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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 478-270-8 | 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:
- 2006-10-20 to 2007-06-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD Guideline 201 (Alga, Growth Inhibition Test) and EU method C.3 (Algal Inhibition Test) without deviations.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate given by the Department of Health of the Government of the United Kingdom
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): VRT-753136 hcl
- Molecular formula: Not applicable
- Molecular weight: Not applicable
- Smiles notation: Not applicable
- InChl: Not applicable
- Structural formula attached as image file: Not applicable
- Substance type: No data
- Physical state: White powder
- Analytical purity: 100 area %
- Impurities: 0.03 area% of unknowns
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: 2006-09-15
- Batch number 25515
- Lot No. AF6-001
- Expiration date of the lot/batch: 2008-05
- Stability under test conditions: No data
- Storage condition of test material: Room temperature
- Other: No data
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
No data
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: All concentrations
- Sampling method: ). At the start of the definitive test, four samples (10 mL) were taken from flasks containing the freshly-prepared control and test medium; after 72 hours, the contents of the replicate flasks for each group were pooled and further samples taken for analysis. Additional samples were also taken from four flasks containing VRT-753136 hcl at 100 mg/L but with no algal cells, in order to obtain information on the extent of adsorption/absorption of the test substance by the algal cells.
- Sample storage conditions before analysis: On each occasion, two of the samples were analyzed immediately; the remaining samples were stored frozen. The liquid slope cultures were stored in an illuminated refrigerator.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance (100 mg) was dissolved in algal culture medium (1000 mL) in a volumetric flask. The contents of the flask were shaken and used directly as the test medium. An aliquot (3.53 mL) of the secondary algal inoculum was added to a portion (900 mL) of the test medium, to give an initial cell density of 1 x 104 cells/mL. An aliquot (100 mL) of the inoculated test medium was added to each of the test vessels.
- Eluate: Not applicable
- Differential loading: Not applicable
- Controls: Sterile algal nutrient medium
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Unicellular green algae
- Strain: CCAP 278/4
- Source (laboratory, culture collection): Axenic, uni-cellular algae were obtained from the Culture Collection of Algae and Protozoa (CCAP), SAMS Research Services Ltd., Dunstaffnage Marine Laboratory, Dunbeg, Oban, Argyll, Scotland.
- Age of inoculum (at test initiation): At least a three-day-old secondary culture
- Method of cultivation: Liquid slope culture; transferred every 3 days
ACCLIMATION
- Acclimation period: At least three days
- Culturing media and conditions (same as test or not): Same as test
- Any deformed or abnormal cells observed: No
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Post exposure observation period:
- None
Test conditions
- Hardness:
- No data
- Test temperature:
- The temperature ranged from 21.4 to 21.8 deg C at time 0 and 22.4 to 22.5 deg C at time 72 h.
The temperature of the incubator ranged between 23.0 and 23.9 deg C. - pH:
- The pH ranged from 7.51 to 7.72 at time 0 and 8.29 to 8.68 at time 72 h.
- Dissolved oxygen:
- Not applicable
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- Nominal-Control concentration: 100 mg/L
Measured- 95.6 mg/L
The measured concentrations of VRT-753136 hcl in samples of the test cultures ranged between 94 and 98% of its nominal value during the test, giving an overall mean measured level of 95.6 mg/L. - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): Closed- stoppered with foam bungs covered with aluminum foil that was secured by autoclave tape.
- Material, size, headspace, fill volume: 250 mL conical flasks, 100 mL media
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): Incubated without renewal of meduim
- Initial cells density: Estimated to be 1.07 x 104/mL
- Control end cells density: No data
- No. of organisms per vessel: Not applicable
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- No. of vessels per vehicle control (replicates): Not applicable
GROWTH MEDIUM
- Standard medium used: Yes
- Detailed composition if non-standard medium was used: Not applicable
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Four stock solutions were prepared using filtered, dechlorinated tap water which had been softened and treated by reverse osmosis, before microfiltration and purification (resistivity of 18 Megohm/cm). Aliquots of stock solutions 1-3 were further diluted with the same diluent and autoclaved again to produce the working strength nutrient medium. Stock solution 4 was added to the medium on the day of use. The pH of the medium after equilibration with air is approximately 8.
- Total organic carbon: No data
- Particulate matter: No data
- Metals: No data
- Pesticides: No data
- Chlorine: No data
- Alkalinity: No data
- Ca/mg ratio: No data
- Conductivity: No data
- Culture medium different from test medium: No
- Intervals of water quality measurement: Not applicable
OTHER TEST CONDITIONS
- Sterile test conditions: Yes; Stock solutions were sterilised by autoclaving (solutions 1-3) or by membrane filtration (solution 4) before being stored at 4 deg C in the dark.
- Adjustment of pH: Yes
- Photoperiod: Contiunous light
- Light intensity and quality: approximately 6142 Lux (Day 0: 6160 Lux; Day 1: 6240 Lux; Day2: 6160 Lux; Day 3: 6006 Lux)
- Salinity (for marine algae): Not applicable
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Beckman Coulter Counter
- Chlorophyll measurement: Not applicable
- Other: No
TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable since is a single limit test
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study
- Test concentrations: Nominal test concentrations of 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- other: EbC50
- Effect conc.:
- > 95.6 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Basis for effect:
- other: Area under the growth curve
- Duration:
- 72 h
- Dose descriptor:
- other: ErC50
- Effect conc.:
- > 95.6 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 95.6 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Details on results:
- - Exponential growth in the control (for algal test): Yes
- Observation of abnormalities (for algal test): No microscopic abnormalities of the cells were detected in the test group.
- Unusual cell shape: No
- Colour differences: No
- Flocculation: No
- Adherence to test vessels: No
- Aggregation of algal cells: No
- Other: No
- Any stimulation of growth found in any treatment: No
- Any observations that might cause a difference between measured and nominal values: After 72 hours, analysis of samples of medium containing VRT-753136 hcl at 100 mg/L, which had been incubated without algal cells gave similar results to test media incubated in the presence of algal cells. These results indicate that the presence of algal cells did not affect the stability of the test substance.
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- The data were compiled in an Excel spreadsheet and analysed using SAS 8.2 (SAS Institute 1999). The area under the curve was divided by initial count and total time to give AUCP (Area Under the Curve expressed as a Proportion of the initial cell count), where a value of 1 represents no growth and a value of 0 represents complete toxicity (all algae killed). In order to estimate the concentration at which 50% inhibition of growth occurred (EC50), sigmoidal curves were fitted to AUCP and growth rate. For both variables, 0% inhibition was defined as the control mean and 100% inhibition was defined as no growth. The minimum of the curve (for infinite concentration) was bounded between 0 and 1 for AUCP and between -1000 and 0 for growth rate. For AUC and growth rate, Williams’ test (1971, 1972) was also used to compare the treated group with control unless there was evidence of a non-monotonic dose-response relationship, in which case Dunnett’s test (1955, 1964) was used.
Any other information on results incl. tables
Not applicable
Applicant's summary and conclusion
- Conclusions:
- After 72 hours of exposure to VRT-753136 hcl, neither the EbC50 nor the ErC50 could be determined but both must be >95.6 mg/L.
The “no observed effect concentration” (NOEC) was 95.6 mg/L.
After 72 hours, no significant inhibition of algal growth had been observed. - Executive summary:
Not applicable
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.