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EC number: 310-132-3 | CAS number: 61902-31-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 53235
- 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:
- 2017-11-10 - 2017-11-17 (start of experiment - end of experiment)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 221 (Lemna sp. Growth Inhibition Test)
- Version / remarks:
- 23rd March, 2006
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 761/2009, Annex VI, C.26: „Lemna sp. Growth Inhibition Test“. Dated 24 August 2009
- Version / remarks:
- August 24, 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, section 3.1.2 Media preparation methods, Direct addition. OECD Series on Testing and Assessment No. 23, Paris September 2000
- Version / remarks:
- September 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Expiry date: April 29, 2020
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: Six replicate samples were analysed from the test solutions at the start and at the end of the renewal periods. Six replicate samples were analysed from the control as well. The samples were concentrated 5-fold before the measurement.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: As the test item is poorly soluble in deionized water as well in the test medium, preparation of test solution was performed using the WAF method (according to OECD Series on Testing and Assessment No. 23). - Test organisms (species):
- Lemna gibba
- Details on test organisms:
- TEST ORGANISM
- Common name: Duckweed
- Strain: G3
- Source (laboratory, culture collection): In-house culture kept under axenic conditions; preculture was prepared at least 7 days before the tests; healthy colonies with 3-4 fronds. Originally, the culture was obtained from Friedrich Schiller Universität, Institut für Allgemeine Botanik und Pflanzenphysiologie, Jena, Germany.
- Preculture: 7 - 10 days (7 days in this study) before testing, sufficient colonies are transferred from the stock culture aseptically into fresh sterile medium and cultured under the conditions of the test prior to beginning the test. - Test type:
- semi-static
- Water media type:
- other: 20X AAP Medium
- Limit test:
- yes
- Total exposure duration:
- 7 d
- Remarks on exposure duration:
- At the start, frond numbers in the test vessels were recorded. The number and appearance of fronds of Lemna g. were determined in each testing vessel during the 168-hour test on the 3rd, 5th and 7th days.The test item on final biomass were also assessed.
- Hardness:
- Not specified
- Test temperature:
- The cultures were maintained at a temperature in the range of 24 +/- 2 ºC (22.2 - 24.5°C in the climate chamber and 22.9 – 23.1 °C in the test vessels.
- pH:
- 7.72 to 8.11
- Nominal and measured concentrations:
- Nominal: 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Incubation chamber used: Yes
- Test vessel: All-glass beakers (total capacity of 400 mL) were used and were covered by glass petri dishes, with total capacity of 400 mL were used. The volume of the test liquid in the vessels was 160 mL. Each test unit was uniquely identified with study code, test item concentration (and control) and replicate.
- Material, size, headspace, fill volume: Glass, total capacity = 400 mL, fill volume = 160 mL, - Type: Closed
- Type of cover: covered by glass petri dishes
- Aeration: No
- Agitation: No
- Renewal rate of test solution: Renewed twice during the test (on days 3 and 5).
- No. of vessels per concentration: 6
- No. of vessels per control: 6
GROWTH MEDIUM
- Standard medium used: Yes (20 X AAP Medium)
OTHER TEST CONDITIONS
- Sterile test conditions: Yes
- Adjustment of pH: No
- Photoperiod: Illuminated continuously
- Light intensity and quality: 6500-10000 lux (with a spectral range of 400-700 nm)
EFFECT PARAMETERS MEASURED
- Determination of frond number: Manual counting
- Determination of biomass: Measured as frond counts
RANGE-FINDING STUDY (non-GLP)
In order to select appropriate test concentrations for use in the definitive test, preliminary range-finding test was conducted to determine the approximate toxicity of the test item. In the preliminary range-finding test a test item stock solution was prepared by adding 0.04 g of test item into 400 mL dilution water (20X AAP medium) to get the nominal concentration of 100 mg test substance /L. The stock solution was handled in ultrasonic bath for 10 minutes then filtrated through a membrane filter (0.22 μm) to separate the possible non-dissolved test material. The test item solution of 10 mg/L was prepared by the 10-fold dilution of the stock solution. Untreated control ran parallel in the test. The pre-test was performed with two replicates per test item treated group (containing 11 fronds in total per test vessel) for a period of 7 days. A concurrent control was run (with three replicates).
The preliminary range-finding test was not performed in compliance with the GLP-Regulations and is excluded from the Statement of Compliance. - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol
- Key result
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.591 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr. (dissolved fraction)
- Basis for effect:
- growth rate
- Key result
- Duration:
- 7 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.591 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr. (dissolved fraction)
- Basis for effect:
- growth rate
- Key result
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.591 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr. (dissolved fraction)
- Basis for effect:
- yield
- Key result
- Duration:
- 7 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.591 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr. (dissolved fraction)
- Basis for effect:
- yield
- Results with reference substance (positive control):
- The date of the last study with reference item 3,5-dichlorophenol was: 08 – 15 September 2017.
Endpoints of this study were: EyfnC50 (7 day, yield based on frond numbers): 3.980 mg/L, ErfnC50 (7 day, growth rate based on frond numbers): 6.053 mg/L, EydwC50 (7 day, yield based on dry weight): 2.906 mg/L, ErdwC50 (7 day, growth rate based on dry weight): 6.206 mg/L. - Reported statistics and error estimates:
- For the determination of the LOEC and NOEC, the calculated mean growth rate and yield at the calculated test concentration were tested on significant differences to the control value using Independent Sample T-test by SPSS PC+ software program. The data were checked for homogeneity of variance by Levene’s test.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a Growth Inhibition Test with Lemna gibba according to OECD 221 and Commission Regulation (EC) No 761/2009, Annex VI, C.26 the 7-d LOEC of the test item for growth rate and biomass were determined to be > 0.591 mg/L (geom. mean measured). The 7-d NOEC of the test item both for growth rate and biomass was determined to be 0.591 mg/L (geom.mean measured).
- Executive summary:
The toxicity of the test item to Lemna gibba was assessed in a semi-static study according to OECD Guideline 221, Commission Regulation (EC) No 761/2009, Annex VI, C.26 and GLP principles. As the test item is poorly soluble in deionized water as well in the test medium, preparation of test solutions was performed using the WAF method (in accordance with OECD Series on Testing and Assessment No. 23). Based on the results of the preliminary experiment, the nominal concentration of 100 mg/L was investigated in the main study (limit test). The measured concentrations deviated more than 20 % from the nominal at the start and at the end of the renewal periods, therefore the geometric mean of the measured concentrations were calculated to determine exposure concentration. The corresponding calculated concentration was 0.591 mg/L (based on total product). The test included six replicates and the control group with six replicates.400 mL Petri dishes-covered glass beakers were filled with 160 mL testing solutions and two Lemna gibba colonies with four, and one colony with three fronds were added to each vessel. Growth and morphological changes were assessed on days 3, 5 and 7. For determination of the test item concentrations, samples were taken from the test solution and control at the start and at the end of each renewal period. Test item concentration was determined using UV/VIS spectrophotometric method. For determination of the NOEC and LOEC values Independent Sample T-test was used (2-tailed, α = 0.05). All validity criteria were met and therefore the study can be considered as valid. The test item had no toxic effect at aquatic saturation (i.e. limit test concentration) on Lemna gibba; the overall LOEC is higher than the nominal concentration of 100 mg/L (solubility level) of the test item in the test medium, which corresponds to the mean measured concentration of 0.591 mg/L, based on water accommodated fraction of the total product.
Reference
Summary of the Biological Endpoints
Endpoints for response variables |
Concentration(mg/L) |
|
Growth Rate |
NOEC |
0.591 |
LOEC |
> 0.591 |
|
Yield |
NOEC |
0.591 |
LOEC |
> 0.591 |
Calculation of Exposure Concentration
Nominal |
Measuredconcentration(mg/L) |
Mean measuredconcentration |
|||||
1strenewal period |
2ndrenewal period |
3rdrenewal period |
|||||
Start |
End |
Start |
End |
Start |
End |
||
Control |
- |
- |
- |
- |
- |
- |
- |
100 (WAF*) |
0.65 |
0.50 |
0.73 |
0.51 |
0.72 |
0.49 |
0.591 |
- not detected
* water accommodated fraction (OECD No. 23.)
Growth rates (µ) and Percentage Inhibition ofµbased on Frond Number
Concentration |
Growth rate (µ) and % inhibition ofµ |
||
Nominal |
Measured |
0–168 h(based on frond number) |
|
µ |
% Iµ |
||
Control |
- |
0.3534 |
- |
100 (WAF) |
0.591 |
0.3535 |
-0.02* |
*: negative value indicates increase in comparison to the control.
Growth rates (µ) and Percentage Inhibition ofµbased on Dry Weight
Concentration |
Growth rate (µ) and % inhibition ofµ |
||
Nominal |
Measured |
0–168 h(based on dry weight) |
|
µ |
% Iµ |
||
Control |
- |
0.39742 |
- |
100 (WAF) |
0.591 |
0.38439 |
3.28 |
Yield (y) and Percentage Inhibition of Yield based on Frond Number
Concentration |
Yield (y) and % inhibition of yield |
||
Nominal |
Measured |
0–168 h(based on frond number) |
|
y |
% Iy |
||
Control |
- |
119.83 |
- |
100 (WAF) |
0.591 |
119.83 |
0.00 |
Yield (y) and Percentage Inhibition of Yield based on Dry Weight
Concentration |
Yield (y) and % inhibition of yield |
||
Nominal |
Mean measured |
0–168 h(based on dry weight) |
|
y |
% Iy |
||
Control |
- |
0.00838 |
- |
100 (WAF) |
0.591 |
0.00761 |
9.24 |
Symptoms, Changes of Lemna gibba Plants Observed during the Test
Concentration |
3rdday of |
5thday of |
7thday of |
||||
Nominal |
Mean measured |
Symptoms |
Degree of change |
Symptoms |
Degree of change |
Symptoms |
Degree of change |
Control |
- |
– |
– |
– |
– |
– |
– |
100 |
0.591 |
– |
– |
– |
– |
– |
– |
"–":the plants were healthy, there was not any symptom observed
Description of key information
The test item had no toxic effect at aquatic saturation (i.e. limit test concentration) on Lemna gibba; the overall LOEC is higher than the nominal concentration of 100 mg/L of the test item in the test medium, which corresponds to the mean measured concentration of 0.591 mg/L, based on water accommodated fraction of the total product.
Key value for chemical safety assessment
- EC10 or NOEC for freshwater plants:
- 0.591 mg/L
Additional information
The toxicity of the test item toLemna gibbawas assessed in a semi-static study according to OECD Guideline 221, Commission Regulation (EC) No 761/2009, Annex VI, C.26 and GLP principles. As the test item is poorly soluble in deionized water as well in the test medium, preparation of test solutions was performed using the WAF method (in accordance with OECD Series on Testing and Assessment No. 23). Based on the results of the preliminary experiment, the nominal concentration of 100 mg/L was investigated in the main study (limit test). The measured concentrations deviated more than 20 % from the nominal at the start and at the end of the renewal periods, therefore the geometric mean of the measured concentrations were calculated to determine exposure concentration. The corresponding calculated concentration was 0.591 mg/L (based on total product). The test included six replicates and the control group with six replicates. 400 mL Petri dishes-covered glass beakers were filled with 160 mL testing solutions and twoLemna gibbacolonies with four, and one colony with three fronds were added to each vessel. Growth and morphological changes were assessed on days 3, 5 and 7. For determination of the test item concentrations, samples were taken from the test solution and control at the start and at the end of each renewal period. Test item concentration was determined using UV/VIS spectrophotometric method. For determination of the NOEC and LOEC values Independent Sample T-test was used (2-tailed, α = 0.05). All validity criteria were met and therefore the study can be considered as valid. The test item had no toxic effect at aquatic saturation (i.e. limit test concentration) onLemna gibba; the overall LOEC is higher than the nominal concentration of 100 mg/L (solubility level) of the test item in the test medium, which corresponds to the mean measured concentration of 0.591 mg/L, based on water accommodated fraction of the total product.
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