Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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:
- effects on growth of green algae
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- other: Analytical method developed for Daphnia and algae medium
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- july 2011
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- december 2015
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD guidance document No. 23, second edition, GUIDANCE DOCUMENT ON AQUEOUS-PHASE AQUATIC TOXICITY TESTING OF DIFFICULT TEST CHEMI-CALS
- Version / remarks:
- February 2019
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: SANCO/3029/99: “Residues: Guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex II (part A, Section 4) and Annex III (part A, Section 5) of Directive 91/414”
- Version / remarks:
- rev. 4 dated 11. July 2000
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Low molecular weight organic substances from fast pyrolysis bio-oil
- IUPAC Name:
- Low molecular weight organic substances from fast pyrolysis bio-oil
- Reference substance name:
- Monomers from fast pyrolysis bio-oil
- IUPAC Name:
- Monomers from fast pyrolysis bio-oil
- Reference substance name:
- Dimers from fast pyrolysis bio-oil
- IUPAC Name:
- Dimers from fast pyrolysis bio-oil
- Reference substance name:
- Trimers from fast pyrolysis bio-oil
- IUPAC Name:
- Trimers from fast pyrolysis bio-oil
- Reference substance name:
- Higher oligomers from fast pyrolysis bio-oil
- IUPAC Name:
- Higher oligomers from fast pyrolysis bio-oil
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid: viscous
- Remarks:
- Brown /black highly vicous liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: At the end of the test, an extra replicate for each treatment and the control without algae was prepared. To avoid adsorption onto the algae cells, the content of the TOC and the content of the two components of the test item in the test solutions was measured in extra replicates without algae cells at the beginning and at the end of the experiment.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Because the test item is a poorly water soluble UVCB substance with constituents of di-ferent water solubility, in accordance with the OECD guidance document no. 23, water-accommodated fractions (WAF) were prepared for the test.
- Loading: WAF was created by weighing the nominal load of 100 / 56 / 32 / 18 / 10 mg/L, adding the corresponding amount of algal medium (demineralised water enriched with minerals but without algae) and shaking vigorously for 24 ± 1 hours. Hence, the real load was 100.3 / 55 / 32.5 / 17.8 / 10.3 mg/L
- Evidence of undissolved material: To remove undissolved components the solutions were filtrated through 0.45 µm PTFE filters
- Other relevant information: As the test item is highly viscous, it was placed in a water bath (30 ± 2 °C) and stirred thoroughly with a stirring staff until it is visibly homogeneous before usage.
Test organisms
- Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Unicellular freshwater green alga
- Strain: 86.81
- Source (laboratory, culture collection): MBM Sciencebridge GmbH (Institut für Pflanzenphysiologie of Universität Göttingen)
- Age of inoculum (at test initiation): cell concentration of 3 *103 cells/mL
- Method of cultivation: The algae are kept as stock culture on solid agar at 2 - 8 °C. From the stock culture, a permanent culture was prepared. From an aliquot of the permanent culture, the pre-culture was prepared
- pre-culture: For the pre-culture an aliquot of the permanent culture was brought into nutrient medium and incubated under continuous lighting for 4 days under test conditions (Lighting: within the specified range of 4440 – 8880 lux; 21– 24 °C). The resulting culture grew exponentially. Before usage, the pre-culture was checked for the absence of cell aggregates and the cell number of the culture was determined.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- 21.5 – 23.2 °C
- pH:
- 7.6-8.9
- Nominal and measured concentrations:
- 10 / 18 / 32 / 56 / 100 mg/L nominal concentration
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass flasks total volume 65 mL
- Initial cells density: 3 *103 cells/mL
- Control end cells density: 571120 cells/mL
- volume solution: 45 ±1 mL
- No. of vessels per concentration (replicates): 3 test solution+algae, 1 test solution only
- No. of vessels per control (replicates): 6 algae medium+algae, 1 algae medium only
GROWTH MEDIUM
- Standard medium used: yes
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: under continuous lighting
- Light intensity and quality: within the specified range (4440 – 8880 Lux)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: electronic particle counter
- Other: appearance of the algae and detect abnormalities
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1, 10, 100 mg/L loading rate
- Results used to determine the conditions for the definitive study: yes
CULTURING APPARATUS
-Details on culturing apparatus used: orbital shaker - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9)
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: concentrations refer to nominal loading rates
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 55.53 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: concentrations refer to nominal loading rates
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: concentrations refer to nominal loading rates
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- 62.86 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- yield
- Remarks on result:
- other: concentrations refer to nominal loading rates
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 34.13 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- yield
- Remarks on result:
- other: concentrations refer to nominal loading rates
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- yield
- Remarks on result:
- other: concentrations refer to nominal loading rates
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 56 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- yield
- Remarks on result:
- other: concentrations refer to nominal loading rates
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 56 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: concentrations refer to nominal loading rates
- Details on results:
- - Exponential growth in the control: yes
- Observation of abnormalities (for algal test): no - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50: 72h ErC50 0.64 mg/L (0.58 – 0.71 mg/L), 72h EyC50 0.32 mg/L (0.31 – 0.33 mg/L)
- Other: - Reported statistics and error estimates:
- Calculation of results was performed with the help of validated software. Calculation was performed with Microsoft Excel® and ToxRat® Professional, version 3.3.0.
Any other information on results incl. tables
Non-GLP pre-test results (72h)
Loading ratein mg/L |
Inhibition in % |
|
Growth rate |
Yield |
|
Blank control |
0 |
0 |
1 |
0.3 |
1.9 |
10 |
1.7 |
9.7 |
100 |
51.5 |
94.8 |
Cell Number/mL
Nominal Concentration in mg/L |
Parameter |
Cell Number/mL |
|||
0 h |
24 h |
48 h |
72 h |
||
Blank control |
Mean |
3020 |
16470 |
107073 |
571120 |
SD |
0 |
1941 |
5571 |
16190 |
|
10 |
Mean |
3020 |
16253 |
120373 |
571680 |
SD |
0 |
646 |
7614 |
9626 |
|
18 |
Mean |
3020 |
15813 |
125333 |
544940 |
SD |
0 |
603 |
4490 |
15522 |
|
32 |
Mean |
3020 |
14900 |
119687 |
583733 |
SD |
0 |
242 |
10879 |
30417 |
|
56 |
Mean |
3020 |
13567 |
49640 |
316320 |
SD |
0 |
4048 |
1484 |
13316 |
|
100 |
Mean |
3020 |
11340 |
25940 |
115387 |
SD |
0 |
859 |
1422 |
1528 |
Microscopical Observations
Nominal Concentration in mg/L |
Normal and Healthy Appearance of the Algae |
Blank control |
Yes |
10 |
Yes |
18 |
Yes |
32 |
Yes |
56 |
Yes |
100 |
No cells visible |
Growth Rate µ, Yield
Nominal Concentration in mg/L |
Parameter |
Growth Rate (0-72 h) [day-1] |
Yield (0-72 h) |
Blank control |
Mean |
1.75 |
568100 |
SD |
0.01 |
16190 |
|
10 |
Mean |
1.75 |
568660 |
SD |
0.01 |
9626 |
|
18 |
Mean |
1.73 |
541920 |
SD |
0.01 |
15522 |
|
32 |
Mean |
1.75 |
580713 |
SD |
0.02 |
30417 |
|
56 |
Mean |
1.55 |
313300 |
SD |
0.01 |
13316 |
|
100 |
Mean |
1.21 |
112367 |
SD |
0.00 |
1528 |
SD =Standard Deviation
Inhibition Values
Nominal concentration in mg/L |
% Inhibition |
|
Growth Rate (0-72 h) |
Yield (0-72 h) |
|
Blank control |
0 |
0 |
10 |
0,0 |
-0,1 |
18 |
0,9 |
4,6 |
32 |
-0,4 |
-2,2 |
56 |
11,3 |
44,9 |
100 |
30,5 |
80,2 |
Negative inhibition values indicate a stimulation of algal growth compared to the blank control.
Biological Results of the Test Item
Parameter |
Value |
95 % confidence interval |
NOEL (Growth Rate) 72 h |
32 mg/L |
-- |
NOEL (Yield) 72 h |
32 mg/L |
-- |
LOEL (Growth Rate) 72 h |
56 mg/L |
-- |
LOEL (Yield) 72 h |
56 mg/L |
-- |
72h ErL10 |
55.53 mg/L |
|
72h EyL10 |
34.13 mg/L |
29.41 – 38.00 mg/L |
72h ErL50 |
> 100 mg/L |
-- |
72h EyL50 |
62.86 mg/L |
59.16 – 66.86 mg/L |
Analytical Determination, LC-MS-MS
A LC-MS-MS method for the determination of the test item was validated using two components as markers, chosen because they could be clearly assigned as components of the test item and could be quantified in aqueous medium during validation.
At the beginning, the measured concentrations lay between 35 % and 66 % of the loading rates for component 1 and between 14 % and 30 % of the loading rates for component 2. At the end of the test, at the lowest concentration 10 mg/L the measured concentration was lower than LOQ for both components. At the other concentrations the measured concentrations lay between 32 % and 45 % of the loading rates for component 1 and between 9 % and 15 % of the loading rates for component 2.
The details are given in the following tables:
Measured Concentrations and % of Nominal Loading, Component 1
Nominal Concentration in mg/L |
Measured Concentration in mg/L t = 0 h |
% of Nominal Loading t = 0 h |
Measured Concentration in mg/L t = 72 h |
% of Nominal Loading t = 72 h |
10 |
6.61 |
66% |
< LOQ |
-- |
18 |
9.23 |
51% |
8.11 |
45% |
32 |
12.75 |
40% |
11.27 |
35% |
56 |
20.98 |
37% |
18.12 |
32% |
100 |
34.74 |
35% |
32.61 |
33% |
Measured Concentrations and % of Nominal Loading, Component 2
Nominal Concentration in mg/L |
Measured Concentration in mg/L t = 0 h |
% of Nominal Loading t = 0 h |
Measured Concentration in mg/L t = 72 h |
% of Nominal Loading t = 72 h |
10 |
3.04 |
30% |
< LOQ |
-- |
18 |
3.99 |
22% |
2.63 |
15% |
32 |
4.69 |
15% |
3.43 |
11% |
56 |
8.65 |
15% |
6.39 |
11% |
100 |
14.01 |
14% |
9.23 |
9% |
Analytical Determination, TOC
Additionally, the total amount of dissolved test item in the test solutions was estimated by calculation based on the carbon content of the test item (60.83 %) and TOC measurement.
Due to the poor solubility of the test item, the measured TOC concentrations were very low. However, at higher loading rates, the measured TOC concentrations also increase.
The almost identical TOC concentrations in the respective test solutions at the beginning and end of the test confirms that the concentration of the test substance or the test substance and its degradation products was present in the test solution over the test period.
Measured Concentrations IC and TC
Nominal |
Measured TC |
Measured TC |
Measured IC |
Measured IC |
mg/L |
mg/L |
mg/L |
mg/L |
mg/L |
Blank control |
7.41 |
7.43 |
7.77 |
7.55 |
10 |
8.68 |
8.18 |
7.51 |
7.54 |
18 |
9.36 |
8.64 |
7.50 |
7.55 |
32 |
9.46 |
9.04 |
7.59 |
7.56 |
56 |
10.75 |
10.35 |
7.75 |
7.33 |
100 |
12.31 |
11.58 |
7.35 |
7.11 |
Calculated Concentrations TOC
Nominal |
Calculated TOC (TC-IC) |
Calculated TOC (TC-IC) |
mg/L |
mg/L |
mg/L |
Blank control |
0 |
0 |
10 |
1.16 |
0.65 |
18 |
1.87 |
1.10 |
32 |
1.87 |
1.48 |
56 |
3.00 |
3.02 |
100 |
4.96 |
4.48 |
Calculated Test item Concentrations
Nominal |
Calculated Concentration Test Item |
Calculated Concentration Test Item |
% of Nominal concentration |
% of Nominal concentration |
mg/L |
mg/L |
mg/L |
% |
% |
10 |
1.92 |
1.07 |
19% |
11% |
18 |
3.07 |
1.81 |
17% |
10% |
32 |
3.07 |
2.43 |
10% |
8% |
56 |
4.94 |
4.96 |
9% |
9% |
100 |
8.15 |
7.36 |
8% |
7% |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- 72 h exposure of the green algae, Desmodesmus subspicatus, to the test item resulted in an EL50 growth of >100 mg/l and an EL50 yield of 62.86 mg/L
- Executive summary:
One valid experiment was performed exposing for 72 hours the green algae, Desmodesmus subspicatu, to the test item according to OECD 201 guideline. Because the test item is a poorly water soluble UVCB substance with constituents of different water solubility, in accordance with the OECD guidance document no. 23, water-accommodated fractions (WAF) were prepared for the test solution. The study was performed using five loading rates 10 / 18 / 32 / 56 / 100 mg/L.
Analytical monitoring was performed with a LC-MS-MS-Method validated using two components as markers, chosen because they could be clearly assigned as components of the test item and could be quantified in aqueous medium during validation. At the beginning, the measured concentrations lay between 35 % and 66 % of the loading rates for component 1 and between 14 % and 30 % of the loading rates for component 2. At the end of the test, at the lowest loading rate of 10 mg/L, the measured concentration was lower than LOQ for both components. At the other concentrations (loading rates) the measured concentrations lay between 32 % and 45 % of the loading rates for component 1 and between 9 % and 15 % of the loading rates for component 2.
Additionally, the total amount of dissolved test item in thetest solutions was estimated by calculation based on the carbon content of the test item (60.83 %) and TOC measurement.Due to the poor solubility of the test item, the correlation between measured concentration (based on TOC measurement) and nominal loading was weak. However, at higher loading rates, the measured TOC concentrations also increase. The almost identical TOC concentrations in the respective test solutions at the beginning and end of the testconfirms that the concentration of the test substance or the test substance and its degradation products was present in the test solution over the test period.
As the test item is a UVCB substance, according to OECD guidance document No. 23 (2019), the results are presented, based on the nominal WAF loading rates (see OECD guidance document no 23, § 177). Growth rate µ and the yield were determined from the cell number.
Significant inhibition of algal growth was observed at the two highest loading rates 56 mg/L and 100 mg/L.
The following results for the test item, Pyrolytic Lignin, were determined after 72 hours of exposure:
Endpoint
NOEL
LOEL
EL10
EL50
Growth Rate
32 mg/L
56 mg/L
55.53 mg/L
> 100 mg/L
Yield
32 mg/L
56 mg/L
34.13 mg/L
62.86 mg/L
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.