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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
not specified
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Justification for type of information:
We present a summary report that offers good evidence that the substance has no long term toxicology, partly based on decades of use of this class of compound in medical applications, and therefore no testing is required. Some relevant literature articles are also included.

Data source

Referenceopen allclose all

Reference Type:
other: In-house review
Title:
Unnamed
Year:
2017
Report Date:
2017
Reference Type:
review article or handbook
Title:
Perfluorocarbon Liquid: Its Application in Vitreoretinal Surgery and Related Ocular Inflammation
Author:
Qi Yu, Kun Liu, Li Su, Xin Xia and Xun Xu
Year:
2014
Bibliographic source:
BioMed Research International Volume 2014 (2014), Article ID 250323, 6 pages
Reference Type:
publication
Title:
Fate of Perfluorochemicals in Animals after Intravenous Injection or Hemodilution with Their Emulsions
Author:
K Yokoyama ,K Yamanouch, H Ohyanagii and T Mitsuno
Year:
1978
Bibliographic source:
Chem. Pharm. Bull., 26(3), 1978, 956-966
Reference Type:
publication
Title:
Contrast echocardiography in critical care: echoes of the future? A review of the role of microsphere contrast achocardiography
Author:
DG Platts and JF Fraser
Year:
2011
Bibliographic source:
Critical Care and Resuscitation, Volume 13(1), 2011, 44-55
Reference Type:
publication
Title:
Local Brain Temperature Reduction Through Intranasal Cooling With the RhinoChill Device Preliminary Safety Data in Brain-Injured Patients
Author:
Alex Abou-Chebl, MD; Gene Sung, MD; Denise Barbut, MD, MRCP; Michel Torbey, MD
Year:
2011
Bibliographic source:
Stroke . 2011;42:2164-2169
Reference Type:
publication
Title:
Early Perfluorodecalin Lung Distension in Infants With Congenital Diaphragmatic Hernia
Author:
G.M. Walker, K.F. Kasem, S.J. O’Toole, A. Watt, C.H. Skeoch, and C.F. Davis
Year:
2003
Bibliographic source:
J Pediatr Surg. 2003 Jan;38(1):17-20; discussion 17-20.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
This is a weight of evidence, so necessarily from a collection of sources, much of it from literaure sources that do not specify guidelines.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels

Key result
Dose descriptor:
NOEL
Effect level:
> 0 - < 10 000 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
clinical signs
mortality
Remarks on result:
other: All testing indicates no effect
Remarks:
This endpoint is a weight of evidence based on decades of experience of perfluorocarbons, in particular in medical applications, all of which indicates there is no long term toxicity. This entry in the Effects Level" table exists only to ensure the endpoint passes validation.

Target system / organ toxicity

Key result
Critical effects observed:
no

Applicant's summary and conclusion