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EC number: 275-148-4 | CAS number: 71033-19-7
- 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
- Endpoint:
- toxicity to aquatic plants other than algae
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From the 2nd of July to the 3rd of August, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Test conducted according to an internationally accepted test guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 221 (Lemna sp. Growth Inhibition Test)
- Deviations:
- yes
- Remarks:
- Temperature 23.2- 26.4°C during the whole test period; Light intensity 6620-8430 lux(variation ±16%) at the start of the test and 6530-8520 lux (max. variation ±17%) at the end of the exposure period
- Qualifier:
- according to guideline
- Guideline:
- other: EU C.26 Commission Regulation (EU) 2016/266 of 7 December 2015
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Disodium 3,3'-[sulphonylbis[p-phenyleneazo(5-imino-3-methyl-1H-pyrazole-4,1-diyl)]]bis(benzenesulphonate)
- EC Number:
- 275-148-4
- EC Name:
- Disodium 3,3'-[sulphonylbis[p-phenyleneazo(5-imino-3-methyl-1H-pyrazole-4,1-diyl)]]bis(benzenesulphonate)
- Cas Number:
- 71033-19-7
- Molecular formula:
- C32H26N10Na2O8S3
- IUPAC Name:
- disodium 3,3'-[sulphonylbis[p-phenyleneazo(5-imino-3-methyl-1H-pyrazole-4,1-diyl)]]bis(benzenesulphonate)
- Test material form:
- solid: particulate/powder
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- At the beginning of the test, as well as after 3, 5 and 7 days
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- STEINBERG Medium
Test organisms
- Test organisms (species):
- Lemna minor
- Details on test organisms:
- TEST ORGANISMS
Exponential growing plant monoculture of Lemna minor (Umweltbundesamt, FGIII 2.5, Überwachungsverfahren Abwasserentsorgung, Schichauweg 58, D-12307 Berlin)
TEST SYSTEM
Culture: All-glass vessel containing sterile Swedish standard-Medium (SIS Medium) and the exponential growing plant monoculture, comprising 2-5 fronds.
Cultivation: At least seven days before testing, sufficient colonies are transferred aseptically into fresh sterile medium and cultured for 7 - 10 days under the conditions of the test
Illumination: Continuous (6500–10000 lux)
Temperature: 24 ± 2 °C
Study design
- Test type:
- static
- Water media type:
- freshwater
- Remarks:
- STEINBERG Medium
- Limit test:
- no
- Total exposure duration:
- 7 d
Test conditions
- Test temperature:
- 23.2 and 26.4°C during the whole test period; which is not within the required 24±2 °C. S
ince the growth criterion in the control was fulfilled, this minimal deviation of +0.4°C does not have a significant impact on the outcome of the study. - pH:
- 7.0 - 8.2
Determined in the combined replicate test solutions at the beginning and at the end of the test.
The pH value in the control drifted by 0.7 units during the whole test period, which is therefore in the range as required by the guideline (required: not more than 1.5). - Nominal and measured concentrations:
- 130, 50.0, 19.2, 7.40 and 2.84 mg/L nominal concentration of the test item (corresponding to 100, 38.5, 14.8, 5.69 and 2.19 mg/L active ingredient). At all concentrations, the test item was fully dissolved, no suspended matter or supernatant was visible
- Details on test conditions:
- Test vessels
400 ml beakers, all-glass, with 200 mL of test medium. The beakers are covered with black paper up until the 200 ml mark to ensure that illumination comes only from above and not from the sides.
Pre-culture: Exponentially growing plant monoculture of Lemna minor (the culture was visibly free from contamination by other organisms such as algae and protozoa).
Illumination: Intensity: continuous (6500–10000 lux), Homogeneity: ±15%.
The light intensity was 6620-8430 lux (mean 7270 lux; max. variation ±16%) at the start of the test and 6530-8520 lux (mean 7258 lux, max. variation ±17%) at the end of the exposure period. The light homogeneity was not in the 15% range, but since the test vessels were randomly re-placed and since the growth criterion in the control was fulfilled, this deviation is not expected to have a significant impact on the outcome of the study. - Reference substance (positive control):
- yes
- Remarks:
- Yearly, with 3,5-dichlorophenol. According to guideline ISO/CD 20079, the ErC50 value based on the frond number should lie in the range 1.8–3.6 mg/l; this level of sensitivity was attained (data from 29 July 2016)
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 91 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- frond number
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 91 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- frond number
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 91 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Remarks:
- dry weight
- Basis for effect:
- other:
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- 12.5 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Remarks:
- dry weight
- Basis for effect:
- other:
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.27 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: Frond Number: growth rate and yield Dry Weight: growth rate and yield
- Details on results:
- PRELIMINARY NON-GLP TEST
% inhibition yield of Frond Number: 19% at 100 mg/L nominal concentration (99.9 mg/L measured at the beginning, 97.7% mg/L measured at the end of the test)
% inhibition growth rate of Frond Number: 9% at 100 mg/L nominal concentration (99.9 mg/L measured at the beginning, 97.7% mg/L measured at the end of the test)
The HPLC measurements indicated that the test item concentrations decrease and do not remain in the recommended 80-120% range of the nominal concentration. Nonetheless, the definitive test was performed under static conditions in accordance with the sponsor.
DEFINITIVE TEST
The test concentrations of during the 7 day test period were determined by HPLC analysis at the beginning of the test, as well as after 3, 5 and 7 days of exposure. These analyses confirmed the right dosage of the test item, and showed that the concentrations of the test item decreased over the whole 7 day test period. The measured concentrations of the active ingredient at the beginning of the test were 95.6, 36.6, 13.6, 5.05 and 1.94 mg/L and 87.1, 31.4, 8.30, 3.82 and 1.18 mg/L (91, 86, 61, 76 and 61%, respectively, of the initial value) after 7 days. Therefore, the effective concentrations (ErC50 and EyC50) were assessed based on the geometric mean (GM) of the measured concentrations, which were 1.48, 4.27, 10.9, 33.1 and 91.0 mg/L.
FROND NUMBER:
Growth rate inhibition:
the following effects as compared to the untreated controls were observed: 10% at 100 mg/L, 4% at 38.5 mg/L and 4% at 14.8 mg/L. No significant effects were observed at the nominal concentrations of 5.69 and 2.19 mg/L, as determined by Dunnett’s test.
Yield:
the following effects as compared to the untreated controls were observed: 23% at 100 mg/L, 10% at 38.5 mg/L and 10% at 14.8 mg/L. No significant effects were observed at the nominal concentrations of 5.69 and 2.19 mg/L, as determined by Dunnett’s test. Based on these data the median effect concentrations to Lemna minor with respect to growth rate (ErC50) and to yield (EyC50) for the endpoint frond number were both estimated to be >91.0 mg/L measured concentration of active ingredient.
The no-observed-effect concentrations to Lemna minor with respect to growth rate (NOErC) and yield (NOEyC) for the endpoint frond number were both 4.27 mg/l measured concentration of active ingredient, as determined by Dunnett’s test.
DRY WEIGHT
Growth rate inhibition:
the following effects as compared to the untreated controls were observed: 33% at 100 mg/L, 27% at 38.5 mg/L, 23% at 14.8 mg/L, 16% at 5.69 mg/L and 12% at 2.19 mg/L. With respect to yield inhibition, the following effects as compared to the untreated controls were observed: 66% at 100 mg/L, 58% at 38.5 mg/L, 51% at 14.8 mg/L, 39% at 5.69 mg/L and 32% at 2.19 mg/L.
Yield:
the following effects as compared to the untreated controls were observed: 66% at 100 mg/L, 58% at 38.5 mg/L, 51% at 14.8 mg/L, 39% at 5.69 mg/L and 32% at 2.19 mg/L.
Based on these data the median effect concentration to Lemna minor with respect to growth rate (ErC50) and to yield (EyC50) for the endpoint dry weight were estimated to be respectively >91.0 mg/L and 12.5 mg/L (95%confidence limits: 7.52-21.0 mg/L) measured concentration of active ingredient. The no-observed-effect concentrations to Lemna minor with respect to growth rate (NOErC) and yield (NOEyC) for the endpoint dry weight were both <1.48 mg/L measured concentration of active ingredient, as determined by Dunnett’s test.
APPEARANCE OF THE PLANTS
In the blank control the plants were healthy, as well as at the test concentrations of 2.19, 5.69, 14.8 and 38.5 mg/L. At 100 mg/L, the size of the plants were only about two thirds of the plants in the control. Apart from the smaller size, the plants appeared healthy.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- The doubling time of frond number in the control must be less than 2.5 days (60 h), corresponding to approximately a seven-fold increase in seven days and an average specific growth rate of 0.275 d-1
- Conclusions:
- ErC50 frond number, on duckweed Lemna minor (7 days) >91 mg/L
ErC50 dry weight, on duckweed Lemna minor (7 days) >91 mg/L
geometric mean of the measured concentrations of the active ingredient. - Executive summary:
Method
The inhibitory effects to the duckweed Lemna minor were investigated over a period of 7 days, based on the frond number and biomass (dry weight), following the guideline OECD 221. The test item is solid, well soluble (328.5 ± 1.81 g/L at 20.0 ± 0.5°C) and has a purity of 77.1% (active ingredient). The test solutions were prepared by respective dilutions of a stock solution in STEINBERG medium. The test was performed at the nominal test item concentrations of 130, 50.0, 19.2, 7.40 and 2.84 mg/L, corresponding to 100, 38.5, 14.8, 5.69 and 2.19 mg/L of the active ingredient. Three parallel test vessels were used for each test concentration of the test item and six vessels for the blank controls.
Observations
The test concentrations during the 7 day test period were determined by HPLC analysis at the beginning of the test, as well as after 3, 5 and 7 days of exposure.
These analyses confirmed the right dosage of the test item, but showed that the concentrations of the test item decreased over the whole 7 day test period (91, 86, 61, 76 and 61%, respectively, of the initial value). Therefore, the effective concentrations (ErC50 and EyC50) were assessed based on the geometric mean (GM) of the measured concentrations of the active ingredient. The two endpoints frond number and biomass (dry weight) were investigated at days 3, 5 and 7, and each of them were assessed as growth rate and yield.
Conclusion
The 7 day ErC50 of on the duckweed Lemna minor was > 91.0 mg/L. This value is based on the geometric mean of the measured concentrations of the active ingredient. The validity criterion was fulfilled.
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