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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 221-487-8 | CAS number: 3115-68-2
- 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:
- From 15 November 2015 to 22 December 2015
- 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:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Solubility in water: completely miscible
- Stability in water: stable - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations sampled: all test concentrations (and the control), at t=0 and t=48h
- Volume: 2.4 mL from the approximate centre of the test vessels
- At the end of the exposure period, the replicates were pooled at each concentration before sampling
- Sample storage conditions before analysis: in a freezer - Vehicle:
- no
- Details on test solutions:
- The test substance was completely miscible in test medium. No correction was made for the purity/composition of the test substance. Preparation of test solutions started with the highest concentration and stock solution of 100 mg/L in the combined limit/range-finding and final test, respectively. No special treatment other than vigorous mixing (vortexing) was needed to fully dissolve the test substance in test medium at the highest concentration prepared. Lower tested concentrations were prepared by subsequent dilutions of the highest concentration and stock solution in test medium. All final solutions were clear and colourless.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Species: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions.
- Source: In-house laboratory culture with a known history.
- Validity of batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
- Characteristics: For the test selection of young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 180 mg CaCO3/L
- Test temperature:
- 19.3 - 20.6 °C
- pH:
- 7.7 - 8.0
- Dissolved oxygen:
- 9.4 - 9.8 mg/L
- Nominal and measured concentrations:
- - 1.0, 1.8, 3.2, 5.6 and 10 mg/L (nominal)
- Analysis of the samples showed that concentrations were stable and in agreement with nominal (90-100% relative to nominal) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL, all-glass
- Aeration: No aeration of the test solutions
- Feeding: No feeding
- No. of organisms per vessel: 5 per vessel containing 80 mL of test solution
- No. of vessels per concentration (replicates): 4
- Introduction of daphnids: Within 41 minutes after preparation of the test solutions
- No. of vessels per control (replicates): 4
TEST MEDIUM
Adjusted ISO medium. The following chemicals (analytical grade) were dissolved in tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, The Netherlands):
CaCl2.2H2O: 211.5 mg/L
MgSO4.7H2O: 88.8 mg/L
NaHCO3: 46.7 mg/L
KCl: 4.2 mg/L
OTHER TEST CONDITIONS
- Adjustment of pH: Not applicable
- Photoperiod: 16 hours photoperiod daily
EFFECT PARAMETERS MEASURED
The 48h-EC50 value was calculated from the weibits of the percentages of affected daphnids and the logarithms of the corresponding test item concentrations using the maximum likelihood estimation method (ToxRat Professional v 3.0.0).
RANGE-FINDING STUDY
- Test concentrations: 0.10, 1.0, 10 and 100 mg/L (nominal)
-- At 100 mg/L and control: Twenty daphnids (four replicates, 5 daphnids per vessel)
-- At 0.10, 1.0 and 10 mg/L: Ten daphnids (two replicates, 5 daphnids per vessel)
- Results used to determine the conditions for the definitive study: 100% immobility was already observed at 24 hours of exposure in the 100 mg/L group, while immobility of 100% was
further observed after 48 hours at the 10 mg/L group. No immobility was observed in the control or in any of the lower concentrations during the test period. Therefore, the expected EC50 was between nominal concentrations of 1.0 and 10 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- (sensitivity check using potassium dichromate)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 4.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: Analytically confirmed nominal concentration; 95%-confidence interval: 3.4 - 4.7 mg/L
- Details on results:
- - At t=24h, only at 10 mg/L daphnids were immobilised (20%)
- At t=48h, daphnids were immobilized at 3.2 (40%), 5.6 (80%) and 10 mg/L (100%) - Results with reference substance (positive control):
- In the latest sensitivity check, performed in the period 15 - 17 September 2015, an 48h-EC50 of 0.39 mg/L was determined. The sensitivity of the daphnia was within the range determined with the historical data collected at the testing laboratory.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a study performed in accordance with OECD 202 (2004) and according to GLP principles, an 48h-EC50 of 4.1 mg/L was determined for the substance, based on analytically confirmed nominal concentrations.
- Executive summary:
In a study performed in accordance with OECD 202 (2004) and according to GLP principles, the acute toxicity of the substance to daphnids was investigated. A final test was performed based on the results of a preceding combined limit/range-finding test. Twenty daphnids per group (four replicates, five daphnids per replicate) were exposed to an untreated control and to nominal concentrations of 1.0, 1.8, 3.2, 5.6 and 10 mg/L prepared from a stock of 100 mg/L. The total exposure period was 48 hours and samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test, from all test concentrations. Analysis of the samples showed that concentrations were stable and in agreement with nominal (90-100% relative to nominal). The study met the acceptability criteria. Under the conditions of the present study, the 48h-EC50 was 4.1 mg/L based on analytically confirmed nominal concentrations (95% confidence interval between 3.4 and 4.7 mg/L).
Reference
Analysis of the samples taken from 1.0, 1.8, 3.2, 5.6 and 10 mg/L at the start and at the end of the final test showed that measured concentrations were stable and in agreement with nominal (90-100% relative to nominal). Based on these results, effect parameters were expressed in terms of analytically confirmed nominal concentrations.
Table 1 : Initial number of daphnia per concentration per replicate
Replicate | Control | 1.0 | 1.8 | 3.2 | 5.6 | 10 |
A | 5 | 5 | 5 | 5 | 5 | 5 |
B | 5 | 5 | 5 | 5 | 5 | 5 |
C | 5 | 5 | 5 | 5 | 5 | 5 |
D | 5 | 5 | 5 | 5 | 5 | 5 |
Total | 20 | 20 | 20 | 20 | 20 | 20 |
Table 2 : Number of immobile daphnia per concentration per replicate after 48-h exposure
Replicate | Control | 1.0 | 1.8 | 3.2 | 5.6 | 10 |
A | 0 | 0 | 0 | 3 | 4 | 5 |
B | 0 | 0 | 0 | 2 | 5 | 5 |
C | 0 | 0 | 0 | 2 | 3 | 5 |
D | 0 | 0 | 0 | 1 | 4 | 5 |
Total | 20 | 20 | 20 | 20 | 20 | 20 |
Table 3 : Measured concentrations in fresh and old solutions. The slight concentrations measured in the control was probably carry over since a similar response was observed in the analytical blank. This is not considered to have affected the outcome of the study.
Concentration (mg/L, nominal) | Concentration (mg/L, measured, 0h) | Concentration (mg/L, measured, 48h) |
Control | 0.00088 | 0.00054 |
1.0 | 0.99 | 0.99 |
1.8 | 1.74 | 1.69 |
3.2 | 3.21 | 2.97 |
5.6 | 5.26 | 5.03 |
10 | 9.17 | 9.23 |
Description of key information
In a study performed in accordance with OECD 202 (2004) and according to GLP principles, an 48h-EC50 of 4.1 mg/L was determined for the substance, based on analytically confirmed nominal concentrations.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 4.1 mg/L
Additional information
In a study performed in accordance with OECD 202 (2004) and according to GLP principles, the acute toxicity of the substance to daphnids was investigated. A final test was performed based on the results of a preceding combined limit/range-finding test. Twenty daphnids per group (four replicates, five daphnids per replicate) were exposed to an untreated control and to nominal concentrations of 1.0, 1.8, 3.2, 5.6 and 10 mg/L prepared from a stock of 100 mg/L. The total exposure period was 48 hours and samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test, from all test concentrations. Analysis of the samples showed that concentrations were stable and in agreement with nominal (90-100% relative to nominal). The study met the acceptability criteria. Under the conditions of the present study, the 48h-EC50 was 4.1 mg/L based on analytically confirmed nominal concentrations (95% confidence interval between 3.4 and 4.7 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.