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Diss Factsheets
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EC number: 701-039-2 | CAS number: 156324-78-6
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- in vitro and/or in vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- The substance is an alicyclic carbonate with a hydroxy substituent of a molecular weight which does not preclude absorption. No predictions of toxicokinetic behaviour from SAR can be made. lt is a solid block of low vapour pressure, and hence significant Inhalation exposure is not anticipated. The moderate water solubility may be associated with rapid absorption and elimination via the kidneys in urine. Hydrolysis occurs under neutral and alkaline conditions, at a sufficient rate to suggest exposure to decomposition products may be important. However, the substance is stable to hydrolysis at acidic pH, indicating decomposition would not occur in the stomach. There are no potentially ionizable groups in the parent compound, and hence absorption by passive diffusion across membranes will not by pH dependent. The relatively high Pow indicates ready passage across membranes.
No systemic toxic effects were observed at the maximum dose of 2000 mg/kg in an acute dermal toxicity limit test. Hence there is no evidence of dermal absorption. Dose-related toxic effects occurred in the 28-day oral sub-acute toxicity study, indicating oral absorption. However, only minor clinical signs were observed in the acute oral toxicity limit test at 2000 mg/kg.
The substance was toxic to human lymphocytes in the negative in vitro chromosome aberration test, but cytoxicity was reduced in the presence of S9. There was a similar, but less marked, reduction in toxicity to bacteria in the negative Ames test in the presence of S9. This suggests that biotransformation may occur as a result of microsomal enzyme activity. To some extent this is supported by the morphological adaptive liver changes seen in the 28-day oral toxicity study which may have been associated with microsomal enzyme induction.
The substance may be absorbed orally, as indicated by the dose-related effects in the 28-day sub-acute oral toxicity study. Absorption would be consistent with the moderate water solubility, relatively-high Pow and absence of ionizing groups in the molecule. Hydrolysis could occur in the gastro-intestinal tract, but not under the acidic stomach condition's and in plasma. Hence the parent compounds and/or their hydrolysis products may be absorbed. Biotransformation may occur in the liver and, in view of the compounds, water solubility, excretion is most likely to occur via the kidneys. This excretory route is further evidenced by the kidney changes observed in the 28-day oral toxicity study. Significant elimination of the involatile parent compounds via the lungs in expired air is not anticipated.
There is no evidence for dermal absorption, since no effects were seen in the acute dermal toxicity study in a close structural analogue.
Significant inhalation exposure is not anticipated for this solid block of low vapour pressure. However, following any inhalation exposure, absorption may be anticipated an the basis of the moderate water solubility and relatively-high Pow. The rate of hydrolysis is too slow to permit significant decomposition in the lungs.
Reference
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
The substance is an alicyclic carbonate with a hydroxy substituent of a molecular weight which does not preclude absorption. No predictions of toxicokinetic behaviour from SAR can be made. lt is a solid block of low vapour pressure, and hence significant Inhalation exposure is not anticipated. The moderate water solubility may be associated with rapid absorption and elimination via the kidneys in urine. Hydrolysis occurs under neutral and alkaline conditions, at a sufficient rate to suggest exposure to decomposition products may be important. However, the substance is stable to hydrolysis at acidic pH, indicating decomposition would not occur in the stomach. There are no potentially ionizable groups in the parent compound, and hence absorption by passive diffusion across membranes will not be pH dependent. The relatively high Pow indicates ready passage across membranes.
No systemic toxic effects were observed at the maximum dose of 2000 mg/kg in an acute dermal toxicity limit test. Hence there is no evidence of dermal absorption. Dose-related toxic effects occurred in the 28-day oral sub-acute toxicity study, indicating oral absorption. However, only minor clinical signs were observed in the acute oral toxicity limit test at 2000 mg/kg.
The substance was toxic to human lymphocytes in the negative in vitro chromosome aberration test, but cytoxicity was reduced in the presence of S9. There was a similar, but less marked, reduction in toxicity to bacteria in the negative Ames test in the presence of S9. This suggests that biotransformation may occur as a result of microsomal enzyme activity. To some extent this is supported by the morphological adaptive liver changes seen in the 28-day oral toxicity study which may have been associated with microsomal enzyme induction.
The substance may be absorbed orally, as indicated by the dose-related effects in the 28-day sub-acute oral toxicity study. Absorption would be consistent with the moderate water solubility, relatively-high Pow and absence of ionizing groups in the molecule. Hydrolysis could occur in the gastro-intestinal tract, but not under the acidic stomach condition's and in plasma. Hence the parent compounds and/or their hydrolysis products may be absorbed. Biotransformation may occur in the liver and, in view of the compounds, water solubility, excretion is most likely to occur via the kidneys. This excretory route is further evidenced by the kidney changes observed in the 28-day oral toxicity study. Significant elimination of the involatile parent compounds via the lungs in expired air is not anticipated.
There is no evidence for dermal absorption, since no effects were seen in the acute dermal toxicity study in a close structural analogue.
Significant inhalation exposure is not anticipated for this solid block of low vapour pressure. However, following any inhalation exposure, absorption may be anticipated on the basis of the moderate water solubility and relatively-high Pow. The rate of hydrolysis is too slow to permit significant decomposition in the lungs.
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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