72 hours were 31.6 mg/L and 3.16 mg/L, respectively. The EC50-values of the test item for inhibition of growth rate (ErC50) and yield (EyC50) with 95 % Confidence Intervals after 72 hours were 117 (99.7 – 138) and 19.5 (14.6 – 24.9) mg/L, respectively.
The NOEC-values of the active ingredient for inhibition of growth rate and inhibition of yield after 72 hours were 6.10 mg/L a.i. and 0.610 mg/L a.i., respectively. The LOEC-values of the active ingredient for inhibition of growth rate and inhibition of yield after 72 hours were 19.3 mg/L a.i. and 1.93 mg mg/L a.i., respectively. The EC50-values of the active ingredient for inhibition of specific growth rate (ErC50) and yield (EyC50) with 95 % Confidence Intervals after 72 hours were 71.6 (60.8 – 84.3) and 11.9 (8.90 – 15.2) mg/L a.i., respectively.
All effect levels are given based on nominal concentrations of Sodium methyl oleyl taurate. - Executive summary:
The toxicity of Sodium methyl oleyl taurate(batch number: DEB4003485)to the unicellular freshwater green alga Desmodesmus subspicatus was determined according to the principles of OECD 201 (2006) at Dr.U.Noack-Laboratorienin 31157 Sarstedt, Germany from 2012-12-10 to
2012-12-13. The aim of the study was to assess the effects on growth rate and yield over a period of 72 hours.The study was conducted under static conditions with an initial cell density of 4332 cells/mL. Based on a preliminary test 6 concentration levels were tested in a geometrical series with a nominal dilution factor of : 1.00 - 3.16 - 10.0 - 31.6 - 100 - 316 mg/L corresponding to active ingredient (a.i.) concentrations of 0.610 - 1.93 - 6.10 - 19.3 - 61.0 - 193 mg a.i./L. Three replicates were tested for each test item concentration and six replicates for the control. Environmental conditions were determined to be within the acceptable limits.
The concentrations of the test item Sodium methyl oleyl taurate (C18:1-part) were analytically verified by LC-MS/MS at the start and the end of the exposure of all test concentrations and the control.
The measured concentrations of the test item Sodium methyl oleyl taurateat the start of the exposure were in the range of 93 to 103 % and after 72 hours in the range of 82 to 98 % of the nominal values. Therefore, all effect values given are based on the nominal test item and active ingredient (a.i.) concentrations of Sodium methyl oleyl taurate.IMPORTANT NOTE TO AVOID CONFUSION:
As the registration substance is a UVCB this means that the test item is 100% active ingredient.
Table 1: NOEC, LOEC, EC - values and 95 % Confidence Intervals of Sodium methyl oleyl taurate
(0-72 hours)based on nominal test item and active ingredient (a.i.) concentrations [mg/L]
Growth Rate Inhibition
Nominal [mg/L]
NOEC
10.0
LOEC
31.6
ErC10
11.1 (6.75 – 16.5)
ErC20
29.2 (22.6 – 36.3)
ErC50
117 (99.7 – 138)
Inhibition of Yield
NOEC
1.00
LOEC
3.16
EyC10
2.55 ( – 9.81)
EyC20
9.28 (5.65 – 14.4)
EyC50
19.5 (14.6 – 24.9)
Reference
Cell Densities
|
Nominal concentration |
Replicate |
Cell density [cells/mL] |
|||||||
Test item [mg/L] |
Active ingredient [mg/L a.i.] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
|
|||
316 |
193 |
1 |
4332 |
9329 |
7797 |
7492 |
|
|||
2 |
4332 |
7747 |
8332 |
10219 |
|
|||||
3 |
4332 |
8511 |
7036 |
7851 |
|
|||||
Mean |
4332 |
8529 |
7722 |
8521 |
|
|||||
100 |
61.0 |
1 |
4332 |
10254 |
19431 |
78554 |
|
|||
2 |
4332 |
10757 |
22157 |
84787 |
|
|||||
3 |
4332 |
10552 |
20069 |
76038 |
|
|||||
Mean |
4332 |
10521 |
20552 |
79793 |
|
|||||
31.6 |
19.3 |
1 |
4332 |
10493 |
30973 |
159493 |
|
|||
2 |
4332 |
9395 |
33876 |
186408 |
|
|||||
3 |
4332 |
9448 |
31350 |
197636 |
|
|||||
Mean |
4332 |
9779 |
32066 |
181179 |
|
|||||
10.0 |
6.10 |
1 |
4332 |
13531 |
81365 |
641408 |
|
|||
2 |
4332 |
14748 |
90193 |
544070 |
|
|||||
3 |
4332 |
16622 |
85042 |
546272 |
|
|||||
Mean |
4332 |
14967 |
85533 |
577250 |
|
|||||
3.16 |
1.93 |
1 |
4332 |
16088 |
124647 |
600491 |
|
|||
2 |
4332 |
16553 |
102739 |
558286 |
|
|||||
3 |
4332 |
17739 |
95706 |
533817 |
|
|||||
Mean |
4332 |
16793 |
107697 |
564198 |
|
|||||
1.00 |
0.610 |
1 |
4332 |
21777 |
107248 |
622003 |
|
|||
2 |
4332 |
22598 |
138151 |
731638 |
|
|||||
3 |
4332 |
25721 |
137742 |
794129 |
|
|||||
Mean |
4332 |
23365 |
127714 |
715923 |
|
|||||
Control |
1 |
4332 |
17506 |
119822 |
636187 |
|
||||
2 |
4332 |
19148 |
137245 |
789380 |
|
|||||
3 |
4332 |
21604 |
108771 |
774253 |
|
|||||
4 |
4332 |
18852 |
113425 |
648673 |
|
|||||
5 |
4332 |
16056 |
123602 |
699543 |
|
|||||
6 |
4332 |
22925 |
129389 |
755037 |
|
|||||
Mean |
4332 |
19349 |
122042 |
717179 |
|
Evaluation after 72 hours
Statistically significant differences of growth rates and yield compared to
control values are marked (+), not significant differences are marked (-).
Nominal concentration |
Replicate |
Growth rate |
Growth rate inhibition |
Yield |
Inhibition of yield |
|||
Test item [mg/L] |
Active ingredient [mg/L a.i.] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
316 |
193 |
1 |
0.183 |
89.3 |
3160 |
99.6 |
||
2 |
0.286 |
83.2 |
5887 |
99.2 |
||||
3 |
0.198 |
88.4 |
3519 |
99.5 |
||||
Mean |
(+) |
0.222 |
86.9 |
(+) |
4189 |
99.4 |
||
100 |
61.0 |
1 |
0.966 |
43.3 |
74222 |
89.6 |
||
2 |
0.991 |
41.8 |
80455 |
88.7 |
||||
3 |
0.955 |
43.9 |
71706 |
89.9 |
||||
Mean |
(+) |
0.971 |
43.0 |
(+) |
75461 |
89.4 |
||
31.6 |
19.3 |
1 |
1.20 |
29.4 |
155161 |
78.2 |
||
2 |
1.25 |
26.3 |
182076 |
74.5 |
||||
3 |
1.27 |
25.2 |
193304 |
72.9 |
||||
Mean |
(+) |
1.24 |
27.0 |
(+) |
176847 |
75.2 |
||
10.0 |
6.10 |
1 |
1.67 |
2.12 |
637076 |
10.6 |
||
2 |
1.61 |
5.34 |
539738 |
24.3 |
||||
3 |
1.61 |
5.26 |
541940 |
24.0 |
||||
Mean |
(+)1 |
1.63 |
4.24 |
(+) |
572918 |
19.6 |
||
3.16 |
1.93 |
1 |
1.64 |
3.41 |
596159 |
16.4 |
||
2 |
1.62 |
4.84 |
553954 |
22.3 |
||||
3 |
1.61 |
5.71 |
529485 |
25.7 |
||||
Mean |
(+)1 |
1.62 |
4.65 |
(+) |
559866 |
21.5 |
||
1.00 |
0.610 |
1 |
1.66 |
2.72 |
617671 |
13.4 |
||
2 |
1.71 |
-0.46 |
727306 |
-2.03 |
||||
3 |
1.74 |
-2.07 |
789797 |
-10.8 |
||||
Mean |
(-) |
1.70 |
0.06 |
(-) |
711591 |
0.18 |
||
Control |
1 |
1.66 |
631855 |
|||||
2 |
1.74 |
785048 |
||||||
3 |
1.73 |
769921 |
||||||
4 |
1.67 |
644341 |
||||||
5 |
1.70 |
695211 |
||||||
6 |
1.72 |
750705 |
||||||
Mean |
1.70 |
712847 |
Section-by-Section and Average Specific Growth Rates of the Control Group
(0 – 72 hours)
Replicate No. |
Specific growth rate [d-1] |
Mean (0 - 72 h) |
SD ± |
CV |
Mean CV [%] |
|||
section-by-section |
||||||||
0 - 24 hours |
24 - 48 hours |
48 - 72 hours |
||||||
Control |
1 |
1.40 |
1.92 |
1.67 |
1.66 |
0.264 |
15.8 |
12.7 |
2 |
1.49 |
1.97 |
1.75 |
1.74 |
0.242 |
13.9 |
||
3 |
1.61 |
1.62 |
1.96 |
1.73 |
0.203 |
11.7 |
||
4 |
1.47 |
1.80 |
1.74 |
1.67 |
0.174 |
10.4 |
||
5 |
1.31 |
2.04 |
1.73 |
1.70 |
0.367 |
21.7 |
||
6 |
1.67 |
1.73 |
1.76 |
1.72 |
0.0497 |
2.89 |
||
Mean |
1.70 |
|
||||||
SD ± |
0.03 |
|
||||||
CV [%] |
1.81 |
|
Description of key information
In this study Sodium methyl oleyl taurate was found to inhibit the growth of the freshwater green alga Desmodesmus subspicatus after 72 hours. The NOEC-values of the test item for inhibition of growth rate and inhibition of yield after 72 hours were 10.0 mg/L and 1.00 mg/L, respectively. The LOEC-values of the test item for inhibition of growth rate and inhibition of yield after 72 hours were 31.6 mg/L and 3.16 mg/L, respectively. The EC50-values of the test item for inhibition of growth rate (ErC50) and yield (EyC50) with 95 % Confidence Intervals after 72 hours were 117 (99.7 – 138) and 19.5 (14.6 – 24.9) mg/L, respectively.
The NOEC-values of the active ingredient for inhibition of growth rate and inhibition of yield after 72 hours were 6.10 mg/L a.i. and 0.610 mg/L a.i., respectively. The LOEC-values of the active ingredient for inhibition of growth rate and inhibition of yield after 72 hours were 19.3 mg/L a.i. and 1.93 mg mg/L a.i., respectively. The EC50-values of the active ingredient for inhibition of specific growth rate (ErC50) and yield (EyC50) with 95 % Confidence Intervals after 72 hours were 71.6 (60.8 – 84.3) and 11.9 (8.90 – 15.2) mg/L a.i., respectively.
All effect levels are given based on nominal concentrations of Sodium methyl oleyl taurate.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 117 mg/L
- EC10 or NOEC for freshwater algae:
- 11.1 mg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
