Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
other: theoretical assessment based on all available info
Adequacy of study:
key study
Study period:
February 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP assessment report

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008
Reference Type:
other: study report update
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Objective of study:
other: toxicokinetic assessment
Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Assessment of all available data
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[2-(oxolan-2-yl)propan-2-yl]oxolane
EC Number:
700-263-8
Cas Number:
89686-69-1
Molecular formula:
C11 H20 O2
IUPAC Name:
2-[2-(oxolan-2-yl)propan-2-yl]oxolane

Test animals

Species:
other: none, theoretical assessment
Strain:
other: none, theoretical assessment

Administration / exposure

Route of administration:
other: oral, dermal and inhalation
Vehicle:
other: not applicable
Details on exposure:
see assessment

Results and discussion

Main ADME results
Type:
absorption
Results:
For risk assessment purposes, the oral, dermal, and inhalation absorption is set at 100%

Any other information on results incl. tables

The relatively small molecular weight (184.28), the water solubility (7.31 g/L) and the moderate logPow (between 0 and 4) of the substance indicates that uptake from the gastro-intestinal (GI) tract can take place through aqueous pores and by passive diffusion. In general, a substance needs to be dissolved before it can be taken up from the gastro-intestinal tract after oral administration (1). It is therefore likely that Ditetrahydrofurylpropane will be absorbed to a high extent from the GI tract. For risk assessment purposes therefore, the oral absorption of Ditetrahydrofurylpropane is set at 100%. The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption percentage.

Following absorption, Ditetrahydrofurylpropane being a small water-soluble molecule is expected to distribute widely through the body. Based on its lipophylic character, Ditetrahydrofurylpropane is likely to distribute into cells and the intracellular concentration might be higher than the extracellular concentration. Based on its relatively low molecular weight (184.28), excretion is expected to be predominantly via urine (2).

The water solubility (7.31 g/L) of Ditetrahydrofurylpropane indicates that the substance will dissolve in the mucus lining of the respiratory tract and subsequently be absorbed through aqueous pores (taking the molecular weight <200 into account). The log Pow (> 0) indicates a potential for absorption directly across the respiratory tract epithelium. As it is likely that Ditetrahydrofurylpropane will be absorbed to a high extent after inhalation via the lungs, for risk assessment purposes the inhalation absorption for this substance is set at 100%.

Ditetrahydrofurylpropane being a water soluble liquid (7.31 g/L) has the potential to be dermal absorbed as the surface moisture of the skin will not limit the availability. The logPow of 2.7 favours dermal absorption (values between 2 and 3 are optimal). Furthermore, the moderately skin irritating properties of the substance may result in damage of the skin and thus enhance penetration. Based on these properties, 100% dermal absorption of Ditetrahydrofurylpropane is proposed for risk assessment purposes; being in accordance with the criteria as given in the REACH Guidance on information requirements and chemical safety assessment (3) (10% dermal absorption if MW > 500 and log Po/w < -1; otherwise 100% dermal absorption). The results of the skin sensitisation study confirm that dermal absorption will take place.

Based on the present data, no additional conclusions can be drawn on the distribution, metabolism and excretion of Ditetrahydrofurylpropane after dermal and inhalatory absorption.

Applicant's summary and conclusion

Conclusions:
The evaluation of currently available information on Ditetrahydrofurylpropane led to the following toxicokinetic assessment:
- For risk assessment purposes, the oral absorption is set at 100%.
- For risk assessment purposes the inhalation absorption is set at 100%.
- For risk asssessment purposes the dermal absorption is set at 100%.