Evidence map›Paper›PMID 37860941›Full record

ArticleInternational journal of toxicology

The Nonclinical Assessment of Trans-1,3,3,3-tetrafluoropropene (HFO-1234ze (E)), a Near Zero Global Warming Potential Propellant for Use in Metered Dose Inhalation Products.

Paul S Giffen, Joanne D Kilgour, Matthew Jacobsen, Karen Thacker, Ann A Holmberg

Open access · hybridAbstract read
In one paragraph

Article in International journal of toxicology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. [Inhaled Respiratory Therapy and Global Warming].Farmaceuticos comunitarios · 2025
    Observational
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Paul S GiffenDepartment of Respiratory & Immunology Toxicology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK.ORCID 0000-0002-6820-0127
Joanne D KilgourApconiX, Macclesfield, UK.
Matthew JacobsenDepartment of Pathology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK.ORCID 0000-0002-2713-1188
Karen ThackerDepartment of Regulatory Toxicology and Safety Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK.
Ann A HolmbergDepartment of Drug Metabolism and Pharmacokinetics, Research and Early Development, Respiratory and Immunology (R&I), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
AstraZeneca (United Kingdom) · GBAstraZeneca (Sweden) · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

HFO-1234ze (E) is proposed as a near zero global warming propellant for use in metered dose inhaled (MDI) products. This paper describes the non-clinical safety assessment in mice, rats, and dogs and supplements previously reported data (genetic toxicology, short-term toxicology, and reproductive toxicology). In all species, HFO-1234ze (E) was only detectable in blood for a short period after dosing with no evidence of accumulation. HFO-1234ze (E) was without any toxicological effects at very high doses in subchronic (13-week mouse) and chronic (39-week dog) studies. Chronic (26-week) administration to rats at very high doses was associated with an exacerbation of rodent progressive cardiomyopathy, a well-documented background finding in rodents. In a 2-generation study, extremely high doses were associated with the early euthanasia of some lactating female rats. This finding was considered to be significantly influenced by a state of negative energy balance, reflecting the specific vulnerability of rats during lactation. These findings are considered to not pose a risk to humans with typical MDI use given they occurred at doses which far exceed those expected in patients. Overall, the nonclinical safety data for HFO-1234ze (E) support its further development as an MDI propellant.

Indexed as

FluorocarbonsGlobal WarmingAdministration, InhalationAnimalsDogsFemaleLactationMiceRats1,3,3,3-tetrafluoropropeneFluorocarbonsHFO-1234ze (E)inhalationmetered dose inhalernonclinicalsafetytoxicokineticstoxicologytrans-1,3,3,3-tetrafluoropropene

Identifiers

PMID37860941
PMCPMC10851632
OpenAlexW4387798082

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.