Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 219-348-1 | CAS number: 2421-28-5
- 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

Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
BTDA is hydrolysed in contact with water, and likely is poorly absorbed and metabolised. Distribution to organs is not significant and excretion is likely through the fecal route. It has a low potential for bioaccumulation.
Absorption: Low water solubility, low order of acute oral toxicity and lack of systemic toxicity suggest relatively low potential for absorption across the skin, gastrointestinal tract and respiratory tract. BTDA shows no significant dermal or ocular absorption. The weight of evidence suggests that BTDA may be absorbed in the respiratory tract, depending upon the size particle.
Distribution: Based on the lack of systemic toxicity and the presence of slight irritation in the gastrointestinal and respiratory tract, distribution following oral or inhalation exposure is limited to the primary organ of contact. Given the lack of systemic toxicity it is unlikely that significant quantities of BTDA are distributed to or expressed in breast milk.
Metabolism: In vitro genetic toxicity studies do not suggest that BTDA is metabolised to reactive species. BTDA hydrolysis products may cause slight irritation following direct contact with the moist environment of GI tract, eyes and respiratory tract.
Excretion: Fecal excretion is likely the major route of elimination of unabsorbed and unchanged BTDA.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 10
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 10
Additional information
1,3-Isobenzofurandione, 5,5'-carbonylbis- (BTDA) is a solid low molecular weight anhydride, susceptible to hydrolysis in water. BTDA is not acutely toxic by the oral, dermal or inhalation routes in animal studies. Low water solubility and lack of systemic toxicity would suggest relatively low potential for absorption across the skin, gastrointestinal tract and respiratory tract. Particulates may be absorbed in the lung and have increased potential to cause local toxicity. Distribution to organs is not significant and there is no evidence that BTDA is metabolized. Excretion of unchanged BTDA is likely via fecal elimination however the database is limited. Future opportunities to undertake selected in vivo studies on BTDA will provide additional knowledge, useful for risk assessment, on the toxicokinetic behavior of this substance.
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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