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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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: FDA TAD 4.08
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:
Nominal Test Concentrations: Control, 10, 20, 40, 80 and 160 mg/L
Mean Measured Concentrations: 0.00, 9.7, 19, 39, 78 and 160 mg/L
- Sampling method: Analytical samples were taken at 0, 24, and 48-hours
- Sample storage conditions before analysis: 4°C - Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Source: in-house daphnid culture from ABC
Primary culture source: Columbia National Fisheries Research Laboratory (CNFRL), Columbia, Missouri - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 134 to 252 mg/L CaCO3
- Test temperature:
- 21°C
- pH:
- 8.2 to 8.5
- Dissolved oxygen:
- 7.6 to 8.1 mg/L
- Nominal and measured concentrations:
- nominal: 10, 20, 40, 80, and 160 mg/L
analytical: 9.7, 19, 39, 78, and 160 mg/L - Details on test conditions:
- TEST SYSTEM
- Type (delete if not applicable): all test vessels were covered with loose-fitting petri dish covers to minimize evaporation
- Material, size, headspace, fill volume: 250 mL glass beakers containing a 210 test volume
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): no renewal, static system
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
Source/preparation of dilution water: Hard Blended Water:
Hardness: 152 mg/L (as CaCO3)
Alkalinity: 164 mg/L (as CaCO3)
pH: 8.4
Temperature: 25.4°C
Dissolved Oxygen: 7.9 mg/L
Conductivity: 320 µmbos/cm
- Culture medium different from test medium: No
- Intervals of water quality measurement: daily
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16h light : 8h dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobilization
VEHICLE CONTROL PERFORMED: no
RANGE-FINDING STUDY:
A range-finding experiment was conducted with Metformin HC1 using five Daphnia magna in each of the exposure concentrations of control, 1.0, 10, 100, and 1000 mg/L. No immobility or abnormal effects were observed in the control, 1.0, and 10 mg/L test concentrations after 24 and 48 hours. The 100 mg/L test solution showed 40% immobilization after 24 hours and 80% immobilization after 48 hours. The 1000 mg/L test solution showed 100% immobilization after 24 hours.
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 130 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% confidence limits: 78 - 160 mg/L
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 78 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities:
No
- Observations on body length and weight: No
- Other biological observations: No
- Mortality of control: No
- Other adverse effects control: No
- Immobilisation of control: No
- Abnormal responses: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- The following reference toxicant tests with Daphnia magna have been conducted by ABC Laboratories within a year of the acute study with Metformin HCl. The reference toxicant test were conducted using potassium chloride supplied by Sigma Chemical Company. The potassium chloride tests were conducted from August 25, 1993 through August 27, 1993, December 7, 1993 through December 9, 1993, February 23, 1994 through February 25, 1994, and June 8, 1994 through June 10, 1994. The 48-hour LC50 values were 707, 707, 676, and 707 mg/L, respectively. The expected 48-hour LC50 range was 700-1100 mg/L (3). From February 23, 1994 through February 25, 1994, and June 8, 1994 through June 10, 1994 reference toxicity tests were conducted with cadmium chloride. The 48-hour LC50 values were 0.024 and 0.12 mg/L for the cadmium chloride tests, respectively. The expected 48-hour LC50 range for cadmium chloride was 0.010-0.090 mg/L. The cadmium chloride was supplied by the U.S. EPA Environmental Monitoring and Support Laboratory, Cincinnati, Ohio. All data are on file at ABC Laboratories.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 24- and 48-hour estimated EC50, values for Daphnia magna exposed to metformin HCl were > 160 mg/L and 130 mg/L, respectively. A NOEC of 78 mg/L was determined.
- Executive summary:
Study Design
The acute toxicity of Metformin HCl to Daphnia magna was assessed in a GLP study using the methods patterned after the FDA Technical Assistance Document 4.08.
Water quality parameters of temperature, dissolved oxygen, pH, hardness, and alkalinity were measured throughout the test and were within acceptable limits. The daphnids used for this study were first-instar daphnids (< 24 hours old) and were cultured at ABC Laboratories. Culture records indicated the adult daphnids were in good condition.
The study was conducted at the nominal concentrations of 10, 20, 40, 80, and 160 mg/L of Metformin HCl in quadruplicate replicate. A fifth replicate for each level was prepared and was used to perform 0- and 24-hour water quality measurements. There were five daphnids per replicate for a total of 20 daphnids exposed to each concentration and the control. Hard blended water was used as the dilution water for this study. Water quality parameters of temperature, dissolved oxygen, pH, total hardness, and total alkalinity were measured at 0, 24, and 48 hours of the study.
Results
All water quality parameters were within acceptable limits with the exception of control replicate B which had been contaminated with water from the test system waterbath. The hardness measurement of replicate B of the control exceed the required range of 130-160 mg/L as CaCO3.
Samples were collected at 0, 24, and 48 hours for analytical confirmation. The overall mean measured concentrations were 9.7, 19, 39, 78, and 160 mg/L of Metformin HCl.
The 24- and 48-hour estimated EC50, values for Daphnia magna exposed to metformin HCl were > 160 mg/L and 130 mg/L, respectively. The 48-hour no-observed effect concentration was 78 mg/L, based on the lack of immobility and abnormal effects at this concentration.
Conclusion
The 24- and 48-hour estimated EC50, values for Daphnia magna exposed to metformin HCl were > 160 mg/L and 130 mg/L , respectively. From the data obtained a NOEC of 78 mg/L metformin HCl was determined.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- no further details are being provided
- Analytical monitoring:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- see publication for details
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- no
- Hardness:
- no data
- Test temperature:
- 20 +/- 1 °C
- pH:
- no data
- Dissolved oxygen:
- no data
- Salinity:
- no data
- Conductivity:
- no data
- Nominal and measured concentrations:
- Generally, test substance applied in at least five concentrations (1, 3.2 10, 32, 100 mg/L). Depending on the results, some tests were repeated including lower (0.1 and 0.32 mg/L) or higher (320 mg/L) concentrations.
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 64 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- no data
- Conclusions:
- The EC50 obtained after 48 h exposure to the test material ammounts to 64 mg/L.
Referenceopen allclose all
For details see executive summary
Description of key information
A 48h-EC50 of 64 mg/L was determined in a literature study following the European Guideline: ‘Methods for determination of ecotoxicity; Annex V, C2, Daphnia acute immobilisation test’ (Commission of the European Communities, 1992). However, no analysis of the test item concentration during the study was performed. Furthermore, no details regarding purity, batch, expiration etc. of the test item are available and, thus, this result is only used as supportive information.
A valid study under GLP conditions including the verification of the different test item concentrations was also performed. The 24- and 48-hour estimated EC50 values for Daphnia magna exposed to metformin HCl were > 160 mg/L and 130 mg/L, respectively. A NOEC of 78 mg/L was determined.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 130 mg/L
Additional information
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.