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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 413-090-5 | 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
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:
- 14 June 2006 to 28 July 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- yes
- Remarks:
- To reduce shading effects of the coloured test substance, the test was earned out with strong illumination (110 - 120 uE) and with a reduced test volume of 25 ml in 300 ml Erlenmeyer flasks.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- yes
- Remarks:
- To reduce shading effects of the coloured test substance, the test was earned out with strong illumination (110 - 120 uE) and with a reduced test volume of 25 ml in 300 ml Erlenmeyer flasks.
- Principles of method if other than guideline:
- The above deviation is recognised for coloured substances, and is considered appropriate for the testing of dyestuffs.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not applicable. - Analytical monitoring:
- yes
- Details on sampling:
- In order to avoid an impairment of the test system, an additional replicate was used for analysis and pH measurement at the beginning of the test (control: replicate VII; test concentrations: replicate IV). Analysis at the end of the test is performed using replicate I, while pH measurement is performed using the total volume replicates I-III.
In order to check whether or not significant amounts of the test item are incorporated into the algal biomass during the test period, a test flask at the highest test concentration without algae was used in parallel to the geometric series of test concentrations. The results of measured item concentrations in these test media without algae are indicated by the symbol.
- Vehicle:
- no
- Details on test solutions:
- A stock solution was prepared to give the desired series of test concentrations. To achieve this 125.0 mg of the test item were added to 1 litre of dilution water.
Analytical Procedure - Standard Solutions used for Calibration
21.2 mg of the test item were dissolved in 50% Acetonitrile (50 ml Acetonitrile and 50 ml Milliporewater) and made up with 50% Acetonitrile to the mark in a 100 ml volumetric flask to prepare a stock solution of 212 mg/1. Defined volumes of this stock solution were diluted with 50% Acetonitrile to obtain standard solutions in the range of 0.053 to 4.24 mg/1.
Although the overall method sensitivity may be better, the concentration of the lowest used calibration solution is employed as the limit of quantification.
These solutions were used to calibrate the HPLC-system. - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- Name: Desmodesmus subspicatus
Source: Non-axenic strain of the test species obtained from 'The Collection of Algal Cultures' of the Institute of Plant Physiology at the University of Gottingen (Germany)
Maintenance of stock cultures: Exponentially-growing stock cultures are maintained in the test facility under constant temperature conditions (23 +- 2°C) at a light intensity in the range 60 - 120 μE. x m-2 x s-1 (measured in the range 400 to 700 nm using a spherical quantum flux meter). The nutrient medium (according to BRINGMANN & KUHN (1977) is renewed once a week. Cell density measurements are made using a microcell counter.
Preparation of pre-cultures: Pre-cultures are set up three days before the start of a test. They are grown under identical exposure conditions as the stock cultures, except from the use of a different nutrient medium.
Test cultures: The algal inocula for a test are taken from an exponentially-growing pre-culture and are mixed with the nutrient medium to make up to a final cell density of about 5000 cells per millilitre in the test medium - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No post exposure period
- Hardness:
- No data
- Test temperature:
- 21-25 deg C
- pH:
- 8
- Dissolved oxygen:
- No data
- Salinity:
- Not applicable.
- Nominal and measured concentrations:
- 1.9, 4.3, 9.4, 20.7, 45.5 and 100 mg/l stock solution
- Details on test conditions:
- Test vessels: 300 ml Erlenmeyer flasks with cotton stoppers
Culturing apparatus: Light chamber in which a temperature in the range 21°C to 25°C can be maintained at +/- 2°C, and continuous uniform illumi nation is provided in the spectral range 400 to 700 nm. Magnetic stirrers kept the algae in suspension.
Light intensity: At the average of the test solutions, a light intensity in the range 110 to 120 μE. x m-2 x s-1 , or an equivalent range of 7333 to 8000 lx, is recommended to use.
Cell density measurements: Cell densities are measured in a microcell counter or, alternatively, are determined by means of a microscopic counting chamber.
Experimental design: 6 test concentrations plus 1 control
3 replicates per concentration, 6 replicates per control
initial cell density in the test cultures approximately 5000 cells per millilitre
additionally highest test concentration without algae
Test concentration/s (nominal): 1.9, 4.3, 9.4, 20.7, 45.5 and 100 mg/1
Method of administration: stock solution
Duration of exposure: 72 hours
Criteria of effects: The criteria of adverse effects used in this study were the item-induced inhibition of growth [b] and growth rate [r], respectively, of the algal population. - Reference substance (positive control):
- no
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 65.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 3.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 908 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 30.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 20.7 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- Analysis of the growth and growth rate of the algal population within the 72 h exposure period (by probit analysis and DUNNETT's test, respectively) give the following results:
Results [mg/L]:
95% confidence limits [mg/L]
EbC 50 (0-72 h) : 65.6 45.7 - 113
EbC10(0-72 h) : 3.8 1.3 - 6.8
ErC 50 (0-72 h) : 908 496 - 2472
ErC 10 (0-72 h) : 30.9 22.9 - 38.5
NOEC [b] (ta 0.05) : 4.3
NOEC [r] (ta 0.05) : 20.7
All results are expressed in terms of nominal concentrations concentrations. Recovery rates ranged from 85.4 - 89.4% of nominal values at 0 hours, and from 84.7 - 88.6% of nominal values at 72 hours, respectively. - Results with reference substance (positive control):
- Not applicable.
- Reported statistics and error estimates:
- Growth and growth rates were used to calculate a No Observed Effect Concentration and a Lowest Observed Effect Concentration according to DUNNETT (1955, 1964). No significant statistics or error estimates were reported.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Analysis of the growth and growth rate of the algal population within the 72 h exposure period (by probit analysis and DUNNETT's test, respectively) give the following results:
Results [mg/l]:
95% confidence limits [mg/l]
EbC 50 (0-72 h) : 65.6 45.7 - 113
EbC10(0-72 h): 3.8 1.3 - 6.8
ErC 50 (0-72 h): 908 496 - 2472
ErC 10 (0-72 h): 30.9 22.9 - 38.5
NOEC [b] (ta 0.05): 4.3
NOEC [r] (ta 0.05): 20.7 - Executive summary:
A study was performed to assess adverse effects of Reaktiv Gelb F68072 FW on the growth (= increase in cell density) and the growth rate (= rate of increase in cell density with time) of the planktonic freshwater algal species Desmodesmus subspicatus over several generations.
The study was conducted in accordance with EEC Methods for Determination of Ecotoxicity Annex to Directive 92/69/EEC (O.J. No. L383A, 29.12.92) Part C, Method 3 'Algal inhibition test' which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 201 'Alga, Growth Inhibition Test'. Study conducted in compliance to with GLP.
Exponentially growing algal cells were exposed for a period of 72 hours to a range of concentrations, nominally 1.9, 4.3, 9.4, 20.7, 45.5 and 100 mg/1 of Reaktiv Gelb F68072 FW dissolved in water.
The cell densities were measured at 24 hour intervals. Inhibition of the algal population was measured as reduction in growth (indexb) and growth rate (indexr), relative to control cultures grown under identical conditions. Growth and growth rates were used to calculate a No Observed Effect Concentration and a Lowest Observed Effect Concentration according to DUNNETT (1955, 1964). The following values were determined:
Results [mg/1]:
EbC 50 (0-72 h)
: 65.6
95% confidence limits [mg/1]
45.7-113
EbC 10 (0-72 h)
: 3.8
1.3 - 6.8
ErC 50 (0-72 h)
: 908
496 - 2472
ErC 10 (0-72 h)
: 30.9
22.9 - 38.5
NOEC [b] (ta0.05)
: 4.3
NOEC [r] (ta0.05)
: 20.7
All results are expressed in terms of nominal concentrations. Recovery rates ranged from 85.4 - 89.4% of nominal values at 0 hours, and from 84.7 - 88.6% of nominal values at 72 hours, respectively.
To reduce shading effects of the coloured test substance, the test was earned out with strong illumination (110 - 120 uE) and with a reduced test volume of 25 ml in 300 ml Erlenmeyer flasks.
The test substance is not deemed to trigger the requirements for classification and labelling on the basis of these results alone, as it has:
- a) Been proven to degrade rapidly in the aquatic environment (on the basis of hydrolysis)
- b) Has an absence of chronic effects at 1.0 mg/l as demonstrated in the chronic toxicity to Daphnia study.
Reference
Mean growth (b) [integral of biomass]
Nominal concentration [mg/L] | Area under growth curve | Inhibition (+) / Increase (-) [%] |
Control | 320278 | 0.0 |
1.9 | 339444 | -6.0 |
4.3 | 270000 | 15.7 |
9.4 | 247778 | 22.6 |
20.7 | 231111 | 27.8 |
45.5 | 172778 | 46.1 |
100 | 128889 | 59.8 |
Mean growth rate (r)
Nominal concentration | Growth rate | Inhibition (+) / Increase (-) |
[mg/L] | [1/d] | [%] |
Control | 1.50 | 0.0 |
1.9 | 1.51 | -0.8 |
4.3 | 1.47 | 2.2 |
9.4 | 1.42 | 5.3 |
20.7 | 1.41 | 6.2 |
45.5 | 1.31 | 13.0 |
100 | 1.21 | 19.4 |
Description of key information
Under the conditions of the study, the Er50 (72h) for Desmodesmus subspicatus was found to be 908 mg/L test substance (nominal concentration). Further, the NOEC for growth rate was found to be 20.7 mg/L (nominal) test substance.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 908 mg/L
- EC10 or NOEC for freshwater algae:
- 20.7 mg/L
Additional information
- a) Been proven to degrade rapidly in the aquatic environment (on the basis of hydrolysis)
- b) Has an absence of chronic effects at 1.0 mg/l as demonstrated in the chronic toxicity to Daphnia study.
A study was performed to assess adverse effects of Reaktiv Gelb F68072 FW on the growth (= increase in cell density) and the growth rate (= rate of increase in cell density with time) of the planktonic freshwater algal species Desmodesmus subspicatus over several generations.
The study was conducted in accordance with EEC Methods for Determination of Ecotoxicity Annex to Directive 92/69/EEC (O.J. No. L383A, 29.12.92) Part C, Method 3 'Algal inhibition test' which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 201 'Alga, Growth Inhibition Test'. Study conducted in compliance to with GLP.
All results are expressed in terms of nominal concentrations concentrations. Recovery rates ranged from 85.4 - 89.4% of nominal values at 0 hours, and from 84.7 - 88.6% of nominal values at 72 hours, respectively.
To reduce shading effects of the coloured test substance, the test was earned out with strong illumination (110 - 120 uE) and with a reduced test volume of 25 ml in 300 ml Erlenmeyer flasks.
The test substance is not deemed to trigger the requirements for classification and labelling on the basis of these results alone, as it has:
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.