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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 945-069-6 | 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:
- 20 Jan - 23 Jan 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline study with acceptable restrictions: Initial measured concentration was used to evaluate NOEC and EC50 in spite that the concentration after 72 hours was notably lower than at inition and not within 20 % of nominal concentration. Analytical purity is only 77.2%.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- yes
- Remarks:
- Nominal concentration was used to evaluate NOEC and EC50 in spite that the concentration after 72 hours was not within 20 % of nominal concentration.
- GLP compliance:
- yes
- Remarks:
- according to the Japanese GLP Standard
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: Samples were taken directly from each vessel.
- Sample storage conditions before analysis: no storage before analysis - Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test substance was measured and mixed with vehicle. Purified water was added bit by bit to prepare the stock solution (1000 mg/L). Stock solution was diluted with test media.
- Controls: blank control and vehicle control
- Chemical name of vehicle: HCO-40
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 10000 mg/L in a stock solution, 1 mg/L in final concentration
- Evidence of undissolved material: Test water was clear and colourless at the study initiation. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: algae
- Strain: ATCC22662
- Source: American Type Culture Collection
- Age of inoculum: ≤ 3 days
- Method of cultivation: on a shaker
ACCLIMATION
- Acclimation period: 16 Jan - 20 Jan 2004
- Culturing media and conditions: same as test - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 22.8 - 23.2; (23 ± 2 °C)
- pH:
- 7.9 - 10.0
- Nominal and measured concentrations:
- Nominal concentration: 0.100 mg/L
Measured concentration: 0.0845 mg/L at the study initiation, 0.0019 mg/L at the end of the study - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer-flask
- Type: closed with air-permeable cap
- Material: glass; Size: 300 mL; Fill volume: 100 mL
- Initial cells density: 10000 cells/mL
- Control end cells density: 3056200 ± 155000 cells/mL
- No. of vessels per concentration: 3
- No. of vessels per control: 3
- No. of vessels per vehicle control: 3
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: no
- Intervals of water quality measurement: Temperature and ph were measured at 24, 48 and 72 hours after test begin.
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no adjustment
- Photoperiod: continuously
- Light intensity and quality: 4000 lux
EFFECT PARAMETERS MEASURED: Algal growth was recorded after 72h test duration.
- Determination of cell concentrations: counting chamber; electronic particle counter
TEST CONCENTRATIONS
- Range finding study: performed
- Test concentrations: 0.1 mg/L
- Results used to determine the conditions for the definitive study: Growth rate was 92% compared with control group and 94 % with vehicle control group. The measured concentration was 0.001 mg/L after 72 hours. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (analytical grade)
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.085 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.085 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.085 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.085 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Details on results:
- - Exponential growth in the control: yes
- Observation of abnormalities: No abnormality was observed. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50: 0.432 ± 0.074 mg/L - Reported statistics and error estimates:
- Student's t-test for NOEC
Reference
Table 1: Measured concentration of the test substance
Nominal Conc. [mg/L] |
Measured Conc. [mg/L], (Percent of nominal) |
|
0 h |
72 h |
|
Control |
<0.1 |
<0.1 |
Solvent control |
<0.1 |
<0.1 |
0.100 |
0.0845 (85) |
0.0019 (2) |
Table 2: Growth inhibition [%]
Nominal Concentration [Measured conc. at 0 h] [mg/L] |
Biomass |
Growth rate (24-48 h) |
Growth rate (24-72 h) |
Inhibition [%] * |
Inhibition [%] * |
Inhibition [%] * |
|
Control |
- |
- |
- |
Solvent control |
- |
- |
- |
0.100 [0.0845] |
- 6.5 |
2.4 |
- 0.4 |
*: Values are the growth inhibition [%] relative to the solvent control.
Description of key information
In a test on algae exposure to 0.1 mg/L bis(2-ethylhexyl) azelate (measured initial concentration 0.0084 mg/L) did not lead to decreased growth rates or inhibition of biomass. The EC50 for growth rate is > 0.0084 mg/L (measured) and the NOEC is 0.0084 mg/L (measured). As this concentration is above the reported water solubility of bis(2-ethylhexyl) azelate, no toxicity of this substance is expected up to maximum solubility (MOE 2004). Therefore the NOELR is set at 0.1 mg/L.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 0.1 mg/L
- EC10 or NOEC for freshwater algae:
- 0.1 mg/L
Additional information
The substance tested is considered a close analogue of diesters of alcohols, C7-9-iso-, C8-rich, 2-ethylhexyl and nonanedioic acid and a worst case due to the presence of 2-ethylhexan-1-ol as part of the starting materials of both diesters of alcohols, C7-9-iso-, C8-rich, 2-ethylhexyl and nonanedioic acid and bis(2-ethylhexyl) azelate. Therefore the outcome of the study that indicates no toxicity at the water solubility level is considered representative for diesters of alcohols, C7-9-iso-, C8-rich, 2-ethylhexyl and nonanedioic acid (see rationale for read-across)
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.