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EC number: 231-837-1 | CAS number: 7758-23-8
- 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:
- 20/8/1984 to 7/11/1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- details on bodyweight observations during and at the end of the test period were not reported
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Study states protocols were consitent with or exceeded the requirements of EPA and OECD guidelines at the time of the study.
- GLP compliance:
- not specified
- Test type:
- standard acute method
Test material
- Reference substance name:
- Calcium bis(dihydrogenorthophosphate)
- EC Number:
- 231-837-1
- EC Name:
- Calcium bis(dihydrogenorthophosphate)
- Cas Number:
- 7758-23-8
- Molecular formula:
- CaH4O8P2
- IUPAC Name:
- calcium dihydrogen phosphate
- Details on test material:
- - Name of test material (as cited in study report): monocalcium phosphate anhydrous
- Physical state: solid; white powder
- Analytical purity: no data
- Lot/batch No.: 525
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan
- Age at study initiation: no data
- Weight at study initiation: Male: 202-250 g
Female: 153-226 g
- Fasting period before study: 16-18 hours prior to treatment
- Housing: no data
ENVIRONMENTAL CONDITIONS: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
dose volume to body weight ratio (mL/kg): 10 - Doses:
- Male: single dose of 5000 mg/kg bw
Female: 5000, 4467, 3981, 3162 mg/kg bw - No. of animals per sex per dose:
- 10 males / females per dose group.
40 females in control group. - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes (dead animals were also subject to necropsy)
- Other examinations performed: clinical signs
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 986 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3 341 - < 4 757
- Mortality:
- Male:
At a dose level of 5000 mg/kg bw 3 out of 10 rats died within the first 24 hours (1 rat died before the first observation).
In the vehicle control group no rats died.
Female:
At a dose level of 5000 mg/kg 7 rats died within 24 hours.
At a dose level of 4467 mg/kg 7 rats died within 24 hours.
At a dose level of 3981 mg/kg 3 rats died within 24 hours.
At a dose level of 3162 mg/kg 3 rats died within 24 hours.
No rats died in the control group. - Clinical signs:
- other: Male: Dose level: 5000 mg/kg. The following adverse clinical signs were noted; mild to moderate depression (9 rats), diahorrea (1 rat) and piloerection (8 rats). The survivors appeared normal within 24 hours. Dose level: 0 mg/kg. All rats appeared norma
- Gross pathology:
- See below for details of necropsy.
Any other information on results incl. tables
NECROPSY:
Male; dose level 5000 mg/kg.10 rats were necropsied. Observations for the rats that died during the test included evidence of salivation (1 rat); clear discharge from the nostrils (2 rats); pale lungs (1 rat), reddened lungs (1 rat), a purple-spotted thymus (1 rat), a pale liver (1 rat), darkened spleens (2 rats); test material-like fluid in the gastrointestinal tract (1 rat); a distended stomach filled with clear fluid (1 rat); reddened stomach mucosa (1 rat); pale intestines (1 rat); pale kidneys (1 rat); and gelatinous appearing intestines (1 rat). The survivors were necropsied following termination on day 14. Observations for 1 rat included pale lungs, a pale liver, a darkened spleen, test material-like fluid in the stomach and dark gelatinous-like material lining the stomach.
Male, dose level 0 mg/kg.10 rats were necropsied following termination on day 14 and appeared normal.
Female, dose level 5000 mg/kg.10 rats were necropsied. Observations for the rats that died included evidence of lacrimation (3 rats); reddish stains at the nostrils (1 rat), mottled lungs (4 rats); clear fluid in the thoraic cavity (2 rats); greenish lungs (2 rats); purple-spotted thymus (2 rats); pale livers (6 rats); darkened or dark-tipped spleens (7 rats); test material-like fluid in the gastrointestinal tract (1 rat); distended stomachs filled with clear fluid (4 rats); pale kidneys (5 rats); pale intestines (3 rats); and pale uterine horns (6 rats). The survivors were necropsied following termination on day 14 and appeared normal.
Female, dose level 4467 mg/kg. 9 rats were necropsied (1 rat was cannibalised and therefore not necropsied). Observations for the remaining rats that died during the test included yellowish anogenital stains (2 rats); evidence of lacrimation (1 rat); pale lungs (1 rat); discoloured lungs (1 rat); mottled livers (1 rat); pale kidneys (2 rats); a darkened spleen (1 rat); reddened intestines (1 rat) and gelatinous appearing intestines ( 1rat). The survivors were necropsied following termination on day 14 and appeared normal.
Female, dose level 3981 mg/kg.10 rats were necropsied. Observations for the rats that died included cannabalised facial areas (2 rats); pale lungs (3 rats); pale kidneys (4 rats); reddish-yellow gelatinous fluid in the intestines (4 rats), darkened spleens (2 rats); and a pale spleen (1 rat). The survivors were necropsied following termination on day 14 and appeared normal.
Female, dose level 3162 mg/kg.10 rats were necropsied. Observations for the rats that died included a purple-spotted thymus (1 rat); reddened lungs (3 rats); pale, dark-edged livers (3 rats); darkened spleens (2 rats); and pale kidneys ( 2 rats). The survivors were necropsied following termination on day 14 and appeared normal.
Female, dose level 0 mg/kg. 40 rats were necropsied following termination on day 14 and appeared normal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of calcium bis(dihydrogenorthophosphate) in the male rat was calculated to be >5,000 mg/kg bw and the LD50 in female rats was calculated to be 3986 mg/kg bw.
This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling in accordance with Regulation EC (No.) 1272/2008 (EU CLP). Calcium bis(dihydrogenorthophosphate) is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP).
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