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EC number: 203-571-6 | CAS number: 108-31-6
- 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
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.075 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.75 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.007 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 4.46 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.06 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.006 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 0.01 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 6.67 mg/kg food
- Assessment factor:
- 30
Additional information
According to the available toxicity data for aquatic organisms, LC50/ EC50of the short-term toxicity test for fish, Daphnia and Algae are 75mg/l ofOncorhynchus mykissandLepomis macrochirus, 330mg/l of Daphnia magna,150mg/l ofPseudokirchneriella subcapitatarespectively. The lowest shot-term LC50from fresh water is 75mg/l from fish and is considered as the most relevant information for deriving for PNECaqua-freshwater. Then a PNECaquatic-fresh waetrof 0.075 mg/l has been derived by dividing the LC50of 75 mg/l for fish acute toxicity test by an assessment factor of 1000.
No measured data are currently available for marine organisms therefore the marine PNEC is derived from data obtained for freshwater species (fish) (LC50= 75 mg/l), applying an assessment factor of 10000 to give PNECseawater= 0.0075 mg/l.
The intermittent releases PNEC is derived from data obtained for freshwater species (fish)(LC50= 75 mg/l), applying an assessment factor of 100 to give PNECaqua - intermittent releases= 0.75 mg/l.
The PNEC for waste-water treatment is 4.46 mg/l based on the IC50of 44.6 mg/l and an assessment factor of 10.
No toxicity data are currently available for sediment-dwelling organisms,therefore it is not possible to determine a PNECsedbased on measured data. According to the Technical Guidance Document, PNECsedcan be calculated by the equilibrium partitioning method. Hence, PNECsed= 0.06mg/kg, whichwill be used for risk characterization.
No toxicity data are currently available for marine sediment-dwelling organisms, therefore it is not possible to determine a PNECmarine-sedbased on measured data. According to the Technical Guidance Document, PNECmarine-sedcan be calculated by the equilibrium partitioning method. Hence, PNECmarine-sed=0.006mg/kg, whichwill be used for risk characterization.
No toxicity data are currently available for soil organisms. According to the Technical Guidance Document, PNECsoilcan be calculated by the equilibrium partitioning method. Hence, PNECsoil=0.01 mg/kg will be used for risk characterization.
A Henry’s Law constant of 3.6×10-3Pa.m3/mol can be calculated from the vapour pressure (0.015 kPa at 20℃)and water solubility(4.07×105mg/L). This indicates a preference for water compared to air, and hence a low rate of volatilization from surface water to air. Maleic anhydride and maleic acid are readily biodegraded in water. And the evaluation on the environmental transport and distribution by Fugacity models indicates the very limited distribution ofmaleic anhydride and maleic acid to the air. So, the possibility ofmaleic anhydride and contributing to atmospheric effects is likely to be very small.
The most relevant data for derivation of the PNECoral for secondary poisoning for maleic anhydrideis is from a 24-month study in rat. NOAEL of 10 mg/kg bw/d is available. Using the conversion factors given in the Technical Guidance Document:
NOAEL = 10 mg/kg bw/d
NOEC mammal = NOAEL mammal × CONV mammal = 10 mg/kg bw/d × 20 (animal age >6 weeks) = 200 mg/kg food
According to the Technical Guidance Document an assessment factor of 30 is appropriate for the results of a study of this duration. Therefore, applying this assessment factor:
PNEC oral = NOEC mammal /AF = 200/30 = 6.67 mg/kg food
Conclusion on classification
Acute aquatic toxicity testing indicates a low order of toxicity when the effect of pH is taken into consideration. The combination of low aquatic toxicity, low logkow and readily biodegradability suggest no significant hazard of long-term effects in the aquatic environment. And maleic anhydride and maleic acid are not persistent in the environment and are not expected to bioaccumulate in food webs.
Therefore, maleic anhydride is expected little hazard to the aquatic and terrestrial compartment. And based on its relative low Henry’s law constant and limited distribution to the air, it is expected little hazard to the atmosphere compartment as well. Therefore,maleic anhydride is not classified for environment of Commission Regulation (EC) No: 790/2009.
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