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EC number: 246-119-3 | CAS number: 24280-93-1
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 5th, 1993 to September 28th, 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under recognised test methods.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Deviations:
- yes
- Remarks:
- See "Principles of method if other than guideline"
- Principles of method if other than guideline:
- The study was conducted in compliance with the U.S. Food and Drug Administration (FDA) Good Laboratory Practice regulations (21 CFR, Part 58). Deviations are as follows: a) Protocol Section: 4.5 Test Procedure - Biological: the definitive test concentrations selected for this study (400, 600, 800, 1000, and 1200 mg/L did not follow the 1.5 to 2.0 ratio specified in the protocol. reason: the range selected bracketed the suspected EC50 more closely than a 1.5 to 2.0 ratio series would have. b) Protocol Section: 4.6 Test Procedure - Chemical and physical: The dissolved oxygen in the test solutions was below the 60% limit by the 24 hour observation period. the control dissolved oxygens were at least 845 saturation for the duration of the study. Reason: mycophenolic acid impacted the dissolved oxygen content in the test water. Effect on the study: None. Daphnids are able to suvive and reproduce in water with very low dissolved oxygen content. The specification for 60% saturation is derived from the DO tolerance level for fish.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Mycophenolic acid
- EC Number:
- 246-119-3
- EC Name:
- Mycophenolic acid
- Cas Number:
- 24280-93-1
- Molecular formula:
- C17H20O6
- IUPAC Name:
- 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoic acid
- Details on test material:
- - Name of test material (as cited in study report): Mycophenolic Acid
- Substance type: Monoconstituent
- Physical state: brown powder
- Impurities (identity and concentrations): Phthalide 0.2 %; 1-Hydroxy PMPA 0.21 %
- Storage condition of test material: was stored in a refrigerator
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:0-, 400-, 600-, 800-, 1000-, and 1200-mg/L nominal test concentrations
- Sampling method: samples were taken at 0, 24, and 48 hours during the study to determine the measured concentration of the test substance for each test level
- Sample storage conditions before analysis:
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- Hard Blended Dilution Water: 146 mg/L as CaCO3 /total hardness), 166 mg/L as CaCO3 (total alkalinity), 8.2 (pH), 21.1 degree Celsius (temperature) 300 microMhos/cm (conductivity), and 9.1 mg/L (dissolved oxygen)
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Source: ABC Laboratories in-house daphnid culture. The primary culture was obtained from the Columbia National Researsch Laboratory (CNFRL), Columbia, Missouri, in 1977
- Age at study initiation (mean and range, SD): Only neonates (less than 24 hours old) were selected for testing.
- Method of breeding: in a temperature-controlled area at 20-21 degree Celsius.Lighting at 60-65 footcandles on a 16-hours daylight photoperiod. Daphnia were fed every day a suspension of at least one algae species, a supplement of trout chow, active dry yeast
- Feeding during test: the neonates were not fed during the study.
ACCLIMATION
- Acclimation period: since culturing and testing conditions were the same no acclimatation period was necessary
- Acclimation conditions (same as test or not): same as test
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- Does not apply
Test conditions
- Hardness:
- 146 mg/L as CaC03
- Test temperature:
- 21.1 degree Celsius
- pH:
- 8.2
- Dissolved oxygen:
- 9.1 mg/L
- Nominal and measured concentrations:
- Nominal test concentrations:0-, 400-, 600-, 800-, 1000-, and 1200-mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel:250-ml glass beakers
- Type (delete if not applicable): covered with loose-fitting petri dish covers
- No. of organisms per vessel: five
- No. of vessels per concentration (replicates): four
- No. of vessels per control (replicates): four
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: hard blended water
- Total hardness of 130-160 mg/L as CaCO3
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Photoperiod: 16-hours daylight photoperiod with 30-minute simulated dawn and dusk periods
- Light intensity: 650 to 664 lux 16-hours daylight photoperiod with 30-minute simulated dawn and dusk periods
- Temperature (waterbath) range from 19 to 21 degree Celsius
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Not applicable
TEST CONCENTRATIONS
Nominal test concentrations:0-, 400-, 600-, 800-, 1000-, and 1200-mg/L - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Remarks:
- 50% immobilization or mortality
- Effect conc.:
- 755 mg/L
- Nominal / measured:
- meas. (not specified)
- Basis for effect:
- mobility
- Remarks:
- behaviour
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 440 mg/L
- Nominal / measured:
- meas. (not specified)
- Basis for effect:
- mobility
- Remarks:
- behaviour
- Details on results:
- Based on the mean measured concentrations of mycophenolic acid the 48-hour EC50 and NOEC for Daphnia magna exposed to mycophenolic acid were 755 and 440 mg/L, respectively.
- Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- Statistical analysis of the concentration vs. effect data (immobility) was conducted by using a computerised EC50 program. This program calculates the EC50 and its 95% confidence limits using the binimial, the moving average, and the probits tests. The program uses different methods of analyzing the data since no one method of analysis is appropriate for all possible sets of data that may be obtained. The method(s) of calculation selected for presentation in this report was that which gave the narrowest confidence limits for the EC50. However, if no immobility occured or if a dose response could not be demonstrated over a reasonable range (<37 to >63%), the EC50 and /or its 95% confidence limits could not be calculated. A 48-hour dose-response slope was calculated by transforming percent immobile to probit values and then calculation via linear regression.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- This study was designed to determine the 48-hour EC50 value and NOEC for Daphnia maga exposed to mycophenolic acid in a static system. The mean measured concentrations for the study were <3.00, 440, 657, 868, 1080, and 1320 mg/L mycophenolic acid. The abnormal effects of daphnid immobility, surfacing, and daphnids tending to the bottom of the vessel were observed in the 657, 868, 1080, and 1320 mg/L test solutions. Based onthe mean measuredconcentrations, the 48-hour EC50 and NOEC were 775 and 440 mh/L mycophenolic acid respectively.
- Executive summary:
The primary objective of this test with Daphnia magna was to evaluate the acute toxicity of mycophenolic acid, CAS No. 24280-93-1, to Daphnia magna under static conditions. The test was designed to yield EC50values following 24 and 48 hours of exposure.
Samples were. taken from each test solution at 0, 24, and 48 hours of the definitive test to determine the measured concentration for each test level. The test concentrations were determined by using high-performance liquid chromatography. The measured concentrations were determined to be 440, 657, 868, 1080, and 1320 mg/L for the nominal concentrtions of 400, 600, 800, 1000, and 1200 mg/L, respectively.
Based on the mean measured concentrations of mycophenolic acid the 48-hour EC,, and NOEC forDaphnia magnaexposed to mycophenolic acid were 755 and 440 mg/L, respectively.
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