Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 214-230-6 | CAS number: 1115-70-4
- 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
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Metformin hydrochloride
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: bulk
- Reference substance:
- Metformin hydrochloride
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Metformin HCl is highly water soluble and has a very low octanol-water partition coefficient. It is thus not likely to accumulate in biotic tissues or to sorb to organic material. In aerobic aquatic systems, the compound dissipated steadily from the water phase via degradation and adsorption to sediment. Based on the DT50 value of 14.2 days in the river system, metformin HCl is considered to be biodegradable in aerobic aquatic systems (river).
In general, metformin HCl has a very low hazardous potential on aquatic organisms. In acute aquatic toxicity tests, metformin HCl did not cause any adverse effects to fish (Lepomis macrochirus) and only weak effects to invertebrates (Daphnia magna). Chronic toxicity testing with aquatic organisms also resulted in either no (Desmodesmus subspicatus, Daphnia magna, Danio rerio) or weak (Lemna minor) adverse effects at the concentrations tested. The lowest NOEC from aquatic toxicity studies was the 34d-NOEC of >=12 mg/L obtained in the Early life stage test with Danio rerio. For effects on sediment organisms, the 28d-NOEC for Chironomus riparius was 31.25 mg/L The Phase II Tier A and B fate and effects analyses for the different environmental compartments (surface water, ground water, sewage treatment plant, sediment, bioaccumulation and terrestrial compartment) did not result in a risk for any of the compartments. Therefore, it can be concluded that metformin HCl does not pose an environmental risk
Reference
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.