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EC number: 828-215-2 | CAS number: 172796-84-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 26 June 2006 and 17 July 2006.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- phosphonic acid, [2-(4-aminophenyl)-1-hydroxyethylidene]bis-, monosodium salt
- EC Number:
- 828-215-2
- Cas Number:
- 172796-84-8
- Molecular formula:
- C8H12NO7P2Na
- IUPAC Name:
- phosphonic acid, [2-(4-aminophenyl)-1-hydroxyethylidene]bis-, monosodium salt
- Reference substance name:
- 4-aminophenylacetic acid
- EC Number:
- 214-828-7
- EC Name:
- 4-aminophenylacetic acid
- Cas Number:
- 1197-55-3
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- 4-aminophenylacetic acid
- Reference substance name:
- EBP dimer
- Molecular formula:
- C16H22N2O12P4
- IUPAC Name:
- EBP dimer
- Test material form:
- solid: particulate/powder
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- Identification: EBP
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: GLS-SH-042606
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
OTHER SPECIFICS:
- Description: light brown powder
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rats were supplied by Charles River (UK) Ltd, Margate, Kent, UK. On receipt the animals were randomly allocated to cages. The animals were nulliparous and non-pregnant. After an acclimatisation period of at least five dats the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were eight to twelve weeks of age. The bodyweights fell within an interval of ±20% of the mean initial bodyweight of the first treated group.
The animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK) was allowed throughtout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- Preparation of test material
For the purpose of the study the test material was freshly prepared, as required, as a suspension at the appropriate concentration in arachis oil BP. Arachis oil BP was used because the test material did not dissolve/suspend in distilled water. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2 groups of 3 female rats at 2000 mg/kg
- Control animals:
- no
- Details on study design:
- Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose.
Groups of fasted animals were treated as follows:
Dose Level (mg/kg) Concentration (mg/ml) Dose Volume (mg/kg) Number of Rats (Female)
2000 200 10 3
2000 200 10 3
All animals were dosed once by oral gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each group to confirm the survival of the previously dosed animals.
The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnornmalities was recorded. No tissues were retained.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity. Yellow-coloured staining of the bedding was noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used: EU CLP
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified).
- Executive summary:
Introduction. The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:
- OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 17 December 2001)
- Method B1 tris Acute Toxicity (Oral) of Commission Directive 2004/73/EC
Method. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted femaled at the same dose level.
The test material was administered orally as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality. There were no deaths.
Clinical observations. There were no signs of systemic toxicity. Yellow-coloured staining of the bedding was noted during the study.
Bodyweight. All animals showed expected gains in bodyweight over the studt period.
Necropsy. No abnormalities were noted at necropsy.
Conclusion. The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified).
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