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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-956-5 | 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:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. Minor deviations not considered to impact the reliability of the study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- no positive reference control; seperation factor slightly above guideline preference (2.2)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- yes
- Remarks:
- see above
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Deviations:
- yes
- Remarks:
- see above
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, 12 Nohsan No 8147, Agricultural Production Bureau, November 24 2000.
- Deviations:
- yes
- Remarks:
- see above
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23 (2000)
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: February 2014; signature: April 2014
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: All loading levels and the control were analytically verified via GC-MS at the start (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours). Test substance loadings were prepared as Water Accommodated Fraction (WAF).
- Sampling method: The analysis described within this report was the analysis of one of the constituents measured at a specific wavelength.
The test concentrations of tracer constituent were measured using gas chromatography with mass spectrometric detection system (GC-MS). At the start of the definitive test, two samples (50 mL) were taken from the freshly-prepared control and test media. After 48 hours, the contents of the replicate flasks for each group were pooled and further samples taken for analysis. This was to assess the stability of the WAF.
- Sample storage conditions before analysis: All original samples were stored at room temperature before preparation and a separate sample stored frozen if required. - Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphinds
- Strain: Daphnia magna (Straus)
- Source: National Institute for Applied Chemical Research (IRCHA), France
- Age at study initiation (mean and range, SD): < 24 hours.
- Method of breeding: Parthenogenesis
- Feeding during test: No.
- Food type: Cultures were fed daily with a suspension of the unicellular green algae, Pseudokirchneriella subcapitata, to provide nominally 0.1 to 0.2 mg carbon per daphnid, per day, except during the initial two days when a slightly lower ration was given.
- Amount: See above.
- Frequency: See above. No feeding during test conditions.
ACCLIMATION
- Acclimation period: None. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- The adjusted-ISO medium M7 hardness: 168 mg/L expressed as CaCO3 and the pH: 7.8 ± 0.1
- Test temperature:
- The temperature continuously measured in a temperature control vessel varied between 20.0 and 21.0°C during the test, and complied with the requirements as laid down in the guideline (18-22°C, constant within 2°C).
- pH:
- Test conditions remained within the limits prescribed by the guideline; pH: 7.6-8.2 not varying by 1.5 units the end of the test. Actual pH: 7.8 ± 0.1
- Dissolved oxygen:
- Test conditions remained within the limits prescribed by the guideline; oxygen:>3 mg/L at the end of the test. Actual oxygen: start: 8.6 ± 0.25 mg/L and end: 9.2 ± 0.2 mg/L
- Nominal and measured concentrations:
- Range finding tests were performed prior to the definitive test: Information is provided in table 1. at concentrations 0 (control), 1, 10 and 100 mg/L.
Definitive test: nominal concentrations:
Five water accommodated fractions (WAF) were prepared with nominal loadings of the test item in the range: 0 (control), nominal loading rates of 1.94, 4.27, 9.39, 20.7, 45.5 and 100 mg/L. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 120 ml
- Type (delete if not applicable): loosely covered; static.
- Material, size, headspace, fill volume: Glass, 100 ml medium (therefore headspace ca. 20 ml) in the definitive study
- Aeration: No aeration of the test solutions.
- No. of organisms per vessel: Control and test item: 20 per concentration, 5 per vessel containing 100 ml of test solution (definitive test)
- No. of vessels per concentration (replicates): 4 (four replicates, 5 daphnia per vessel).
- No. of vessels per control (replicates): 4 (four replicates, 5 daphnia per vessel).
- No. of vessels per vehicle control (replicates): Not applicable.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionised water; used to prepare softened-ISO Medium M4. The following macro salts and micro elements were diluted in water and added to ISO Medium M4:
Microelements (mg/L): H3BO3 2.86 ; MnCl2.4H2O 0.36 ; LiCl 0.31 ; RbCl 0.071 ; SrCl2.6H2O 0.152 ; NaBr 0.016 ; Na2MoO4.2H2O 0.063 ; CuCl2 2H2O 0.017 ; ZnCl2 0.013 ; CoCl2.6H2O 0.010 ; KI 0.0033 ; Na2SeO3 0.0022 ; NH4VO3 0.00058 ; Fe-EDTA solution 3.50; Macro salts (mg/L): CaCl2.2H2O 147 ; MgSO4.7H2O 61.5 ; KCl 5.80 ; NaHCO3 64.8 ; Na2SiO3.9H2O 6.83 ; NaNO3 0.274 ; KH2PO4 0.143 ; K2HPO4 0.184 and Vitamins (mg/L): Thiamine hydrochloride 0.075 ; Cyanocobalamine (Vitamin B12) 0.0010 ; Biotin (Vitamin H) 0.00075 respectively
- Culture medium different from test medium: No, softened-ISO Medium M4 (above), renewed by three times per week.
OTHER TEST CONDITIONS
- Adjustment of pH: None.
- Photoperiod:16 hours photoperiod daily; 8 hours dark. With periods of subdued lighting at the beginning and end of each light phase.
- Light intensity: Not reported.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility (including mortality), 24 hours and at 48 hours. - Reference substance (positive control):
- no
- Duration:
- 24 h
- Dose descriptor:
- EL50
- Effect conc.:
- 25.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL: 19.60 -32.90 mg/L; nominal based on WAF
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- 10.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CL: 7.98 - 14.80 mg/L; nominal based on WAF
- Duration:
- 48 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 1.94 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: None
- Observations on body length and weight: Not applicable.
- Other biological observations:
- Mortality of control: No mortalities.
- Other adverse effects control: None.
- Abnormal responses: None.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None.
- Effect concentrations exceeding solubility of substance in test medium: No. - Reported statistics and error estimates:
- Statistical analysis was performed using the SAFEStat LD50 application (version 1.5), SAS 9.1.3 (SAS Institute, 2002). Test results were expressed in terms of the nominal loading rates (EL50).
The “no observed effect loading rate” (NOELR) was derived by direct inspection of the data and based on the 10% effect seen at the end of the test. - Validity criteria fulfilled:
- yes
- Conclusions:
- The test substance 48h-EL50 was 10.9 mg/L (C.I. 7.98 - 14.80 mg/L) based on nominal loading rates.The NOELR was 1.94 mg/L.
- Executive summary:
The acute toxicity to Daphnia magna was carried out according to OECD TG 202 Daphnia sp., Acute Immobilisation Test, EU Method C.2, US EPA 850.1010 and Japanese, Test Data for Registration of Agricultural Chemicals, 12 Nohsan No. 8147 guidelines under GLP. Groups of twenty Daphnia, less than 24 hours old, were exposed to water accommodated fractions (WAF) of test substance prepared from aqueous mixtures with nominal loading rates of 1.94, 4.27, 9.39, 20.7, 45.5 and 100 mg/L. Aliquots of the test substance were added to softened Elendt M4 medium; these mixtures were stirred for approximately 24 hours in the dark and then left to stand for approximately 24 hours in the dark before the WAFs were removed and filtered (0.2 μm pore size), before being used directly as test media. The test substance comprised several constituents. One constituent was analysed as a tracer to assess the stability of the WAF system. The analysis described within this report was the analysis of one of the constituents measured at a specific wavelength using the gas chromatography with mass spectrometric detection system (GC-MS) method. In samples of freshly prepared media, the concentrations of the tracer constituent at the beginning of the test ranged between 1.44 to 48.4 mg/L. Measured levels of the tracer constituent in samples at the end of the test ranged between 1.11 and 44.3 mg/L, between 77 and 107 % of the initially measured concentrations. The geometric mean of the measured concentrations of the tracer constituent was 1.26, 2.40, 5.71, 10.2, 23.6 and 46.3 mg/L for the remaining levels. Since the test substance is a complex mixture, its toxicity cannot be attributed to a single constituent or a mixture of constituents, but to the test substance as a whole. Therefore the nominal loading rates of the test substance were used in the determination of study end-points, as it is recommended in the OECD Guidance Document No 23 on Aquatic Toxicity Testing of Difficult Substances and Mixtures (OECD, 2000). Observations of the Daphnia in each control and test vessel were made after approximately 24 and 48 hours. After 48 hours, 100% immobilisation occurred at the nominal loading rate of 100 mg/L, and no immobilisation occurred at the nominal loading rate of 1.94 mg/L. The following study end-points were determined using the nominal loading rates of the test substance at 48 hours: EL50: 10.9 (C.I. 7.98 – 14.80) mg/L. The No Observed Effect Loading Rate (NOELR) was determined to be 1.94 mg/L.
Reference
Table 1. Environmental concentrations during the final test
Nominal loading rate of the test substance |
Measured tracer constituent # |
Temperature |
pH |
Dissolved Oxygen (%ASV) |
Dissolved Oxygen (mg/L) |
||||
(mg/L) |
0 h |
48 h |
0 h |
48 h |
0 h |
48 h |
0 h |
48 h |
|
Control |
nd |
21.2 |
20.7 |
7.70 |
7.72 |
98 |
102 |
8.80 |
9.25 |
1.94 |
1.26 |
21.2 |
20.7 |
7.81 |
7.73 |
97 |
100 |
8.67 |
9.04 |
4.27 |
2.40 |
21.2 |
20.8 |
7.85 |
7.75 |
96 |
100 |
8.54 |
9.05 |
9.39 |
5.71 |
21.1 |
20.8 |
7.87 |
7.77 |
98 |
100 |
8.79 |
9.02 |
20.7 |
10.2 |
21.1 |
20.8 |
7.86 |
7.75 |
99 |
104 |
8.84 |
9.38 |
45.5 |
23.6 |
21.0 |
20.8 |
7.89 |
7.77 |
97 |
104 |
8.73 |
9.40 |
100 |
46.3 |
21.0 |
20.9 |
7.90 |
7.76 |
97 |
104 |
8.71 |
9.39 |
Nd: None detected (less than the limit of detection of 0.05 mg/L)
ASV: Air saturation value (100% ASV = 9.09 mgO2/L at 20ºC)
The total hardness and alkalinity of the batch of softened Elendt M4 medium used were 168 and 39 mg/L as CaCO3, respectively
Continuous monitoring of an additional vessel containing dilution medium = 21.2 to 21.6°C
# Geometric mean between concentration of trace constituent at t=0 and t=48h
Table 2. Number of introduced daphnids and incidence of immobility in the definitive test
Nominal loading rate of the test substance |
Measured tracer constituent # |
Cumulative numbers of immobile Daphnia |
|||||||||||
24 hours |
48 hours |
||||||||||||
|
|
R1 |
R2 |
R3 |
R4 |
Total |
% |
R1 |
R2 |
R3 |
R4 |
Total |
% |
Control |
nd |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.94 |
1.26 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4.27 |
2.40 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
3 |
4 |
20 |
9.39 |
5.71 |
0 |
0 |
0 |
1 |
1 |
5 |
3 |
4 |
0 |
2 |
9 |
45 |
20.7 |
10.2 |
4 |
2 |
1 |
4 |
11 |
55 |
3 |
4 |
5 |
5 |
17 |
85 |
45.5 |
23.6 |
3 |
1 |
5 |
4 |
13 |
65 |
1 |
5 |
5 |
5 |
16 |
80 |
100 |
46.3 |
5 |
5 |
5 |
5 |
20 |
100 |
5 |
5 |
5 |
5 |
20 |
100 |
nd: None detected (less than the limit of detection of 0.05 mg/L)
R: Replicate number
# Geometric mean between concentration of trace constituent at t=0 and t=48h
Description of key information
EL50 (invertebrates) = 10.9 mg/L ; WAF loading 48hour-freshwater, OECD TG 202, 2015
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 10.9 mg/L
Additional information
The acute toxicity to Daphnia magna was carried out according to OECD TG 202 Daphnia sp., Acute Immobilisation Test, EU Method C.2, US EPA 850.1010 and Japanese, Test Data for Registration of Agricultural Chemicals, 12 Nohsan No. 8147 guidelines under GLP. Groups of twenty Daphnia, less than 24 hours old, were exposed to water accommodated fractions (WAF) of test substance prepared from aqueous mixtures with nominal loading rates of 1.94, 4.27, 9.39, 20.7, 45.5 and 100 mg/L. Aliquots of the test substance were added to softened Elendt M4 medium; these mixtures were stirred for approximately 24 hours in the dark and then left to stand for approximately 24 hours in the dark before the WAFs were removed and filtered (0.2 μm pore size), before being used directly as test media. The test substance comprised several constituents. One constituent was analysed as a tracer to assess the stability of the WAF system. The analysis described within this report was the analysis of one of the constituents measured at a specific wavelength using the gas chromatography with mass spectrometric detection system (GC-MS) method. In samples of freshly prepared media, the concentrations of the tracer constituent at the beginning of the test ranged between 1.44 to 48.4 mg/L. Measured levels of the tracer constituent in samples at the end of the test ranged between 1.11 and 44.3 mg/L, between 77 and 107 % of the initially measured concentrations. The geometric mean of the measured concentrations of the tracer constituent was 1.26, 2.40, 5.71, 10.2, 23.6 and 46.3 mg/L for the remaining levels. Since the test substance is a complex mixture, its toxicity cannot be attributed to a single constituent or a mixture of constituents, but to the test substance as a whole. Therefore the nominal loading rates of the test substance were used in the determination of study end-points, as it is recommended in the OECD Guidance Document No 23 on Aquatic Toxicity Testing of Difficult Substances and Mixtures (OECD, 2000). Observations of the Daphnia in each control and test vessel were made after approximately 24 and 48 hours. After 48 hours, 100% immobilisation occurred at the nominal loading rate of 100 mg/L, and no immobilisation occurred at the nominal loading rate of 1.94 mg/L. The following study end-points were determined using the nominal loading rates of the test substance at 48 hours: EL50: 10.9 (C.I. 7.98 – 14.80) mg/L. The No Observed Effect Loading Rate (NOELR) was determined to be 1.94 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.