Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Aggregated data from various studies on perfluorocarbons
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
Perfluorocarbons form a class of compounds with very similar propertioes with regards to living systems. They have been used in numerous medical applications, and so various studies have been performed by other parties and these have established how the materials behave.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Principles of method if other than guideline:
General experience of perfluorocarbons
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Being both hydrophobic and lipophobic, perfluorocarbons are not expected to be absorbed to any significant amount.
Details on distribution in tissues:
Perfluorocarbons injected into the blood stream tend to briefly accumulate in the liver and spleen.
Details on excretion:
Perfluorocarbons are excreted by exhalation via the lungs (based on studies in which they are introduced into the blood stream)

Metabolite characterisation studies

Metabolites identified:
no
Details on metabolites:
Investigations into medical applications indicate perfluorocarbons are not metabolised. This is confirmed by their very high stability to strong acid, strong base, oxidisers, reducers and high temperature.

Applicant's summary and conclusion

Conclusions:
No bioaccumulation potential based on study results
All evidence indicates perfluorocarbons are rapidly excluded without being metabolised.
Executive summary:

Testing for medical applications has shown that perfluorocarbons are rapidly excluded by exhalation, without being metabolised.