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EC number: 237-249-1 | CAS number: 13708-85-5
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12/2008 to 04/2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD guideline under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Disodium phosphonate
- EC Number:
- 237-249-1
- EC Name:
- Disodium phosphonate
- Cas Number:
- 13708-85-5
- Molecular formula:
- Na2HPO3
- IUPAC Name:
- disodium phosphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Disodium phosphonate (BRÜGGOLEN H10)
- Substance type: inorganic
- Physical state: solid
- Analytical purity: 95%
- Composition of test material, percentage of components:
- Lot/batch No.: 07090801
- Expiration date of the lot/batch: 08.09.2009
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstraße 27, 33178 Borchen, Germany
- Age at study initiation: 5 to 8 weeks
- Weight at study initiation: 160 - 180 g
- Housing: open makrolon cages type 2000P (TechniPlast)
- Diet (e.g. ad libitum): Maintenance diet rat/mouse, pellets, No. 1324 (Altromin GmbH & Co. KG, 32791 Lage), ad lib.
- Water (e.g. ad libitum): Autoclaved community tap water, ad lib.
- Acclimation period: 8 days (male), 9 days (female)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): Freshly prepared before application - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
63 mg/kg bw
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
250 mg/kg bw
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw
Basis:
nominal in water
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: In a previously performed dose range finding study with dose escalation, the test item was administered in doses up to 2000 mg/kg body mass over a time period of 19 days and produced no observable toxic effects in the test animals. In accordance with the sponsor,
1000 mg/kg was determined as high dose for the present test.
- Rationale for animal assignment (if not random):
rats were weighed individually and grouped into weight categories, the main group consisting of animals weighing between 100 g and 120 g. These were placed consecutively into prepared cages. Rats weighing more than 120 g, but not more than 140 g, and rats weighing less than 100 g, but more than 80 g, were caged alternately after the main weight group was placed. - Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once weekly
BODY WEIGHT: Yes
- Time schedule for examinations: once weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: once weekly
- Dose groups that were examined: all
HAEMATOLOGY: Yes
- Time schedule for collection of blood: On day 29
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: On day 29
- Animals fasted: No data
- How many animals: all
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: once weekly
- Dose groups that were examined: all
- Battery of functions tested: sensory activity / grip strength / motor activity / unusual behaviour - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table)
HISTOPATHOLOGY: Yes (see table)
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Detailed clinical signs, food and water consumption, motoric activity, and reactivity to sensory stimuli showed no remarkable abnormalities.
The mean body mass increase of all experimental groups was within normal range for rats of
this strain and age.
Analysis of haematology and serum biochemistry showed normal results in the vast majority
of parameters monitored. The only alteration in comparison to their control group occurred in the male high dose group where the level of glutamic-oxaloacetic transaminase (GOT) was
significantly lowered. GOT acts as an indicator for liver dysfunctions and could indicate
beginning liver stress.
The histomorphological examination of the selected rat organs did not reveal morphological
lesions considered to be related to the test item. No morphological differences were noted
between the groups. All microscopic findings noted in various organs of animals of the high dose group did not distinguish significantly treated rats from control animals or the
differences noted were regarded as random events. All these findings are considered to be spontaneous in nature and within the normal background pathology commonly seen in rats of
this strain and age.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- food efficiency
- gross pathology
- haematology
- histopathology: neoplastic
- histopathology: non-neoplastic
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
- water consumption and compound intake
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
A daily oral administration of the test item Disodium phosphonate to Wistar rats at a dose level of 63, 250 and 1000 mg/kg body mass over a time period of 28 days resulted in very few and only mild systemic and local effects in test animals treated with the high dose (1000 mg /kg) but did not produce any pathological evidence of a local or systemic toxicity of the test item.
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