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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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 29 - July 3, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: FDA TAD 4.11
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 95.3, 171, 309. 555, and 1000 mg/L
- Sampling method: Analytical samples were taken at 0, 48, and 96-hours of the toxicity test.
- Sample storage conditions before analysis: in a refrigerator at - 4°C - Vehicle:
- no
- Test organisms (species):
- Lepomis macrochirus
- Details on test organisms:
- TEST ORGANISM
- Common name: Bluegill (Lepomis macrochirus)
- Source: Osage Catfisheries Osage Beach, Missouri
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): Mean ± SD Standard Length: 26 ± 1 mm, Standard Length Range 23 - 28 mm
- Weight at study initiation (mean and range, SD): Mean ± SD Wet Weight: 0.37 ± 0.06 g
- Method of breeding: NA
- Maintenance of the brood fish: NA
ACCLIMATION
- Acclimation period: The fish were held in well water approximately 3 weeks then transferred to hard blended dilution water for 8 days prior to the test. A sublot of bluegill was acclimated to the test temperature and test dilution water for approximately 72 hours prior to the definitive test.
- Acclimation conditions (same as test or not): The culture room was maintained on a 16-hour daylight photoperiod with a 30-minute transition period.
- Type and amount of food during acclimation: The fish were fed newly hatched brine shrimp nauplii (Anemia sp.) and/or a commercially available fish food once or twice per day.
- Health during acclimation (any mortality observed): NA
FEEDING DURING TEST : No - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 144 to 158 mg/L as CaCO3
- Test temperature:
- 22 (± 1)°C
- pH:
- 7.9 to 8.4
- Dissolved oxygen:
- 5.3 to 8.4 mg/L
- Nominal and measured concentrations:
- nominal: 95.3, 171, 309. 555, and 1000 mg/L
measured: 95.5, 170, 300, 555, and 982 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 5-gallon glass vessels
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 15 L
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): NA
- Renewal rate of test solution (frequency/flow rate): NA
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): NA
- Biomass loading rate: NA
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The water was prepared by blending naturally hard well water with well water that had been demineralized by reverse osmosis. This blended water was prepared to yield a total hardness of 130-160 mg/L as CaCO3.
- Total organic carbon: <1.0 mg/L
- Particulate matter: NA
- Metals: NA
- Pesticides: NA
- Chlorine: NA
- Alkalinity: 160 mg/L (as CaCO3)
- Ca/mg ratio: NA
- Culture medium different from test medium: No
- Intervals of water quality measurement: Total alkalinity and hardness (mg/L as CaCO3) were measured in all test chambers at 0 and 96 hours. Temperature (°C). dissolved oxygen (mg/L), and pH were measured in all test chambers at 0, 24, 48, 72, and 96 hours of testing.
OTHER TEST CONDITIONS
- Adjustment of pH: NA
- Photoperiod: The test was on a 16-hour daylight photoperiod with a 30-minute transition period.
- Light intensity: Light intensity measured during the test was 59 footcandles (635 lux).
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Lethality
TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline: NA
- Range finding study : A range-finding test of 96 hours duration was conducted to determine the concentration range for the definitive study. The preliminary test concentrations were set at 0.10, 0.32, 1.0, 3.2, 10, 32, and 100 mg/L. Each concentration consisted of a single replicate with 10 fish per chamber. The test solutions at every level remained clear and free of precipitate for the duration of the study. There were no mortality or abnormal effects noted in any test chamber.
- Test concentrations: 95.3, 171, 309, 555, and 1000 mg/L: - Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 982 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 982 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks:
- and other abnormal effects
- Details on results:
- The 96-hour LCso was determined to be > 982 mg/L based on the mean measured concentrations of metformin HCI. The 96-hour no-observed effect concentration (NOEC) was 982 mg/L, which was based on the lack of mortality and abnormal effects at this concentration.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96-hour LCso was determined to be > 982 mg/L based on the mean measured concentrations of metformin HCI. The 96-hour no-observed effect concentration (NOEC) was 982 mg/L, which was based on the lack of mortality and abnormal effects at this concentration.
- Executive summary:
Study design
The 96-hour toxicity of metformin HCl to freshwater fish was studied with bluegill (Lepomis macrochirus) in a static test according to FDA TAD 4.11.
A total of 20 fish per concentration was exposed. The study was conducted at test material concentrations of 95.3, 171, 309, 555, and 1000 mg/L. The test concentrations were analytically quantified from samples collected at 0, 48 and 96 hours.
Results
The 3-, 6-, 12-, 24-, 48-, 72-, and 96-hour LC50values for metformin HCI were all > 982 mg/L. All results were based on the measured concentrations of 95.5, 170, 300, 555, and 982 mg/L. The 96-hour noobserved-effect concentration (NOEC) was 982 mg/L, based on the lack of mortality or observed abnormal/sublethal effects at this concentration.
Conclusion
The 96-hour LCso was determined to be > 982 mg/L based on the mean measured concentrations of metformin HCI. The 96-hour no-observed effect concentration (NOEC) was 982 mg/L, which was based on the lack of mortality and abnormal effects at this concentration.
Reference
Description of key information
The 96-hour LC50 was determined to be > 982 mg/L based on the mean measured concentrations of metformin HCI. The 96-hour no-observed effect concentration (NOEC) was 982 mg/L, which was based on the lack of mortality and abnormal effects at this concentration.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 982 mg/L
Additional information
The 96-hour LC50 was determined to be > 982 mg/L.
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