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EC number: 947-390-7 | 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
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- 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
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- 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:
- from November 28th 2017 to March 8th 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This study was performed according to OECD guideline 202 with GLP compliance
- 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:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspection on 4, 5, and 6th of July, 2016, certificate signed on 10th of January 2017.
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Dry area, protected from light, in a refrigerator (temp 2-8°C), store under Nitrogen in a closed container after first opening. - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: loading rates (spaced by a factor of 2.00): 6.25, 12.50, 25.00, 50.00, 100.00 and 200.00 mg.L-1.
- Sampling method: Single samples for analysis were taken from the control and all test solutions at the start (t=0h), at t=24h (new and old solutions) and at the end of the test (t=48h). - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
The study was carried out using WAFs (Water Accommodated Fractions). The WAFs (for fresh media at t=0h and t=24h) were prepared under closed conditions and by slow-stirring.
The mixing vessels were cylindrical glass bottles sealed with screw caps and fitted with a drain port near the bottom for drawing off the WAFs. The volume of each mixing vessel was approximately 1 L. A magnetic stirring bar was placed in each mixing vessel completely filled with test water (with a minimum of headspace). The loading rates of the test item were weighed in glass flasks (approximate volume: 100 mL) filled with minimum headspace with test water (from the mixing vessel) and were immediately sealed with screw caps after weighing. Each glass flask was placed in a water bath for 10-15 minutes at approx. 50°C, followed by sonication for approx. 10 minutes. Based on experience on similar substances, the heating/sonication step is a method allowing to remove the paste fragments stuck to the glass of the flasks and to extract the soluble fraction of the test item as much as possible. Then the mixing vessels were carefully filled with the contents of the glass flasks and thereafter were closed immediately. The mixing was initiated with the vortex in the centre extending maximally around 10% vessel depth from the top to the bottom of the vessel. After 24 +/- 2 hours of gentle stirring in the dark at room temperature, the WAFs were allowed to stand for at least 1 hour before use. The first 100 mL were removed via the drain port. Then the WAFs were filtered and added into test vessels that were immediately sealed with screw caps after introduction of daphnids. No small bubble was observed in the test vessels. The test solution in test vessels was observed to be clear and colourless. The test was carried out without adjustment of the pH. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: daphnids
- Strain/clone: Daphnia magna (Straus), clone 5
- Source: LIEBE - CNRS UMR 7146 - UFR SciFA - Université de Lorraine Campus Bridoux - Bât. IBISE, 8, rue du Général Delestraint - 57070 METZ, bred in the Laboratoires des Pyrénées et des Landes.
- Age at test start : < 24 hours old
- Feeding during test : No feeding
- Test type:
- semi-static
- Water media type:
- other: Reconstituted water (Elendt M4 medium), as prescribed by OECD Guideline 202
- Limit test:
- no
- Total exposure duration:
- 48 d
- Hardness:
- Approximately 250 mg.L-1 (as CaCO3)
- Test temperature:
- The temperature of the test medium was situated between 20.8 and 20.9°C throughout the test.
- pH:
- between 7.36 and 8.75
- Dissolved oxygen:
- Between 7.13 mg/L and 8.67 mg/L.
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- Nominal loading rates : 6.25, 12.50, 25.00, 50.00, 100.00 and 200.00 mg/L.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: cylindrical glass bottles sealed with screw caps
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 1 L
- Aeration: No aeration of the test solutions occurred throughout the test
- Renewal rate of test solution (frequency/flow rate): A semi-static test was performed with renewal of test solutions after 24 hours (because of the properties of some constituents of the test item).
- No. of organisms per vessel: 5 daphnids per vessel each completely filled with test solution and without headspace
- No. of vessels per concentration/control (replicates): 4 replicates with daphnids per treatment group
OTHER TEST CONDITIONS
- Adjustment of pH: The test was carried out without adjustment of the pH.
- Photoperiod: 16h light / 8h dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility of daphnids
RANGE-FINDING STUDY
- Test concentrations: nominal loading rates of 1, 10, 32 and 100 mg.L-1
- Results used to determine the conditions for the definitive study: Immobility observed after 48 hours : 30 % for daphnids treated at 10 mg/L ; 40 % for daphnids treated at 32 mg/L and 50 % for daphnids treated at 100 mg/L. - Reference substance (positive control):
- yes
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- 25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL: 20.008 – 31.237 mg/L
- Details on results:
- See tables in "Any other information on results incl. tables".
The measured water quality parameters (i.e. pH-value, dissolved oxygen, total water hardness and water temperature) were within the acceptable limits during the study.
Single samples for analysis were taken from the control and all test solutions at the start (t=0h), at t=24h (new and old solutions) and at the end of the test (t=48h). Concentration of dissolved organic material was checked by analysis of total organic carbon (TOC) in the control medium and the WAFs. TOC analysis was not performed in compliance with the OECD GLP principles but was adapted to fit the specific parameters of the test item, in accordance with ISO 17025.
The results of analysis of the samples taken during the final test are described in the Table 6.1.3/ 4. Concentration of dissolved organic material in the control and the WAFs was checked by TOC analysis at start (t=0h), at t=24h (new and old solutions) and at the end of the test (t=48h).
Due to the complex nature of the substance, it was difficult to well solubilise the substance in the water medium (heating, sonication, mixing without headspace …). Even if the TOC analyses indicated that few organic compounds were found throughout the test in the WAFs, analytical results showed that WAFs concentrations were overall stable between the start and the end of each exposure period (t=0h-t24hold and t=24hfresh-t=48h), within the ± 20% of the initial TOC concentrations values.
Therefore, according to the results of the TOC analysis, due to the complex nature of the WAF and since the test item was a UVCB substance, the results were based on the nominal test loading rates and as Effective Loading Rate 50, according to the OECD No. 23 - Results with reference substance (positive control):
- On August 17, 2017 (most recent test), the 24h-EC50 was 0.92 mg.L-1. Hence, the sensitivity of the clone of Daphnia magna was in agreement with OECD 202 (expected 24h-EC50: 0.6 mg.L-1 to 2.1 mg.L-1) at this time.
- Validity criteria fulfilled:
- yes
- Remarks:
- The validity criteria have been fulfilled in the present study.
- Conclusions:
- The analytical results of this test showed that WAFs concentrations were overall stable between the start and the end of each exposure period (t=0h-t24h(old) and t=24h(fresh)-t=48h), within the ± 20% of the initial TOC concentrations values.
After 48 hours of exposure, immobilisation rates were 0% at 6.25 mg.L-1, 5% at 12.50 mg.L-1, 75% at 50.00 mg.L-1 and 90% at 25.00, 100.00 and 200.00 mg.L-1.
Under the experimental conditions and based on nominal loading rates, the 48-hour EL50 value estimated was 25.00 mg.L-1. - Executive summary:
A study was performed to assess the acute toxicity of the test item to Daphnia magna. The OECD guideline No. 202, referenced as Method C.2, was followed. The study was perfomed in closed and semi-static conditions, for 48 hours.
Following a preliminary range-finding test, daphnids were exposed to Water Accommodated Fractions (WAFs) of the test item over a range of nominal loading values of 6.25, 12.50, 25.00, 50.00, 100.00 and 200.00 mg.L-1 and to a control. The immobility of the daphnids was determined by visual observation after 24 and 48 hours. Concentration of dissolved organic material in the control and the WAFs was checked by analysis of Total Organic Carbon (TOC) at start (t=0h), at t=24h (new and old solutions) and at the end of the test (t=48h).
The analytical results of this test showed that WAFs concentrations were overall stable between the start and the end of each exposure period (t=0h-t24hold and t=24hfresh-t=48h), within the ± 20% of the initial TOC concentrations values. After 48 hours of exposure, immobilisation rates were 0% at 6.25 mg.L-1, 5% at 12.50mg.L-1, 75% at 50.00mg.L-1 and 90% at 25.00, 100.00 and 200.00 mg.L-1.
The EL50 at each of the observation times was as follows:
Time (h)
EL50(mg test item.L-1)
95% confidence limits (mg test item.L-1)
24
82.623
58.491 – 130.823
48
25.000
20.008 – 31.237
Statistical analyses were performed by the computer program ToxRat. Since the probit model was not appropriate at t=48h, the trimmed Spearman-Karber method was used for estimation of the EL50including the 95% confidence interval.
Under the experimental conditions and based on nominal loading rates, the 48 -hour EL50value estimated was 25.00 mg.L-1.
Reference
Table 6.1.3/ 1 : Acute immobilisation of daphnids after 24 and 48 hours in the range-finding test (semi-static test).
Nominal concentration* (mg test item.L-1) |
Replicate |
Number of daphnids exposed |
Response at 24h |
Response at 48h |
|||
Number |
Total % |
Number |
Total % |
||||
Control |
1 2 |
5 5 |
0 0 |
0 |
0 0 |
0 |
|
1 |
1 2 |
5 5 |
0 0 |
0 |
0 0 |
0 |
|
10 |
1 2 |
5 5 |
0 0 |
0 |
1 2 |
30 |
|
32 |
1 2 |
5 5 |
1 0 |
10 |
4 0 |
40 |
|
100 |
1 2 |
5 5 |
2 1 |
30 |
3 2 |
50 |
* WAF prepared at the given loading rate.
Table 6.1.3/ 2 : Concentrations of the test item in test water - TOC analysis results (range-finding test)
|
TOC (mg.L-1) |
|||
Nominal concentration* (mg test item.L-1) |
Start (t=0h) |
t=24h Old |
t=24h Fresh |
End (t=48h) |
Control |
1.73 |
1.83 |
1.66 |
1.86 |
1 |
2.20 |
1.93 |
1.19 |
1.89 |
10 |
3.06 |
2.50 |
3.24 |
2.90 |
32 |
6.65 |
4.90 |
4.66 |
3.64 |
100 |
10.80 |
8.44 |
10.30 |
8.54 |
* WAF prepared at the given loading rate.
Table 6.1.3/ 3 : Acute immobilisation of daphnids after 24 and 48 hours in the final test.
Nominal concentration*(mg test item.L-1) |
Replicate |
Number of daphnids exposed |
Response at 24h |
Response at 48h |
||
Number |
Total % |
Number |
Total % |
|||
Control |
1 2 3 4 |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 0 0 |
0 |
6.25 |
1 2 3 4 |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 0 0 |
0 |
12.50 |
1 2 3 4 |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 1 0 |
5 |
25.00 |
1 2 3 4 |
5 5 5 5 |
2 1 1 2 |
30 |
4 5 5 4 |
90 |
50.00 |
1 2 3 4 |
5 5 5 5 |
3 1 1 2 |
35 |
4 3 3 5 |
75 |
100.00 |
1 2 3 4 |
5 5 5 5 |
3 4 3 3 |
65 |
5 4 5 4 |
90 |
200.00 |
1 2 3 4 |
5 5 5 5 |
4 4 1 4 |
65 |
5 5 3 3 |
90 |
* WAF prepared at the given loading rate.
Table 6.1.3/ 4 : Concentrations of the test item in test water - Results of the determination of TOC analysis (mg.L-1) - Final test.
Nominal concentration* (mg test item.L-1) |
Start (t=0h) |
t=24h Old |
Relative loss to initial value (t=0h - t=24hold)(%) |
t=24h Fresh |
End (t=48h) |
Relative loss to initial value (t=24hfresh- t=48h)(%) |
Control |
1.32 |
1.07 |
19 |
1.19 |
1.10 |
8 |
6.25 |
2.69 |
2.80 |
-4 |
2.40 |
2.12 |
12 |
12.50 |
3.32 |
3.49 |
-5 |
2.39 |
2.37 |
1 |
25.00 |
5.18 |
5.43 |
-5 |
4.80 |
4.33 |
10 |
50.00 |
7.44 |
8.65 |
-16 |
6.85 |
5.73 |
16 |
100.00 |
12.50 |
12.50 |
0 |
10.00 |
10.20 |
2 |
200.00 |
17.60 |
17.40 |
1 |
9.01 |
9.95 |
-10 |
* WAF prepared at the given loading rate.
Description of key information
OECD Guideline 202, GLP, key study, validity 1:
48h-EL50 (Daphnia magna) = 25.00 mg/L (95% CL: 20.008 – 31.237 mg/L), based on nominal loading rates
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 25 mg/L
Additional information
A study was performed to assess the acute toxicity of the test item to Daphnia magna. The OECD guideline No. 202, referenced as Method C.2, was followed. The study was perfomed in closed and semi-static conditions, for 48 hours.
Following a preliminary range-finding test, daphnids were exposed toWater Accommodated Fractions (WAFs) of the test item over a range of nominal loading values of 6.25, 12.50, 25.00, 50.00, 100.00 and 200.00mg.L-1and to a control.The immobility of the daphnids was determined by visual observation after 24 and 48 hours. Concentration of dissolved organic material in the control and the WAFs was checked by analysis of Total Organic Carbon (TOC) at start (t=0h), at t=24h (new and old solutions) and at the end of the test (t=48h).
The analytical results of this test showed that WAFs concentrations were overall stable between the start and the end of each exposure period (t=0h-t24holdand t=24hfresh-t=48h), within the ± 20% of the initial TOC concentrations values.After 48 hours of exposure, immobilisation rates were 0% at 6.25mg.L-1, 5% at 12.50mg.L-1, 75% at 50.00mg.L-1and 90% at 25.00, 100.00 and 200.00mg.L-1.
The EL50at each of the observation times were 82.623 mg/L (95% CL : 58.491 – 130.823) at 24 h, and 25.00 mg/L (95% CL : 20.008 – 31.237) at 48 h. Statistical analyses were performed by the computer program ToxRat.
Since the probit model was not appropriate at t=48h, the trimmed Spearman-Karber method was used for estimation of the EL50including the 95% confidence interval.
Under the experimental conditions and based on nominal loading rates,the 48 -hour EL50value estimated was 25.00 mg.L-1 based on nominal loading rates.
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