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Diss Factsheets
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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
Endpoint summary
Administrative data
Description of key information
Sub-chronic toxicity:
Inhalation: NOAEC = 3.3 mg/m3 for rat (similar to OECD TG 413)
Inhalation: NOAEC = 9.8 mg/m3 for monkey (similar to OECD TG 413)
Chronic toxicity:
Oral: NOAEL = 10 mg/kg bw/day for rat (similar to OECD TG 452)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 10 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 3.3 mg/m³
- Study duration:
- subchronic
- Species:
- rat
Additional information
In a six-month inhalation study in which rats, hamsters, and monkeys were exposed to 0, 1.1, 3.3, or 9.8 mg/m3 (0, 0.3, 0.8, or 2.4 ppm), respiratory tract and eye irritation were observed in rats and hamsters exposed to 3.3 or 9.8 mg/m3 (0.8 or 2.4 ppm) and monkeys to 9.8 mg/m3(2.4 ppm), with body weight reductions only in male rats from the high-exposure group at study termination. Hyperplastic changes in the nasal tissues, which ranged in severity from trace to mild, were present in rats at all exposure levels and in hamsters in the mid- and high-exposure levels. Metaplastic changes in the nasal tissues occurred in both rats and hamsters at all exposure levels. Both the hyperplastic and metaplastic changes in the nasal passages are considered indicative of irritation and judged to be reversible. The NOAEC for rats is 3.3 mg/m3 (0.8 ppm) and the NOAEC for hamsters and monkeys is 9.8 mg/m3 (2.4 ppm). The NOAECs are taken forward in preference to the NOAEC which was identified in a 4-week inhalation study in which rats were dosed at concentrations of 0, 12, 32 and 86 mg/m3 as it was derived from a study of longer duration.
Oral feeding studies with maleic anhydride have resulted in kidney damage in rats at relatively high doses (> 100 mg/kg/day after 90 days of exposure), with the effects being more severe in males than in females. The effects appear to be largely in the tubular cells, with some effects also occurring in the glomeruli. The kidney effects are likely due to maleic acid, since maleic anhydride rapidly hydrolyzes to maleic acid under aqueous conditions and maleic acid is known to cause kidney damage with the target site being tubular cells. However, no kidney effects were observed in rats that were fed diets containing 32 and 100 mg/kg/day maleic anhydride for two years. A dietary study in dogs dosed at 0, 20, 40, or 60 mg/kg maleic anhydride, seven days a week for 90 days, showed no adverse effects related to maleic anhydride exposure, except for decreased food intake for the first few weeks in the high-dose group. The NOAEL (10 mg/kg bw/day) in the two-year study is taken forward in preference to the other N(L)OAELs as it was derived from a study of longer duration. Maleic anhydride could cause local irritation after inhalation exposure, but no severe systemic effects after dietary intake.
Justification for classification or non-classification
This substance could not be presumed to have the potential to produce significant toxicity in humans at generally low to moderate exposure concentrations in repeated-dose toxicity studies.
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