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EC number: 285-107-2 | CAS number: 85029-82-9
- 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:
- Experimental start date 02 May 2017 Experimental completion date 11 May 2017
- 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 Guidelines for Testing of Chemicals (April 2004) No 202 "Daphnia sp., Acute Immobilisation Test"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- Method C.2 of Commission Regulation (EC) No. 440/2008
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
Physical state/Appearance: Clear amber viscous liquid
Purity: 100% product
Expiry Date: 24 June 2018
Storage Conditions: Room temperature in the dark- Analytical monitoring:
- yes
- Remarks:
- The concentration of total organic carbon in the test preparations was verified by TOC analysis at 0 and 48 hours
- Details on sampling:
- The concentration of total organic carbon in the test preparations was verified by TOC analysis at 0 and 48 hours
- Vehicle:
- no
- Details on test solutions:
- Due to the low aqueous solubility and complex nature of the test item, for the purposes of the study the test medium was prepared as a Water Accommodated Fraction (WAF) of the test item using a 23-Hour stirring period followed by a 1-Hour standing period.
- Test organisms (species):
- other: The test was carried out using first instar Daphnia magna derived from in-house laboratory cultures.
- Details on test organisms:
- Adult daphnids were maintained in 150 mL glass beakers containing Elendt M7 medium (see Annex 2) in a temperature controlled room maintaining the water temperature at 18 to 22 °C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with
20 minute dawn and dusk transition periods. Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension. Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing. The
diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- Not reported
- Test temperature:
- Temperature was maintained at 21 ºC to 22 ºC throughout the test
- pH:
- 7.7 - 7.9 See Table 3 Water Quality Measurements
- Dissolved oxygen:
- 8.2 to 8.7 See Table 3 Water Quality Measurements
- Salinity:
- N/A
- Conductivity:
- N/A
- Nominal and measured concentrations:
- Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to Water Accommodated Fractions (WAFs) of the test item over a range of nominal loading rates of 1.0, 3.2, 10, 32 and 100 mg/L
- Reference substance (positive control):
- yes
- Remarks:
- A positive control (Envigo Study Number XT01HS) used potassium dichromate as the reference item. Details of the positive control are given in Annex 3. The positive control was conducted between 20 October 2016 and 22 October 2016
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Remarks:
- EL50 (mg/L Loading Rate WAF)
- Effect conc.:
- 36 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: WAF
- Basis for effect:
- mobility
- Remarks on result:
- other: The test was considered to be valid
- Remarks:
- 95% Confidence Limits (mg/L Loading Rate WAF) 25 - 53
- Duration:
- 48 h
- Dose descriptor:
- other: NOEL
- Remarks:
- No Observed Effect Loading Rate (NOEL) (mg/L)
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: WAF
- Basis for effect:
- mobility
- Remarks on result:
- other: The test was considered to be valid
- Details on results:
- Total Organic Carbon (TOC) analysis of the test preparations at 0 hours showed measured concentrations to range from 1.02 to 16.91 mg C/L whilst concentrations in the range of less than the limit of quantification (LOQ), determined to be 1.0 mg C/L, to 51.65 mg C/L were obtained at 48 hours.
The dissolved test item may have been one or several components of the test item. Given that the toxicity cannot be attributed to a single component or a 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 the following results:
Time Point (Hours) EL50 95% Confidence Limits No Observed Effect Loading Rate Lowest Observed Effect Loading Rate
(mg/L Loading Rate WAF) (mg/L Loading Rate WAF) (NOEL) (mg/L) (LOEL) (mg/L)
48 36 25 - 53 3.2 10 - Results with reference substance (positive control):
- A positive control (Envigo Study Number XT01HS) used potassium dichromate as the reference item. Details of the positive control are given in Annex 3. The positive control was conducted between 20 October 2016 and 22 October 2016
- Validity criteria fulfilled:
- yes
- Conclusions:
- Exposure of the freshwater invertebrate Daphnia magna to the test item has been investigated and gave the following results:
Time Point (Hours) EL50 95% Confidence Limits No Observed Effect Loading Rate Lowest Observed Effect Loading Rate
(mg/L Loading Rate WAF) (mg/L Loading Rate WAF) (NOEL) (mg/L) (LOEL) (mg/L)
48 36 25 - 53 3.2 10 - Executive summary:
A study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to be compatible 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.
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 Water Accommodated Fractions (WAFs) of the test item over a range of nominal loading rates of 1.0, 3.2, 10, 32 and 100 mg/L for 48 hours at a temperature of 21C to 22 C under static test conditions. The number of immobilized daphnia and any adverse reactions to exposure were recorded after 24 and 48 hours.
Total Organic Carbon (TOC) analysis of the test preparations at 0 hours showed measured concentrations to range from 1.02 to 16.91 mg C/L whilst concentrations in the range of less than the limit of quantification (LOQ), determined to be 1.0 mg C/L, to 51.65 mg C/L were obtained at 48 hours.
The dissolved test item may have been one or several components of the test item. Given that the toxicity cannot be attributed to a single component or a 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 the following results:
Reference
Cumulative immobilization data and other observations from the exposure of Daphnia magna
to the test item during the range-finding test are given in Table 1.
No immobilization was observed at 1.0 mg/L loading rate WAF, however, immobilization was observed at 10 and 100 mg/L loading rate WAF. Daphnids covered in debris were observed in the 100 mg/L loading rate WAF vessels at both 24 and 48 hours.
Based on this information loading rates of 1.0, 3.2, 10, 32 and 100 mg/L were selected for the definitive test.
Total Organic Carbon (TOC) analysis of the test preparations at 0 hours showed measured concentrations to range from less than the limit of quantification, determined to be 1.0
Definitive Test
Total Organic Carbon Analysis
Total Organic Carbon (TOC) analysis of the test preparations at 0 hours showed measured concentrations to range from 1.02 to 16.91 mg C/L whilst concentrations in the range of less than the limit of quantification (LOQ), determined to be 1.0 mg C/L, to 51.65 mg C/L were obtained at 48 hours (see Annex 4).
The dissolved test item may have been one or several components of the test item. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.
Immobilization Data
Cumulative immobilization data and other observations from the exposure of Daphnia magna to the test item during the definitive test are given in Table 2. The relationship between percentage immobilization and concentration at 48 hours is given in the attached Figure 1.
Analysis of the immobilization data by Probit analysis using Linear Maximum-Likelihood regression at 24 and 48 hours based on the nominal loading rates gave the following results:
Time (h) |
EL50 (mg/L Loading Rate WAF) |
95% Confidence limits (mg/L Loading Rate WAF) |
24 |
68 |
50 – 100 |
48 |
36 |
25 - 53 |
The No Observed Effect Loading rates after 24 and 48 hours exposure were 10 and 3.2 mg/L loading rate WAF respectively. Correspondingly the Lowest Effect Loading rates were considered to be 32 and 10 mg/L loading rate WAF.
The slopes and their standard errors of the response curves at 24 and 48 hours were
3.3 (SE = 0.070) and 2.4 (SE = 0.079) respectively.
Sub-Lethal Effects
A sub-lethal effect of exposure was observed in the 32 and 100 mg/L loading rate WAF cultures at 48 hours. This response was being covered in debris (see Table 2).
Microscopic examination of the immobilized daphnids at 24 hours showed there to be no abnormalities at 32 mg/L loading rate WAF, the immobilized daphnids in the 100 mg/L loading rate WAF vessels were observed to have debris and/or test item and a damaged carapace attached. Microscopic examination of the immobilized daphnids at 48 hours showed there to be no abnormalities at 10 mg/L loading rate WAF. The immobilized daphnids in the 32 mg/L loading rate WAF vessels were observed to be coated in debris and/or test item whilst those in the 100 mg/L loading rate WAF vessels were observed to have debris and/or test item and a damaged carapace attached.
Given these observations care should be taken in the interpretation of the results as it was not possible to determine whether the effects seen were due to a toxicological and/or physical effect.
Validation Criteria
The test was considered to be valid given that none of the control daphnids showed immobilization or other signs of disease or stress and that the oxygen concentration at the end of the test was equal to or greater than 3 mg/L in the control and test vessels.
Water Quality Criteria
The results of the water quality measurements are given in Table 3. Temperature was maintained at 21oC to 22oC throughout the test, while there were no treatment related differences for oxygen concentration or pH.
Throughout the test the light intensity was observed to be in the range 527 to 565 lux.
Vortex Depth Measurements
The vortex depth was recorded at the start and end of the mixing period and was observed to be a dimple at the water surface on each occasion.
Observations on Test Item Solubility
Observations on the test media were carried out during the mixing and testing of the WAFs. At both the start and end of the mixing period, and following a 1-Hour standing period, the
1.0 and 3.2 mg/L loading rate WAFs were observed to have formed clear colorless water columns with test item floating at the water surface. At the start and end of the mixing period, and following a 1-Hour standing period the 10, 32 and 100 mg/L loading rate WAFs were observed to have formed hazy non-homogenous dispersions, the opacity of which increased with increased loading rate.
Visual examination of the 10, 32 and 100 mg/L loading rate WAFs showed there to be dispersed test item present and hence it was considered necessary to remove the aqueous phase by filtration. Two glass wool plugs and two pieces of filter paper were used to remove as much dispersed test item as possible. After filtration, no micro-dispersions were observed in either the 1.0 or 3.2 mg/L loading rate WAFs. Visual examination of the 10, 32 and 100 mg/L loading rate WAFs showed dispersed test item remained however, it was considered that further filtration would not have removed any more of the undissolved material.
After filtration and for the duration of the test, the control, 1.0 and 3.2 mg/L loading rates were observed to be clear colorless solutions. The 10 mg/L loading rate was observed to be an extremely slightly hazy dispersion, the 32 mg/L loading rate was a slightly hazy dispersions whilst the 100 mg/L loading rate was a hazy dispersion.
Description of key information
Exposure of the freshwater invertebrate Daphnia magna to the test item has been investigated and gave the following results:
Time Point (Hours) |
EL50 (mg/L Loading Rate WAF) |
95% Confidence Limits (mg/L Loading Rate WAF) |
No Observed Effect Loading Rate (NOEL) (mg/L) |
Lowest Observed Effect Loading Rate (LOEL) (mg/L) |
||
48 |
36 |
25 |
- |
53 |
3.2 |
10 |
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 36 mg/L
Additional information
A study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to be compatible 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.
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 Water Accommodated Fractions (WAFs) of the test item over a range of nominal loading rates of 1.0, 3.2, 10, 32 and 100 mg/L for 48 hours at a temperature of 21C to 22 C under static test conditions. The number of immobilized daphnia and any adverse reactions to exposure were recorded after 24 and 48 hours.
Total Organic Carbon (TOC) analysis of the test preparations at 0 hours showed measured concentrations to range from 1.02 to 16.91 mg C/L whilst concentrations in the range of less than the limit of quantification (LOQ), determined to be 1.0 mg C/L, to 51.65 mg C/L were obtained at 48 hours.
The dissolved test item may have been one or several components of the test item. Given that the toxicity cannot be attributed to a single component or a 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 the following results:
Time Point (Hours) |
EL50 (mg/L Loading Rate WAF) |
95% Confidence Limits (mg/L Loading Rate WAF) |
No Observed Effect Loading Rate (NOEL) (mg/L) |
Lowest Observed Effect Loading Rate (LOEL) (mg/L) |
||
48 |
36 |
25 |
- |
53 |
3.2 |
10 |
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