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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 206-986-0 | CAS number: 407-41-0
- 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:
- from 2017-08-21 to 2017-09-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.5400 (Algal Toxicity, Tiers I and II) (January 2012)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- TOXI-COOP ZRT., 8230 Balatonfüred, Arácsi út 97., Hungary
- Analytical monitoring:
- yes
- Details on sampling:
- For determination of the test item concentrations, six replicate samples (5 mL per replicate) were taken from the test concentration and from the control at the start and at the end of the test. The samples were prepared immediately after sampling. Formulation samples were diluted with Ultrapure Water and analysed after derivatization.
- Vehicle:
- no
- Details on test solutions:
- The test solutions used in the test was prepared by mechanical dispersion without using any solubilising agents. A stock solution was first prepared by dissolving an amount of 0.08 g test item in 800 mL dilution water (OECD Medium) to obtain the nominal concentration of 100 mg/L. pH of this test solution was adjusted to that of the culture medium using 1N NaOH.
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green algae
- Strain: 61.81 SAG
- Source: Collection of Algal Cultures, Inst. Plant Physiology, University of Göttingen, Untere Karspüle 2, D-37073 Göttingen, Germany
- Age of inoculum (at test initiation): 4 days - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 22.7 - 23.2 °C
- pH:
- 7.96 - 9.37
- Salinity:
- NA
- Nominal and measured concentrations:
- Nominal concentrations: 0 and 100 mg/L
Measured concentrations: in the range of 101 - 103 % of the nominal concentration - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Material, size, headspace, fill volume: glass, ~250 mL volume, 100 mL test medium
- Initial cells density: 1 x 10^4 cells/mL
- Control end cells density: 126.50 x 10^4 cells/mL
- No. of organisms per vessel: 0.1 mL algal biomass (10^7 algal cells per mL)
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: OECD Medium prepared according to OECD 201
OTHER TEST CONDITIONS
- Adjustment of pH: yes, using 1N NaOH
- Photoperiod: continuously illuminated
- Light intensity and quality: 8038 lux
TEST CONCENTRATIONS
- Range finding study; yes
- Test concentrations: 0.1, 1, 10, 100 mg/L
EFFECT PARAMETERS MEASURED :
- Determination of cell concentrations: microscope with counting chambe at 24, 48 and 72 hours - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Details on results:
- - Abnormal appearance of the algal cells was not observed during the experiment.
- The growth inhibition calculated for the 72 hours exposure in treatment group compared to the control was 0.7 % for the average specific growth rate and 2.7 % for the yield. The results of the statistical evaluation showed that the 0-72 h average specific growth rate and yield at the treatment group (100 mg/L nominal concentration) was not statistically significantly different from the untreated control . - Results with reference substance (positive control):
- The date of the last study with the reference item Potassium dichromate was: 07 – 10 March 2017. The following results were obtained:
The 72h ErC50: 0.99 mg/L, (95 % confidence limits: 0.68 – 1.49 mg/L)
The 72h EyC50: 0.59 mg/L, (95 % confidence limits: 0.47 – 0.75 mg/L) - Validity criteria fulfilled:
- yes
- Conclusions:
- In a 72-h algal growth inhibition test the EC50 based on growth rate was determined to be above 100 mg/L, the EC10 was >100 mg/L and the NOEC was determined to be 100 mg/L, respectively.
- Executive summary:
The effect of the test item on the growth of a unicellular green algal species Raphidocelis subcapitata was determined according to OECD 201, Regulation (EC) No. 226/2016 Method C.3 and EPA OPPTS 850.5400 and under GLP. The study was conducted under static conditions with an initial cell density of 1x10^4 cells/mL for a period of 72 hours. A limit test with one test concentration - 100 mg/L, and control was performed. The measured concentrations of the test item at the start and at the end of the test were in the range of 101 - 103 % of the nominal concentration. The measured concentrations deviated not more than 20 % from the nominal concentration, therefore, the nominal concentration was used to determine exposure concentrations.The EC50-values for inhibition of growth rate (ErC50) and for inhibition of yield (EyC50) were >100 mg/L. The ErC10 and EyC10 values were determined to be >100 mg/L. The NOEC was determined to be 100 mg/L.
Reference
Pre-experiments
In the 1st preliminary test up to 10 mg/L no effect was observed. At concentration level 100 mg/L 100% mortality was observed. Since toxicity was observed in the first preliminary test at the 100 mg/L concentration, a second preliminary test was performed using pH adjustment to determine the approximate toxicity of the test item independent of the pH. After adjustment of the pH of the stock solution no effect was observed also at the highest test concentration. Therefore, adjustment of the pH was performed also in the main test.
Validity criteria
- Cell density in the control cultures increased by a factor of more than 16 (by a factor of 126.50) within 72 hours. This corresponds to a specific growth rate of 1.61 day^-1.
- The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72 h-tests) in the control cultures did not exceed 35 %.
- CV for section-by-section growth rate day 0-1: 12.68 %
- CV for section-by-section growth rate day 1-2: 9.93 %
- CV for section-by-section growth rate day 2-3: 6.94 %
The mean coefficient of variation for section-by-section specific growth rates: 9.85 %.
- The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures did not exceed 7 % in test.
- CV for average specific growth rate day 0-3: 3.39 %
All validity criteria were met, therefore, the study is considered as valid.
Analytical results
Six samples were analysed from the test concentration with two parallel injections of each and six samples were analysed from the control solutions. The measured concentration of the test item was 103 % of the nominal at the start and 101 % at the end of the test.
Table 1. Test item concentrations
Sampling date |
Nominal |
Mean of the measured concentrations |
Measured concentration in percentage of the nominal |
Relative Standard Deviation % (n=6) |
22 August 2017 |
100 |
103.3 |
103 |
0 |
25 August 2017 |
100 |
101.0 |
101 |
1 |
Biological endpoints
Table 2. Growth Rates (r) and percentage inhibition of r during the test period
Test Group |
Growth Rates (r)and % Inhibition ofr |
|||||
0–24 h |
0–48 h |
0–72 h |
||||
r |
% |
r |
% |
r |
% |
|
Control |
0.0518 |
– |
0.0629 |
– |
0.0671 |
– |
100 mg/L(nominal) |
0.0593 |
-14.6 |
0.0628 |
0.2 |
0.0666 |
0.7 |
Table 3. Yield (y) and percentage inhibition of y during the test period
Test Group |
Yield y and % Inhibition of y |
|
0–72 h |
||
y |
% |
|
Control |
125.5 |
– |
100 mg/L(nominal) |
122.2 |
2.7 |
Table 4. The section-by-section specific growth rates in the control cultures
Section-by-Section Growth Rate |
|||
Expressed in hours |
0–24 h |
24-48 h |
48-72 h |
0.0518 |
0.0740 |
0.0755 |
|
Expressed in days |
0-1 day |
1-2 day |
2-3 day |
1.2425 |
1.7755 |
1.8110 |
Description of key information
In a 72-h algal growth inhibition test the EC50 based on growth rate was determined to be above 100 mg/L, the EC10 was >100 mg/L and the NOEC was determined to be 100 mg/L, respectively.
Key value for chemical safety assessment
- EC10 or NOEC for freshwater algae:
- 100 mg/L
Additional information
The effect of the test item on the growth of a unicellular green algal species Raphidocelis subcapitata was determined according to OECD 201, Regulation (EC) No. 226/2016 Method C.3 and EPA OPPTS 850.5400 and under GLP (reference 6.1.5-1). The study was conducted under static conditions with an initial cell density of 1x10^4 cells/mL for a period of 72 hours. A limit test with one test concentration - 100 mg/L, and control was performed. The measured concentrations of the test item at the start and at the end of the test were in the range of 101 - 103 % of the nominal concentration. The measured concentrations deviated not more than 20 % from the nominal concentration, therefore, the nominal concentration was used to determine exposure concentrations.The EC50-values for inhibition of growth rate (ErC50) and for inhibition of yield (EyC50) were >100 mg/L. The ErC10 and EyC10 values were determined to be >100 mg/L. The NOEC was determined to be 100 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.