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Diss Factsheets
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EC number: 211-492-3 | CAS number: 652-67-5
- 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
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Endpoint summary
Administrative data
Description of key information
Sprague Dawley rats were administered ad libitum with isosorbide by dietary admixture at concentrations of 12500, 25000 and 50000 ppm (corresponding to daily dose-levels of 784, 1577 or 3347 mg/kg/day for the males and 937, 2060 or 3970 mg/kg/day for the females) for 13 weeks. This GLP study was equivalent to OECD Test Guideline 408.
The No Observed Effect Level (NOEL) was established at 12500 ppm (corresponding to 748 mg/kg/day in males and 937 mg/kg/day in females) and the No Observed Adverse Effect Level (NOAEL) was set at 50000 ppm (corresponding to 3347 mg/kg/day in males and 3970 mg/kg/day in females).
No supporting oral studies were located and no inhalation or dermal repeat-dose toxicity studies have been conducted.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 3 347 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Additional information
The test item was clinically well tolerated at all dose-levels. No mortality or clinical signs were observed. In addition, no relevant differences related to the test item were noted in the body weight gain or food consumption of treated groups. Treatment with the test item at 25000 or 50000 ppm caused transient increase of water consumption.
No treatment-related hematological, blood biochemistry and urinary parameter changes were recorded.
No histopathological findings were noted at necropsy.
Consequently, following administration of ISOSORBIDE to rats for 13 weeks by dietary admixture, the No Observed Effect Level (NOEL) was established at 12500 ppm (corresponding to 748 mg a.i./kg/day in males and 937 mg a.i./kg/day in females) and the No Observed Adverse Effect Level (NOAEL) was set at 50000 ppm (corresponding to 3347 mg a.i./kg/day in males and 3970 mg a.i./kg/day in females).
Justification for classification or non-classification
The substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) NO. 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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