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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-184-1 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 31.10.1978 to 03.11.1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Objective of study:
- other: absorption, distribution and excretion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- To provide preliminary information about the absorption, distribution and excretion of a compound after its administration to animals.
- GLP compliance:
- no
Test material
- Reference substance name:
- [[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid
- EC Number:
- 239-931-4
- EC Name:
- [[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid
- Cas Number:
- 15827-60-8
- Molecular formula:
- C9H28N3O15P5
- IUPAC Name:
- [(bis{2-[bis(phosphonomethyl)amino]ethyl}amino)methyl]phosphonic acid
- Test material form:
- liquid
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: No data
- Weight at study initiation: 196 to 203 g
- Fasting period before study: yes, overnight and four hours after dosing
- Housing: Metabolism cages
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): No data
- Acclimation period: At least four days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: 31.10.1978 to 03.11.1978
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Not reported
HOMOGENEITY AND STABILITY OF TEST MATERIAL: No details - Duration and frequency of treatment / exposure:
- Single dose
Doses / concentrations
- Dose / conc.:
- 47 mg/kg bw/day
- Remarks:
- 1 ml (10 mg TS/ml) - dose of active 47±2 mg/kg
- No. of animals per sex per dose / concentration:
- Three males in total
- Control animals:
- no
- Positive control reference chemical:
- None
- Details on study design:
- - Dose selection rationale: None given
- Details on dosing and sampling:
- For 72 hours after dosing the animals were housed in metabolism cages designed to separate urine, feces and expired CO2. The rats were fitted with fecal cups. Accumulated urine and feces was collected at 24, 48 and 72 hours after application of the test substance. CO2 was collected from the rats at 8 hour intervals for 72 hours (3 samples/day/rat).
SAMPLE COLLECTION
- Collection of blood: Blood samples taken at terminal sacrifice at 72 hours.
- Collection of urine and faeces: metabolism cages and fecal cups.
- Collection of expired air: metabolism cages
- Terminal procedure: Ether
- Analysis of organs: All organs and tissues removed for analysis.
SAMPLE PREPARATION
- Storage procedure: Samples frozen until analysis.
- Preparation details: Organs and tissues rinsed with water and blotted with paper towel. Fat or connective tissue from the organs removed and placed in sample jars. Organs that have internal cavities (heart, gall and urinary bladders) cut open and rinsed with water. If the urinary bladder contained urine, this urine was rinsed into the urine 48-72 hour collection. Skin samples were taken from the back of the animals. Bone samples were taken from the femur after the bone marrow had been removed. Muscle samples were taken from the hind limb. Adipose tissue samples were taken from the area of the psoas muscle. Carcasses were then frozen with dry ice before grinding in a Wiley mill.
ANALYSIS
- Method type(s) for identification: Liquid scintillation counting
- Liquid scintillation counting results (cpm) converted to dpm as follows: No details
- Validation of analytical procedure: No details
- Limits of detection and quantification: No details
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- 2%
- Type:
- distribution
- Results:
- Affinity for bone (concentration of radioactivity in bone was 9 x greater than any other tissue)
- Type:
- excretion
- Results:
- 98% excreted in feces by 72 hours, 1.3% in urine and 0.4% in CO2.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- 98% of the dose was excreted into feces, leaving 2% that was absorbed.
Total recovery: 100.6 ± 3.3% - Details on distribution in tissues:
- Liver: 0.01± 0.00%
Kidneys: 0.004 ± 0.001%
Testes: 0.001± 0.000%
Carcass: 0.6 ± 0.2%
Cage wash: 0.0± 0.0%
GI tract: 0.005± 0.003%
GI wash: 0.0 ± 0.0%
Lung: 0.0009 ± 0.0001%
Spleen: 0.0002± 0.0002%
Pancreas: 0.0 ± 0.0%
Brain: 0.0 ± 0.0%
Muscle: 0.0 ± 0.0%
Bone: 2.9 ± 0.79 µg/g
Bone Marrow: 0.0 ± 0.0 µg/g
Blood: 0.05 ± 0.05 µg/g
Plasma: 0.03 ± 0.02 µg/g
Adipose: 0.0 ± 0.0 µg/g
- Details on excretion:
- Total excretion in urine: 1.3 ± 0.2%;
Total excretion in feces: 98 ± 4%;
Total excretion in CO2: 0.4 ± 0.0%
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
Table 1 Average excretion (% of dose ± SD) of neutralised DTPMP following oral ingestion.
0 -24 h | 24 -48 h | 48 -72 h | Total | |
Urine | 1.2 ± 0.2 | 0.06 ± 0.009 | 0.03 ± 0.01 | 1.3± 0.2 |
Feces | 94 ± 5.2 | 4.3 ± 1.5 | 0.1 ± 0.005 | 98 ± 4 |
CO2 | 0.4 ± 0.0 (0 -8 h); Not detected (8 -24 h) | Not detected | Not detected | 0.4 ± 0.0 |
Applicant's summary and conclusion
- Conclusions:
- In an oral toxicokinetics study in rats, conducted prior to GLP (reliability score 2), 98% of the dose (oral gavage) of neutralised DTPMP was excreted in feces within 72 hours. Of the remaining dose 1.3% was found in urine and 0.4% in expired CO2. Minor quantities were found in various tissues, but the bone was found to have nine times more (2.9 ± 0.79 µg/g) than any other organ or tissue.
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