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Diss Factsheets
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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
There are no reproductive fertility studies available for DTPA 3Na. In accordance with Annex VIII 8.7.1 Column 2, a screening reproductive toxicity/developmental study (OECD421) was considered unnecessary, since a pre-natal developmental toxicty study on DTPA 5Na is available.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Using a read-across extrapolation approach from a GLP, OECD 414 guideline study on the structural analogue DTPA pentasodiuum salt, the maternal and developmental NOAELs of DTPA trisodium salt in rats are predicted to be 400 and 100 mg/kg bw/day or above (taking stoichiometric considerations into account). The two substances are structurally similar and have the same metal ion, chelating mode of action.
Link to relevant study records
- Endpoint:
- developmental toxicity
- 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 5Na) and the target substance (DTPA 3Na) are the pentasodium and trisodium salts of the same organic acid (Diethylenetriaminepentaacetic acid) and are therefore structurally very similar. The two substances have comparable high water solubility and would be rapidly and fully dissociated into common anions and cations in the gastro-intestinal tract. The absorption, distribution and metabolism of the two substances would therefore be expected to be essentially identical. The common organic acid moiety has a chelating mode of action and the trisodium salt would be expected to exert similar adverse developmental effects by the sequestration of essential metal ions.
- Reason / purpose for cross-reference:
- read-across source
- Specific details on test material used for the study:
- 99% w/w
- Species:
- rat
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- day 6 through day 15 post coitum
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Basis for effect level:
- other: teratology
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 400 mg/kg bw/day (actual dose received)
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects occurring together with maternal toxicity effects, but not as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Conclusions:
- The maternal and developmental rat oral NOAELs of DTPA trisodium salt are predicted to be 400 and 100 mg/kg bw/day or above, respectively.
- Executive summary:
The maternal and developmental rat oral NOAELs of DTPA pentasodium salt are 400 and 100 mg/kg bw/day respectively (OECD 414). DTPA pentasodium salt is structurally similar to DTPA trisodium salt and the analogue has the same metal sequestering systemic mode of action as the target substance. Based on a read-across approach, and taking into account stoichimetry, DTPA trisodium salt is predicted to have similarly or slightly higher oral NOAEL of circa 400 and 100 mg/kg bw/day.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Species:
- rat
- Quality of whole database:
- (Category 1 (Relaible without restriction)
Justification for classification or non-classification
DTPA trisodium salt is considered to meet the CLP criteria for classification as 'reproductive toxicity: category 2.'
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.
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