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EC number: 701-238-4 | CAS number: -
- 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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Remarks:
- There were extremely limited details on the methodology, and the report was just on the histopathology findings.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
- Principles of method if other than guideline:
- There are insufficient details on the method to judge compliance with test guidelines. The two reports available for this study only contain histopathological results.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
- EC Number:
- 701-238-4
- Cas Number:
- 29329-71-3
- Molecular formula:
- HEDP-2Na C2H6Na2O7P2 HEDP-3Na C2H5Na3O7P2
- IUPAC Name:
- Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: no data
- Remarks on MMAD:
- MMAD / GSD: No data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 days (plus 14 day recovery period)
- Frequency of treatment:
- Daily, but period not stated.
Doses / concentrations
- Dose / conc.:
- 5 mg/m³ air
- No. of animals per sex per dose:
- 10 in test group, 5 in control groups
- Control animals:
- yes
- Details on study design:
- Post-exposure period: 14 days
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- Examination of the cornea and conjunctiva did not reveal any adverse effects (except one control male for which corneal and conjunctival keratitis was observed).
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Eosinophilic leukocytes were observed. The edges were either reactionless epithelium or hyperplastic epithelium. This alteration spread between the surrounding epithelium on the one hand and the epiglottis, and adjacent salivary glands on the other. Swelling in this area caused by cellular infiltrates and oedema. Foreign body giant cell formation was evident after the 14 day treatment-free period. Overall, after 14 days of inhalation of 5 mg/m3 CA2, there was erosion of the large mucosa with central necrosis and fibrin deposition. The cell infiltration was mainly monocytes, eosinophils, granulocytes and macrophages. After a further 14 days without treatment, the effect on the epithelium was reversed. However, ions of foreign body giant cells and macrophages were observed clearly in subepithelial areas and consequently, alterations were considered to be clearly treatment-related.
- Clinical biochemistry findings:
- not specified
- Endocrine findings:
- not examined
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The cutaneous mucosa of the nose, skin of the nose and nostrils had occasional incisions. In seven males of the controls and one animal of the test group, the tongue-base was inflamed. Trachea and lung showed only spontaneous alveolar proteinosis (one male animal of the test group and one female control) and occasional calcification diseases (one male of the control group and two females of the test group). Consequently, there was very little evidence of respiratory irritation. The majority of female animals of the test and control groups showed varying degrees of corticomedullary calcification of the kidney. There was evidence of viral inflammation in pancreas and salivary glands.
While the base of the tongue, hard and soft palate and the proximal sections of the esophagus and trachea and the proximal portion of the epiglottis were normal, erosions were found in the distal third of the trachea (side facing the epiglottis) in the treated group. - Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No detectable histological alterations in the nose, larynx or trachea were observed.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 5 mg/m³ air
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a subacute repeated dose toxicity study (reliability score 4), unknown if conducted according to any OECD Test Guidelines and pre-GLP, salt of HEDP (2-3Na) was administered to Wistar rats, nose-only at a concentration of 5 mg/m3. A NOAEL was concluded to be ≥5 mg/m3 based on no detectable histological alterations in the nose, larynx and trachea.
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