Evidence map›Paper›PMID 36351539›Full record

ArticleToxicology in vitro : an international journal published in association with BIBRA2023

Expansion of the application domain of a macromolecular ocular irritation test (OptiSafe™).

Stewart Lebrun, Sara Chavez, Linda Nguyen, Roxanne Chan

Open access · hybridAbstract read
In one paragraph

Article in Toxicology in vitro : an international journal published in association with BIBRA, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Washing with buffered vitamin C after corrosive chemical (sodium hypochlorite) exposure reduces ocular depth of injury.Toxicology in vitro : an international journal published in association with BIBRA · 2025
    Article
  2. Evaluation of a New In Chemico Skin Corrosion Test.Toxicology in vitro : an international journal published in association with BIBRA · 2024
    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

4 authors at 1 institution in 1 country.

Stewart LebrunLebrun Labs LLC, Anaheim, CA, United States of America. Electronic address: SJ@lebrunlabs.com.
Sara ChavezLebrun Labs LLC, Anaheim, CA, United States of America.
Linda NguyenLebrun Labs LLC, Anaheim, CA, United States of America.
Roxanne ChanLebrun Labs LLC, Anaheim, CA, United States of America.
Synlab Czech (Czechia) · CZ

Funding

Non-Animal Test Method to Determine the Ocular Safety of Consumer Products and Chemicals: Phase IIR44ES025501 · NIEHS · LEBRUN LABS, LLC · PI LEBRUN, STEWART · 2019 to 2020
$1.5M
A Nonanimal Test Method to Determine the Ocular Safety of Consumer Products and Chemicals: CommercializationSB1ES025501 · NIEHS · LEBRUN LABS, LLC · PI LEBRUN, STEWART · 2022 to 2023
$296k
Non-Animal Test Method To Determine The Ocular Safety Of Consumer Products and ChemicalsR43ES025501 · NIEHS · LEBRUN LABS, LLC · PI LEBRUN, STEWART · 2015 to 2015
$203k
NIEHS NIH HHS R43 ES025501NIEHS NIH HHS R44 ES025501NIEHS NIH HHS SB1 ES025501
6 · The paper itself

Abstract

The OptiSafe (OS) test is shelf-stable, macromolecular eye irritation test that does not include any animal ingredient or component ("vegan"). The purpose of this study was to evaluate the test's accuracy for an expanded application domain for both the original and recently updated OS method. This study involved the testing of additional ocular corrosives and previously excluded foaming agents ("surfactants") using both the original and updated OS methods and then combining these data with prior validation data for a total of 147 chemicals. Predictivity was evaluated by a statistical comparison of the OptiSafe predictions with historical in vivo "Draize" rabbit eye data for the same chemicals (from public databases). We report that for the detection of chemicals not requiring classification for eye irritation [Globally Harmonized System of Classification and Labeling of Chemicals (GHS) No Category], the accuracy, specificity, and sensitivity were 92.8%, 79.6%, and 100.0%, respectively, for the updated method; for the detection of chemicals inducing extreme eye damage/corrosion (GHS Category 1), the accuracy, specificity, and sensitivity were 79.4%, 71.8%, and 91.7%, respectively, for the updated method. Results indicate that both the original and updated methods have a high accuracy for the expanded application domain that included ocular corrosives and surfactants.

Indexed as

IrritantsToxicity TestsAnimalsAnimal Testing AlternativesDatabases, FactualEyeRabbitsIrritantsApplication domainNonanimal eye irritation testOcular irritationOptiSafeValidation

Identifiers

PMID36351539
PMCPMC9802687
OpenAlexW4308289442

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.