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EC number: 215-538-3 | CAS number: 1330-39-8
- 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
Toxicity to aquatic plants other than algae
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic plants other than algae
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 August 2016 to 31 August 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Not required
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 221 (Lemna sp. Growth Inhibition Test)
- Version / remarks:
- March 2006
- Deviations:
- no
- Principles of method if other than guideline:
- Guideline followed
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Identification: FAT 20063/D TE
Physical state/Appearance: Blue solid
Batch: BS-BOP 01-15 (AT-0032199800)
Purity: 47.9%
Expiry Date: 8 March 2020
Storage Conditions: Approximately 4 ºC in the dark - Analytical monitoring:
- yes
- Details on sampling:
- A nominal amount of test item (200 mg) was dissolved in culture medium and the volume adjusted to 2 liters to give the required test concentration of 100 mg/L and mixed to ensure adequate mixing and homegeneity.
The concentration and stability of the test item in the test preparations were verified by chemical analysis on Day 0 and Day 7. - Vehicle:
- yes
- Remarks:
- Culture medium
- Details on test solutions:
- Range Finding Test
A nominal amount of test item (100 mg) was dissolved in culture medium and the volume adjusted to 1 liter to give a 100 mg/L test concentration from which a series of dilutions was made to give further test concentrations of 10 and 1.0 mg/L. The test was conducted in glass conical flasks (500 mL). Two replicate flasks each containing 250 mL were prepared for each control and test concentration. The test item was dissolved directly in culture medium.
A nominal amount of test item (100 mg) was dissolved in culture medium and the volume adjusted to 1 liter to give a 100 mg/L test concentration from which a series of dilutions was made to give further test concentrations of 10 and 1.0 mg/L.
The control test item was culture medium alone. Each of the prepared concentrations was inverted several times to ensure adequate mixing and homogeneity.
Definitive Test
A nominal amount of test item (200 mg) was dissolved in culture medium and the volume adjusted to 2 liters to give the required test concentration of 100 mg/L. The prepared concentration was inverted several times to ensure adequate mixing and homogeneity.
The control test item was culture medium alone. - Test organisms (species):
- Lemna minor
- Details on test organisms:
- A culture of Lemna minor was obtained from Canadian Phycological Culture Centre, University of Waterloo, Ontario, Canada. Cultures were maintained in the laboratory by the periodic replenishment of culture medium . The culture was maintained in the laboratory at a temperature of 24 ± 1 ºC under continuous illumination (intensity approximately 7000 lux) for at least 7 days prior to the start of the test.
- Test type:
- static
- Water media type:
- other: Culture medium in reverse osmosis purified water (Elga Optima 15+ or Elga Purlab Option R-15 BP)
- Limit test:
- yes
- Total exposure duration:
- 7 d
- Remarks on exposure duration:
- Lemna minor was exposed to an aqueous solution of the test item at a nominal concentration of 100 mg/L (six replicate flasks for a period of 7 days, under constant illumination at a temperature of 24 ± 1 ºC.
- Post exposure observation period:
- None
- Hardness:
- Not tested
- Test temperature:
- Temperature was maintained at 24 ± 1 ºC throughout the test.
- pH:
- Control :
Day 0: 7.6
Day 7: 8.4 - 8.6
100 mg/L
Day 0: 6.9 - 7.0
Day 7: 7.9 - 8.3 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured
- Conductivity:
- Not measured
- Nominal and measured concentrations:
- Day 0
Nominal concentration of Control 0: mg/L
Determined concentration of Control:Nominal concentration of test item: 100 mg/L
Determined concentration of test item: 98.3 mg/L
Day 7
Nominal concentration of Control 0: mg/L
Determined concentration of Control:Nominal concentration of test item: 100 mg/L
Determined concentration of test item: 100 mg - Details on test conditions:
- Range Finding Test
The range-finding test was conducted by exposing Lemna minor to a series of nominal test concentrations of 1.0, 10 and 100 mg/L for a period of 7 days.
At the start of the range-finding test the number of fronds present in each test and control culture was recorded along with observations on frond size, appearance, root length and number of colonies present. The flasks were then incubated at 24 ± 1 ºC under continuous illumination (intensity approximately 7000 lux) on a black non-reflective surface for 7 days. On Days 3 and 5 the test solutions were renewed, and observations on the test organisms were recorded on days 0, 3, 5 and 7.
A static testing regime was employed.
Definitive Test
Each control and test flask was inoculated with 3 colonies of Lemna minor (total 9 fronds). The flasks were then incubated at 24 ± 1 ºC under constant illumination (intensity approximately 7000 lux) on a black non-reflective surface for 7 days.
A static testing regime was employed. - Reference substance (positive control):
- yes
- Remarks:
- A positive control (Envigo Study Number MM01PC) used 3,5-dichlorophenol as the reference item at concentrations of 0.625, 1.25, 2.5, 5.0 and 10 mg/L.
- Duration:
- 7 d
- Dose descriptor:
- EC10
- Remarks:
- frond number
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- EC20
- Remarks:
- frond number
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Remarks:
- frond number
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- EC10
- Remarks:
- frond number
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 7 d
- Dose descriptor:
- EC20
- Remarks:
- frond number
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Key result
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Remarks:
- frond number
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 7 d
- Dose descriptor:
- EC10
- Remarks:
- dry weight
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- EC20
- Remarks:
- dry weight
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Remarks:
- dry weight
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Remarks:
- frond number
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Remarks:
- dry weight
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Remarks:
- frond number
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Key result
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Remarks:
- dry weight
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Details on results:
- Range-finding Test
The results showed no significant effect on growth at the test concentrations of 1.0, 10 and 100 mg/L.
Based on this information a single test concentration of six replicates, of 100 mg/L was selected for the definitive test. This experimental design conforms to a “limit test” to confirm that at the maximum test concentration given in the OECD Test Guidelines, no effect on growth was observed.
Chemical analysis of the 100 mg/L test preparations on Days 0 (fresh media) and Days 3 and 7 (old media) (see Annex 3) showed a measured concentration of 99% of nominal was obtained indicating that the test item was stable under test conditions.
Definitive Test
Verification of Test Concentrations
Chemical analysis of the test preparations on Day 0 (fresh media) and Day 7 (old media) (see Annex 3) showed measured test concentrations to range from 98% to 100% of nominal and so the results are based on nominal test concentrations only.
Validation Criteria
The following data show that the doubling time of the control cultures was 1.81 days in line with the OECD Guideline that states the doubling time should be less than 2.5 days:
Mean frond number in control cultures at Day 0 : 9
Mean frond number in control cultures at Day 7 : 88
Growth Data Based on Frond Number
The following results are based on inhibition of average specific growth rate and yield were determined from the frond number data:
Average Specific Growth Rate
ErC10 (frond number) = >100 mg/L
ErC20 (frond number) = >100 mg/L
ErC50 (frond number) = >100 mg/L
Where:
ErCx = the test concentration that reduced average specific growth rate by x%.
Statistical analysis of the average specific growth rate data was carried out for the control and 100 mg/L test concentration using a Student’s t-test incorporating Bartlett's test for homogeneity of variance (Sokal and Rohlf 1981). There were no statistically significant differences between the control and 100 mg/L test concentration (P0.05) and therefore the "No Observed Effect Concentration" (NOEC) in terms of inhibition of average specific growth rates calculated from frond numbers was 100 mg/L.
Yield
EyC10 (frond number) = >100 mg/L
EyC20 (frond number) = >100 mg/L
EyC50 (frond number) = >100 mg/L
Where:
EyCx = the test concentration that reduced yield by x%.
Statistical analysis of the yield data was carried out for the control and 100 mg/L test concentration. There were no statistically significant differences between the control and 100 mg/L test concentration (P ≥ 0.05) and therefore the "No Observed Effect Concentration" (NOEC) in terms of inhibition of yield calculated from frond numbers was 100 mg/L.
Growth Data Based on Dry Weight
The following results based on inhibition of average specific growth rate and yield were determined from the dry weight data:
Average Specific Growth Rate
ErC10 (dry weight) = >100 mg/L
ErC20 (dry weight) = >100 mg/L
ErC50 (dry weight) = >100 mg/L
Where:
ErCx = the test concentration that reduced average specific growth rate by x%.
Statistical analysis of the average specific growth rate data was carried out for the control and 100 mg/L test concentration as in Section 6.2.4. There were no statistically significant differences between the control and 100 mg/L test concentration (P ≥0.05) and therefore the "No Observed Effect Concentration" (NOEC) in terms of inhibition of average specific growth rate calculated from dry weight was 100 mg/L.
Yield
EyC10 (dry weight) = >100 mg/L
EyC20 (dry weight) = >100 mg/L
EyC50 (dry weight) = >100 mg/L
Where:
EyCx = the test concentration that reduced yield by x%.
Statistical analysis of the yield data was carried out for the control and 100 mg/L test concentration. There were no statistically significant differences between the control and 100 mg/L test concentration (P ≥0.05) and therefore the "No Observed Effect Concentration" (NOEC) in terms of inhibition of yield calculated from dry weight was 100 mg/L.
Observations
All test and control cultures were inspected on Days 0, 2, 5 and 7. - Results with reference substance (positive control):
- A positive control (Envigo Study Number MM01PC) used 3,5-dichlorophenol as the reference item at concentrations of 0.625, 1.25, 2.5, 5.0 and 10 mg/L.
Exposure conditions and data evaluation for the positive control were similar to those in the definitive test. The positive control was conducted between 18 May 2016 and 30 May 2016
Exposure of Lemna minor to the reference item gave the following results:
Response variable Measurement variable EC50 (mg/L) 95% Conf limits NOEC (mg/L) LOEC (mg/L)
Average specific growth rate Frond number 3.4 3.1 - 3.8 0.625 1.25
Average specific growth rate dry weight 3.0 2.7 - 3.2 0.625 1.25
Yield Frond number 1.8 1.6 - 2.2 0.625 1.25
Yield Dry weight 1.4 1.2 - 1.7 0.625 1.25
The results from the positive control with 3,5-dichlorophenol were within the normal ranges for this reference item. - Reported statistics and error estimates:
- Average Specific Growth Rate based on frond numbers
Statistical analysis of the average specific growth rate data was carried out for the control and 100 mg/L test concentration using a Student’s t-test incorporating Bartlett's test for homogeneity of variance. There were no statistically significant differences between the control and 100 mg/L test concentration (P ≥0.05) and therefore the NOEC in terms of inhibition of average specific growth rates calculated from frond numbers was 100 mg/L.
Yield based on frond numbers
Statistical analysis of the yield data was carried out for the control and 100 mg/L test concentration. There were no statistically significant differences between the control and 100 mg/L test concentration (P ≥0.05) and therefore the NOEC in terms of inhibition of yield calculated from frond numbers was 100 mg/L.
Average specific growth rate based on dryweight
Statistical analysis of the average specific growth rate data was carried out for the control and 100 mg/L test concentration. There were no statistically significant differences between the control and 100 mg/L test concentration (P ≥0.05) and therefore the NOEC in terms of inhibition of average specific growth rate calculated from dry weight was 100 mg/L.
Yield based on dry weight
Statistical analysis of the yield data was carried out for the control and 100 mg/L test concentration. There were no statistically significant differences between the control and 100 mg/L test concentration (P≥0.05) and therefore the "No Observed Effect NOEC in terms of inhibition of yield calculated from dry weight was 100 mg/L. - Validity criteria fulfilled:
- yes
- Remarks:
- The doubling time of the control cultures was 1.81 days in line with OECD Guideline 221 that states the doubling time should <2.5 days: Mean frond no. in control cultures at Day 0 :9 ; Mean frond no in control cultures at Day 7: 88
- Conclusions:
- The effect of the test item on the growth of Lemna minor has been investigated over a 7-Day period and gave the following results:
Response variable Measurement variable EC50 (mg/L) NOEC (mg/L)
Average specific growth rate Frond number >100 100
Average specific growth rate Dry weight >100 100
Yield Frond number >100 100
Yield Dry weight >100 100 - Executive summary:
Summary
Introduction
A study was performed to assess the effect of the test item on the growth of the freshwater plantLemna minor. The method followed that described in the OECD Guideline No. 221 “Lemnasp.Growth Inhibition Test (March 2006)”.
Methods
Following a preliminary range-finding test,Lemna minorwas exposed to an aqueous solution of the test item at a nominal concentration of 100 mg/L (six replicate flasks for a period of 7 days, under constant illumination at a temperature of 24 ± 1°C.
The number of fronds in each control and treatment group was recorded on days 0, 2, 5 and 7 along with observations on plant development.
Results
Chemical analysis of the test preparations on Day 0 (fresh media) and Day 7 (old media) showed measured test concentrations to range from 98% to 100% of nominal and so the results are based on nominal test concentrations only.
Exposure of Lemna minorto the test item based on nominal concentrations gave the following results:
Response variable
Measurement variable
EC50
(mg/L)
NOEC
(mg/L)
Average specific growth rate Frond number >100 100 Average specific growth rate Dry weight >100 100 Yield Frond number >100 100 Yield Dry weight >100 100
Reference
None
Description of key information
EC50 (avg specific growth rate based on frond number as well as dry weight) was >100 mg/L. Similarly, EC50 (yield based on frond number and dry weight) was also >100 mg/L.
Key value for chemical safety assessment
- EC50 for freshwater plants:
- 100 mg/L
- EC10 or NOEC for freshwater plants:
- 100 mg/L
Additional information
A study was performed to assess the effect of FAT 20063/D on the growth of the freshwater plantLemna minor. The method followed that described in the OECD Guideline No. 221 “Lemnasp.Growth Inhibition Test (March 2006).
Following a preliminary range-finding test,Lemna minorwas exposed to an aqueous solution of the test item at a nominal concentration of 100 mg/L (six replicate flasks for a period of 7 days, under constant illumination at a temperature of 24 ± 1°C. The number of fronds in each control and treatment group was recorded on days 0, 2, 5 and 7 along with observations on plant development.
Chemical analysis of the test preparations on Day 0 (fresh media) and Day 7 (old media) showed measured test concentrations to range from 98% to 100% of nominal and so the results are based on nominal test concentrations only.
Based on the findings of the study, EC50 (avg specific growth rate based on frond number as well as dry weight) was >100 mg/L. Similarly EC50 (yield based on frond number and dry weight) was also >100 mg/L.
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