Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 915-782-7 | 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
- 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:
- 11-02-2013 to 27-04-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
- Reason / purpose for cross-reference:
- read-across: supporting information
- 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: July 2012 ; signature: November 2012
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.10, 0.32, 1.0, 3.2, 10.0 and 100% v/v nominal.
- Sampling method: Water samples were taken from the control and each test group (replicates R1 - R4 pooled) at 0 and 48 hours for quantitative analysis.
- Sample storage conditions before analysis: Analysed on day of receipt. Duplicate samples were taken and stored at approximately -20 °C for further analysis if necessary. Diluted with acetonitrile. - Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphinds
- Strain: Daphnia magna
- Source: in-house laboratory cultures
- Age at study initiation (mean and range, SD): Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old.
- Method of breeding: Parthenogenesis
- Feeding during test: Yes.
- Food type: Algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension
- Amount: Not reported.
- Frequency: Daily
ACCLIMATION
- Acclimation period: None. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- Reconstituted water had an approximate theoretical total hardness of 250 mg/L as CaCO3
- Test temperature:
- 20 °C. Refer to table 1 for information on temperature in the definitive test.
- pH:
- Rconstituted water had a pH of 7.8 ± 0.2 adjusted (if necessary) with NaOH or HCl. Refer to table 1 for information on pH in the definitive test.
- Dissolved oxygen:
- Reconstituted water was aerated until the dissolved oxygen concentration was approximately air-saturation value. Refer to table 1 for information ondesolved oxygen in the definitive test.
- Nominal and measured concentrations:
- Range-finding test : nominal test concentrations of 0.10, 1.0, 10 and 100% v/v saturated solution.
Definitive test: 0.10, 0.32, 1.0, 3.2, 10, 32 and 100% v/v saturated solution - Details on test conditions:
- TEST SYSTEM
- Test vessel: 150 ml
- Type (delete if not applicable): Closed.
- Material, size, headspace, fill volume: Glass 150 ml, completely filled or ca. 130ml to minimise headspace.
- Aeration: No aeration of the test solutions.
- No. of organisms per vessel: RF test: 10 per concentration and control vessel ; Definitive test: 20 per concentration, 5 per vessel
- No. of vessels per concentration (replicates): 4 (four) replicates, 5 daphnia per vessel.
- No. of vessels per control (replicates): 4 (four) replicates, 5 daphnia per vessel.
- No. of vessels per vehicle control (replicates): Not applicable.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted Water was used as dilution water and prepared from deionised water with conductivity <5 uS cm-1 and pH 7.8 ± 0.2 and 25ml of stock solutions of a. CaCl2.2H2O 11.76 g/L, b. MgSO4.1H2O 4.93 g/L, c. NaHCO3 2.59 g/l, and d. KCl 0.23 g/l.
- Culture medium different from test medium: No, M7 Medium used for culture and test medium
OTHER TEST CONDITIONS
- Adjustment of pH: None.
- Photoperiod: 16 hours light; 8 hours dark photoperiod daily; with 20 minute dawn and dusk transition periods
- Light intensity: Not reported.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility (including mortality), 24 hours and at 48 hours.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Justification for using less concentrations than requested by guideline: Not applicable.
- Range finding study
- Test concentrations: 0, 0.1, 1.0, 10 and 100% (v/v) saturated solution
- Results used to determine the conditions for the definitive study: Yes. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 21 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL: 12 to 38 mg/l
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 12 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 38 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: None
- Observations on body length and weight: Not applicable.
- Other biological observations:
- Mortality of control: No mortalities.
- Other adverse effects control: None.
- Abnormal responses: None.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test preparations were observed to be clear colourless solutions at 0 and 24 hours. However, at 48 hours the 100% v/v saturated solution test concentration was observed to be a clear colourless water column with oily globules of test item dispersed throughout. This indicates that the test item precipitated out of solution between 24 and 48 hours in this test concentration and could have been caused by undissolved test item being forced through the filter. This was thought not to have contributed to the immobilization observed at this concentration as immobilization was also observed at 10 and 32% v/v saturated solution where no precipitated test item was observed.
- Effect concentrations exceeding solubility of substance in test medium: No. - Results with reference substance (positive control):
- - Results with reference substance valid?: Yes.
- Mortality: None reported. Acute immobilisation reported only.
- EC50/LC50: 24h-EC50 was 0.75 mg/l with a 95% confidence interval between 0.56 and 1.0 mg/l. 48h-EC50 was 0.45 mg/l with a 95% confidence interval between 0.42 and 0.48 mg/l. The results from the positive control with potassium dichromate were within the normal range for this reference item.
- Other: Exposure conditions for the positive control were similar to those in the definitive test. - Validity criteria fulfilled:
- yes
- Conclusions:
- The test item 48h-EC50 was 21 (95% CL: 12 – 38) mg/L based on 0-hour analytically measured concentrations.
- Executive summary:
The acute toxicity to Daphnia magna was carried out according to OECD 202 Daphnia sp., Acute Immobilisation Test and EU Method C.2 guidelines under GLP. A pre-study media preparation trial indicated that the use of a saturated solution method of preparation was most appropriate for this test item. Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 daphnids) were exposed to an aqueous solution of the test item at nominal concentrations of 0.1 0, 0.32, 1.0, 3.2, 10, 32 and 100% v/v saturated solution for 48 hours at a temperature of approximately 20 °C under static test conditions. The test item solution was prepared by stirring an excess (500 mg/L) of test item in test medium using a propeller stirrer at approximately 1500 rpm for 24 hours. After the stirring period any undissolved test item was removed by filtration (0.2 um Gelman Acrocap filter, first approximate 500 mL discarded in order to pre-condition the filter) to produce a 100% v/v saturated solution of the test item. The number of immobilized Daphnia were recorded after 24 and 48 hours. Analysis of the freshly prepared media at 0 hours for the 0.10, 0.32, 1.0, 3.2, 10, 32 and 100% v/v saturated solution test concentrations showed measured concentrations of between 0.38 and 304 mg/L. Analysis of the old media at 48 hours for the 0.10, 0.32, 1.0, 3.2, 10, 32 and 100% v/v saturated solution test concentration showed measured concentrations of between 0.42 and 284 mg/L. As the measured concentrations at 48 hours were between 93 - 118% of the measured concentrations at 0 hours, it was considered justifiable to base the results on the 0-Hour measured concentrations. The study met the acceptability criteria prescribed by the guideline. The 48h-EC50 was 21 (95% CL: 12 – 38) mg/L based on 0-hour analytically measured concentrations.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 11-02-2013 to 27-04-2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included in attachment to IUCLID section 13.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across is based on the hypothesis that the source and target substances have common structural features in the same relative positions. The source and target have similar physico-chemical, toxicological properties and because of common metabolism they share common or have similar breakdown products and therefore potential mechanisms of action. Further information is included in attachment to IUCLID section 13.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source and target chemicals have comparable chemical similarity. Further information is included in attachment to IUCLID section 13
3. ANALOGUE APPROACH JUSTIFICATION
The source substance is a chemically similar substance with common metabolism and common or similar degradants of the target substance. Further information is included in attachment to IUCLID section 13
4. DATA MATRIX
Further information is included in attachment to IUCLID section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: July 2012 ; signature: November 2012
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.10, 0.32, 1.0, 3.2, 10.0 and 100% v/v nominal.
- Sampling method: Water samples were taken from the control and each test group (replicates R1 - R4 pooled) at 0 and 48 hours for quantitative analysis.
- Sample storage conditions before analysis: Analysed on day of receipt. Duplicate samples were taken and stored at approximately -20 °C for further analysis if necessary. Diluted with acetonitrile. - Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphinds
- Strain: Daphnia magna
- Source: in-house laboratory cultures
- Age at study initiation (mean and range, SD): Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old.
- Method of breeding: Parthenogenesis
- Feeding during test: Yes.
- Food type: Algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension
- Amount: Not reported.
- Frequency: Daily
ACCLIMATION
- Acclimation period: None. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- Reconstituted water had an approximate theoretical total hardness of 250 mg/L as CaCO3
- Test temperature:
- 20 °C. Refer to table 1 for information on temperature in the definitive test.
- pH:
- Rconstituted water had a pH of 7.8 ± 0.2 adjusted (if necessary) with NaOH or HCl. Refer to table 1 for information on pH in the definitive test.
- Dissolved oxygen:
- Reconstituted water was aerated until the dissolved oxygen concentration was approximately air-saturation value. Refer to table 1 for information ondesolved oxygen in the definitive test.
- Nominal and measured concentrations:
- Range-finding test : nominal test concentrations of 0.10, 1.0, 10 and 100% v/v saturated solution.
Definitive test: 0.10, 0.32, 1.0, 3.2, 10, 32 and 100% v/v saturated solution - Details on test conditions:
- TEST SYSTEM
- Test vessel: 150 ml
- Type (delete if not applicable): Closed.
- Material, size, headspace, fill volume: Glass 150 ml, completely filled or ca. 130ml to minimise headspace.
- Aeration: No aeration of the test solutions.
- No. of organisms per vessel: RF test: 10 per concentration and control vessel ; Definitive test: 20 per concentration, 5 per vessel
- No. of vessels per concentration (replicates): 4 (four) replicates, 5 daphnia per vessel.
- No. of vessels per control (replicates): 4 (four) replicates, 5 daphnia per vessel.
- No. of vessels per vehicle control (replicates): Not applicable.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted Water was used as dilution water and prepared from deionised water with conductivity <5 uS cm-1 and pH 7.8 ± 0.2 and 25ml of stock solutions of a. CaCl2.2H2O 11.76 g/L, b. MgSO4.1H2O 4.93 g/L, c. NaHCO3 2.59 g/l, and d. KCl 0.23 g/l.
- Culture medium different from test medium: No, M7 Medium used for culture and test medium
OTHER TEST CONDITIONS
- Adjustment of pH: None.
- Photoperiod: 16 hours light; 8 hours dark photoperiod daily; with 20 minute dawn and dusk transition periods
- Light intensity: Not reported.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility (including mortality), 24 hours and at 48 hours.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Justification for using less concentrations than requested by guideline: Not applicable.
- Range finding study
- Test concentrations: 0, 0.1, 1.0, 10 and 100% (v/v) saturated solution
- Results used to determine the conditions for the definitive study: Yes. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 21 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL: 12 to 38 mg/l
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 12 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 38 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: None
- Observations on body length and weight: Not applicable.
- Other biological observations:
- Mortality of control: No mortalities.
- Other adverse effects control: None.
- Abnormal responses: None.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test preparations were observed to be clear colourless solutions at 0 and 24 hours. However, at 48 hours the 100% v/v saturated solution test concentration was observed to be a clear colourless water column with oily globules of test item dispersed throughout. This indicates that the test item precipitated out of solution between 24 and 48 hours in this test concentration and could have been caused by undissolved test item being forced through the filter. This was thought not to have contributed to the immobilization observed at this concentration as immobilization was also observed at 10 and 32% v/v saturated solution where no precipitated test item was observed.
- Effect concentrations exceeding solubility of substance in test medium: No. - Results with reference substance (positive control):
- - Results with reference substance valid?: Yes.
- Mortality: None reported. Acute immobilisation reported only.
- EC50/LC50: 24h-EC50 was 0.75 mg/l with a 95% confidence interval between 0.56 and 1.0 mg/l. 48h-EC50 was 0.45 mg/l with a 95% confidence interval between 0.42 and 0.48 mg/l. The results from the positive control with potassium dichromate were within the normal range for this reference item.
- Other: Exposure conditions for the positive control were similar to those in the definitive test. - Validity criteria fulfilled:
- yes
- Conclusions:
- The target substance 48h-EC50 is expected to be 21 (95% CL: 12 – 38) mg/L based on 0-hour analytically measured concentrations.
- Executive summary:
The acute toxicity to Daphnia magna was carried out on a source substance according to OECD 202 Daphnia sp., Acute Immobilisation Test and EU Method C.2 guidelines under GLP. A pre-study media preparation trial indicated that the use of a saturated solution method of preparation was most appropriate for this test item. Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 daphnids) were exposed to an aqueous solution of the test item at nominal concentrations of 0.1 0, 0.32, 1.0, 3.2, 10, 32 and 100% v/v saturated solution for 48 hours at a temperature of approximately 20 °C under static test conditions. The test item solution was prepared by stirring an excess (500 mg/L) of test item in test medium using a propeller stirrer at approximately 1500 rpm for 24 hours. After the stirring period any undissolved test item was removed by filtration (0.2 um Gelman Acrocap filter, first approximate 500 mL discarded in order to pre-condition the filter) to produce a 100% v/v saturated solution of the test item. The number of immobilized Daphnia were recorded after 24 and 48 hours. Analysis of the freshly prepared media at 0 hours for the 0.10, 0.32, 1.0, 3.2, 10, 32 and 100% v/v saturated solution test concentrations showed measured concentrations of between 0.38 and 304 mg/L. Analysis of the old media at 48 hours for the 0.10, 0.32, 1.0, 3.2, 10, 32 and 100% v/v saturated solution test concentration showed measured concentrations of between 0.42 and 284 mg/L. As the measured concentrations at 48 hours were between 93 - 118% of the measured concentrations at 0 hours, it was considered justifiable to base the results on the 0-Hour measured concentrations. The study met the acceptability criteria prescribed by the guideline. The 48h-EC50 was 21 (95% CL: 12 – 38) mg/L based on 0-hour analytically measured concentrations.
Referenceopen allclose all
Table 1. Physico-Chemical Measurements
Mean Measured Concentration (mg/L) |
0 Hours |
24 Hours |
48 Hours |
|||||||
pH |
mg O2/L |
%ASV* |
T °C |
T °C |
pH |
mg O2/L |
%ASV* |
T °C |
||
Control |
R1 |
7.7 |
8.8 |
97 |
20 |
20 |
7.7 |
9.1 |
100 |
20 |
R2 |
7.7 |
8.9 |
98 |
20 |
20 |
7.7 |
9.1 |
100 |
20 |
|
R3 |
7.7 |
8.8 |
97 |
20 |
20 |
7.7 |
9.1 |
100 |
20 |
|
R4 |
7.7 |
8.8 |
97 |
20 |
20 |
7.7 |
9.0 |
99 |
20 |
|
0.40 |
R1 |
7.8 |
8.8 |
97 |
20 |
20 |
7.8 |
8.6 |
96 |
20 |
R2 |
7.7 |
8.8 |
97 |
20 |
20 |
7.8 |
8.9 |
98 |
20 |
|
R3 |
7.7 |
8.8 |
97 |
20 |
20 |
7.8 |
9.0 |
99 |
20 |
|
R4 |
7.7 |
8.5 |
93 |
20 |
20 |
7.8 |
9.0 |
99 |
20 |
|
1.2 |
R1 |
7.7 |
8.9 |
98 |
20 |
20 |
7.8 |
8.8 |
97 |
20 |
R2 |
7.7 |
8.8 |
97 |
20 |
20 |
7.9 |
8.9 |
98 |
20 |
|
R3 |
7.6 |
8.9 |
98 |
20 |
20 |
7.9 |
9.0 |
99 |
20 |
|
R4 |
7.6 |
8.8 |
97 |
20 |
20 |
7.9 |
9.0 |
99 |
20 |
|
3.4 |
R1 |
7.6 |
8.8 |
97 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
R2 |
7.6 |
8.8 |
97 |
20 |
20 |
7.9 |
8.8 |
97 |
20 |
|
R3 |
7.6 |
8.8 |
97 |
20 |
20 |
7.9 |
8.8 |
97 |
20 |
|
R4 |
7.6 |
8.8 |
97 |
20 |
20 |
7.9 |
8.9 |
98 |
20 |
|
12 |
R1 |
7.5 |
8.8 |
97 |
20 |
20 |
7.9 |
8.8 |
97 |
20 |
R2 |
7.4 |
8.8 |
97 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
|
R3 |
7.4 |
8.9 |
98 |
20 |
20 |
7.9 |
8.8 |
97 |
20 |
|
R4 |
7.4 |
8.9 |
98 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
|
37 |
R1 |
7.4 |
8.8 |
97 |
20 |
20 |
7.9 |
8.4 |
92 |
20 |
R2 |
7.4 |
8.8 |
97 |
20 |
20 |
7.9 |
8.4 |
92 |
20 |
|
R3 |
7.3 |
8.8 |
97 |
20 |
20 |
7.9 |
8.4 |
92 |
20 |
|
R4 |
7.3 |
8.8 |
97 |
20 |
20 |
7.9 |
8.4 |
92 |
20 |
|
125 |
R1 |
7.3 |
8.8 |
97 |
20 |
20 |
7.9 |
8.6 |
95 |
20 |
R2 |
7.3 |
8.8 |
97 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
|
R3 |
7.3 |
8.8 |
97 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
|
R4 |
7.2 |
8.8 |
97 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
|
294 |
R1 |
7.2 |
8.8 |
97 |
20 |
20 |
7.9 |
8.8 |
97 |
20 |
R2 |
7.2 |
8.8 |
97 |
20 |
20 |
8.0 |
9.0 |
99 |
20 |
|
R3 |
7.2 |
8.8 |
97 |
20 |
20 |
8.0 |
9.0 |
99 |
20 |
|
R4 |
7.2 |
8.7 |
96 |
20 |
20 |
8.0 |
8.8 |
97 |
20 |
*ASV = Dissolved oxygen concentration expressed as a percentage of Air Saturation Value
R1 – R4 = Replicates 1 to 4
Table 2. Cumulative Immobilization Data in the Range-finding Test
Nominal Concentration (% v/v Saturated Solution) |
0-Hour Measured Concentration (mg/L) |
Cumulative Immobilized Daphnia (Initial Population: 10 Per Replicate) |
|
24 Hours |
48 Hours |
||
Control |
- |
0 |
0 |
0.10 |
0.25 |
0 |
0 |
1.0 |
2.3 |
0 |
3 |
10 |
20 |
0 |
5 |
100 |
130 |
10 |
10 |
- = not applicable
Table 3. Cumulative Immobilization Data in the Definitive Test
Nominal Concentration (%v/v Saturated Solution) |
0-Hour Measured Concentration (mg/L) |
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate) |
|||||||||||
24 Hours |
48Hours |
||||||||||||
R1 |
R2 |
R3 |
R4 |
Total |
% |
R1 |
R2 |
R3 |
R4 |
Total |
% |
||
Control |
. |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.10 |
0.38 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.32 |
1.2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.0 |
3.1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3.2 |
12 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
38 |
3 |
3 |
3 |
3 |
12 |
60 |
5 |
5 |
5 |
5 |
20 |
100 |
32 |
133 |
5 |
5 |
5 |
5 |
20 |
100 |
5 |
5 |
5 |
5 |
20 |
100 |
100 |
304 |
5 |
5 |
5 |
5 |
20 |
100 |
5 |
5 |
5 |
5 |
20 |
100 |
R1 – R4 = Replicates 1 to 4
- = not applicable
Table 1. Physico-Chemical Measurements
Mean Measured Concentration (mg/L) |
0 Hours |
24 Hours |
48 Hours |
|||||||
pH |
mg O2/L |
%ASV* |
T °C |
T °C |
pH |
mg O2/L |
%ASV* |
T °C |
||
Control |
R1 |
7.7 |
8.8 |
97 |
20 |
20 |
7.7 |
9.1 |
100 |
20 |
R2 |
7.7 |
8.9 |
98 |
20 |
20 |
7.7 |
9.1 |
100 |
20 |
|
R3 |
7.7 |
8.8 |
97 |
20 |
20 |
7.7 |
9.1 |
100 |
20 |
|
R4 |
7.7 |
8.8 |
97 |
20 |
20 |
7.7 |
9.0 |
99 |
20 |
|
0.40 |
R1 |
7.8 |
8.8 |
97 |
20 |
20 |
7.8 |
8.6 |
96 |
20 |
R2 |
7.7 |
8.8 |
97 |
20 |
20 |
7.8 |
8.9 |
98 |
20 |
|
R3 |
7.7 |
8.8 |
97 |
20 |
20 |
7.8 |
9.0 |
99 |
20 |
|
R4 |
7.7 |
8.5 |
93 |
20 |
20 |
7.8 |
9.0 |
99 |
20 |
|
1.2 |
R1 |
7.7 |
8.9 |
98 |
20 |
20 |
7.8 |
8.8 |
97 |
20 |
R2 |
7.7 |
8.8 |
97 |
20 |
20 |
7.9 |
8.9 |
98 |
20 |
|
R3 |
7.6 |
8.9 |
98 |
20 |
20 |
7.9 |
9.0 |
99 |
20 |
|
R4 |
7.6 |
8.8 |
97 |
20 |
20 |
7.9 |
9.0 |
99 |
20 |
|
3.4 |
R1 |
7.6 |
8.8 |
97 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
R2 |
7.6 |
8.8 |
97 |
20 |
20 |
7.9 |
8.8 |
97 |
20 |
|
R3 |
7.6 |
8.8 |
97 |
20 |
20 |
7.9 |
8.8 |
97 |
20 |
|
R4 |
7.6 |
8.8 |
97 |
20 |
20 |
7.9 |
8.9 |
98 |
20 |
|
12 |
R1 |
7.5 |
8.8 |
97 |
20 |
20 |
7.9 |
8.8 |
97 |
20 |
R2 |
7.4 |
8.8 |
97 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
|
R3 |
7.4 |
8.9 |
98 |
20 |
20 |
7.9 |
8.8 |
97 |
20 |
|
R4 |
7.4 |
8.9 |
98 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
|
37 |
R1 |
7.4 |
8.8 |
97 |
20 |
20 |
7.9 |
8.4 |
92 |
20 |
R2 |
7.4 |
8.8 |
97 |
20 |
20 |
7.9 |
8.4 |
92 |
20 |
|
R3 |
7.3 |
8.8 |
97 |
20 |
20 |
7.9 |
8.4 |
92 |
20 |
|
R4 |
7.3 |
8.8 |
97 |
20 |
20 |
7.9 |
8.4 |
92 |
20 |
|
125 |
R1 |
7.3 |
8.8 |
97 |
20 |
20 |
7.9 |
8.6 |
95 |
20 |
R2 |
7.3 |
8.8 |
97 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
|
R3 |
7.3 |
8.8 |
97 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
|
R4 |
7.2 |
8.8 |
97 |
20 |
20 |
7.9 |
8.7 |
96 |
20 |
|
294 |
R1 |
7.2 |
8.8 |
97 |
20 |
20 |
7.9 |
8.8 |
97 |
20 |
R2 |
7.2 |
8.8 |
97 |
20 |
20 |
8.0 |
9.0 |
99 |
20 |
|
R3 |
7.2 |
8.8 |
97 |
20 |
20 |
8.0 |
9.0 |
99 |
20 |
|
R4 |
7.2 |
8.7 |
96 |
20 |
20 |
8.0 |
8.8 |
97 |
20 |
*ASV = Dissolved oxygen concentration expressed as a percentage of Air Saturation Value
R1 – R4 = Replicates 1 to 4
Table 2. Cumulative Immobilization Data in the Range-finding Test
Nominal Concentration (% v/v Saturated Solution) |
0-Hour Measured Concentration (mg/L) |
Cumulative Immobilized Daphnia (Initial Population: 10 Per Replicate) |
|
24 Hours |
48 Hours |
||
Control |
- |
0 |
0 |
0.10 |
0.25 |
0 |
0 |
1.0 |
2.3 |
0 |
3 |
10 |
20 |
0 |
5 |
100 |
130 |
10 |
10 |
- = not applicable
Table 3. Cumulative Immobilization Data in the Definitive Test
Nominal Concentration (%v/v Saturated Solution) |
0-Hour Measured Concentration (mg/L) |
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate) |
|||||||||||
24 Hours |
48Hours |
||||||||||||
R1 |
R2 |
R3 |
R4 |
Total |
% |
R1 |
R2 |
R3 |
R4 |
Total |
% |
||
Control |
. |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.10 |
0.38 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.32 |
1.2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.0 |
3.1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3.2 |
12 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
38 |
3 |
3 |
3 |
3 |
12 |
60 |
5 |
5 |
5 |
5 |
20 |
100 |
32 |
133 |
5 |
5 |
5 |
5 |
20 |
100 |
5 |
5 |
5 |
5 |
20 |
100 |
100 |
304 |
5 |
5 |
5 |
5 |
20 |
100 |
5 |
5 |
5 |
5 |
20 |
100 |
R1 – R4 = Replicates 1 to 4
- = not applicable
Description of key information
48-h EC50 (Read-Across: 4-methyl-2-phenyltetrahydro-2H-pyran ; aquatic invertebrates) = 21 mg/L (C.I. 12 – 38 mg/L) based on 0-hour measured concentrations, 48-hour, freshwater, OECD TG 202, 2013
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 21 mg/L
Additional information
Key study : OECD TG 202, 2013 : Read-Across - SOURCE (4-methyl-2-phenyltetrahydro-2H-pyran): The acute toxicity to Daphnia magna was carried out according to OECD 202 Daphnia sp., Acute Immobilisation Test and EU Method C.2 guidelines under GLP. A pre-study media preparation trial indicated that the use of a saturated solution method of preparation was most appropriate for this test item. Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 daphnids) were exposed to an aqueous solution of the test item at nominal concentrations of 0.1 0, 0.32, 1.0, 3.2, 10, 32 and 100% v/v saturated solution for 48 hours at a temperature of approximately 20 °C under static test conditions. The test item solution was prepared by stirring an excess (500 mg/L) of test item in test medium using a propeller stirrer at approximately 1500 rpm for 24 hours. After the stirring period any undissolved test item was removed by filtration (0.2 um Gelman Acrocap filter, first approximate 500 mL discarded in order to pre-condition the filter) to produce a 100% v/v saturated solution of the test item. The number of immobilized Daphnia were recorded after 24 and 48 hours. Analysis of the freshly prepared media at 0 hours for the 0.10, 0.32, 1.0, 3.2, 10, 32 and 100% v/v saturated solution test concentrations showed measured concentrations of between 0.38 and 304 mg/L. Analysis of the old media at 48 hours for the 0.10, 0.32, 1.0, 3.2, 10, 32 and 100% v/v saturated solution test concentration showed measured concentrations of between 0.42 and 284 mg/L. As the measured concentrations at 48 hours were between 93 - 118% of the measured concentrations at 0 hours, it was considered justifiable to base the results on the 0-Hour measured concentrations. The study met the acceptability criteria prescribed by the guideline. The 48h-EC50 was 21 (95% CL: 12 – 38) mg/L based on 0-hour analytically measured concentrations.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.