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EC number: 813-880-3 | CAS number: 2055396-18-2
- 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 fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2013-1-21 - 2013-1-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP study meeting all of the critical quality criteria. Analytical certificate present.Validated chemical analysis method used. Appropriate guideline followed. Considered valid without significant restrictions.
- Justification for type of information:
- The underlying hypothesis for the read-across is that chelates have the same mode of action based on their ability to chelate, remove or add metal cations to body causing perturbation of body’s micronutrients balance.
The source substance is a chelating agent in a target substance. The only difference between the target and the main source substance is presence of iron (Fe) and potassium (K) cations instead H+ cations. As iron and potassium are an essential macro- and microelements required by all forms of life, is considered not to influence the toxicological activity.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study according to international guideline (EPA-600/3 -75 -009 and ASTM method E729 -80). Limited reporting on test species. No chemical analyses of test concentrations. No data available to determine whether validity criteria are met.
- Justification for type of information:
- A substantial body of evidence exists that the toxicity profiles of chelates depends mainly on metal ion, its affinity to this metal, and their ability to supply or to sequester it from the body/environment. Both EDTA and DTPA are chelates with similar structure and physico-chemical properties tham their toxicity are also similar. Please see RA statement in section 13.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: EPA-600/3-75-009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ASTM Standard E 729-80
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- no
- Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- Pimephales promelas
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Sublethal observations / clinical signs:
No data
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The acute toxicity (96h-LC50) of sodium ferric EDTA towards Pimephales promelas is >100 mg/l.
- Executive summary:
The acute toxicity (96h-LC50) of sodium ferric EDTA towards Pimephales promelas was investigated according to EPA-600/3 -75 -009 and ASTM method E729 -80. The toxicity value was found to be >100 mg/l.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium hydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)
- EC Number:
- 235-627-0
- EC Name:
- Sodium hydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)
- Cas Number:
- 12389-75-2
- Molecular formula:
- C14-H18-Fe-N3-O10.H.Na
- IUPAC Name:
- Iron(3+) ion sodium 5-[bis(carboxylatomethyl)amino]-3-{[bis(carboxylatomethyl)amino]methoxy}pentanoate
- Reference substance name:
- Diethylenetriaminepentaacetic acid, ferric sodium complex
- IUPAC Name:
- Diethylenetriaminepentaacetic acid, ferric sodium complex
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Product Name: Dissolvine : De-FE 11
Chemical Name: Diethylenetriaminepentaacetic acid, ferric sodium complex
Purity:97.2
Appearance: Yellow / Green Crystals
Cas Number: 12389-75-2
Project Number: T12050
Constituent 1
Constituent 2
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken of the only test concentration and the control solution at the start and at the end of the test as well as before and after solution refreshment.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test chemical is soluble and prone to photo degradation. For this reason a semi static method with solution refreshment was chosen. A solution of approximately 100 mg/L was made by adding of an accurately weighed amount of the test substance to the test media and stirring until a homogenous solution was achieved. For both the first and the second stock solutions 0.5000 g of the test substance was weighed and dissolved in 5000 ml of test medium measured using a volumetric flask.
The pH of the first stock solution was 7.3 and this was adjusted to 8.1 with NaOH. The pH of the second stock solution was 6.9 and was adjusted to 8.2 with NaOH.
The stock solution was used directly in the test as the only test concentration. DSW was used directly in the control group.
The test medium was Dutch Standard Water (DSW), with a pH of approximately 8.2, and a conductivity between 550 and 650 µs/cm s-1, containing per
liter of de-ionized water: 200 mg of CaCl2•2H2O, 180 mg of MgSO4•7H2O, 100 mg of NaHCO3 and 20 mg of KHCO3. The guideline criteria requires the CaCO3 content to be between 10 and 250 mg/L. Hardness and conductivity in the test water was measured measured once at the start of the study as ºdH using the appropriate Dr Lange test kit and converted to the CaCO3 equivalent. Due to the total hardness kit measuring Calcium (as well as magnesium) the test kit was validated by analyzing a known CaCl2 Standard solution.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- The test was performed with juvenile Danio rerio (zebra fish) which, were accepted for use in testing according to laboratory standard operating procedures and as recommended in the corresponding OECD guideline . The batch was obtained from the “Dieren vriend” in Arnhem the Netherlands. The fish in stock were fed one to three times per day with commercially available dry, deep frozen food, or fresh Artemia salina nauplii /juvenile Daphnia magna neonates. Feeding was stopped 24 hours before the test was started, and the animals were not fed during the test. A representative number of test fish (10 at random) were weighed prior to the test and measured after the test to assess compliance with guideline criteria. The same number of
fish were measured at the end of the study for compliance with the length recommendations for this species.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- Length of fish measured post exposure as well as a general physical examination.
Test conditions
- Hardness:
- 233 mg/L as calcium carbonate
- Test temperature:
- 22.2 to 22.9°C.
- pH:
- 7.8 to 8.1
- Dissolved oxygen:
- 7.7 to 9.0 mg/L
- Salinity:
- Not measured
- Nominal and measured concentrations:
- Nominal = 100 mg/L
Measured (lowest measured value)= 93.2 mg/L - Details on test conditions:
- The test was performed as a semi static limit test which means that the test media was replaced after 48 hours to ensure test solution stability and
only a single test concentration was tested. The minimum requirement of 7 fish per test concentration and control were used for ethical reasons.
Under otherwise identical test conditions, the fish were exposed to the chosen concentration of the test substance as described below and mortality and sub-lethal effects were recorded at least at 30 minutes, 1, 2 and 4 hours after exposure and then and then at least 24, 48, 72 and 96 hours
with intermediate observations as often as possible. Particular attention was given to the test animals at the start of the test and directly after solution refreshment.
The fish were randomly placed in the test 3 liter glass test vessels / aquaria which were positioned in the test room in a random manner.
During the test the vessels were covered with glass plates. The test solutions present in the test vessels were aerated gently with water saturated air purified by an active coal filter and a cotton filter during testing. - Reference substance (positive control):
- no
- Remarks:
- No longer permitted by Article 14 Animal testing expert.
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: Measured Concentrations >80% (Nominal used)
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: N/A
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: Measured Concentration >80% (Nominal used)
- Basis for effect:
- behaviour
- Remarks:
- No behavioural effects observed
- Remarks on result:
- other: N/A
- Details on results:
- The results indicate no effects on mortality or behaviour at an analytically confirmed concentration of 100 mg/L.
- Results with reference substance (positive control):
- Not conducted
- Reported statistics and error estimates:
- N/A
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Chemical analysis results
Sample
Concentration (mg/L)
0 h
48 h (old)
48 h (new)
96 h
Control
< LOQ
< LOQ
< LOQ
< LOQ
100 mg/L
104.1
93.2
104.2
95.6
Biological results
Conc.
(mg/L)
No. of fish exposed
0 hours
30 minutes
1 hour
4 hours
No. dead
Effects
No. dead
Effects
No. dead
Effects
No. dead
Effects
0 (Control)
7
-
7AN
-
7AN
-
7AN
-
7AN
100
7
-
7AN
-
7AN
-
7AN
-
7AN
Conc.
(mg/L)
5.5 hours
20.5 hours
24 hours
29.5 hours
No. dead
Effects
No. dead
Effects
No. dead
Effects
No. dead
Effects
0 (Control)
-
7AN
-
7AN
-
7AN
-
7AN
100
-
7AN
-
7AN
-
7AN
-
7AN
Conc.
(mg/L)
45.5 hours
48 hours
53.25 hours
72 hours
No. dead
Effects
No. dead
Effects
No. dead
Effects
No. dead
Effects
0 (Control)
-
7AN
-
7AN
-
7AN
-
7AN
100
-
7AN
-
7AN
-
7AN
-
7AN
Conc.
(mg/L)
75.5 hours
80.5 hours
96 hours
No. dead
Effects
No. dead
Effects
No. dead
Effects
0 (Control)
-
7AN
-
7AN
-
7AN
100
-
7AN
-
7AN
-
7AN
AN=Appearing Normal
- = Not applicable
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test substance is considered as non toxic to Danio Rerio.
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.
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