1,1,1,2,2,3,3,4,5,5,5-undecafluoro-4-(trifluoromethyl)pentane

Developmental toxicity / teratogenicity

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

Reference

Reference 1

Reference Type:

other: In-house review

Title:

Unnamed

Year:

2017

Report date:

2017

Reference 2

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 3

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 4

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 5

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 6

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

Test material information

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