9 Peer-Reviewed Publications · 2019–2025

Peer-Reviewed Research Supporting OptiSafe & DermaSafe SCT

All 9 publications in Toxicology In Vitro and Cutaneous and Ocular Toxicology — validating the OptiSafe nonanimal eye irritation test for cosmetics (OECD TG 496) and DermaSafe SCT in chemico skin corrosion test. NIH/NIEHS funded since 2015.

7OptiSafe (OECD TG 496)
1DermaSafe SCT
1Eye Wash Program
OptiSafe

OptiSafe Eye Irritation Test — Publications

7 peer-reviewed publications validating OptiSafe as a nonanimal eye irritation test for cosmetics, chemicals, and GHS classification. OptiSafe is listed in OECD Test Guideline 496 (June 2024) — the international standard for nonanimal eye irritation testing.

OptiSafeToxicology In Vitro · 2023NIEHS Paper of the Month 2023

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

Lebrun S, Chavez S, Nguyen L, Chan R

Expands the validated chemical space of OptiSafe to include additional surfactant classes, preservatives, and cosmetic actives. Demonstrates that the antioxidant-corrected OptiSafe method correctly classifies a broader range of cosmetic ingredients — supporting its use as a general-purpose eye irritation test for cosmetic formulation safety.

Relevance to cosmetic & chemical industry: Directly relevant to cosmetic manufacturers testing new ingredients and formulations. Expands the range of cosmetic chemicals OptiSafe can reliably classify for GHS eye irritation.
irritationtestcosmeticsapplicationdomainOECDnonanimal
OptiSafeCutaneous and Ocular Toxicology · 2023OTSS SOT Paper of the Year 2024

Further optimisation of a macromolecular ocular irritation test (OptiSafe™)

Lebrun S, Chavez S, Nguyen L, Chan R

Reports further protocol optimisation of the OptiSafe macromolecular eye irritation test, improving classification accuracy for cosmetic ingredients and reducing variability. Introduces refined incubation conditions and spectrophotometric thresholds that became part of the OECD TG 496 listed method.

Relevance to cosmetic & chemical industry: Describes the optimised OptiSafe protocol used in commercial test kits. Cosmetic manufacturers and CROs using OptiSafe kits benefit directly from the accuracy improvements reported here.
nonanimalirritationtestoptimisationcosmeticingredientsafety
OptiSafeToxicology In Vitro · 2022

Ascorbic acid specifically reduces the misclassification of nonirritating reactive chemicals in the OptiSafe™ macromolecular eye irritation test

Lebrun S, Chavez S, Chan R, Nguyen L, Jester JV

Identifies that reactive chemicals (aldehydes, epoxides, isocyanates) cause false-positive results in macromolecular eye irritation tests by directly reacting with the test macromolecules. Adding ascorbic acid to the assay specifically blocks this reaction, reducing the false-positive rate from ~40% to ~20% for reactive chemicals without affecting true irritant classification.

Relevance to cosmetic & chemical industry: Critical for cosmetic manufacturers testing reactive preservatives, fragrances, and actives. The ascorbic acid correction is now standard in OptiSafe commercial kits.
irritationtestfalsepositivereactivechemicalscosmeticsascorbic
OptiSafeToxicology In Vitro · 2021

Same-chemical comparison of nonanimal eye irritation test methods: Bovine corneal opacity and permeability, EpiOcular™, isolated chicken eye, ocular Irritection®, OptiSafe™, and short time exposure

Lebrun S, Nguyen L, Chavez S, Chan R, Le D, Nguyen M, Jester JV

The first same-chemical head-to-head comparison of all major nonanimal eye irritation test methods on an identical chemical set: BCOP, ICE, EpiOcular, ocular Irritection, OptiSafe, and short time exposure. Demonstrates that OptiSafe is the only fully cell-free, in chemico method in the comparison — requiring no animal-derived tissue or cell culture — while achieving comparable accuracy to tissue-based methods.

Relevance to cosmetic & chemical industry: The definitive reference for cosmetic manufacturers and CROs choosing between nonanimal eye irritation test methods. Directly answers the question: how does OptiSafe compare to BCOP, ICE, and EpiOcular for cosmetic safety testing?
nonanimalirritationtestcomparisonBCOPEpiOcularcosmeticsOECD
OptiSafeToxicology In Vitro · 2021

Modeling the antioxidant properties of the eye reduces the false-positive rate of a nonanimal eye irritation test (OptiSafe)

Lebrun SJ, Chavez S, Chan R, Nguyen L, Jester JV

Demonstrates that incorporating a mathematical model of the eye's natural antioxidant defense (ascorbate, glutathione) into the OptiSafe assay reduces the false-positive rate from ~40% to ~20%. Establishes the biochemical rationale for the antioxidant correction that is now standard in OptiSafe commercial kits.

Relevance to cosmetic & chemical industry: Explains why OptiSafe achieves higher accuracy than earlier macromolecular eye irritation tests. Relevant to cosmetic manufacturers and CROs requiring high-accuracy GHS eye irritation classification.
nonanimalirritationtestaccuracyantioxidanttearchemistryfalse
OptiSafeCutaneous and Ocular Toxicology · 2020OECD TG 496 Validation

Validation of the OptiSafe™ eye irritation test

Choksi N, Lebrun S, Nguyen M, Daniel A, DeGeorge G, Willoughby J, Layton A, Lowther D, Merrill J, Matheson J, Barroso J, Yozzo K, Casey W, Allen D

The formal independent validation study of OptiSafe conducted by NICEATM (NTP Interagency Center for the Evaluation of Alternative Toxicological Methods) and Lebrun Labs. Demonstrates that OptiSafe meets OECD validation criteria for a nonanimal eye irritation test method. This paper directly supported the listing of OptiSafe in OECD Test Guideline 496 in June 2024.

Relevance to cosmetic & chemical industry: The foundational validation paper that established OptiSafe as a regulatory-grade nonanimal eye irritation test. Required reading for cosmetic manufacturers and regulatory affairs professionals evaluating OptiSafe for GHS submissions.
OptiSafeirritationtestvalidationOECDcosmeticsafetytesting
OptiSafeToxicology In Vitro · 2019

An in vitro depth of injury prediction model for a histopathologic classification of EPA and GHS eye irritants

Lebrun S, Xie Y, Chavez S, Chan R, Jester JV

Presents the foundational in vitro depth of injury model that underpins the OptiSafe biochemistry. Demonstrates that spectrophotometric measurement of macromolecular damage predicts histopathologic depth of injury in the cornea — the mechanistic basis for GHS eye irritation classification using OptiSafe.

Relevance to cosmetic & chemical industry: Foundational mechanistic paper for the OptiSafe platform. Establishes the scientific basis for using in chemico macromolecular damage measurement to predict GHS eye irritation categories — directly relevant to cosmetic ingredient safety testing.
irritationclassificationvitrodepthinjurycosmeticshistopathology

Ready to use OptiSafe for your cosmetic eye irritation testing?

OECD TG 496 listed · GHS Category 1 / 2 / NC · No animals · Results in under 24 hours

DermaSafe SCT

DermaSafe SCT Skin Corrosion Test — Publications

1 peer-reviewed publication validating DermaSafe SCT as a nonanimal in chemico skin corrosion test for cosmetics and chemicals. Achieves 98% global accuracy — the highest of any validated skin corrosion method. NIH/NIEHS SBIR Fast-Track R44 ES036065.

DermaSafe SCTToxicology In Vitro · 2024DermaSafe SCT Validation

Evaluation of a New In Chemico Skin Corrosion Test

Lebrun S, Nguyen L, Ho KV

Presents the validation of DermaSafe SCT — a novel, fully cell-free in chemico skin corrosion test. Achieves 98% global corrosive/non-corrosive accuracy across GHS categories 1A, 1B+1C, and Not Corrosive, and DOT packing groups II and III. The highest accuracy of any currently validated skin corrosion method.

Relevance to cosmetic & chemical industry: Primary validation paper for DermaSafe SCT. Cosmetic manufacturers, chemical companies, and CROs use this method for GHS skin corrosion labeling compliance and DOT packing group classification.
chemicoskincorrosiontestcosmeticsclassificationDermaSafe

Ready to use DermaSafe SCT for cosmetic skin corrosion testing?

GHS 1A / 1B+1C / Not Corrosive · DOT packing groups · 98% accuracy · No animals

Eye Wash

Antioxidant Eye Wash Program — Publications

1 peer-reviewed publication demonstrating that buffered vitamin C (ascorbic acid) eye wash reduces ocular depth of injury after corrosive chemical exposure. NIH/NEI CounterAct Award R21 EY033713.

Eye WashToxicology In Vitro · 2025

Washing with buffered vitamin C after corrosive chemical (sodium hypochlorite) exposure reduces ocular depth of injury

Lebrun S, Nguyen L, Romero J, Chan R

Demonstrates that washing with buffered ascorbic acid (vitamin C) after sodium hypochlorite (bleach) exposure significantly reduces ocular depth of injury compared to saline. Foundational evidence for the antioxidant eye wash program funded by NIH/NEI CounterAct Award R21 EY033713.

Relevance to cosmetic & chemical industry: Supports the antioxidant eye wash research program. Relevant to emergency responders, chemical manufacturers, and occupational safety professionals.
emergencywashocularchemicalinjurybufferedvitamin

Interested in the antioxidant eye wash research program?

NIH/NEI CounterAct funded · U.S. Patent US12648892B2 · Ocular chemical injury

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Complete Citation List

All publications are open-access via PubMed Central (PMC). Click any PMID to view the full text.

  1. 1

    Washing with buffered vitamin C after corrosive chemical (sodium hypochlorite) exposure reduces ocular depth of injury

    Lebrun S, Nguyen L, Romero J, Chan R. Toxicology In Vitro. 2025. doi: 10.1016/j.tiv.2024.106006. PMID: 39746384 Free PMC article.

    Eye Wash
  2. 2

    Evaluation of a New In Chemico Skin Corrosion Test

    Lebrun S, Nguyen L, Ho KV. Toxicology In Vitro. 2024. doi: 10.1016/j.tiv.2024.105944. PMID: 39341469 Free PMC article.

    DermaSafe SCTDermaSafe SCT Validation
  3. 3

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

    Lebrun S, Chavez S, Nguyen L, Chan R. Toxicology In Vitro. 2023. doi: 10.1016/j.tiv.2022.105515. PMID: 36351539 Free PMC article.

    OptiSafeNIEHS Paper of the Month 2023
  4. 4

    Further optimisation of a macromolecular ocular irritation test (OptiSafe™)

    Lebrun S, Chavez S, Nguyen L, Chan R. Cutaneous and Ocular Toxicology. 2023. doi: 10.1080/15569527.2023.2170067. PMID: 36669195 Free PMC article.

    OptiSafeOTSS SOT Paper of the Year 2024
  5. 5

    Ascorbic acid specifically reduces the misclassification of nonirritating reactive chemicals in the OptiSafe™ macromolecular eye irritation test

    Lebrun S, Chavez S, Chan R, Nguyen L, Jester JV. Toxicology In Vitro. 2022. doi: 10.1016/j.tiv.2022.105313. PMID: 35033652 Free PMC article.

    OptiSafe
  6. 6

    Same-chemical comparison of nonanimal eye irritation test methods: Bovine corneal opacity and permeability, EpiOcular™, isolated chicken eye, ocular Irritection®, OptiSafe™, and short time exposure

    Lebrun S, Nguyen L, Chavez S, Chan R, Le D, Nguyen M, Jester JV. Toxicology In Vitro. 2021. doi: 10.1016/j.tiv.2020.105070. PMID: 33352259 Free PMC article.

    OptiSafe
  7. 7

    Modeling the antioxidant properties of the eye reduces the false-positive rate of a nonanimal eye irritation test (OptiSafe)

    Lebrun SJ, Chavez S, Chan R, Nguyen L, Jester JV. Toxicology In Vitro. 2021. doi: 10.1016/j.tiv.2021.105208. PMID: 34216722 Free PMC article.

    OptiSafe
  8. 8

    Validation of the OptiSafe™ eye irritation test

    Choksi N, Lebrun S, Nguyen M, Daniel A, DeGeorge G, Willoughby J, Layton A, Lowther D, Merrill J, Matheson J, Barroso J, Yozzo K, Casey W, Allen D. Cutaneous and Ocular Toxicology. 2020. doi: 10.1080/15569527.2020.1787431. PMID: 32586141 Free PMC article.

    OptiSafeOECD TG 496 Validation
  9. 9

    An in vitro depth of injury prediction model for a histopathologic classification of EPA and GHS eye irritants

    Lebrun S, Xie Y, Chavez S, Chan R, Jester JV. Toxicology In Vitro. 2019. doi: 10.1016/j.tiv.2019.104628. PMID: 31419508 Free PMC article.

    OptiSafe

Ready to use these validated methods for your cosmetic safety testing?

OptiSafe (OECD TG 496 eye irritation test) and DermaSafe SCT (skin corrosion test) are available as test kits at InChemico.com or as contract testing services at LebrunLabs.com.

Lebrun Labs
Eye & Skin Research

Developer of the OptiSafe eye irritation test and DermaSafe SCT skin corrosion test — validated new approach methodologies (NAMs) for GHS classification. NIH/NIEHS SBIR funded.

Anaheim, CA · lebrunlabs.net

Contact

Lebrun Labs LLC3301 E. Miraloma Ave., Suite 194Anaheim, CA 92806(714) 345-4689[email protected]

Lebrun Labs LLC develops and validates new approach methodologies (NAMs) for chemical safety testing. The OptiSafe eye irritation test (IVD EIT, OECD TG 496 listed, NIH/NIEHS funded: R43ES025501, R44ES025501, R44ES031881, SB1 ES025501, SB1 ES038803) classifies GHS ocular hazard categories without animal tissue or cell culture. The DermaSafe SCT skin corrosion test (NIH/NIEHS SBIR R44ES036065) classifies GHS skin corrosion categories and DOT packing groups using an in chemico, cell-free spectrophotometric method. Both methods are supported by eight peer-reviewed publications in Toxicology In Vitro and Cutaneous and Ocular Toxicology, five U.S. patents, and 11 NIH grants awarded since 2015.

Research supported by the National Institute of Environmental Health Sciences under Awards R44ES031881, SB1 ES025501, SB1 ES038803 (OptiSafe eye irritation test) and R44ES036065 (DermaSafe SCT skin corrosion test), and by the National Eye Institute under Award R21 EY033713. Content does not represent official NIH views. Testing services provided through LebrunLabs.com.

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