1,3-dioxolane

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:

2000

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

Test material information

Constituent 1

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.

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."