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EC number: 680-378-7 | CAS number: 138624-11-0
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11-04-2001 to 09-05-2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- To evaluate the esophageal irritation potential of an oral buffered formulation of
alendronate sodium following weekly esophageal infusion for 4 weeks. - GLP compliance:
- yes
Test material
- Reference substance name:
- sodium;(4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate
- Cas Number:
- 121268-17-5
- Molecular formula:
- C4H12NaNO7P2 · 3 H2O
- IUPAC Name:
- sodium;(4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate
- Test material form:
- solid: particulate/powder
Constituent 1
Results and discussion
Any other information on results incl. tables
Results
1. Mortality, Physical Signs, Body Weight, and Food Consumption
All dogs survived to the termination of the experiment. There were no
treatment-related physical signs. Emesis was seen in some drug-treated dogs
during the recovery from anesthesia. This was not considered related to drug
treatment. There were no drug-related effects on body weight or food
consumption.
2. Gross and Light Microscopic Changes
There were no drug-related gross or light microscopic changes in the esophagi
of dogs exposed weekly to the oral buffered formulation of alendronate sodium at
a concentration of 3.73 mg/mL. In contrast, there was gross and/or histologic
evidence of esophageal irritation in dogs infused at the highest concentration
(7.47 mg/mL); at necropsy, in 2 dogs, there was focal reddening of the distal
esophageal mucosa and histologically there was very slight to moderate
esophagitis (erosive or ulcerative) in all dogs.
Conclusions
This study has demonstrated that the oral buffered formulation of alendronate sodium, at a concentration of 3.73 mg/mL, is not irritating to the esophageal mucosa in dogs. At the highest concentration (7.47 mg/mL) studied, there was gross and light microscopic evidence of esophageal irritation in dogs after weekly exposure for 4 weeks.
Applicant's summary and conclusion
- Conclusions:
- There were no drug-related antemortem changes in dogs. In dogs infused with 3.73 mg/mL,
there was no gross or light microscopic evidence of esophageal irritation. At a higher
concentration (7.47 mg/mL), esophagitis (erosive or ulcerative) was evident in all dogs.
This finding is relevant for classification of the substance as a respiratory irritant using the criteria set out in the Classificaiton, Labelling and Packaging Regulations 1272/2008/EC.
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