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Diss Factsheets
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EC number: 267-956-0 | CAS number: 67953-76-8
- 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:
- 12.03.1985 to 17.04.1985 (inclusive of limit, range-finder and LD50 tests)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See read-across justification in IUCLID Section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 850 mg/kg bw
- 95% CL:
- >= 2 489 - <= 3 211
- Remarks on result:
- other:
- Remarks:
- (equivalent to 940 mg/kg bw active salt, which is equivalent to 659 mg/kg bw active acid)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no post-dose fast
- Principles of method if other than guideline:
- Bio/dynamics protocol based on US guidelines. Broadly compatible with OECD guideline.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Tetrasodium (1-hydroxyethylidene)bisphosphonate
- EC Number:
- 223-267-7
- EC Name:
- Tetrasodium (1-hydroxyethylidene)bisphosphonate
- Cas Number:
- 3794-83-0
- Molecular formula:
- C2H8O7P2.4Na
- IUPAC Name:
- tetrasodium (1-hydroxyethane-1,1-diyl)bis(phosphonate)
- Test material form:
- liquid
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 Breeding Laboratories
- Age at study initiation: 9-12 weeks
- Weight at study initiation: 220-329 g
- Fasting period before study: 18 hours overnight prior to dosing
- Housing: Six per cage, suspended, stainless steel with wire mesh bottoms
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67-76 (equivalent to 19.4-24.4 °C)
- Humidity (%): 30-70 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hours dark /12 hours light
IN-LIFE DATES: Limit test: From: 21.03.85 To: 22.03.85
Range-finding test: From: 27.03.85 To: 03.04.85
LD50 test: From: 03.04.85 To: 17.03.85
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 3.8 mL/kg in the limit test, 1.5 mL/kg in the range-finding test, and 3.1 mL/kg in the LD50 test.
- Doses:
- Limit test: 5000 mg/kg bw.
Range-finding test: 50, 100, 500, 1000 or 2000 mg/kg bw
LD50 determination: 2000, 2500, 3200 or 4000 mg/kg bw - No. of animals per sex per dose:
- Limit test: 5
Range-finding test: 1
LD50 determination: 5 - Control animals:
- no
- Details on study design:
- Animals used in the range-finding test were observed for viability twice daily and deaths were recorded. The following observations were made on all other animals.
Viability check: twice daily.
Clinical signs: approximately 1, 2 and 4 hours after dosing and daily thereafter for 14 days
Body weights: Pre-fasting, post-fast, just prior to dosing, and Days 7 and 14 after dosing.
Macroscopic examination: Not on range-finding test animals. A macroscopic examination was conducted on all other animals. - Statistics:
- The LD50 with 95% confidence limits was calculated using the method of Miller, Lloyd C. and M.L. Tainter., Estimation of the ED50 and its error by means of Logarithmic-Probit graph paper, Proc.Soc.Exp.Bio.Med. 57: 261-264 (1944).
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 850 mg/kg bw
- 95% CL:
- >= 2 489 - <= 3 211
- Remarks on result:
- other: (equivalent to 940 mg/kg bw active salt, which is equivalent to 659 mg/kg bw active acid).
- Mortality:
- RANGE FINDING TEST: No deaths at any dose level.
LD50 DETERMINATION TEST/LIMIT TEST: At 2000 mg/kg, 1 animal died (day 3 after dosing)
At 2500 mg/kg, 4 animals died (1-4 hours after dosing)
At 3200 mg/kg, 7 animals died (1 hour - day 8 after dosing)
At 4000 mg/kg, 8 animals died (1-4 hours after dosing)
At 5000 mg/kg, all 10 animals died (2-7 hours after dosing) - Clinical signs:
- other: LD50 determination: Observations in all groups for up to four hours post-dosing, included ataxia and/or tremors, oral and nasal discharge, hypoactivity, soft stool and faecal and/or urinary staining.
- Gross pathology:
- LD50 determination: Macroscopic abnormalities observed at necropsy were primarily changes to the lungs (discolouration) and gastrointestinal tract (red or black walls, or red or black fluid present, suggestive of an irritant effect). Most of the animals in the 2500, 3200 and 4000 mg/kg dose groups had enlarged kidneys at necropsy, and one animal in the 4000 mg/kg bw group had unilateral renal pallor, dilated renal pelvis and red fluid surrounding the kidney.
- Other findings:
- None reported.
Any other information on results incl. tables
Table 1 Summary of deaths in LD50 determination study.
Dose | Mortality | Time to death | ||
mg/kg bw | Males | Females | Combined | |
2000 | 1/5 | 0/5 | 1 | day 3 |
2500 | 1/5 | 3/5 | 4 | 1 -4 h |
3200 | 3/5 | 4/5 | 7 | 1 h to day 8 |
4000 | 4/5 | 4/5 | 8 | 1 -4 h |
5000 | 5/5 | 5/5 | 10 | 2 -7 h |
LD50 | 3100 | 2500 | 2850 | |
95% conf limit | 2365 -3635 | 1802 -3198 | 2489 -3211 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral study, conducted using a protocol similar to the now deleted OECD Test Guideline 401 but pre-GLP, an LD50 of 2850 mg/kg was determined for HEDP-4Na in the rat. This is equivalent to 940 mg/kg/day bw active salt and 659 mg/kg bw/day active acid.
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