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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-675-9 | CAS number: 1341-38-4
- 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
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Isooctyl palmitate
- EC Number:
- 215-675-9
- EC Name:
- Isooctyl palmitate
- Cas Number:
- 1341-38-4
- Molecular formula:
- C24H48O2
- IUPAC Name:
- 6-methylheptyl hexadecanoate
- Test material form:
- liquid
- Remarks:
- a colourless liquid
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- A range-finding test was conducted to find the concentrations that cause algae growth inhibition. Based on the results of the range-finding test, a definitive test was carried out with the following concentrations of test Item : 0 (control); 1; 3,2; 10; 32 and 100 mg.L-1.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The stock solution used in the range-finding test was prepared by dissolving 0.0250 g of the test item in 250 mL of with OECD medium, resulting in a concentration of 100 mg.L-1. To assist solubilization, the solution was stirred for 20 minutes in a magnetic stirrer and 20 minutes of ultrasonic dispersion was also applied. The stock solution of 0.1; 1; 10 and 100 mg.L-1 were prepared from dilution of the stock solution.
The stock solution used in the definitive test was prepared by dissolving 0.1000 g of the test item in 1000 mL of with OECD medium, resulting in a concentration of 100 mg.L-1. To assist solubilization, the solution was stirred for 20 minutes in a magnetic stirrer and 20 minutes of ultrasonic dispersion was also applied. The stock solution of 1; 3.2; 10; 32 and 100 mg.L-1 were prepared from dilution of the stock solution.
From these initial stock solutions, a series of dilutions was prepared in order to obtain the desired tested concentrations (Tables 3 and 4).
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- The test system was obtained from Culture Collection of Algae at Goettingen University - SAG 61.81 on October, 08th, 2013, and is recommended by the Guideline OECD 201 (2011).
The stock culture was prepared and maintained under lab-controlled conditions in solid medium with protease peptone. Its composition is described in Table 1.
The inoculated solid medium was kept inside a culture room, with controlled temperature of 21 to 24°C and luminosity of 2100 10% lux. After algae cultures reached an ideal growth (about one week), they were maintained at temperature of 2 to 6°C and luminosity of 100 to 200 lux in order to slow down the algae growth.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- 22.0 to 22.2 ℃
- Details on test conditions:
- A range-finding test was carried out using the following concentrations of test item: control; 0.1; 1; 10 and 10 mg.L-1 of test Item, with two replicates per concentration. The algae inoculum was transferred aseptically to each test flask, with calculated volume to yield an initial cell concentration of 5 x 103 cells.mL-1.
After 72 hours, samples of each test flask were taken in order to count the cells and to determine the concentrations, using a Neubauer chamber and a microscope, that caused algal growth reduction.
Based on the results obtained in the range-finding test, the definitive test was carried out with the following concentrations of test item: control; 1; 3.2; 10; 32 and 100 mg.L-1. The test was performed with six replicates per each concentration and control, therefore tree replicate was prepared for determinations of pH and chemical analysis. The algae inoculum was transferred aseptically to each test flask, with calculated volume to yield an initial cell concentration of 5 x 103 cells.mL-1.
All test flasks were randomly positioned in an incubating chamber with controlled temperature and kept under continuous shaking and lighting conditions. Every day the flasks were relocated to different places inside the incubating chamber.
Tables 3 and 4 show the stock solution and medium volumes used to obtain the concentrations of the range-finding and definitive tests.
The definitive test was carried out under the conditions described below:
Temperature: 22.0 to 22.2oC
Light: 6.126 lux (average)
Photoperiod: continuous light
Shaker velocity: 130.6 rpm (average)
Test duration: 72 hours
Temperature was measured daily using a digital thermometer. The pH was measured at the beginning of the test and at 72 hours (Table 8).
One aliquot was taken from each test flask in order to determine the algal growth over the period of 24, 48 and 72 hours after the start of the test. A Neubauer chamber and a microscope were used to determine the cell number (cells.mL-1).
A test with the reference item, potassium dichromate, was also carried out in order to verify the sensitivity of the test system. The procedure for this test was the same as for the definitive test described above, with initial cell concentration of 5 x 103 cells.mL-1 for each concentration and using nominal concentrations of 0 (control); 0.18; 0.32; 0.56; 1.00 and 1.80 mg.L-1 and two replicates for each test concentrations. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 3.2 mg/L
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- ca. 23.32 mg/L
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- ca. 1 mg/L
- Basis for effect:
- growth rate
- Details on results:
- The 72-hours EyC50 value of test item, obtained in this study with Pseudokirchneriella subcapitata, was 23.32 mg.L-1 (95% confidence limits = 17.06 to 31.87 mg.L-1) and the 72-hours ErC50 value was not determined because the highest tested concentration (100 mg.L-1) caused only 22% of the inhibition in the algae growth, therefore, the 72-hours EyC50 value was greater than 100 mg.L-1. The highest concentration of the test item in which was not observed any statistically significant adverse effect on algal growth (NOEC) over the test period (72 hours) was 3.2 mg.L-1 and the lowest test item concentration at which was observed significant reducing effect on growth (LOEC) was 1 mg.L-1.
- Results with reference substance (positive control):
- The 72-hours EyC50 value of the reference item potassium dichromate was 0.66 mg.L-1 (confidence limits at 95% = 0.60 to 0.72 mg.L-1), demonstrating that the toxic sensitivity of the algae was within the accepted range (ISO, 1989), which report toxicity ranged between 0.60 to 1.03 mg.L-1.
Any other information on results incl. tables
In order to check the validity of the test, the biomass in the control cultures should increase exponentially by a factor of at least 16 within 72 hours. The mean coefficient of variation (CV) for section-by-section specific growth rates in the control cultures must not exceed 35% and the CV of average specific growth rate during the entire test period in replicate control cultures must not exceed 7%. In fact, in the present study, the biomass in the control cultures increased 1119 times at end of the test (Table 9). The mean coefficient of variation (CV) of the growth ratein the control group was 28.7% (Table 10) and the CV of average specific growth rate during the entire test period in replicate control cultures was 0.2% (Table 11), showing therefore, the validity of this study.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 72-hours EyC50 value was 23,32 mg.L-1 and the 72-hours ErC50 value was not determined because the highest tested concentration (100 mg.L-1) caused only 22% of the inhibition in the algae growth, therefore, the 72-hours EyC50 value was greater than 100 mg.L-1. The highest test Item concentration which no observed significant adverse effect (NOEC) on algal growth was 3.2 mg.L-1 and the lowest test Item concentration at which was observed significant reducing effect on growth (LOEC) was 1 mg.L-1.
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.