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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
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 developmental 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, and in particular attention is drawn to the last, in which the lungs of premature babies are filled with a perfluorocarbon.

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 literature sources that do not specify guidelines.

Test material

Constituent 1
Reference substance name:
Perfluorocarbons
IUPAC Name:
Perfluorocarbons

Test animals

Species:
other: This is a weight of evidence, so necessarily from a collection of sources, much of it from literature sources that do not specify

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

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: Not specified
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 developmental toxicity. This entry in the Effects Level" table exists only to ensure the endpoint passes validation.

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOEL
Effect level:
> 0 - < 10 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: Not specified
Remarks on result:
other: Not specified
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 developmental toxicity. This entry in the Effects Level" table exists only to ensure the endpoint passes validation.

Overall developmental toxicity

Developmental effects observed:
no

Applicant's summary and conclusion