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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 250-792-9 | CAS number: 31765-95-4
- 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
- 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:
- see Any other information on materials and methods
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: Saturn Grey LCGCAS: 31765-95-4Batch No.: 8010/2008Appearance: black powderStorage: dark dry room, closed container, at laboratory temperatureExpiration date: February 2018
- Analytical monitoring:
- yes
- Details on sampling:
- see Details on analytical methods
- Vehicle:
- no
- Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM - Common name: Desmodesmus subspicatus - Strain: Brinkmann - Source (laboratory, culture collection): The Botanic Institute of the Czech Academy of Science, Třeboň (27.5.2016) - Method of cultivation: Inoculum culture was kept 3-4 days under conditions at which the test was performed. After this period the culture was in the state of the exponential growth and had the cell density suitable for the performance of the test.
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 21 - 24°C controlled at ± 2°C
- pH:
- preliminary test: 7.4 - 8.0limit test: 7.7 - 8.1
- Nominal and measured concentrations:
- Preliminary test - nominal concentration: 1 mg/l - determined concentration: 1.1 mg/l (0 h) - determined concentration: 1.0 mg/l (72 h) - nominal concentration: 100 mg/l - determined concentration: 98.3 mg/l (0 h) - determined concentration: 99.2 mg/l (72 h) - nominal concentration: 100 mg/l (without algae) - determined concentration: 100.7 mg/l (0 h) - determined concentration: 100.5 mg/l (72 h)Limit test - nominal concentration: 100 mg/l - determined concentration: 92.5 mg/l (0 h) - determined concentration: 94.5 mg/l (72 h) - nominal concentration: 100 mg/l (without algae) - determined concentration: 94.5 mg/l (0 h) - determined concentration: 95.3 mg/l (72 h)
- Details on test conditions:
- TEST SYSTEM - Test vessel: Erlenmeyer flasks with stoppers venting air - Aeration: without - Initial cells density: 5000 cells per 1 mL - Control end cells density: Burker´s counting chamber - No. of vessels per concentration (replicates): 3 (preliminary test), 6 (limit test) - No. of vessels per control (replicates): 3 (preliminary test), 6 (limit test) GROWTH MEDIUM - Standard medium used: yes OTHER TEST CONDITIONS - Sterile test conditions: yes - Adjustment of pH: no - Photoperiod: continuous white light - Light intensity and quality: 4 440 - 8 880 lux EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : - Determination of cell concentrations: Burker´s counting chamber TEST CONCENTRATIONS - Test concentrations: 1, 5, 10, 50 and 100 mg/L
- Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- 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
- 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
- Details on results:
- see Table 1 and 2
- Results with reference substance (positive control):
- - Reference substance: potassium dichromate - EC50 = 0.87 mg/L (72 h, growth rate) - Interlaboratory data: EC50 = 0.51 - 1.19 mg/L (72 h, growth rate)
- Reported statistics and error estimates:
- The determination of NOEC value was done by ANOVA (Analysis of Variance) analysis. Used ANOVA method is the part of statistical software QC.Expert 2.5 1998-2000 (product of TriloByte Ltd., Czech Republic).
- Validity criteria fulfilled:
- yes
- Conclusions:
- The inhibition of growth rate was 31.7 % in the limit test. Therefore, exact value of EC50 could not be calculated and the value of EC are given in the form of a range.There is stated in the guideline that, if evidence is available to demonstrate that the concentration of the test substance has been satisfactorily maintained within ± 20 per cent of the nominal or measured initial concentration throughout the test, the results can be based on nominal or measured initial values. So the nominal concentrations were used for all evaluations and results.growth rate: EC50 > 100 mg/L (72 h, Desmodesmus subspicatus) (nominal concentration)growth rate: NOEC > 100 mg/L (72 h, Desmodesmus subspicatus) (nominal concentration)
- Executive summary:
The test substance, Direct Black 112, was tested for growth inhibition on algae Desmodesmus subspicatus. The test was performed according to method C.3. - Freshwater Algae and Cyanobacteria, Growth Inhibition Test, Commission Regulation (EC) No. 761/2009, Annex IV.
The preliminary test was performed in a range of the test substance nominal concentrations 1 – 100 mg/L. The analytical results showed, that the test substance Direct Black 112 was sufficiently stable in the test medium at conditions of the test in concentration range 1 – 100 mg/L. The highest inhibition of growth rate was 29.7 % and the highest inhibition of yield was 77.6 % in the preliminary test. Based on no toxicity of the test substance found in the preliminary test (measured by growth rate), the limit test was performed subsequently. Only the value of EC50 (72h) based on growth rate is needed for the classification and risk assessment of chemicals, so the value of EC50 (72h) based on yield was not calculated. The concentration of 100 mg/L was tested in the limit test.
The guideline specify that if evidence is available to demonstrate that the concentration of the test substance in limit test has been satisfactorily maintained within ± 20 per cent of the nominal or measured initial concentration throughout the limit test, then the results can be based on nominal or measured initial values, which is the case of this study. The nominal concentrations were used for all evaluations and results.
The inhibition of growth rate was 31.7 % in the limit test. Therefore, exact value of EC50 could not be calculated and the value of EC are given in the form of a range.
growth rate: EC50 > 100 mg/L (72 h, Desmodesmus subspicatus) (nominal concentration)
growth rate: NOEC > 100 mg/L (72 h, Desmodesmus subspicatus) (nominal concentration)
Reference
Table 1: Growth rate – preliminary test
Nominal concentration (mg/L) | Replicates | Growth rate for section-by-section | Growth rate 0-72 h | ||
0-24 h | 24-48 h | 48-72 h | |||
100 | 1 | 1.32 | 0.69 | 1.47 | 1.16 |
2 | 1.32 | 0.85 | 1.35 | 1.17 | |
3 | 1.32 | 0.69 | 1.47 | 1.16 | |
50 | 1 | 1.83 | 0.18 | 1.50 | 1.17 |
2 | 1.83 | 0.18 | 1.58 | 1.20 | |
3 | 1.61 | 0.41 | 1.54 | 1.19 | |
10 | 1 | 1.83 | 1.10 | 1.44 | 1.46 |
2 | 1.61 | 1.32 | 1.42 | 1.45 | |
3 | 1.83 | 1.10 | 1.53 | 1.49 | |
5 | 1 | 2.01 | 0.92 | 1.86 | 1.60 |
2 | 2.01 | 0.85 | 1.84 | 1.57 | |
3 | 2.01 | 0.92 | 1.85 | 1.59 | |
1 | 1 | 2.17 | 0.94 | 1.78 | 1.63 |
2 | 2.17 | 1.00 | 1.65 | 1.61 | |
3 | 2.17 | 0.89 | 1.78 | 1.61 | |
Control | 1 | 2.30 | 1.25 | 1.46 | 1.67 |
2 | 2.17 | 1.46 | 1.23 | 1.62 | |
3 | 2.17 | 1.42 | 1.44 | 1.68 |
Table 2: Growth rate – limit test
Nominal concentration (mg/L) | Replicates | Growth rate for section-by-section | Growth rate 0-72 h | ||
0-24 h | 24-48 h | 48-72 h | |||
100 | 1 | 2.01 | 0.15 | 1.00 | 1.06 |
2 | 1.83 | 0.47 | 0.81 | 1.04 | |
3 | 1.83 | 0.34 | 1.05 | 1.07 | |
4 | 1.83 | 0.34 | 0.94 | 1.04 | |
5 | 1.83 | 0.47 | 0.86 | 1.06 | |
6 | 2.01 | 0.29 | 0.86 | 1.06 | |
Control | 1 | 2.01 | 1.15 | 1.51 | 1.56 |
2 | 2.01 | 1.15 | 1.37 | 1.51 | |
3 | 2.17 | 1.05 | 1.36 | 1.53 | |
4 | 1.83 | 1.10 | 1.76 | 1.56 | |
5 | 2.17 | 1.10 | 1.39 | 1.55 | |
6 | 2.01 | 1.10 | 1.47 | 1.53 |
Description of key information
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 100 mg/L
- EC10 or NOEC for freshwater algae:
- 100 mg/L
Additional information
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.