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EC number: 807-448-3 | 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:
- 2014-03-18 to 2014-04-24
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- Principles of method if other than guideline:
- Studiy complies with latest guideline in that environmental measurements were only taken from one replicate vessel of the control and test group. This deviates from the original study plan.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark - Analytical monitoring:
- yes
- Details on sampling:
- Range-finding study
Stability - A sample of each loading rate WAF was taken for analysis at 0 and 48 hours. All samples were stored at approximately -20°C prior to analysis. Only concentrations within the range to be used for the definitive test were analysed.
Definitive test
Concentration and stability - Samples taken at 0 and 48 hours.
Water samples taken from control and 100 mg/L loading rate WAF test group at 0 (from bulk test preparation) and 48 hours (replicates R1 - R4 pooled) for quantitative analysis. All samples were stored at approximately -20°C prior to analysis.
Duplicate samples were taken and stored at approximately -20°C for further analysis if necessary. - Details on test solutions:
- Validation of mixing period
Pre-study investigational work was performed to determine if stirring for a prolonged period produced significantly higher levels of dissolved test item in the WAF.
A WAF of nominal loading rate of 100 mg/L was prepared, in duplicate, in deionised reverse osmosis water. One loading rate was stirred for a period of 23 hours and the other for 95 hours. After a 1-hour standing period, the mixtures were removed by siphon and samples taken for TOC.
Range-finder
Nominal amounts of test item (5, 50 and 500 mg) were added separately to the surface of 5 litres of test water to give the 1.0, 10 and 100 mg/L loading rates respectively. After the addition of the test item the water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface. The stirring was stopped aafter 23 hours and the mixtures allowed to stand for 1 hour. Microscopic observations made on the WAF indicated that a significant amount of dispersed test material was present in the water column and hence it was justified to remove the WAF by filtering through a glass wool plug (2-4 cm in length). A wide bore glass tube covered at one end with Nescofilm was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. A glass wool plug was inserted into the opposite end of the tubing and the WAF removed by mid-depth siphoning (the first 75 - 100 mL discarded) to give the 1.0, 10 and 100 mg/L loading rate WAF. Microscopic observations were performed on the WAF after filtering and showed no dispersed test item present.
Definitive test
A limit test at a single loading rate of 100 mg/L was conducted to confirm the range-finder results.
The test concentration was prepared in the same manner as for the range finder. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Source: in-house laboratory cultures
- Age at study initiation (mean and range, SD): 1st instar, < 24 hours
- Method of breeding: Culture conditions ensured that reproduction was by parthenogenesis.
- Feeding during test no
- Food type: mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension
- Frequency: Cultures fed daily prior to the test - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- none
- Hardness:
- 250 mg/L as CaCO3
- Test temperature:
- 21°C
- pH:
- 7.8-8.1
- Dissolved oxygen:
- 8.6-8.9 mg O2/L
- Salinity:
- not applicable
- Nominal and measured concentrations:
- nominal: 0.1, 10 and 100 mg/L loading rate WAFs
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass jars, covered to reduce evaporation
- fill volume: 200 mL
- Aeration: no
- Renewal rate of test solution (frequency): 24 hours
- No. of organisms per vessel: 5 (range-finder 10)
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (ISO medium) used for both the range-finding and definitive tests.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light/8 hours darkness
- Light intensity: 556-794 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility 24 & 48 hours
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.1, 10 or 100 mg/L loading rate WAFs
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- 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
- Remarks on result:
- other: loading rate WAF
- Duration:
- 48 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 100
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: loading rate WAF
- Details on results:
- Rnage-finder
No immobilisation was observed at 1.0, 10 and 100 mg/L loading rate WAF.
Based on this information a single loading rate of four replicates,of 100 mg/L was seleceted for the definitive test. This experimental design conforms to a "Limit Test" to confirm no immobilisation or adverse reactions to exposure are observed.
Chemical analysis of the 100 mg/L loading rate WAF test preparations at 0 and 48 hours showed that measured concentrations of 0.58 and 0.32 mg/L were obtained respectively.
Definitive test
Chemical analysis of the 100 mg/L loading rate at 0 and 48 hours showed measured test concentrations of 0.62 and 0.49 mg/L respectively.
The dissolved test item may have been one or several components of the test item. Given that toxicity cannot be attributed to a single component or mixture of components but to the test item as a whole, the results were based on nominal loading rates only.
Immobilisation data
There was no immobilisation in 20 daphnids exposed to 100 mg/L loading rate WAF for a period of 48 hours.
The No Observed Effect Loading Rate after 24 and 48 hours was 100 mg/L loading rate WAF.
It was considered unneccessary and unrealistic to test at loading rates in excess of 100 mg/L
Test item solubility
Observations on the test media were carried out during the mixing and testing of the WAF.
At the start of the mixing period the 100 mg/L loading rate was observed to be a clear colourless water column with test item globules at the surface. After 23 hours stirring and a 1-hour standing period the 100 mg/L loading rate was observed to remain as at the start of stirring. Microscopic examination of the WAF showed that microparticles of the test item were present in the water column and therefore it was considered justifiable to remove the WAF by filtering. Microscopic examination after filtering showed the undissolved test item had been removed. During the test the 100 mg/L loading rate was observed to be a clear, colourless solution. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Mortality:
- EC50/LC50 (48h) = 0.77 mg/L (95% CI = 0.73 - 0.82 mg/L)
- Other: NOEC (48h) = 0.56 mg/L - Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of the test item to the freshwater invertebrate Daphnia magna was assessed in accordance with OECD Guideline 202 and gave a 48-Hour EL50 value of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.
- Executive summary:
Introduction
A study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to becompatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp. Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.
Methods
Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF)
Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to a WAF of the test item at a single nominal loading rate of 100 mg/L for 48 hours at a temperature of approximately 21 °C under static test conditions. The numbers of immobilized Daphnia and any adverse reactions were recorded after 24 and 48 hours.
Results
Chemical analysis of the 100 mg/L loading rate at 0 and 48 hours showed measured test concentrations of 0.62 and 0.49 mg/L respectively. The dissolved test item may have been one or several components of the test item. Given that toxicity cannot be attributed to a single component or mixture of components but to the test item as a whole, the results were based on nominal loading rates only.
Exposure of Daphnia magna to the test item gave EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.
It was considered unneccessary and unrealistic to test at loading rates in excess of 100 mg/L
Reference
Validation of mixing period
Preliminary investigation work in dicated that there was no significant increase in the amount of dissolved test item when the preparation period was extended for longer than 24 hours.
Description of key information
The acute toxicity of the test material to Daphnia magna was assessed in accordance with OECD Guideline 202. Exposure of Daphnia magna to the test item gave EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
The key study was performed on the reference substance.
Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF)
Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to a WAF of the test item at a single nominal loading rate of 100 mg/L for 48 hours at a temperature of approximately 21 °C under static test conditions. The numbers of immobilized Daphnia and any adverse reactions were recorded after 24 and 48 hours.
Chemical analysis of the 100 mg/L loading rate at 0 and 48 hours showed measured test concentrations of 0.62 and 0.49 mg/L respectively. The dissolved test item may have been one or several components of the test item. Given that toxicity cannot be attributed to a single component or mixture of components but to the test item as a whole, the results were based on nominal loading rates only.
Exposure of Daphnia magna to the test item gave EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.
It was considered unneccessary and unrealistic to test at loading rates in excess of 100 mg/L.
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