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EC number: 701-479-5 | 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-01-11 to 2013-01-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol
- EC Number:
- 701-479-5
- Molecular formula:
- C42H82O7
- IUPAC Name:
- C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol
- Details on test material:
- - Name of test material (as cited in study report): Diglycerol diisostearate
- Physical state: Viscous liquid, light yellow
- Analytical purity: 100 % (w/w) UVCB
- Purity test date: 2012-02-29
- Lot/batch No.: ESD0012304
- Expiration date of the lot/batch: 2013-06-09
- Stability under test conditions: Stable
- Storage condition of test material: Keep container tightly closed and dry.
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Five water accommodated fractions (WAF): 6.40 - 16.0 - 40.0 - 100 - 250 mg/L
- Sampling method: All test item loadings and the control were analytically verified via analysis of organic carbon (TOC, according to DIN EN 1484) at the start and at the end of the test. Separate replicates for the test item analysis after 0 and 72 hours were prepared without algae and incubated under test conditions. Results below 2 mg/L were given as < 2 mg/L.
- Sample storage conditions before analysis: None, direct analysis
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Five water accommodated fractions (WAF) were prepared with nominal loadings of the test item in the range of 6.40 to 250 mg/L set up in a geometric series with a factor of 2.5:
6.40 - 16.0 - 40.0 - 100 - 250 mg/L.
For each loading level, an appropriate amount of the test item was weighed out. The test item was applied onto a glass slide. The glass slide with the test item was inserted in a brown glass flask with an appropriate amount of dilution water. These dispersions were stirred for at least 72 hours with 1100 rpm at room temperature.
After a separation phase of 1 hour, the aqueous phase or WAF was removed by siphoning (from the approximate centre of the glass flask) to give the loading rate WAF.
- Eluate: DIlution water
- Differential loading: 6.40 - 16.0 - 40.0 - 100 - 250 mg/L
- Controls: Six replicates (without test item) were tested under the same test conditions as the test vessels.
Test organisms
- 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.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
Test conditions
- Hardness:
- 0.24 mmol Ca+Mg/l
- Test temperature:
- min.: 21.5 max.: 22.5, mean value: 22.0
- pH:
- Nominal test item loading pH-value
[mg/L] Start; 0 hours End; 72 hours
250 7.58 7.92
100 7.62 7.96
40.0 7.75 7.99
16.0 7.83 8.00
6.40 7.99 8.16
Control 8.10 8.21 - 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 4910 cells/mL
- Control end cells density: Mean 776146 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 first Study (0-72 hours)
Water
accommodated
fraction [mg/L] Growth Rate Inhibition [%] Yield Inhibition [%]
100 12 44
40.0 7 28
16.0 1 7
6.40 -3 -14
2.56 -3 -18
- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 250 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- 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:
- NOEL/LOEL were determined by calculation of statistical significance of growth rate and yield. As a standard One Way Analysis of Variance (ANOVA) and DUNNETT’s test were used for NOEL/LOEL 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 a-value (acceptable probability of incorrectly concluding that there is a difference) is a=0.05.
Any other information on results incl. tables
Cell Densities
Nominal test item loading |
Replicate |
Cell density [cells/mL] |
|||
[mg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
250 |
1 |
4332 |
23013 |
157619 |
939592 |
2 |
4332 |
18364 |
136654 |
1105931 |
|
3 |
4332 |
18154 |
133698 |
936981 |
|
Mean |
4332 |
19844 |
142657 |
994168 |
|
100 |
1 |
4332 |
18588 |
115727 |
725323 |
2 |
4332 |
13968 |
142076 |
894964 |
|
3 |
4332 |
14072 |
133232 |
755452 |
|
Mean |
4332 |
15543 |
130345 |
791913 |
|
40.0 |
1 |
4332 |
16742 |
136862 |
642515 |
2 |
4332 |
15691 |
123124 |
737117 |
|
3 |
4332 |
16327 |
101418 |
619273 |
|
Mean |
4332 |
16253 |
120468 |
666302 |
|
16.0 |
1 |
4332 |
20207 |
87542 |
527251 |
2 |
4332 |
14537 |
139567 |
603894 |
|
3 |
4332 |
11615 |
111356 |
553165 |
|
Mean |
4332 |
15453 |
112822 |
561437 |
|
6.40 |
1 |
4332 |
17824 |
145863 |
1013719 |
2 |
4332 |
23859 |
147265 |
1128984 |
|
3 |
4332 |
19078 |
126974 |
999630 |
|
Mean |
4332 |
20254 |
140034 |
1047444 |
|
Control |
1 |
4332 |
21047 |
138579 |
836970 |
2 |
4332 |
18305 |
146360 |
815427 |
|
3 |
4332 |
21201 |
127433 |
860479 |
|
4 |
4332 |
15122 |
127622 |
663461 |
|
5 |
4332 |
19591 |
128075 |
780109 |
|
6 |
4332 |
13845 |
128741 |
700430 |
|
Mean |
4332 |
18185 |
132802 |
776146 |
Evaluation after 72 hours
Statistically significant differences of growth rates and yield compared to
control values are marked (+), non significant differences are marked (-).
Nominal test item loading |
Replicate |
Growth rate |
Inhibition of growth rate |
Yield |
Inhibition of yield |
||
[mg/L] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
250 |
1 |
1.79 |
-3.77 |
935260 |
-21.2 |
||
2 |
1.85 |
-6.92 |
1101599 |
-42.7 |
|||
3 |
1.79 |
-3.72 |
932649 |
-20.8 |
|||
Mean |
(+)# |
1.81 |
-4.80 |
(+)# |
989836 |
-28.3 |
|
100 |
1 |
1.71 |
1.22 |
720991 |
6.58 |
||
2 |
1.78 |
-2.83 |
890632 |
-15.4 |
|||
3 |
1.72 |
0.44 |
751120 |
2.68 |
|||
Mean |
(-) |
1.74 |
-0.39 |
(-) |
787581 |
-2.04 |
|
40.0 |
1 |
1.67 |
3.56 |
638183 |
17.3 |
||
2 |
1.71 |
0.91 |
732785 |
5.06 |
|||
3 |
1.65 |
4.27 |
614941 |
20.3 |
|||
Mean |
(-) |
1.68 |
2.91 |
(-) |
661970 |
14.2 |
|
16.0 |
1 |
1.60 |
7.37 |
522919 |
32.3 |
||
2 |
1.65 |
4.76 |
599562 |
22.3 |
|||
3 |
1.62 |
6.45 |
548833 |
28.9 |
|||
Mean |
(+) |
1.62 |
6.19 |
(+) |
557105 |
27.8 |
|
6.40 |
1 |
1.82 |
-5.24 |
1009387 |
-30.8 |
||
2 |
1.85 |
-7.31 |
1124652 |
-45.7 |
|||
3 |
1.81 |
-4.97 |
995298 |
-29.0 |
|||
Mean |
(+#) |
1.83 |
-5.84 |
(+)# |
1043112 |
-35.2 |
|
Control |
1 |
1.76 |
832638 |
||||
2 |
1.75 |
811095 |
|||||
3 |
1.76 |
856147 |
|||||
4 |
1.68 |
659129 |
|||||
5 |
1.73 |
775777 |
|||||
6 |
1.70 |
696098 |
|||||
Mean |
1.73 |
771814 |
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 |
1.58 |
1.89 |
1.80 |
1.76 |
0.157 |
8.93 |
17.6 |
2 |
1.44 |
2.08 |
1.72 |
1.75 |
0.320 |
18.3 |
||
3 |
1.59 |
1.79 |
1.91 |
1.76 |
0.163 |
9.24 |
||
4 |
1.25 |
2.13 |
1.65 |
1.68 |
0.442 |
26.4 |
||
5 |
1.51 |
1.88 |
1.81 |
1.73 |
0.196 |
11.3 |
||
6 |
1.16 |
2.23 |
1.69 |
1.70 |
0.534 |
31.5 |
||
Mean |
1.73 |
|
||||||
SD ± |
0.03 |
|
||||||
CV [%] |
2.00 |
|
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study no inhibition on growth of the freshwater green alga Desmodesmus subspicatus was found after 72 hours exposure to the test item Diglycerol diisostearate. The nominal EL50-values for inhibition of growth rate (ErL50) and yield (EyL50) after 72 hours were both > 250 mg/L, respectively. The nominal NOEL-values for inhibition of growth rate and yield after 72 hours were for both 250 mg/L, respectively.
All effect values given are based on nominal test item loadings of Diglycerol diisostearate. - Executive summary:
The toxicity of Diglycerol diisostearate (batch number: ESD0012304)to the unicellular freshwater green alga Desmodesmus subspicatus was determined according to the principles of OECD 201 at Dr.U.Noack-Laboratorienin 31157 Sarstedt, Germany from 2013-01-11 to 2013-01-31 with the definitive exposure phase from 2013-01-28 to 2013-01-31. 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. Five water accommodated fraction (WAF) were prepared with a nominal loading of 6.40 - 16.0 - 40.0 - 100 - 250 mg test item/L and removal of particulate matter by sedimentation. Three replicates were used for each water accommodated fraction and six for the control. The environmental conditions were within the acceptable limits.
All test loadings of Diglycerol diisostearate, and the control were analytically verified via analysis of total organic carbon (TOC) at the start and the end of the exposure.
All effect values given are based on nominal test item loadings of Diglycerol diisostearate. The growth inhibition results of the test item are summarized in Table 1.
NOEL, LOEL, EL - values and 95 % Confidence Intervals of Diglycerol diisostearate
(0-72 hours)based on nominal test item loadings [mg/L]
Inhibition of Growth Rate
NOEL
250
LOEL
>250
ErL10
>250
ErL20
>250
ErL50
>250
Inhibition of Yield
NOEL
250
LOEL
>250
EyL10
>250
EyL20
>250
EyL50
>250
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