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Diss Factsheets
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EC number: 936-831-9 | 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- The degradation products of the test item were analytically determined. The test item could not be analyzed due to the low solubility and the fast
degradafion of. Thus, the resulting degradation products will be more relevant for any toxic effects on the test organisms under natural conditions.
For the analysis of the actual test item concentrafions the following samples were taken:
just before test start:
- duplicate samples from the test medium
- duplicate samples from the control
after 48 and 96 hours:
- duplicate samples from the test medium
(stability samples) - duplicate samples from the control
All samples were taken from the approximate center of the aquaria without mixing the test media.
The concentration of the degradation products was analyzed in the duplicate test medium samples from all sampling fimes (0, 48 and 96 hours).
From the control samples only one of the duplicate samples was analyzed from the corresponding sampling fimes. The samples were analyzed
immediately after sampling without prior storage. - Vehicle:
- no
- Details on test solutions:
- According to the results of a pre-experiment (without GLP) the test item was not soluble at a concentration of 100 mg/L in test water and no
homogeneous dispersion could be prepared. A filtrate of a supersaturated dispersion of the test item was prepared. The undiluted filtrate
was tested as the only test concentration. Additionally, a control was tested in parallel (test water without test item). A supersaturated dispersion with a nominal concentration of 100 mg/L (= loading rate) was prepared by weighing 700 mg of the test item into 7 liters test water. No auxiliary solvent
or emulsifier was used. The test item was mixed into the test water as homogeneously as possible by ultrasonic treatment for 15 minutes and by
intense stirring for 96 hours at room temperature in the dark to dissolve a maximum concentrafion of the the test item in the dispersion.
The long stirring period of 96 hours was chosen because the concentrafion of dissolved degradation product continuously increased over a stirring
time of about 96 hours (results of a pre-test; without GLP).
The supersaturated stock dispersion of the test item was filtered through a membrane
filter (Schleicher & Schuell, Type NC45, pore size 0.45 microm) after the 96 hours stirring period just before the preparafion of the test medium. The undiluted filtrate of the supersaturated dispersion with the maximum concentrafion of dissolved degradation product was used as the only test
medium.
The test medium was prepared just before introducfion of the fish (= start of the test). - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Source: Zoohaus Schaub, CH-4410 Liestal, Switzerland
- Age at study initiation (mean and range, SD): 3.4 +- 0.1 cm
- Weight at study initiation (mean and range, SD): 0.41 +- 0.03 g
- Feeding during test: none
ACCLIMATION
- Acclimation period: 1 week
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: commercial fish diet (TETRA MIN Hauptfutter)
- Health during acclimation (any mortality observed): no mortality observed - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 2.5 mmol/L (=250 mg/L) as CaCO3
- Test temperature:
- 22 deg. C
- pH:
- 7.9
- Dissolved oxygen:
- > 8.3 mg/L
- Nominal and measured concentrations:
- loading rate of 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 5 L glass aquaria
- Aeration: slight aearation during test period
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: < 1 g fish wet wgt per liter test medium
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Ca/mg ratio: 4:1
CaCl2 X 2H2O 2.0 mmol/L (= 294 mg/L)
MgSO4 X 7H2O 0.5 mmol/L (=123 mg/L)
NaHCO3 0.75 mmol/L (= 65 mg/L)
KCI 0.075 mmol/L (= 5.8 mg/L)
Water Hardness 2.5 mmol/L (= 250 mg/L) as CaCO2
Alkalinity 0.8 mmol/L
Na : K = 10 : 1 (based on molarity)
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
- Light intensity:
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study: - Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: none
- Mortality of control: none
- Other adverse effects control: none - Sublethal observations / clinical signs:
In conclusion, the test substance and its degradation products had no toxic effect on
the fish up to their solubility limit in test water under the present test condifions.
Reference
Description of key information
With high probability acutely not harmful to aquatic organisms. No toxic effects were observed within the range of solubility.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- >= 100 mg/L
Additional information
According to regulation (EC) No 1907/2006, Annex XI, paragraph 1.5., substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or "category" of substances. Environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). The substance consists of two main components, a component with a C18 chain (60%) and C16 chain (30%) component. The structure of both substances is the same except the chain length.
The substance with C18 is already notified under EC 445-990-9. It is expected that the structural difference between the octadecanoate and the hexadecanoate does not affect the physico-chemical properties, the toxicological and ecotoxicologocal profile as well as the environmental fate. Furthermore, it can be assumed that the degradation products of EC 445-990-9 are very similar to the degradation products of the mixture containing the octadecanoate and the hexadecanoate. Therefore read-across to EC 445-990-9 is scientifically justified for physico-chemical properties, the toxicological and ecotoxicologocal profile as well as environmental fate.
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.
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