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EC number: 211-463-5 | CAS number: 646-06-0
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- other: Summary report on the Toxicity of 1,3-dioxolane under the US EPA High Production Volume (HPV) Challenge Programme
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Report is a robust summary of data available for 1,3-dioxolane, and was used by the US EPA to determine if further studies were necessary under the High Production Volume (HPV) Challenge Program. Reliability of individual studies is directly addressed in the report.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
- Type of study / information:
- Report is a summary of data for 1,3-dioxolane available at the time of the report. Multiple Study Types/Endpoints are represented.
Test material
- Reference substance name:
- 1,3-dioxolane
- EC Number:
- 211-463-5
- EC Name:
- 1,3-dioxolane
- Cas Number:
- 646-06-0
- Molecular formula:
- C3H6O2
- IUPAC Name:
- 1,3-dioxolane
- Details on test material:
- Details on test material given in individual study reports.
Constituent 1
Results and discussion
Any other information on results incl. tables
Conclusion from the US EPA HPV report on 1,3 -dioxolane:
"Examination of the entire data set for Dioxolane indicates that there is a low priority for additional studies on this material. Dioxolane is mildly toxic by oral administration or by inhalation. After acute exposure to high levels, reversible CNS depression, typical of most volatile solvents, appears to be the primary effect. After repeated dose or subchronic administration, effects on the blood forming systems, manifest as reduction in WBCs and platelets and changes in spleen weight appear to be the most sensitive target organs in rats. The inhalation NOEL for these effects was found to be 300 ppm for females and 1000 ppm for males in a 13-week study. The oral gavage NOEL was found to be 75 mg/kg/day in a 14 -day study. After oral administration to pregnant females, developmental delays and perinatal mortality are found only at maternally toxic doses. Reproductive effects are only apparent at maternally toxic levels. The weight of evidence indicates that Dioxolane has low genotoxic potential.
The current exposure pattern is restricted to industrial workers involved in the manufacture and subsequent use of Dioxolane. Monitoring data indicate that typical exposures are below 1.0 ppm, which is at least two orders of magnitude below the inhalation 13-week NOEL. It is unlikely that Dioxolane will have any adverse effect at this exposure level. Ferro and Ticona are aware of no consumer exposure to Dioxolane.
Studies on aquatic organisms indicate a low order of acute toxicity for Dioxolane to fish, invertebrates or aquatic plants. Volatility limits the concern for chronic effects in the aquatic environment and data from plant effluents indicate that the levels being released from manufacture are less than 0.1 ppm in plant outfalls.
This analysis shows that Dioxolane has a low potential for harming the either human health or the environment and it is concluded that additional studies would not add significant information. No additional studies are recommended to fill the requirements of the EPA HPV Challenge Program."
Applicant's summary and conclusion
- Conclusions:
- Overall conclusion from US EPA HPV Program Report for 1,3-dioxolane was:"This analysis shows that Dioxolane has a low potential for harming the either human health or the environment and it is concluded that additional studies would not add significant information. No additional studies are recommended to fill the requirements of the EPA HPV Challenge Program."
- Executive summary:
Conclusion from US EPA HPV Challenge Report for 1,3 -dioxolane:
"Examination of the entire data set for Dioxolane indicates that there is a low priority for additional studies on this material. Dioxolane is mildly toxic by oral administration or by inhalation. After acute exposure to high levels, reversible CNS depression, typical of most volatile solvents, appears to be the primary effect. After repeated dose or subchronic administration, effects on the blood forming systems, manifest as reduction in WBCs and platelets and changes in spleen weight appear to be the most sensitive target organs in rats. The inhalation NOEL for these effects was found to be 300 ppm for females and 1000 ppm for males in a 13-week study. The oral gavage NOEL was found to be 75 mg/kg/day in a 14-day study. After oral administration to pregnant females, developmental delays and perinatal mortality are found only at maternally toxic doses. Reproductive effects are only apparent at maternally toxic levels. The weight of evidence indicates that Dioxolane has low genotoxic potential.
The current exposure pattern is restricted to industrial workers involved in the manufacture and subsequent use of Dioxolane. Monitoring data indicate that typical exposures are below 1.0 ppm, which is at least two orders of magnitude below the inhalation 13-week NOEL. It is unlikely that Dioxolane will have any adverse effect at this exposure level. Ferro and Ticona are aware of no consumer exposure to Dioxolane.
Studies on aquatic organisms indicate a low order of acute toxicity for Dioxolane to fish, invertebrates or aquatic plants. Volatility limits the concern for chronic effects in the aquatic environment and data from plant effluents indicate that the levels being released from manufacture are less than 0.1 ppm in plant outfalls.
This analysis shows that Dioxolane has a low potential for harming the either human health or the environment and it is concluded that additional studies would not add significant information. No additional studies are recommended to fill the requirements of the EPA HPV Challenge Program."
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