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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study provides incidental data on the metabolism of 1,1,1,3,3,3-hexafluoropropane-2-ol in human subjects.

Data source

Reference
Reference Type:
publication
Title:
Metabolism and Toxicity of the new anesthetic agents
Author:
Kharasch E D
Year:
1996
Bibliographic source:
Acta anaesthesiologica Belgica, Vol.47, No. 1, pp.7-14

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline followed
Deviations:
not applicable
Principles of method if other than guideline:
The plasma and urinary metabolites of the anaesthetic Sevflurane were investigated in anaesthetised human subjects.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,1,3,3,3-hexafluoropropan-2-ol
EC Number:
213-059-4
EC Name:
1,1,1,3,3,3-hexafluoropropan-2-ol
Cas Number:
920-66-1
Molecular formula:
C3H2F6O
IUPAC Name:
1,1,1,3,3,3-hexafluoropropan-2-ol
Details on test material:
Sevoflurane
Radiolabelling:
no

Test animals

Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Data were obtained from anaesthetised humans

Administration / exposure

Route of administration:
inhalation: gas
Vehicle:
unchanged (no vehicle)
Details on exposure:
Exposure of human subjects
Duration and frequency of treatment / exposure:
Single anaesthetic exposure
Doses / concentrations
Remarks:
Doses / Concentrations:
No data
No. of animals per sex per dose / concentration:
No data
Control animals:
no
Positive control reference chemical:
Not applicable
Details on study design:
The plasma and urinary metabolites of the anaesthetic Sevoflurane were investigated in anaesthetised human subjects.

Results and discussion

Preliminary studies:
No preliminary studies conducted.

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Not relevant for this study
Details on distribution in tissues:
Not investigated
Details on excretion:
1,1,1,3,3,3-hexafluoropropane-2-ol was excreted as the glucuronic acid conjugate

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
1,1,1,3,3,3-hexafluoropropane-2-ol was conjugated with glucuronic acid, with no evidence of defluorination.

Any other information on results incl. tables

1,1,1,3,3,3 -hexafluoropropane-2 -ol and its-glucuronide were identified as metabolites of Sevoflurane in exposed humans.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
1,1,1,3,3,3-hexafluoropropane-2-ol is rapidly conjugated to glucuronic acid and rapidly excreted in the urine of exposed humans. There was no evidence of defluorination and no bioaccumulation is predicted.
Executive summary:

1,1,1,3,3,3 -hexafluoropropane-2 -ol was identified as a metabolite of the anaesthetic Sevoflurane in human subjects. 1,1,1,3,3,3 -hexafluoropropane-2 -ol did not undergo further defluorination but was rapidly conjugated to glucuronic acid and rapidly excreted in the urine.