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EC number: 201-353-5 | CAS number: 81-48-1
- 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
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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
- 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:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Purity: 95.2 %
- Batch Number: AAFE 046203
- Chemical name: Solvent Violet 13
- Appearance: Violet powder
- Water solubility: < 1 mg/L
- Stability in water and light at room temperature: Stable
- pH vlaue: Neutral (in aqueous solution)
- Melting point: 185 °C
- TOC: 76.57 %
- Expiry date: 2016-10-27 - Analytical monitoring:
- yes
- Remarks:
- The saturated solution and the control after O h (new media) and 48 h (old media) were analytically verified via DOC analysis according to DIN EN 1484.
- Details on sampling:
- Sampling schedule:
- Control: at 0 and 48 hours
- Test concentration: at 0 and 48 hours
Storage
Test Item
- Recommended storage: Room temperature
- Storage at test facility: Room temperature, protected from moisture and light - Vehicle:
- no
- Details on test solutions:
- Because the substance is insoluble in water Water Accommodated Fractions (WAF) were used to test effects at limit effective loadings and no specific analysis was performed. The content of the test item during the exposure period was verified by DOC determination.
Test Item
Stock solution: The stock solution (100 mg/L test item were weighed out) was prepared with dilution water in brown glass flask one day prior to application.
Dispersion treatment: The stock solution was shaken at room temperature with 20 rpm for 24 h (rotating shaker 3040, GFL). Undissolved particles were removed by membran filtration (0.45 μm, RC, SCHLEICHER & SCHUELL).
Control
Dilution water without test item tested under the same conditions as the test groups. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- - Test organism: Daphnia magna STRAUS (Clone 5)
- Origin: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu)
- Breeder: DR.U.NOACK-LABORATORIEN, 31157 Sarstedt, Germany
- Culture: 2-3 L glass vessels with approximately 1.8 L culture medium, at 20 ± 2 °C, in an incubator, 16 h illumination, illumination (max. 20µE·m-2 xs-1)
- Culture medium: Elendt M4, according to Elendt (1990), modified to a total hardness of 160 to 180 mg CaC03/L
- Feeding: At least 5 times per week ad libitum with a mix of Desmodesmus subspicatus and Chlorella vulgaris (cell density of > 10E-6 cells/mL)
- Number of test organisms per concentration and control: 20 animals, divided into 4 parallel samples, each with 5 animals
- Age of test organisms: 2 - 24 hold - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 14.3 °dH (256 mg/L CaCO3)
- Test temperature:
- 20.3 °C
- pH:
- 7.76 (mean value of 4 replicates after 48 h)
- Dissolved oxygen:
- 8.67 (mean value of 4 replicates after 48 h)
- Salinity:
- n.a.
- Nominal and measured concentrations:
- 100 mg/L of the test item corresponds to 1.2 mg/L DOC after 48 hours
- Details on test conditions:
- PRE-TREATMENT OF TEST ITEM AND PREPARATION OF TEST CONCENTRATIONS:
- The stock solution (100 mg/L test item were weighed out) was prepared with dilution water in brown glass flask one day prior to application and was shaken at room temperature with 20 rpm for 24 h (rotating shaker 3040, GFL)
- Undissolved particles were removed by membran filtration {0.45 µm, RC, SCHLEICHER & SCHUELL)
- The pH was measured to be 7.9
EXPOSURE CONDITIONS:
- Test vessels: glass beakers, holding 5 neonates in 20 ml of test medium
- Test concentration: 1 (100 mg/L), plus 1 control
- Number of neonates: 5 per vessel
- Acclimation: at least 2 h in dilution water
- Replicates: 4 per concentration/control
- Feeding during exposure: None
- Method of initiation: neonates were placed in prepared media
- Illumination: diffuse light, illumination range max. 20 µE·mE-2*sE-1
- Photoperiod: 16 h light:8 h dark
- Temperature of incubation unit: 18 to 22.0 +/- 1 °C
- Aeration: none
- Medium renewal: none
- Monitoring data: pH, dissolved oxygen and temperature, measured after 0 and 48 hours
- Criteria of effects: The criterion of adverse effects used in th is study was the item-induced alteration of the normal mobility behaviour and the loss of motory actions of the neonates, observed at 24 and 48 hours - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate p.a. (SIGMA) (Batch No. 065K1349; purity 99.9 %); Test concentrations: 1.66 - 1.99 - 2.39 - 2.87 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- The tested saturated solution* was visually clear throughout exposure. The percentage immobility was determined in the tested saturated solution* and the control after 24 h and 48 h. There is no biologically significant effect neither in the tested saturated solution nor in the control group.
*The maximum dissolved concentration of the test item that can be achieved under the test conditions in the test medium, acc. to OECD Series, No. 23 (2000)6 - Results with reference substance (positive control):
- The 24 h-EC50-value of 2.09 mg/L with 95 % confidence interval (1.98-2.21 mg/L) was calculated by analyses for reference item sigmoidal dose-response regression. Calculation of the confidence intervals for EC50 were carried out using standard procedures according to CLOPPER and PEARSON (1934 ). The range of validity was 1.0 mg/L < EC50 (24 h) < 2.5 mg/L.
- Reported statistics and error estimates:
- EC-values and statistical analyses for reference item
EC50-values was only calculated for the reference item by sigmoidal dose-response regression. Calculation of the confidence intervals for EC50 were carried out using standard procedures according to CLOPPER and PEARSON (1934 ).
Software: All data were computer generated and rounded for presentation from the full derived data. Consequently, if calculated manually based on the given data minor variations may occur from these figures. Calculations were carried out using software:
- GraphPad Prism4 (2005), GRAPHPAD SOFTWARE, INC. - Validity criteria fulfilled:
- yes
- Remarks:
- (The immobilisation and other abnormalities in the controls did not exceed 10 % by the end of the test. The dissolved oxygen concentration remained above 3 mg/L throughout the exposure period)
- Conclusions:
- At the saturated solution of Solvent Violet 13 (1.2 mg/L DOC) no biologically significant effect was determined to Daphnia magna under static conditions over a period of 48 hours.
- Executive summary:
ln the acute immobilization test with Daphnia magna (STRAUS) the effects of the saturated solution (1.2 mg/L DOC) of Solvent Violet 13, was determined according to OECD 202 (2004) and Directive 92/69/EC Method C (1992). The Iimit test was conducted under static conditions over a period of 48 hours. 20 test organisms were exposed to the saturated solution and the control. A reference test with potassium dichromate was carried out once per month to check the test system and test conditions. The EC50-value of the reference item of 2.09 mg/L after 24 h was within the prescribed concentration range of 1.0 to 2.5 mg/L according to AQS. Water quality parameters pH-value and dissolved oxygen concentration, measured at 0 and 48 h, were determined to be within the acceptable Iimits. The validity criteria of the test guideline were fulfilled. At the saturated solution of Solvent Violet 13 no biologically significant effect was determined. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute Daphnia study.
Reference
DOC-Analysis
Analysis of New (0h) and Old Media (48h)
DOC [mg/L] | |||||||
0 h | 48 h | Overall | |||||
Parallel determination | Mean | Parallel determination | Mean | Mean | |||
Saturated solution | 1.2 | 1.2 | 1.2 | 1.2 | 1.1 | 1.1 | 1.2 |
Control | 1.3 | 1.3 | 1.3 | 1.3 | 1.3 | 1.3 | 1.3 |
Description of key information
ln the acute immobilization test with Daphnia magna (STRAUS) the effects of the saturated solution (1.2 mg/L DOC) of Solvent Violet 13, was determined according to OECD 202 (2004) and Directive 92/69/EC Method C (1992). The Iimit test was conducted under static conditions over a period of 48 hours. 20 test organisms were exposed to the saturated solution and the control. A reference test with potassium dichromate was carried out once per month to check the test system and test conditions. The EC50-value of the reference item of 2.09 mg/L after 24 h was within the prescribed concentration range of 1.0 to 2.5 mg/L according to AQS. Water quality parameters pH-value and dissolved oxygen concentration, measured at 0 and 48 h, were determined to be within the acceptable Iimits. The validity criteria of the test guideline were fulfilled. At the saturated solution of Solvent Violet 13 no biologically significant effect was determined. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute Daphnia study.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
"Should read: > 100 mg/L (1.2 mg/L DOC)"
Solvent Violet 13 has been tested up to the limit of solubility in the test water. According to Directive 93/21/EEC ( adaptation to Directive 67/548/EEC ) the ecotoxicological classification is not toxic to Daphnia magna after 48 hours.
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.
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