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Diss Factsheets
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EC number: 203-743-0 | CAS number: 110-17-8
- 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
Fumaric acid was practically nontoxic when tested in guideline-comparable studies of acute oral and acute dermal toxicity. Inhalation testing is not required since a non-toxic response can be predicted based on the absence of inhalation exposure since the granulometry test confirms virtually no particles within the rat respirable range (< 6 % of particles are respirable i.e. < 10 micron). However, since human exposure via inhalation of a larger range of particles may be considered a possibility, an inhalation study was completed in rats at the maximum practical atmosphere concentration. 1.3 mg/L resulted in no adverse effects of inhalation exposure and confirmed the theoretical predictions.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 10 700 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Dose descriptor:
- LC50
- Value:
- 1 306 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 20 000 mg/kg bw
Additional information
The single dose oral toxicity of fumaric acid in Sprague-Dawley rats was reported as 10700 mg/kg for males and 9300 mg/kg for females. Single dose dermal toxicity of fumaric acid using female New Zealand albino rabbits was reported as 20000 mg/kg.
Since the percent particles within the respirable range is very low (< 6 % are < 10 micron), exposure via inhalation is predicted to be low to none. Under these circumstances a study conducted at the limit dose of 5 mg/L is likely to elicit no adverse response, in the absence of significant levels of respiratory exposure. Since the result can be predicted it is unjustifiable to conduct a mammalian study to determine inhalation toxicity more precisely.
However, data was available from an acute inhalation study in rats, conducted at the maximum achievable atmosphere concentration - 1.306 mg/L or 1306 mg/m³. No adverse effects were observed at the practical limit dose concentration.
Justification for classification or non-classification
It is not proposed to classify fumaric acid for acute oral toxicity or for acute dermal toxicity based on experimental results.
The predicted absence of inhalation exposure would also preclude classification for respiratory effects. The experimental results confirm that no classification is needed in accordance with EU CLP or GHS classification systems.
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.
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