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EC number: 812-963-1 | CAS number: 178436-06-1
- 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 aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-10-16 to 2017-10-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ceramide III
- IUPAC Name:
- Ceramide III
- Test material form:
- solid
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
Test solutions
- Vehicle:
- no
- Remarks:
- No analytical monitoring was carried out due to the low solubility of the test item.
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
In view of the difficulties associated with the evaluation of aquatic
toxicity of poorly water soluble and multi-component test items, a
modification of the standard method for the preparation of aqueous
media was performed. An approach endorsed by several important
regulatory authorities in the EU and elsewhere (ECETOC 1996 and
OECD 2000) is to expose the organisms to a Water Accommodated
Fraction (WAF) of the test item in cases where the test item is a
complex mixture and is poorly soluble in water and in the permitted
solvents. Using this approach, aqueous media were prepared by
mixing the test item with water for a prolonged period sufficient to
ensure equilibration between the test item and the water phase. After
completion of mixing and following a settlement period, the test item
phase was separated by siphon and the test organisms were exposed
to the aqueous phase, the WAF (which may contain dissolved and/or
suspended and/or emulsified fractions of the test item mixture).
Exposure are expressed in terms of the original concentration of the
test item in water at the start of the mixing period (loading rate)
irrespective of the actual concentration of the test item in the WAF.
Preparation of the water
accommodated fraction
One water accommodated fraction (WAF) was prepared with a
nominal loading of the test item of 100 mg/L. The loading level are
based on the results of a preliminary range finding test (for results,
please refer to Annex I).
An appropriate amount of the test item was weighed out and
transferred into a measuring flask with an appropriate amount of the
test media (see Table 1 and Table 2). This dispersion was shaken for
at least 24 hours with 20 rpm at room temperature. After a separation
phase of 1 hour at room temperature, the aqueous phase or WAF was
removed by siphoning (from the approximate centre of the glass flask).
The resulting water accommodated fraction (WAF) was used in a limit
test.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Strain: Daphnia magna STRAUS (Clone 5)
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), 14195 Berlin, Germany
- Age at study initiation (mean and range, SD): 2 to 24 hours old daphnids
- Method of breeding: In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 ± 2°C, in an incubator, 16 h illumination, light intensity of max. 20 µE m-2 s-1
- Feeding during test: no
ACCLIMATION
- Acclimation period: At least 2 hours in river water
- Acclimation conditions (same as test or not): same
- Type and amount of food: culture daphnids are fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with an algae cell density of > 1E06 cells/mL. The algae are cultured at the test facility
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- river water: 80.1 mg CO3/L;
culture medium: 160 -180 mg CaCO3 /L - Test temperature:
- 19 - 20 °C
- pH:
- start: 7.92 (test 100 mg/l) 8.09 (control); end: 7.65 (test 100 mg/l) 7.60 (control)
- Dissolved oxygen:
- start: 8.74 mg/l (test 100 mg/l) 9.85 mg/l (control); end: 8.12 mg/l (test 100 mg/l) 8.43 mg/l (control)
- Conductivity:
- 220 µS/cm
- Nominal and measured concentrations:
- 100 mg/l water accomodated fraction (nominal)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers (4 (ID) x 7 (H) cm) with a capacity of 50 mL, loosely covered with watch glasses
- Renewal rate of test solution (frequency/flow rate): static
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
river water as specified in section "any other information on materials and methods"
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: Diffuse light; light intensity of max. 1500 lx
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Immobilisation was determined in all groups after 24 and 48 hours.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: limit test
Range finding study
- Test concentrations: 100 mg/l loading, nominal, prepared in natural river water
2 replicates with 10 daphnids each
- Results used to determine the conditions for the definitive study: no immobilisation - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: nominal loading ot test item
- Basis for effect:
- mobility
- Details on results:
- - immobilisation of test item: 0 %
- immobilisation of control: 0 % - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50: 1.92 mg/L (95% CI 1.11 - 2.00 mg/L) - Reported statistics and error estimates:
- EC-values and statistical analyses for reference item:
An EC50-value was calculated for the reference item by sigmoidal dose-response regression. The 95 % confidence limits for the EC50 were calculated from the best-fit values, the standard error and the t-distribution with the validated software GraphPad Prism.
Any other information on results incl. tables
The percentage of immobility, determined in the WAF and in the control after 24 and 48 hours, is given in Table 4. The absolute numbers of immobile daphnids are presented inTable 5. Other adverse effects did not appear.
The study was performed under static conditions in natural river water.
Table 4: Immobilization Rates after 24 and 48 hours of Exposure in the Definitive Test
(n = 20, divided into 4 replicates with 5 daphnids each)
CERAMIDEIII Nominal loading of the test item in the WAF [mg/L] |
IMMOBILIZATION [%] |
|||||||||
24 hours |
48 hours |
|||||||||
Replicates |
Replicates |
|||||||||
1 |
2 |
3 |
4 |
MV |
1 |
2 |
3 |
4 |
MV |
|
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table5: Absolute Numbers of immobile Daphnids after 24 and 48 hours of Exposure in the Definitive Test
(n = 20, divided into 4 replicates with 5 daphnids each)
CERAMIDEIII Nominal loading of the test item in the WAF [mg/L] |
Number of immobile Daphnids / Total number of Daphnids |
|||||||||
24 hours |
48 hours |
|||||||||
Replicates |
Replicates |
|||||||||
1 |
2 |
3 |
4 |
MV |
1 |
2 |
3 |
4 |
MV |
|
100 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 20 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 20 |
Control |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 20 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 20 |
Additional Observations during the Definitive Test
The WAF was visually clear with finely distributed test item particles, which precipitated at the surface of the test solution and at the bottom of the test vessel after 24 hours of the exposure.
Water Quality Parameters
The measured water quality parameters(i.e. pH-value, dissolved oxygen concentration, water temperature, conductivity and total hardness) were within the acceptable limits.
During the test period, the temperature in the incubator was 19 – 20 °C.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 48-hour EL10 as well as EL50 to Daphnia magna (effect immobilisation) was > 100mg/L water accomodated fraction nominal.
- Executive summary:
The 48-h-acute toxicity of Ceramide III to Daphnia magna was studied under static conditions according to OECD Guideline 202 (2004) in a limit test. Daphnids were exposed to control and test chemical at a nominal concentration 100 mg/L water accommodated fraction in natural river water for 48 h.
Mortality/immobilization was observed daily.
The 48-hour EL10 as well as EL50 was > 100mg/L water accomodated fraction nominal.
This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.
Results Synopsis
Test Organism Age: max. 24 h old daphnids
Test Type: Static limit test
Water accommodated fraction
48-hour EL10: > 100mg/L
Endpoint(s) Effected: mobility
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