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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-714-0 | CAS number: 1474044-77-3
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 April 2016 to 15 June 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.20 (Daphnia magna Reproduction Test)
- Version / remarks:
- Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000
- Principles of method if other than guideline:
- The test was performed on a water accomodated fraction
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0, 0.46, 1.0, 2.2, 4.6 and 10 mg/L
- Sampling times: on day 0, 6, 9, 10 and 14 from fresh solutions; on day 2, 8, 10 and 16 from old solutions
- Sample storage conditions before analysis: stored in freezer (≤ -15°C). Storage stability of samples under these conditions was demonstrated in project 498817.
- On the day of analysis, the test samples were defrosted at room temperature. The samples were diluted in a 1:1 (v:v) ratio with acetonitrile and analysed. Calibration solutions were injected in duplicate. Test samples and QC samples were analysed by single injection. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION:Preparation of test solutions started with individual loading rates ranging from 0.46 to 100 mg/L applying 2-day period of magnetic stirring. The obtained mixtures containing undissolved material were filtered through a 0.45 µm membrane filter (RC55, Whatman). All tested solutions were clear and colourless.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Daphnia magna (Crustacea, Cladocera) (Straus, 1820)
- Source: in-house culture
- Age of parental stock: at least third generation (2nd to 5th brood of parental daphnids 2-4 weeks of age)
- Feeding during test: algae suspension + marinure (ratio 5:1)
- Amount: 0.3 mg C/daphnia/day (adjusted in the weekend)
- Frequency: daily (and once per weekend)
mortality <20%, no presence of males, no ephippia or discoloured animals and there was no delay in the production of the first brood. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 196-232 as mg CaCO3/L
- Test temperature:
- 19-21°C
- pH:
- fresh solutions: 7.7-8.1
old solutions: 7.8-9.2 - Dissolved oxygen:
- fresh solutions: 8.3-9.4 mg/L
old solutions: 7.6-12 mg/L - Nominal and measured concentrations:
- Nominal: 0, 0.46, 1.0, 2.2, 4.6 and 10 mg/L
Measured (average): NA, 0.0052, 0.17, 0.14, 0.20 and 0.28 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: all glass 60 mL
- Type: closed
- Aeration: no
- Renewal rate of test solution: every 48 hours (except on day 8 and 9 every 24 hours)
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 20
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M7, as prescribed by Dr. Elendt-Schneider
:Composition of medium M7 (TOC 0.051mg/L):
Adjusted ISO medium: the following chemicals (analytical grade) are dissolved in tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands):
Macro salts: CaCl2.2H2O 211.5 mg/L
MgSO4.7H2O 88.8 mg/L
NaHCO3 46.7 mg/L
KCl 4.2 mg/L
Medium M7: trace elements, macro nutrients and vitamins are added to freshly prepared ISO medium to reach the following concentrations:
Trace elements: B 0.125 mg/L
Fe 0.05 mg/L
Mn 0.025 mg/L
Li, Rb and Sr 0.0125 mg/L
Mo 0.0063 mg/L
Br 0.0025 mg/L
Cu 0.0016 mg/L
Zn 0.0063 mg/L
Co and I 0.0025 mg/L
Se 0.0010 mg/L
V 0.0003 mg/L
Na2EDTA.2H2O 2.5 mg/L
Macro nutrients:
Na2SiO3.9H2O 10.0 mg/L
NaNO3 0.27 mg/L
KH2PO4 0.14 mg/L
K2HPO4 0.18 mg/L
Vitamins: Thiamine 75.0 µg/L
B12 1.0 µg/L
Biotin 0.75 µg/L
The hardness: 180 mg/L expressed as CaCO3 and the pH: 7.7 ± 0.3.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h daily
- Light intensity: at the start: 693-751 lux ; the end: 609-682 lux
EFFECT PARAMETERS MEASURED :
Parental
Number of living, immobile and dead parental daphnids; e very workday and upon renewal on non-workdays.
Presence of eggs in the brood pouch: every workday and upon renewal on non-workdays.
Body length: at the end of the test.
Offspring
Appearance first brood: Wwen observed.
Newborn daphnids (number and condition): every workday and upon renewal on non-workdays (young were removed).
Presence of unhatched eggs: when observed.
Incidence of immobility:when observed.
Test medium
Temperature, oxygen and pH: at the start of the test and just before and after each renewal in one of the vessels of each test group with surviving daphnids.
Hardness: weekly in fresh and old media from the control and the highest test concentration
Light: at the start and the end of the test
TEST CONCENTRATIONS
- Range finding study: yes 10 days at 0,1.0, 10 and 100 mg/L (renewal at day 1, 3 and 6); performed with WAF concentrations over 24 and 48 h 85-98% of initial, over 72 hours 60-71% of initial --> attributed to adsorption to algae
- Results used to determine the conditions for the definitive study: mortality of all parental daphnids at 100 mg/L; reduced reproduction at 10 mg/L - Reference substance (positive control):
- no
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- 4.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- 2.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- 10 < mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: no dose response
- Details on results:
- - Observations on body length: significantly decreased at 4.6 and 10 mg/L
- Other biological observations: discoloration at 4.6 and 10 mg/L
- Parental mortality (immobility): 5, 10, 10, 30, 0 and 40% at 0, 0.46, 1.0, 2.2, 4.6 and 10 mg/L (in absence of a dose response no statistical significant effect could be assessed)
- Effect on reproduction:
mean cummulative number of juveniles per introduced parent: 166.1, 165.6, 170.7, 132.7, 155.2 and 113.5 at 0, 0.46, 1.0, 2.2, 4.6 and 10 mg/L
mean cummulative number of juveniles per surviving parent: 169.4, 182.0, 181.7, 157.1, 155.2 and 141.7 at 0, 0.46, 1.0, 2.2, 4.6 and 10 mg/L
- Day of first brood: no treatment related effects - Reported statistics and error estimates:
- very extensive statistical evaluation of the results was performed leading to the following:
Effect parameters
Parameter Loading rate (mg/L)
NOEL for reproduction 4.6*
EL10 for reproduction 2.7 (0.46-16)* ; 5.2 (3.3-8.2)#
EL50 for reproduction >10
NOEL for mortality 10
NOEL for growth 2.2
() – 95% confidence intervals, * - based on introduced daphnids, # - based on surviving parents**- based on absence of dose-response - Executive summary:
In a semi-static daphnia reproduction study (OECD 211) daphnids were exposed during 21 days at loading rates of 0, 0.46, 1.0, 2.2, 4.6 and 10 mg/L (WAF). Mean measured concentrations were NA, 0.0052, 0.17, 0.14, 0.20 and 0.28 mg/L. Effects on growth were reported at a loading rate of 2.2 mg/L. The NOEL for reproduction and mortality were 4.6 and 10 mg/L(expressed as loading rate).
Reference
Description of key information
In a semi-static daphnia reproduction study (OECD 211) daphnids were exposed during 21 days at loading rates of 0, 0.46, 1.0, 2.2, 4.6 and 10 mg/L (WAF) to close analogue of the substance (its calcium salt). Mean measured concentrations based on the acid part of the molecule were NA, 0.0052, 0.17, 0.14, 0.20 and 0.28 mg/L. Effects on growth were reported at a loading rate of 2.2 mg/L. The NOEL for reproduction and mortality were 4.6 and 10 mg/L(expressed as loading rate).
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.2 mg/L
Additional information
The NOAEL is based on effects on reproduction.
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.