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EC number: 832-827-5 | 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 aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 December 2019 to 13 December 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- OECD Guideline for Testing of Chemicals, Section 2, No. 202, “Daphnia sp., Acute Immobilisation Test”, updated 13 April 2004.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Version / remarks:
- EPA Guideline 712-C-96-114: OCSPP 850.1010, “Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids” April 1996.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- Commission Regulation (EU) 2017/735 of 14 February 2017 amending, for the purpose of its adaptation to technical progress, the Annex to Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Annex IV Part C, C.2.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- No further details specified in the study report.
- Analytical monitoring:
- yes
- Details on sampling:
- Duplicate samples were taken (2 x ~15 mL from three replicates) in glass tubes at the beginning and at the end of the experiment from the control and at the applied test concentration level.
- Vehicle:
- no
- Details on test solutions:
- The test solutions were prepared using a saturated solution method according to the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD No. 23 (2000).
Saturated test item solution with the nominal loading rate of 100.0 mg/L (water accommodated fractions, WAF) was prepared with direct addition of the test item, mixed into the algal growth medium (ISO Medium) and then continuously stirred gently for approximately 48 hours using magnetic stirrer. Then, the emulsion was settled for approximately 1 hour, and the middle layer was collected as the test solution. This test solution (100.0 mg/L WAF) was divided into two parts. The non-dissolved test material was removed by filtration through a fine (0.22 µm) filter to give the appropriate WAF solution in the first case, while the other set was not filtered and used as test solution as it is.
Prior to treatment of each renewal period, test item solutions were prepared by the method described above just before introduction of the Daphnia (start of the treatments). - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Species and strain: Daphnia magna
Source: István Szent University, 2100 Gödöllő, Páter Károly u. 1, Hungary
Breeding: The Daphnia are bred in Ecotoxicological Laboratory of Charles River Laboratories Hungary Kft.
The health of the stock animals is continuously monitored by visual daily checking. Abnormal behaviour or significant decrease of population is recorded.
Justification of strain:Daphnia magna is the standard species of the acute immobilisation test.
Number of animals: There were 20 animals in test group and control group respectively, divided into 4 replicates (5 animals / replicate)
Age of the animals:They were less than 24 h old at the beginning of the test
Acclimatization:There was no acclimatization because the water used was similar to the culture water - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- No post exposure observation period specified in the study report.
- Hardness:
- The reconstituted water (ISO medium) had a total hardness of 248 mg/L (as CaCO3).
- Test temperature:
- The water temperature was measured at the start and at the end of the renewal periods in one control test vessel. The test temperature was in the range of 20.5 – 20.9°C measured in the test vessels.
The additionally measured temperature in the climate chamber was between 20.4 – 21.1°C - pH:
- The pH of the test solution was not adjusted and not varied by more than 1.5 units in any one test. The pH was measured at the start and at the end of the renewal periods in one test vessel both in the control and test item group and was in the range of 7.11 – 7.70.
- Dissolved oxygen:
- The dissolved oxygen concentration was measured in the control and in the test concentration in one replicate at the start and at the end of the renewal periods and was in the range of 7.0 – 8.9 mg/L.
- Salinity:
- No specified
- Conductivity:
- Not specified
- Nominal and measured concentrations:
- nominal loading rate (WAF)
- Details on test conditions:
- PERFORMANCE OF THE TEST
The test duration was 48 hours. Twenty animals, divided into four groups (glass beaker with a volume of 50 mL) of five animals each (~40 mL test solution/flask; 8 mL test solution/animal) were used at the test concentration and for the control in a semi-static system. The animals were not fed during the test.
Based on the analytical method validation (Study Code: 19/045-920AN), the test was performed under semi-static conditions. The frequency of the water renewal periods was 24 hours.
The choice of the test concentration was done on the basis of the results of a preliminary range-finding test.
Preliminary Range-Finding Test
A concentration range-finding test was conducted to determine the approximate toxicity of the test item so that appropriate test concentrations could be selected for use in the definitive test. Ten daphnids (divided into two replicates) in each test concentration and control were exposed for 48 hours under semi-static conditions (in absence of stability data).
Saturated test item solutions with the nominal loading rates of 0.1, 1.0, 10.0 and 100.0 mg/L (water accommodated fractions, WAFs) were individually prepared with direct addition of the test item, mixed into the test medium (aquarium water) and then continuously stirred gently for approximately 48 hours using magnetic stirrer. Then, the emulsions were settled for approximately 1 hour, and the middle layer was collected as the test solution in each tested level.
Test solution at the highest test level (100.0 mg/L WAF) was divided into two parts as described above.
Test item concentrations in the Definitive Test
Because a toxic response was not observed at the highest concentration level during the preliminary concentration range-finding test, a Limit Test was carried out using only one test concentration at 100 mg/L nominal loading rate (WAF) (a filtered and a non-filtered one in parallel to demonstrate that any effect observed is due to physical effects and not toxicity) and one control group in a semi-static system.
OBSERVATIONS
The immobility or mortality of the Daphnia was determined by visual observation 24 and 48 hours after the start of the test. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile.
The number of immobilised animals and the percentage of immobility were determined at 24 and 48 hours.
The water temperature, the oxygen concentrations and pH of the control and the test solution were measured at the beginning and at the end of the renewal periods. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (batch no.: A0345704) is: 05 - 06 September 2019.
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LOELR
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- VALIDITY
There were no immobilized animals in the control group and the dissolved oxygen concentration at the end of the test in the control and test vessels was more than 3 mg/L.
All validity criteria were within acceptable limits and therefore the study can be considered as valid.
IMMOBILISATION
The number of immobilised animals and the percentage of immobility were determined at the 24th and 48th hour.
In addition to immobility, no abnormal behaviour or appearance of test animals was detected.
All of the animals got stuck at the surface of the unfiltered test solution, but separated and swam after gentle agitation of the test beaker; they were not considered to be immobile (with the exception of two animals as see above). However, it was considered that effect was due to physical effects and not toxicity. - Results with reference substance (positive control):
- For the evaluation of the quality of the Daphnia clone and the experimental conditions, Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.
The date of the last study (Study Code: 19/238-023DA) with reference item Potassium dichromate (batch no.: A0345704) is: 05 - 06 September 2019.
The 24h EC50: 0.82 mg/L, (95 % confidence limits: 0.66 – 0.93 mg/L) - Reported statistics and error estimates:
- No statistical analysis was performed because of the lack of toxic effects.
The EL50, NOELR, LOELR and EL100 values were determined directly from the raw data. - Validity criteria fulfilled:
- yes
- Conclusions:
- Acute toxicity of SynNova Base Oil was assessed with Acute immobilisation test on Daphnia magna, over an exposure period of 48 hours in a semi-static system.
All validity criteria were met during this study.
Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of SynNova Base Oil were the followings:
Based on the nominal loading rate (WAF):
The 24h and 48h EL50 value: > 100.0 mg/L
The 48h EL100 value: > 100.0 mg/L
The 48h No-Observed Effect Loading Rate (NOELR): 100.0 mg/L
The 48h Lowest Observed Effect Loading Rate (LOELR): > 100.0 mg/L - Executive summary:
Acute toxicity of SynNova Base Oil on Daphnia magna was assessed in an Acute immobilisation test, over an exposure period of 48 hours in a semi-static test system.
Because no toxic response was observed during the preliminary range-finding test, a Limit Test was carried out using only one test concentration at 100 mg/L nominal loading rate (WAF) (a filtered and a non-filtered one in parallel) and one control group in the definitive test.
The WAF solution was prepared with direct addition of the test item. During the preparation periods, droplets in the top layers were observed in the test solution, so the solution in the middle layer was collected and siphoned into another test vessel as exposure solution, certainly, there no obvious droplets were observed in the exposure solution. Any remaining non-dissolved test chemical component in the WAF has the possibility to cause physical effects on the test organism unrelated to inherent chemical toxicity. For this reason, a filtered and a non-filtered test item group was tested in parallel to demonstrate that any effect observed is due to physical effects and not toxicity.
The test concentration was analytically determined at the start and at the end of the renewal periods. The measured concentration was below the Limit of Detection (LOD = 0.094 mg/L) in both the filtered and non-filtered test item groups during the whole experiment. The biological results are based on the nominal loading rate (WAF).
Twenty animals, divided into four groups (glass beaker) of five animals each were used at the test concentration and for the control.
All validity criteria were met during this study.
Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of SynNova Base Oil were the followings:
Based on the nominal loading rate (WAF):
The 24h and 48h EL50 value: > 100.0 mg/L
The 48h EL100 value: > 100.0 mg/L
The 48h No-Observed Effect Loading Rate (NOELR): 100.0 mg/L
The 48h Lowest Observed Effect Loading Rate (LOELR): > 100.0 mg/L
Reference
Results of the Preliminary Range-Finding Test
Nominal concentrations [mg/L nominal loading rate WAF] |
Untreated control |
0.1 |
1.0 |
10.0 |
100.0 |
100.0* |
Number of treated / immobilised animals |
10 / 0 |
10 / 0 |
10 / 4 |
10 / 6 |
10 / 10 |
10 / 0 |
*Remark: filtered solution
Animals got stuck at the surface of the unfiltered test solutions of 1.0, 10.0 and 100.0 mg/L nominal loading rate WAFs.
Number and percentage of immobilised animals
Test group |
Number of treated animals |
Number of immobilised animals |
|||
24 hours |
48 hours |
||||
Number |
Percent |
Number |
Percent |
||
Control |
20 |
0 |
0 |
0 |
0 |
100.0 mg/L nominal loading rate (unfiltered) |
20 |
0 |
0 |
2 |
10 |
100.0 mg/L nominal loading rate (filtered) |
20 |
0 |
0 |
0 |
0 |
DATA OF TEST CONDITIONS
Test conditions during the Test
Parameter |
Exposure Time |
||||
0 h (fresh media) |
24 h (old media) |
24 h (fresh media) |
48 h (old media) |
||
Temperature (°C) |
20.5 |
20.9 |
20.5 |
20.7 |
|
Oxygen concentration (mg/L) |
control |
8.3 |
8.9 |
8.3 |
8.4 |
Test item (unfiltered) |
7.8 |
8.7 |
7.9 |
8.3 |
|
Test item (filtered) |
7.0 |
8.6 |
7.2 |
8.5 |
|
pH |
Control |
7.61 |
7.43 |
7.11 |
7.17 |
Test item (unfiltered) |
7.65 |
7.53 |
7.24 |
7.27 |
|
Test item (filtered) |
7.70 |
7.55 |
7.147 |
7.25 |
DATA OF IMMOBILISATION
Immobilisation of the test animals
Test group |
Number of animals |
Number of immobilised animals |
|
24 h |
48 h |
||
Control |
5 |
0 |
0 |
5 |
0 |
0 |
|
5 |
0 |
0 |
|
5 |
0 |
0 |
|
100.0 mg/L nominal loading rate (unfiltered)* |
5 |
0 |
0 |
5 |
0 |
0 |
|
5 |
0 |
0 |
|
5 |
0 |
2 |
|
100.0 mg/L nominal loading rate (filtered)* |
5 |
0 |
0 |
5 |
0 |
0 |
|
5 |
0 |
0 |
|
5 |
0 |
0 |
*Remark: All of the animals got stuck at the surface of the unfiltered solution, but separated and swam after gentle agitation of the test beaker, they were not considered to be immobile (with the exception of two animals as shown above).
Description of key information
Based on the nominal loading rate (WAF):
The 24h and 48h EL50 value: > 100.0 mg/L
The 48h EL100 value: > 100.0 mg/L
The 48h No-Observed Effect Loading Rate (NOELR): 100.0 mg/L
The 48h Lowest Observed Effect Loading Rate (LOELR): > 100.0 mg/L
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- 100 mg/L
Additional information
Acute toxicity of SynNova Base Oil on Daphnia magna was assessed in an Acute immobilisation test, over an exposure period of 48 hours in a semi-static test system.
The WAF solution was prepared with direct addition of the test item. During the preparation periods, droplets in the top layers were observed in the test solution, so the solution in the middle layer was collected and siphoned into another test vessel as exposure solution, certainly, there no obvious droplets were observed in the exposure solution. Any remaining non-dissolved test chemical component in the WAF has the possibility to cause physical effects on the test organism unrelated to inherent chemical toxicity. For this reason, a filtered and a non-filtered test item group was tested in parallel to demonstrate that any effect observed is due to physical effects and not toxicity.
The test concentration was analytically determined at the start and at the end of the renewal periods. The measured concentration was below the Limit of Detection (LOD = 0.094 mg/L) in both the filtered and non-filtered test item groups during the whole experiment. The biological results are based on the nominal loading rate (WAF).
Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of SynNova Base Oil were the followings:
Based on the nominal loading rate (WAF):
The 24h and 48h EL50 value: > 100.0 mg/L
The 48h EL100 value: > 100.0 mg/L
The 48h No-Observed Effect Loading Rate (NOELR): 100.0 mg/L
The 48h Lowest Observed Effect Loading Rate (LOELR): > 100.0 mg/L
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