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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-329-9 | 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:
- 25 - 28 Nov 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 2011
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.5400 (Algal Toxicity, Tiers I and II) (January 2012)
- Version / remarks:
- 1996
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- National Institute of Pharmacy and Nutrition, Budapest, Hungary
Test material
- Reference substance name:
- Carboxylic acids, di-, C5-9
- EC Number:
- 701-329-9
- Molecular formula:
- C5di: C5H8O4 C6di: C6H10O4 C7di: C7H12O4 C8di: C8H14O4 C9di: C9H16O4
- IUPAC Name:
- Carboxylic acids, di-, C5-9
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: applied test concentration levels and from the control at the beginning and at the end of the experiment
- Sampling method: 2 mL sampled in glass tubes
- Sample storage conditions before analysis: samples were frozen and kept approximately at -20°C
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: saturated solution method (water accommodated fraction, WAF), test solutions were prepared individually by dispersing/dissolving the amount of test item into the test medium two days before the start of the experiment, shaken for about 24 hours at approximately 30°C, then equilibrated for about 24 hours at approximately 20°C, non-dissolved test material was removed by filtration (0.22 µm) to give the appropriate WAF solutions.
- Differential loading: yes
- Controls: Algal growth medium inoculated with algal cells
- Evidence of undissolved material: test item was stable in media
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green alga
- Strain: 61.81 SAG
- Source: supplied by the SAG: Collection of Algal Cultures, Inst. Plant Physiology,and Universityof Göttingen, Germany
- Age of inoculum: pre-culture incubated about three days
- Method of cultivation: Stock cultures are small algal colonies inoculated onto agar regularly, transferred to fresh agar medium at least once every two months and maintained under standardised conditions according to the test guidelines.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- 22.4 - 22.6°C
- pH:
- 5.15 - 8.41
- Nominal and measured concentrations:
- Nominal loading rate: 0 (control), 6.25, 12.5., 25.0, 50.0 and 100.0 mg/L
Mean measured concentrations: 0 (control), 6.28, 12.36, 24.52, 48.12 and 93.36 mg/L. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL Erlenmeyer flasks
- Type: covered with air-permeable stoppers
- Fill volume: 100 mL
- Initial cells density: 10^4 cells/mL
- Control end cells density: 67.33 10^4 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes (Reconstituted algal growth medium (OECD medium, according to OECD 201)
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: no
- Intervals of water quality measurement: temperature (beginning of the experiment and each day thereafter in a flask filled with water in climate chamber), pH (beginning and at the end of the test, in the control and each concentration)
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: continuous light
- Light intensity and quality: 7922 lux (equivalent to ~107 µE/m2/s), fluorescent lamps (400-700 nm)
EFFECT PARAMETERS MEASURED: cell numbers and abnormal appearance (24, 48 and 72 hours after test start),
- Determination of cell concentrations: microscopic method with a counting chamber
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study
- Test concentrations: control, 0.1, 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: Average of cell number at 72 hours (x 104cell/mL): 71.33 (control), 70.50 (0.1 mg/L), 71.00 (1 mg/L), 70.00 (10 mg/L) and 1.00 - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate tested at least twice a year
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 47.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95%-confidence limits: 43.42 – 52.19 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 23.63 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95%-confidence limits: 20.66 – 27.02
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 24.52 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): Thin cells were observed at the two highest examined concentrations of 50.0 and 100.0 mg/L nominal loading rates (WAFs) - Results with reference substance (positive control):
- - Results with reference substance valid? yes
72h ErC 50: 0.82 mg/L, (95 % confidence limits: 0.76 – 0.90 mg/L) - Reported statistics and error estimates:
- ErL/ErC, EbL/EbC and EyL/EyC values of the test item and their confidence limits were calculated using Probit analysis by TOXSTAT software. Statistical comparisons of biomass, average specific growth rates and yield in controls
and in the treated groups were carried out using analysis of variance (ANOVA) and Bonferroni t-Test (α = 0.05) by TOXSTAT software. For the determination of the LOELR/LOEC and NOELR/NOEC, the calculated mean biomass, growth rates and yield at the test concentrations were compared with controls using the Bonferroni t-Test (α = 0.05) by TOXSTAT software.
Any other information on results incl. tables
Table 1: Measured exposure concentrations
Concentration (mg/L nominal loading rate WAF) |
Measured concentrations (mg/L) |
Geometric mean |
|
0h/start |
72h/end |
mg/L |
|
6.25 |
6.34 |
6.22 |
6.28 |
12.5 |
12.13 |
12.60 |
12.36 |
25.0 |
24.37 |
24.67 |
24.52 |
50.0 |
47.67 |
48.57 |
48.12 |
100.0 |
93.23 |
93.50 |
93.36 |
Table 2: Cell Number (x 10^4 cells/mL)
Concentration [mg/L nominal loading rate WAF] |
|
Number of cells |
|
|
0 h |
24 h |
48 h |
72 h |
|
|
1 |
4 |
17 |
75 |
|
1 |
4 |
18 |
65 |
|
1 |
4 |
18 |
67 |
Control |
1 |
3 |
17 |
66 |
1 |
5 |
20 |
68 |
|
|
1 |
5 |
17 |
63 |
Mean |
1.00 |
4.17 |
17.83 |
67.33 |
SD |
0.0 |
0.8 |
1.2 |
4.1 |
|
1 |
3 |
17 |
66 |
|
1 |
5 |
17 |
65 |
6.25 |
1 |
3 |
17 |
62 |
Mean |
1.00 |
3.67 |
17.00 |
64.33 |
SD |
0.0 |
1.2 |
0.0 |
2.1 |
|
1 |
3 |
17 |
60 |
|
1 |
4 |
18 |
64 |
12.5 |
1 |
3 |
16 |
62 |
Mean |
1.00 |
3.33 |
17.00 |
62.00 |
SD |
0.0 |
0.6 |
1.0 |
2.0 |
|
1 |
3 |
10 |
48 |
|
1 |
3 |
11 |
50 |
25.0 |
1 |
4 |
12 |
51 |
Mean |
1.00 |
3.33 |
11.00 |
49.67 |
SD |
0.0 |
0.6 |
1.0 |
1.5 |
|
1 |
4 |
4 |
9* |
|
1 |
3 |
3 |
11* |
50.0 |
1 |
3 |
3 |
12* |
Mean |
1.00 |
3.33 |
3.33 |
10.67 |
SD |
0.0 |
0.6 |
0.6 |
1.5 |
|
1 |
1 |
2* |
2* |
|
1 |
1 |
1* |
1* |
100.0 |
1 |
1 |
1* |
1* |
Mean |
1.00 |
1.00 |
1.33 |
1.33 |
SD |
0.0 |
0.0 |
0.6 |
0.6 |
* : Thin, deformed cells
Table 3: Validity criteria for OECD 201.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The biomass in the control cultures should have increased exponentially by a factor of at least 16 within the 72-hour test period. |
67.33 |
yes |
The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72-hour tests) in the control cultures must not exceed 35% |
11.59% |
yes |
The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures must not exceed 7% in tests with Pseudokirchneriella subcapitata and Desmodesmus subspicatus. For other less frequently tested species, the value should not exceed 10%. |
1.42% |
yes |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
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.