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EC number: 817-761-7 | 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:
- 14 Dec 2018 - 22 May 2019
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- Adopted March 23, 2006; Annex 5 corrected 28 July 2011.
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aqueous-phase aquatic toxicity testing of difficult test chemicals, OECD series on testing and assessment number 23
- Version / remarks:
- 2000
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol
- EC Number:
- 817-761-7
- Cas Number:
- 765293-81-0
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol
- Test material form:
- other: waxy paste
- Details on test material:
- Appearance: White to pale yellow waxy paste
Test item storage: At room temperature
Stable under storage conditions until: 30 May 2019 (retest date)
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Remarks:
- UPLC-MS
- Details on sampling:
- Samples for possible analysis were taken from all test concentrations and the control according to the schedule below.
Frequency: at t=0 h, t=24 h and t=72 h.
Volume: 2.0 mL from the approximate centre of the test vessels.
Storage: Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Preparation of Test Solutions
The batch of Plandool-H tested was a white to pale yellow waxy paste UVCB and not completely soluble in test medium at the loading rates initially prepared. No correction was made for the purity/composition of the test item.
Preparation of test solutions started with loading rates individually prepared at 1.0, 10 and 100 mg/L. A two-day period of magnetic stirring at 45°C was applied to ensure maximum dissolution of the test item in medium. The obtained mixtures were allowed to settle overnight (approximately a period of 21 - 24 hours). Thereafter, the aqueous Water Accommodated Fractions (WAFs) were collected by means of siphoning and used as test concentrations. All test solutions were clear and colorless at the end of the preparation procedure.
After preparation, volumes of 50 mL were added to each replicate of the respective test concentration. Subsequently, 1 mL of an algal suspension was added to each replicate providing a cell density of 10000 cells/mL.
Any residual volumes were discarded.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Species: Raphidocelis subcapitata, strain: NIVA CHL 1
Source: In-house laboratory culture.
Reason for selection: This system is a unicellular algal species sensitive to toxic items in the aquatic ecosystem and has been selected as an
internationally accepted species.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- 22 - 23 °C
- pH:
- 8.1 - 8.2 (control)
8.0 - 8.7 (treatments) - Details on test conditions:
- Freshwater Algae Culture
Stock culture:
Algae stock cultures were started by inoculating growth medium with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light in a climate room at a temperature of 21-24°C.
Light intensity:
60 to 120 μE/m2/s when measured in the photosynthetically effective wavelength range of 400 to 700 nm.
Stock culture medium: M1.
Pre-culture:
Three days before the start of the test, cells from the algal stock culture were inoculated in culture medium at a cell density of 10000 cells/mL. The pre-culture was maintained under the same conditions as used in the test. The cell density was measured immediately before use.
Pre-culture medium: M2.
Test Concentrations
Plandool-H: WAFs individually prepared at loading rates of 0.32, 1.0, 3.2, 10, 32 and 100 mg/L.
Control(s): Test medium without test item.
Replicates: 3 replicates of each test concentration, 6 replicates of the control, 1 extra replicate of each test group for sampling purposes after 24 hours of exposure, 1 or 2 replicates of each test concentration without algae.
Test Procedure and Conditions
Test vessels: 100 mL, all-glass with aluminium caps, perforated for ventilation, containing 50 mL of test solution
Test Medium: M2
Cell density: An initial cell density of 10000 cells/mL.
Illumination: Continuously using TLD-lamps with a light intensity within the range of 88 to 90 μE.m-2.s-1.
Incubation: Vessels were distributed at random in the incubator and daily repositioned. During incubation the algal cells were kept in suspension by continuous shaking. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- < 0.32 mg/L
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: The 72h-NOELR for growth rate inhibition was below 0.32 mg/L (loading rate) based on statistical significance
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 0.32 mg/L
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: The 72h-NOELR for growth rate inhibition was 0.32 mg/L (loading rate) based on biological relevance.
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- < 0.32 mg/L
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Remarks on result:
- other: Effect concentration is indicated using loading rate
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Effect concentration is indicated using loading rate
- Details on results:
- Combined Limit/Range-Finding Test
Inhibition of algal growth rate and yield was found at all test concentrations at the end of the test. At WAFs (Water-accommodated fraction) prepared at loading rates of 1.0, 10 and 100 mg/L, growth rate inhibition of 14, 9.4 and 8.1% was observed, respectively. Yield inhibition of 49, 38 and 34% was observed, respectively.
Based on these results, samples taken from all test concentrations were analysed. The measured concentrations at the start of the test were 0.039, 0.12 and 0.085 mg/L, respectively. After 24 hours of exposure, the concentrations decreased below the limit of detection.
Final Test
Measured Test Item Concentrations
Samples taken from all test concentrations and the control were analysed. The measured concentrations at the start of the test were 0.080, 0.024 and 0.34 mg/L, for WAFs prepared at loading rates of 3.2, 10 and 32 mg/L. Other measured concentrations were below the limit of detection. At the end of the test, all concentrations were below the limit of detection.
Based on these results and by decision of the sponsor, effect parameters were reported and expressed as loading rates.
The concentrations measured in the samples taken from solutions with algae were comparable with the concentrations measured in the samples without algae. However, since measured concentrations were very low and below the limit of detection at the end of the test, it cannot be stated whether the presence of the algae affected the concentration of the test item in test medium throughout the test or not.
Inhibition of Growth Rate and Inhibition of Yield
Inhibition of growth rates was between 6.3 and 20% at the concentrations of Plandool-H tested. Inhibition of yield was between 29 and 67%. No clear dose-response curve was observed for either growth rate or yield inhibition. Statistically significant inhibition was recorded between the values for growth rate or yield at all of the test concentrations when compared to the control group. However, growth rate inhibition was considered to be biologically not relevant at a WAF prepared at a loading rate of 0.32 mg/L, where the observed inhibition was below 10%. The NOELR based on biological relevance was thus set at 0.32 mg/L.
Microscopic observations at the end of the test revealed a normal and healthy appearance of the algal cells exposed to a loading rate of 1.0 mg/L when compared to the control. - Results with reference substance (positive control):
- -Results with reference substance valid? Yes
- ErC50 (72 h): 1.11 mg/L potassium dichromate
- Date of reference test: 29 Apr - 02 May 2019
Any other information on results incl. tables
Acceptability of the Test
1. In the control, cell density increased by an average factor of at least 16 within the exposure period (i.e. 241).
2. The mean coefficient of variation for section-by-section specific growth rates in the control cultures did not exceed 35% (i.e. 13%).
3. The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures did not exceed 7% (i.e. 0.76%).
RESULTS
Combined Limit/Range-Finding Test
The mean cell densities measured during the combined limit/range-finding test are presented in Table 1. Table 2 and Table 3 present the percentages growth rate inhibition and yield inhibition per concentration, respectively.
Inhibition of algal growth rate and yield was found at all test concentrations at the end of the test. At WAFs prepared at loading rates of 1.0, 10 and 100 mg/L, growth rate inhibition of 14, 9.4 and 8.1% was observed, respectively. Yield inhibition of 49, 38 and 34% was observed, respectively.
Based on these results, samples taken from all test concentrations were analysed. The measured concentrations at the start of the test were 0.039, 0.12 and 0.085 mg/L, respectively. After 24 hours of exposure, the concentrations decreased below the limit of detection.
Samples taken from the control and the vessel without algae were also analysed. However, results were not approved because of possible instrumental problems. Since a final test was performed, this has no impact on the study results or conclusions.
Table 1 Mean Cell Densities (x104 Cells/mL) during the Combined Limit/Range-Finding Test
Time (h) |
Control |
Plandool-H Loading rate: 1.0 mg/L |
Plandool-H Loading rate: 10 mg/L |
Plandool-H Loading rate: 100 mg/L |
0 |
1.0 |
1.0 |
1.0 |
1.0 |
24 |
5.3 |
n.d. |
n.d. |
5.3 |
48 |
31.8 |
n.d. |
n.d. |
31.0 |
72 |
161.2 |
83.0 |
99.8 |
107.1 |
n.d. – not determined
Table 2 Percentage Inhibition of Growth Rate during the Combined Limit/Range-Finding Test
Plandool-H Loading rate (mg/L) |
Mean |
Std. Dev. |
n |
%Inhibition |
Control |
1.694 |
0.0173 |
6 |
|
1.0 |
1.462 |
0.1065 |
3 |
14 |
10 |
1.534 |
0.0106 |
3 |
9.4 |
100 |
1.557 |
0.0222 |
6 |
8.1 |
Table 3 Percentage Inhibition of Yield during the Combined Limit/Range-Finding Test
Plandool-H Loading rate (mg/L) |
Mean |
Std. Dev. |
n |
%Inhibition |
Control |
160.2 |
8.19 |
6 |
|
1.0 |
82.0 |
26.49 |
3 |
49 |
10 |
98.8 |
3.19 |
3 |
38 |
100 |
106.1 |
7.35 |
6 |
34 |
Final Test
Measured Test Item Concentrations
Samples taken from all test concentrations and the control were analysed. The measured concentrations at the start of the test were 0.080, 0.024 and 0.34 mg/L, for WAFs prepared at loading rates of 3.2, 10 and 32 mg/L. Other measured concentrations were below the limit of detection. At the end of the test, all concentrations were below the limit of detection.
Based on these results and by decision of the sponsor, effect parameters were reported and expressed as loading rates.
The concentrations measured in the samples taken from solutions with algae were comparable with the concentrations measured in the samples without algae. However, since measured concentrations were very low and below the limit of detection at the end of the test, it cannot be stated whether the presence of the algae affected the concentration of the test item in test medium throughout the test or not.
Inhibition of Growth Rate and Inhibition of Yield
Table 4 shows group mean growth rates and the percentages of growth rate inhibition (total test period) whereas Table 5 shows the values at different time intervals. The group mean yields and the percentages of yield inhibition are summarized in Table 6.
Inhibition of growth rates was between 6.3 and 20% at the concentrations of Plandool-H tested. Inhibition of yield was between 29 and 67%. No clear dose-response curve was observed for either growth rate or yield inhibition. Statistically significant inhibition was recorded between the values for growth rate or yield at all of the test concentrations when compared to the control group. However, growth rate inhibition was considered to be biologically not relevant at a WAF prepared at a loading rate of 0.32 mg/L, where the observed inhibition was below 10%. The NOELR based on biological relevance was thus set at 0.32 mg/L.
Microscopic observations at the end of the test revealed a normal and healthy appearance of the algal cells exposed to a loading rate of 1.0 mg/L when compared to the control.
Table 4 Growth Rate and Percentage Inhibition for the Total Test Period
Plandool-H Loading rate (mg/L) |
Mean |
Std. Dev. |
n |
%Inhibition |
Control |
1.828 |
0.0139 |
6 |
|
0.32 |
1.713 |
0.0238 |
3 |
6.3# |
1.0 |
1.459 |
0.0742 |
3 |
20* |
3.2 |
1.619 |
0.0231 |
3 |
11* |
10 |
1.638 |
0.0041 |
3 |
10* |
32 |
1.549 |
0.0083 |
3 |
15* |
100 |
1.590 |
0.0102 |
3 |
13* |
* - effect was statistically significant, # - effect was statistically significant however biologically not relevant (<10%).
Table 5 Growth Rate and Percentage Inhibition at Different Time Intervals
Plandool-H Loading rate (mg/L) |
n |
Mean (0-24 h) |
%Inhibition (0-24 h) |
Mean (24-48 h) |
%Inhibition (24-48 h) |
Mean (48-72 h) |
%Inhibition (48-72 h) |
Control |
6 |
2.066 |
|
1.811 |
|
1.609 |
|
0.32 |
3 |
2.200 |
-6.5 |
1.517 |
16 |
1.422 |
12 |
1.0 |
3 |
2.043 |
1.1 |
1.425 |
21 |
0.910 |
43 |
3.2 |
3 |
2.032 |
1.6 |
1.624 |
10 |
1.202 |
25 |
10 |
3 |
2.159 |
-4.5 |
1.571 |
13 |
1.183 |
26 |
32 |
3 |
2.127 |
-3.0 |
1.496 |
17 |
1.025 |
36 |
100 |
3 |
2.132 |
-3.2 |
1.530 |
16 |
1.108 |
31 |
Table 6 Yield and Percentage Inhibition for the Total Test Period
Plandool-H Loading rate (mg/L) |
Mean |
Std. Dev. |
n |
%Inhibition |
Control |
240.3 |
10.12 |
6 |
|
0.32 |
169.9 |
12.34 |
3 |
29* |
1.0 |
79.9 |
17.03 |
3 |
67* |
3.2 |
128.0 |
8.75 |
3 |
47* |
10 |
135.1 |
1.67 |
3 |
44* |
32 |
103.4 |
2.59 |
3 |
57* |
100 |
116.9 |
3.62 |
3 |
51* |
* - effect was statistically significant.
Determination of Effect Concentrations
Table 7 shows the effect parameters based on loading rates.
Table 7 Effect Parameters
Parameter (mg/L) |
NOELR* |
NOELR# |
EL50 |
Value (Growth rate) |
<0.32 |
0.32 |
>100 |
Value (Yield) |
<0.32 |
<0.32 |
n.d.+ |
cl – confidence limit, * - based on statistical significance,#- based on biological relevance,+- due to the lack of a dose-response curve this value got not be statistically determined.
Experimental Conditions
Table 8 shows the pH recorded at the beginning and the end of the test. The pH was within the limits prescribed by the study plan (6-9, preferably not varying by more than 1.5 unit).
During the exposure period the temperature measured in the incubator was maintained between 22 and 23°C. Temperature remained within the limits prescribed by the study plan (21-24°C, constant within ±1°C).
Table 8 pH Levels Recorded during the Final Test
Plandool-H Loading rate (mg/L) |
pH (t=0 h) |
pH (t=72 h) |
Control |
8.1 |
8.2 |
0.32 |
8.1 |
8.0 |
1.0 |
8.6 |
8.1 |
3.2 |
8.6 |
8.2 |
10 |
8.7 |
8.2 |
32 |
8.6 |
8.2 |
100 |
8.6 |
8.2 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
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