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EC number: 944-536-1 | 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
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Series on Testing and Assessment, No. 23, "Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures"
- Version / remarks:
- December 15, 2000
- Qualifier:
- according to guideline
- Guideline:
- other: SANCO/3029/99 rev.4 11/07/00: Residues: Guidance for generating and reporting methods of analysis in support of preregistration data requirements for Annex II (part A; Section 4) and Annex III (part A; Section 5) of directive 91/414
- Version / remarks:
- rev. 4 11/07/00
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Nominal test concetrations of 0.85, 1.9, 4.1, 9.1 and 20 mg/L and the control in fresh media at 0 and 24 hours and aged media after 24 and 48 hours at test media renewal
- Sample storage conditions before analysis: Samples were extracted with cyclohexane immediately after sampling, and stored in a refrigerator at 4 ± 4 ºC, and protected from light until analysis. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test media of the nominal 20 mg test item/L solution was prepared by dissolving 20 and 20.4 mg test item into 1000 and 1020 mL test water by intense stirring for 24 hours. Adequate volumes of this test medium were diluted with test water to prepare the test media of the other desired test concentrations. The test media were prepared just before introduction of the daphnids at the start of the test and test medium renewal on Day 1.
- Controls: Reconstituted water (Elendt M4 media)
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Strain/clone: Clone 5
- Source: Bred at test facility
- Age of parental stock (mean and range, SD): Not reported, but test animals not first brood progeny
- Feeding during test: None
ACCLIMATION
- Acclimation period: None
- Acclimation conditions (same as test or not): Culture media conditions same as test conditions
BREEDING CONDITIONS
- Type and amount of food: Breeding cultures fed green algae (Desmodesmus subspicatus), amount not reported
- Feeding frequency: Stock cultures fed on all working days - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- Media renewal after 24 hours
- Hardness:
- 2.5 mmol/L, equivalent to 150 mg/L, as CaCO3
- Test temperature:
- Test start: 19.8 to 20.4°C
Aged media at 24 hours: 20.0 to 20.1°C
Fresh media at 24 hours: 20.0 to 20.2°C
Aged media at 48 hours: 19.9 to 20.0°C - pH:
- Test start: 8.0 to 8.3
Aged media at 24 hours: 7.8 to 7.9
Fresh media at 24 hours: 7.9
Aged media at 48 hours: 7.9 to 8.0 - Dissolved oxygen:
- Test start: 8.7 to 8.8 mg/L
Aged media at 24 hours: 8.5 to 8.7 mg/L
Fresh media at 24 hours: 8.8 mg/L
Aged media at 48 hours: 8.4 to 8.5 mg/L - Conductivity:
- < 5 μS/cm
- Nominal and measured concentrations:
- Nominal: 0.85, 1.9, 4.1, 9.1 and 20 mg test item/L
Mean measured: 0.655*, 1.58, 3.40, 7.50 and 17.3 mg test item/L
*For values- Details on test conditions:
- TEST SYSTEM
- Test vessel: Beaker
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: Glass, 110 mL, containing maximum amount of test medium possible, with the remaining headspace reduced to the technically possible minimum, with conical glass stopper.
- Renewal rate of test solution (frequency/flow rate): Media renewed after 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Analytical grade salts and additives added to deionised water at the following nominal concentrations;
Main compounds; CaCl2·2 H2O = 293.80 mg/L, MgSO4·7 H2O = 123.30 mg/L, KCl = 5.80 mg/L, NaHCO3 = 64.80 mg/L, Na2SiO3·9 H2O = 10.00 mg/L, NaNO3 = 0.27 mg/L, KH2PO4 = 0.14 mg/L, K2HPO4 = 0.18 mg/L
Trace elements: H3BO3 = 2860 μg/L, MnCl2·4 H2O = 361 μg/L, LiCl = 306 μg/L, RbCl = 71 μg/L, SrCl2·6 H2O = 152 μg/L, NaBr = 16 μg/L, Na2MoO4·2 H2O = 63 μg/L, CuCl2·2 H2O = 17 μg/L, ZnCl2 = 13 μg/L, CoCl2·6 H2O = 10 μg/L, KI = 3.3 μg/L, Na2SeO3 = 2.2 μg/L, NH4VO3 = 0.6 μg/L, Na2EDTA·2 H2O = 2.5 mg/L, FeSO4·7 H2O = 1.0 mg/L
Vitamins: Thiamin HCl = 75.0 μg/L, Cyanocobalamin (B12) = 1.0 μg/L, Biotin (B6) = 0.75 μg/L
- Metals: None reported except test media components
- Alkalinity: 0.9 mmol/L
- Ca/mg ratio: Not reported
- Conductivity: < 5 μS/cm
- Culture medium different from test medium: No
- Intervals of water quality measurement: Water temperature, pH and dissolved oxygen concentrations determined at test start, in aged and fresh media at 24 hours and test end.
OTHER TEST CONDITIONS
- Photoperiod: 16 h light : 8 h dark
- Light intensity: 580 - 640 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mobility after 24 and 48 hours
RANGE-FINDING STUDY
- Results used to determine the conditions for the definitive study: Yes- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate tested at least twice per year
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 6.21 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % CI: 4.98 - 7.76 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 3.1 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % CI: 2.17 - 4.41 mg/L
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.655 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 7.33 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % CI: 5.81 - 9.24 mg/L
- Duration:
- 24 h
- Dose descriptor:
- EC10
- Effect conc.:
- 3.46 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % CI: 2.39 - 5.02 mg/L
- Duration:
- 24 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.655 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Mortality of control: 0 after 48 hours
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No- Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Relevant effect levels: 24 hrs EC50 must be between 0.6 and 2.1 mg potassium dichromate/L
- EC50: 24 hrs EC50: 0.959 mg/L; 48 hrs EC50: 0.765 mg/L, 95% CI: 0.650 - 0.888 mg/L;- Reported statistics and error estimates:
- The 24-hour and 48-hour EC50, EC10 and the 95 % confidence limits were calculated by logit analysis. The NOEC and LOEC after 24 and 48 hours were determined directly from the raw data. All analysis performed using ToxRat Professional, Version 3.2.1.
Summary of Analytical Results
Nominal Test Concentration
(mg test item/L)
Fresh test media (0 h) Aged test media (24 h) Mean measured concentration % of nominal 1 RSD (%) n % of nominal1 RSD (%) n mg test item/L n Control n.a. n.a. 4 n.a. n.a. 4 n.a. 8 0.85 91 9 4 77 12 4 0.655 8 1.9 88 12 4 79 13 4 1.58 8 4.1 87 11 4 78 11 4 3.40 8 9.1 86 10 4 79 12 4 7.50 8 20 91 5 4 82 10 4 17.3 8 1: mean value of all measured samples per treatment group
italics: Values below the LOQ. For values <LOQ, half the LOQ was used for calculation measured concentrations according to OECD Guidance Document No. 23
RSD: relative standard deviation per treatment group
n: number of samples analysed
n.a.: not applicable
Influence of the test itme on the mobility of Daphnia magna
Mean measured
(mg test item/L)
No. of Daphnia tested No. of immobilised Daphnia after % of immobilised Daphnia after 24h 48h 24h 48h Control 20 0 0 0 0 0.655 20 0 0 0 0 1.58 20 1 1 5 5 3.4 20 2 2 10 10 7.5 20 8 12 40 60 17.3 20 20 20 100 100 Influence of test item on the mobility of Daphnia magna
Endpoint (mg test item/L) 24 hours 48 hours EC50 7.33 6.21 95 % CI 5.81 - 9.24 4.98 - 7.76 EC20 4.57 4.00 95 % CI 3.41 - 6.10 3.02 - 5.30 EC10 3.46 3.10 95 % CI 2.39 - 5.02 2.17 - 4.41 NOEC 0.655 0.655 LOEC 1.580 1.580 Values refer to mean measured test concentrations
CI: Confidence Interval
NOEC and LOEC determined directly from the raw data
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on mean measured concentrations, the 48-hour EC50 for the test item to Daphnia magna was 6.21 mg test item /L, with 95 % confidence interval of 4.98 - 7.76 mg test item/L. The 48-hour NOEC was 0.655 mg test item/L.
- Executive summary:
The acute toxicity of the test item to Daphnia magna was determined in a static renewal test following OECD guideline 202, with media renewal after 24 hours. Daphnia were exposed to nominal concentrations of 0.85, 1.9, 4.1, 9.1 and 20 mg test item/L, equivalent to mean measured concentrations of 0.665, 1.58, 3.40, 7.50 and 17.3 mg test item/L, alongside a control. Based on mean measured concentrations, the 48-hour EC50 was 6.21 mg test item/L, with 95 % confidence interval of 4.98 to 7.76 mg test item/L. The 48-hour NOEC was 0.655 mg test item/L.
The study is a GLP compliant, guideline experimental study available as an unpublished study report. There are no restrictions and the study is fully adequate for assessment.
Reference
Description of key information
The 48-hour EC50 of the test item to Daphnia magna was determined to be 6.21 mg test item/L, with 95 % confidence interval of 4.98 to 7.76 mg test item/L, based on mean measured concentrations. The 48 -hour NOEC was 0.655 mg test item/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 6.21 mg/L
Additional information
The acute toxicity of the test item to Daphnia magna was determined in a static renewal test following OECD guideline 202, with media renewal after 24 hours. Daphnia were exposed to nominal concentrations of 0.85, 1.9, 4.1, 9.1 and 20 mg test item/L, equivalent to mean measured concentrations of 0.665, 1.58, 3.40, 7.50 and 17.3 mg test item/L, alongside a control (2017). The study is a GLP compliant, guideline experimental study available as an unpublished study report. There are no restrictions with the study is fully adequate for assessment..
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