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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-349-8 | 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:
- 19 January 2018 to 04 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted in accordance with international guidelines, and in accordance with GLP. All relevant validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- Commission Regulation (EC) No. 440/2008
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:
- Sampling method: Samples were taken from the control and 100 mg/L loading rate WAF test group from the freshly prepared bulk test preparation at 0 and 24 hours and from the old or expired pooled replicates (R1 to R4) at 24 and 48 hours for quantitative analysis.
- Sample storage conditions before analysis: All samples were stored frozen prior to analysis. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Water accommodated fraction (WAF)
- Eluate: ELENDT M7 medium
- Differential loading: Yes
- Controls: Yes, Elendt M7 medium only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): Microscopic observations of the WAF were performed after filtering and showed no test item. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Waterflea
- Strain/clone: Straus (defined by supplier as clone 5)
- Justification for species other than prescribed by test guideline: N/A
- Source: University of Sheffield (UK), bred at Envigo Research Limited
- Age of parental stock (mean and range, SD):
- Feeding during test: None
- Food type:
- Amount:
- Frequency:
ACCLIMATION
- Acclimation period:
- Acclimation conditions (same as test or not):
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed):
QUARANTINE (wild caught) N/A
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- Guideline standard exposure duration
- Hardness:
- Not measured
- Test temperature:
- 18 - 22 °C
- pH:
- 7.9 - 8.4
- Dissolved oxygen:
- 7.8 - 8.9
- Salinity:
- Not measured
- Conductivity:
- Not measured
- Nominal and measured concentrations:
- Nominal loading rates (WAF): 100 mg/L (limit test)
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: Glass
- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel:
- No. of vessels per concentration (replicates):
- No. of vessels per control (replicates):
- No. of vessels per vehicle control (replicates):
- Biomass loading rate:
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Salinity:
- Culture medium different from test medium:
- Intervals of water quality measurement:
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 h light : 8 h dark
- Light intensity:
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
VEHICLE CONTROL PERFORMED: yes/no
RANGE-FINDING STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study:TEST SYSTEM
- Test vessel: 150 mL glass beaker
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 150 mL glass beaker, containing 100 mL test solution
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): esmi-static, renewal after 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: Not applicable
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
ELENDT M7 medium, prepared according to OECD 202 guideline. The pH of the prepared media was 7.9 ±0.3 and stored at approximately 21 ºC.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light; 8 h dark (with 20 minute dusk and dawn transition periods)
- Light intensity: 200 to 1200 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
VEHICLE CONTROL PERFORMED: No
RANGE-FINDING STUDY
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- water accommodated fraction
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: None
- Observations on body length and weight: Not applicable
- Other biological observations: None
- Mortality of control: No
- Other adverse effects control: No
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Not applicable (WAF)
- Effect concentrations exceeding solubility of substance in test medium: No effects were seen up to 100 mg/L (WAF), which is in excess of the test item water solubility. - Results with reference substance (positive control):
- - Results with reference substance valid?
- Relevant effect levels: EC50
- Limit test: No
- Dose-response test: Yes
- ECx: 24 h EC50 = 0.79 mg/L; 48 h EC50 = 0.75 mg/L
- Other:
A positive control (Envigo study number LK67NP) used potassium dichromate as the reference item at concentrations of 0.32, 0.56, 1.0, 1.8 and 3.2 mg/L.
Exposure conditions for the positive control were similar to those in the definitive test.
Analysis of the immobilization data was carried out using the Binomial Distribution method at 24 hours and the Trimmed Spearman-Karber method at 48 hours. All statistical analysis was carried out using the ToxRat Professional computer software package with results based on the nominal test concentrations. The results from the positive control with potassium dichromate were within the normal range for this reference item. - Reported statistics and error estimates:
- Not applicable, no statistics performed in this study.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of the test item to the freshwater invertebrate Daphnia magna has been investigated and gave a 48 Hour EL50 value of greater than 100 mg/L loading rate WAF.
- Executive summary:
A study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.
Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF).
Following a preliminary range‑finding test, 20 daphnids (4 replicates of 5 animals) were exposed to a WAF of the test item at a nominal loading rate of 100 mg/L for 48 hours at a temperature of 20 C to 22 C under semi‑static test conditions. Immobilization and any adverse reactions to exposure were recorded after 24 and 48 hours.
Chemical analysis of the test preparations at 0, 24 and 48 hours showed measured test concentrations of less than the limit of quantification (LOQ) of the analytical method employed were obtained which was determined to be 0.019 mg/L. This does not infer that no test item was in solution, just that any dissolved test item was at a concentration of less than the LOQ.
Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.
Exposure of Daphnia magna to the test item gave EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading (NOEL) rate was 100 mg/L loading rate WAF.
It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.
Reference
Chemical Analysis of Test Loading Rates
Chemical analysis of the test preparations at 0, 24 and 48 hours showed measured test concentrations of less than the LOQ of the analytical method employed were obtained which was determined to be 0.019 mg/L.
Description of key information
48 h EL50 = > 100 mg/L; OECD 202; Squance, 2018
Key value for chemical safety assessment
Additional information
A single key study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.
Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF).
Following a preliminary range‑finding test, 20 daphnids (4 replicates of 5 animals) were exposed to a WAF of the test item at a nominal loading rate of 100 mg/L for 48 hours at a temperature of 20 C to 22 C under semi‑static test conditions. Immobilization and any adverse reactions to exposure were recorded after 24 and 48 hours.
Chemical analysis of the test preparations at 0, 24 and 48 hours showed measured test concentrations of less than the limit of quantification (LOQ) of the analytical method employed were obtained which was determined to be 0.019 mg/L. This does not infer that no test item was in solution, just that any dissolved test item was at a concentration of less than the LOQ.
Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.
Exposure of Daphnia magna to the test item gave EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading (NOEL) rate was 100 mg/L loading rate WAF.
It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.
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.