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EC number: 287-370-9 | CAS number: 85480-89-3
- 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: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
- Principles of method if other than guideline:
- Similar to OECD 451
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt
- EC Number:
- 244-742-5
- EC Name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt
- Cas Number:
- 22036-77-7
- IUPAC Name:
- 22036-77-7
- Details on test material:
- Name of test material (as cited in study report): Ethylenediamine tetra (Methylene Phosphonic Acid)
- Physical state: Solid, but dissolved in water and neutralised with NaOH prior to dosing.
- Analytical purity: 96-97%
- Impurities (identity and concentrations): None identified.
- Composition of test material, percentage of components: No details on composition.
- Isomers composition:- Purity test date: No information.
- Lot/batch No.:Sample 81-0640 was used for weeks 1-68 of dosing and sample 82-0220 was used for weeks 69-107 of dosing
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 94 - 107 weeks (Note,dosage was increased to 333 mg/kg (bw) on day 329 of study)
- Frequency of treatment:
- Daily
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 15 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- other: metaphyseal osteosclerosis
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: metaphyseal osteosclerosis
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Organ weights - No statistically significant differences in absolute or relative organ weights were present between the control or any treatment group for either sex throughout the study.
Opthalmology - No treatment related effects were observed.
Body Weights - Group mean body weights in high dose males significantly decreased from week 55 until termination. No other statistically significant effects were noted in other dosage groups.
Haematology - No significant treatment related effects were observed.
Clinical chemistry – no significant treatment related effects were observed in any of the groups.
Urine analysis - No significant treatment related effects were observed.
Pathology - A significantly increased incidence of metophyseal osteosclerosis in femur, rub & sternum in high dose males and mid/high dose females.
Osteosarcomas involving primarily the long bones in both sexes incidence as follows,
Control – Males and females 0/60 respectively
15 mg/kg (bw) - Males (0/60, females 0/60)
50 mg/kg (bw) - Males (1/60, females 0/60)
150/333 mg/kg (bw) - Males (28/60, females 4/60)
Note, the first palpable bone tumour evident after 35 weeks of treatment, prior to the increase of the high dose level.
Due to the rarity of this type of tumour in rats, the finding one one tumour in the mid dose male group and four such females at the high dose was considered biologically significant, together with the high dose males. The highest incidence of osteoarcoma as found in the tibia. Metastasis sites of these tumours were the lungs, liver, regional lymph nodes, adrenals, kidneys and heart.
Metaphyseal osteoscherosis was significantly increased in the femur, rib and sternum of males at the high dose level and in the females at the mid and high dose levels.
Applicant's summary and conclusion
- Executive summary:
In a well conducted study male and female SD rats were administered EDTMP under (by gavage) resulted in neoplastic (osteosarcomas) and non neoplastic (metaphyseal osteosclerosis) effects which were related to the administration of the test substance.
The non neoplastic effects (metaphyseal osteosclerosis) that were considered to be treatment related at the mid and high dose female group and high dose male group. NOAEL (female) = 15 mg/kg (bw), NOAEL (male) = 50 mg/kg (bw)
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