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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 235-979-5 | CAS number: 13078-36-9
- 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
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26-30 May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Good quality study with analysis, however there is no certificate of analysis. The study was assigned a reliability score of 2 based on the water hardness of 350 mg/L which was outside of the preferred range of 10 - 250 mg/L CaCO3. The toxicity of the test substance is known to decrease with increasing water hardness.
- Justification for type of information:
- The source substance (DTPA 5K) and the target substance (DTPA 3Na) are the pentapotassium and trisodium salts of the same organic acid and are therefore structurally very similar. The source substance has a purity of 97.0%, but since the target material is > 99.9% pure and contains no detectable impurities, the extrapolation of acute oral toxicological properties from the source material to the target material is considered valid as a ‘worst case' scenario. The two substances are of comparable high water solubility. The source material short- term toxicity study was conducted according to OECD test guideline 203 and is considered reliable with restrictions (Category 2).
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- Test water hardness slightly above recommended upper range limit
- Deviations:
- yes
- Principles of method if other than guideline:
- Recommended hardness of water: 10-250 mg/L CaCO3 test water hardness was 350 mg/l CaCO3. This is considered not to have had a significant effect on the results of the test.
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken after 0, 24 and 96 hours and analyses were conducted using a spectophotometer.
- Details on test solutions:
- Test solutions were prepared by direct dispersion in water, control and 1000 mg/L.
Dilutions were made in Laboratory tap water, dechlorinated by the addition of sodium
thiosulphate. Total hardness = 350 mg/l as CaCO,. This value is
slightly higher than the recommended range but is not considered to
have had any significant effects on the results of the test. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- Rainbow trout (salmo gairdneri)
Source: Parkwood trout farm, Wigmore, kent, United Kingdom.
The stock of fish was held since 16 February 1987 and was acclimatised to test conditions from 19 - 26 May 1987.
Temperature: 14 ± 1ºC
Mortalities: 0%
Medication: none
Fish were fed daily with commercial trout pellets, but feeding was discontinued 24h prior to the test.
Mean standard length = 4.8 cm (SD = 0.3 cm), mean weight = 1.77 g (SD = 0.33 g), no data on age of fish. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- no
- Hardness:
- 350 mg/L CaCO3
- Test temperature:
- 14 ºC
- pH:
- 7.2-7.8
- Dissolved oxygen:
- 9.6-9.7 mg O2/L
- Salinity:
- no data
- Nominal and measured concentrations:
- nomimal concentrations: 0 and 1000 mg/L
analyses shoed concentrations to be between 104-127% of the nominal concentration. On average the concentration is within the 80-120% of the
nominal concentration and therfore the reported concentation is indeed 1000 mg/L. - Details on test conditions:
- There was a daily renewal of test media to ensure stability of the test concentrations.
The lighting was controlled at 16h light- 8 h darkness cycle.
Test vessels: Glass aquaria holding 40L of test media. 1 test concentration in duplicate, plus 1 control (20 animals per test concentration).
Fish were placed at random in prepared test media, loading 0.45 g bodyweight/L.
Aeration via narrow bore glass tubes.
Criteria of death: absence of (i) respiratory movement and (ii) response to a physical stimulation. - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 000 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- highest tested concentrations of 1000 mg/L caused no mortality at all.
- Results with reference substance (positive control):
- no reference substance tested
- Sublethal observations / clinical signs:
no mortality occured in this test
- Validity criteria fulfilled:
- yes
- Conclusions:
- Good quality study, however no certifcate of analysis or detailed description of the substance compositionis given, therefore the substance identity
is not sufficient. - Executive summary:
Test Substance: Glycine N-N Bis[2-[Bis(carboxymethyl)amine]ethyl]-pentapotassium salt
Test Species: Rainbow trout (Salmo Gairdneri)
Test type: Acute toxicity 96 h LC50
Test conditions: Semi-static test conditions accordi ng to OECD Guideline No. 203 referenced and EEC Directive 67/584 annex V
C.1 as publishec in 84/449/EEC
RESULTS:
LC50 (3, 6, 24, 48, 72 and 96h) > 1000 mg/L
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The source substance (DTPA 5K) and the target substance (DTPA 3Na) are the pentapotassium and trisodium salts of the same organic acid (Diethylenetriaminepentaacetic acid) and are therefore structurally very similar. The two substances have high water solubility and would be dissociated in the aquatic environment. The trisodium salt is manufactured by the addition of an appropriate molar ratio of sodium hydroxide to the parent acid to give a neutral solution. The target substance is pH 7.5 +/ 0.5) in solution which is comparable to the test conditions used for the short-term fish toxicity test with the penta potassium salt (pH 7.2-7.8). The common organic acid moiety has a chelating mode of action and would be expected to exert long-term, non-specific adverse, systemic effects by the sequestration of essential metal ions, rather than acute toxicity. The counter ions would have no significance influence on the toxicities of the two substances. The extrapolation of short-term aquatic toxicity potential from the source to the target substance is therefore considered valid.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 000 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Conclusions:
- The 96hour LC50 of DTPA trisodium salt to fish is predicted to be in excess of 1000 mg/l.
Referenceopen allclose all
Description of key information
Using a read-across approach from a study conducted on the structural analogue DTPA penta potassium salt, the EC50 of DTPA trisodium salt to fish (Salmo gairdneri) is predicted to be at least 1000 mg/L (on stoichiometric basis). The two substances are structurally very similar, particularly when ionised in the aqueous environment. Moreover, the fish acute toxicity study of DTPA penta potassium salt was undertaken at a pH (7.2-7.8), comparable to the neutral pH of the test substance.
.
Key value for chemical safety assessment
Additional information
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.