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EC number: 200-652-8 | CAS number: 67-43-6
- 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
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- chronic toxicity: other route
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published data, information on methods and results is sufficient to make an assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological Studies on DTPA
- Author:
- Planas-Bohne, F.
- Year:
- 1 976
- Bibliographic source:
- Diagn Treat Inc Radionuclides Proc Int Semin 1975 505-515,1976 Tax - Rattus, Heiligenberg
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: Other
Repeated dose study in rats using twice weekly intraperitoneal injection of the test material for up to 44 weeks. - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Calcium and zinc salts of DTPA
- IUPAC Name:
- Calcium and zinc salts of DTPA
- Details on test material:
- - Name of test material: Ca DTPA and Zn DTPA
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Heiligenberg
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: 5 weeks
- Weight at study initiation: no data
- Fasting period before study: no
- Housing: no data
- Diet (e.g. ad libitum): Altromin-R pellets ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiological saline
- Details on exposure:
- Experiment 1 - Groups of 10 male and 10 female Heiligenberg strain rats were injected intraperitoneally twice a week - one with 0.9% saline, one with 100 µmol/kg Ca-DTPA and one with 100 µmol/kg Zn-DTPA for 44 weeks. Six months after the begining of treatment, the animals were mated with untreated rats. During pregnancy the rats did not receive any treatment and during the nursing time they were injected subcutaneously
Experiment 2 - Groups of rats were exposed doses ranging from 0.037 - 5 mmol/kg/day over a period ranging from 5 - 10 days, administered either once daily or in five fractions per day with an interval of 2 hours - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 5 days - 44 weeks
- Frequency of treatment:
- once daily - twice a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Experiment 1 - 100 µmol/kg Ca-DTPA and 100 µmol/kg Zn-DTPA (The concentration of the stock solutions was 0.4 mmol/ml. The solutions were diluted with 0.9% saline to the concentration required. The injection volume was 1 ml/100 g).
100 µmol/kg Ca-DTPA and 100 µmol/kg Zn-DTPA is equivalent to approximately 40 mg/kg bw/day DTPA acid
Experiment 2 - 0.037 - 5 mmol/kg/day
- No. of animals per sex per dose:
- Experiment 1 - 10 male + 10 female rats/group
Experiment 2 - no data - Control animals:
- not specified
- Details on study design:
- - Dose selection rationale: no data
- Rationale for animal assignment (if not random): no data
Examinations
- Observations and examinations performed and frequency:
- Experiment 1 - The body weight was measured every week and the following parameters recorded every six weeks: the packed cell volume , the haemoglobin (Coulter haemoglobinometer), the number of erythrocytes and leucocytes, and the reticulocytes and platelets. For measuring the absorption of 51Cr(III)-EDTA from the intestine, 10 µCi of 51Cr-EDTA per animal were administered by a gastric tube. Immediately afterwards the animals were placed in metabolic cages allowing quantitative separation of urine and faeces. Six months after the begining of treatment, the animals were mated with untreated rats and evaluated on the reproductive capacity (litter size, weight of foetus and resoprtions/dam) and malformations of the litter
Experiment 2 - mortality - Sacrifice and pathology:
- Experiment 1 - After 44 weeks the animals were sacrificed and a gross autopsy performed. Bone marrow smears were stained and differentiated. Parts of the kidneys, liver, spleen and small intestine were fixed in Bouin’s solution. After the tissues had been embedded in paraffin, 5 µm sections were stained with haematoxyline-eosin. The rest of the kidneys and liver and 10 cm of the small intestine were used to measure the Zn and Mn concentration. The tissues were digested under pressure at 180°C with 65% HNO3 in special teflon vials and the metal concentration was measured after appropriate dilution with triple-distilled water by atomic absorption spectrophotornetry.
Malformations in the litter were evaluated in the latter part of the experiment
Experiment 2 - The surviving animals were sacrificed at the end of the treatment and packed cell volume, the number of erythrocytes/ µl and the number of thrombocytes per 103 erythrocytes in stained smears were determined - Other examinations:
- no data
- Statistics:
- descriptive statistics
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Experiment 1:
There were no effects on body weight and weight gain and treatment with either chelates did not have any untoward effects on the hematological and biochemical parameters. The enteral absorption of 51Cr-EDTA not the urinary excretion of hydroxyproline were affected. Gross pathology and histopathology revealed no changes attributable to the treatment. Evaluaion of bone marrow did not reveal any changes. Concentrations of Zn and Mn in kidneys, liver and small intestine were unaffected by treatment with Ca-DTPA or Zn-DTPA
No abnormalities on the reproductive capacity or malformations in litters were observed in either the Ca-DTPA or the Zn-DTPA groups
Experiment 2:
DTPA when administered as a fraction evoked a more drastic response in lethality rather than when administered as repeated injections
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- Ca-DTPA
- Effect level:
- 100 other: micromole/kg bw
- Sex:
- male/female
- Basis for effect level:
- other: No effects observed
- Dose descriptor:
- NOAEL
- Remarks:
- Zn-DTPA
- Effect level:
- 100 other: micro mole/kg bw
- Sex:
- male/female
- Basis for effect level:
- other: No effects observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- The results of two experiments are presented and discussed. (I) A 44-week treatment of rats with 100 µmol/kg of both Ca-DTPA and Zn-DTPA twice weekly did not bring about any adverse effects in the treated animals or their offspring. (2) Continuous infusion of Ca-DTPA was shown to be drastically more toxic than repeated injections, whereas Zn-DTPA did not show this dependence on the treatment schedule.
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