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Diss Factsheets
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EC number: 202-599-6 | CAS number: 97-65-4
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 969 mg/kg bw
Additional information
Based on the guideline EEC 84/449 B3, a group of ten rats ‑ 5 males and 5 females ‑ was given a single dermal application of itaconic acid formulated in gum arabic, at a dose level of 2000 mg/kg bodyweight. All surviving animals were sacrificed and examined macroscopically on day 15, the end of the observation period. There were no death and no sign of systemic reaction to treatment. Bodyweight gains were normal and no abnormalities were recorded at the macroscopic examination on day 15. The acute lethal dermal dose to rats of itaconic acid was found to be greater than 2000 mg/kg bodyweight.
Based on guideline EEC 84/449 B1, fasted rats 5 males and 5 females per dose were given a single dose by gavage of itaconic acid, formulated in gum arabic at 0, 2560, 3100, 3750, 4130, 4550 and 5000 mg/kg bodyweight. All surviving animals were sacrificed and examined macroscopically on day 15, the end of the observation period.
Clinical signs were ataxia, pilo erection and ptosis associated to cyanosis. Low bodyweight gains were recorded for males at doses higher than 2560 mg/kg and females at 4130 and 4550 mg/kg. Congested stomach and coloured lungs were observed in dead animals. No abnormalities were recorded at macroscopic examination at termination of the study.
The acute oral LD 50 of itaconic acid was estimated to be 2969 mg/kg bodyweight (2530-3485 mg/kg) according to Lichfield and Wilcoxon.
There is also oral toxicity data from QSAR exist, Nonlinear ANN QSAR model for acute oral toxicity – toxic class method (rat) was performed. The predicted value, log (LD50) = 0.92 corresponds to the value of LD50 = 1090 mg/kg bw.
Compared the data from testing and QSAR, it is considered that the testing data (according to EEC 84/449 B1, GLP) has a higher reliability and adequacy. So LD50=2969 is used for CSA.
Justification for classification or non-classification
The LD50 for dermal acute toxicity or oral acute toxicity is > 2000 mg/kg bw and is above the limit for the classification criteria which is 2000 mg/kg bw for both dermal and oral acute toxicity according to the Regulation (EC) No 1272/2008, and itaconic acid is not easily inhaled. According to this Regulation, Itaconic acid is not classified as an acute toxic substance.
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