Nonanimal Eye & Skin Safety Testing for Cosmetics and Chemicals
OptiSafe™ (OECD TG 496 listed) and DermaSafe SCT™ deliver GHS eye irritation and skin corrosion classification without animals — validated in chemico methods trusted by cosmetic manufacturers, chemical companies, and CROs. NIH/NIEHS SBIR funded.
OptiSafe is a new approach methodology (NAM) and in chemico eye irritation test for GHS ocular hazard classification. The method uses specific ocular macromolecules and spectrophotometric damage measurement to assign GHS Category 1 (serious eye damage), Category 2 (eye irritation), and Not Classified outcomes, with no cell culture, live tissue, or animal use.
DermaSafe SCT is a validated new approach methodology (NAM) and in chemico skin corrosion test for GHS classification. The method incubates test substances with specific epithelial macromolecules and measures macromolecular damage spectrophotometrically to assign GHS Category 1A, 1B+1C, or Not Corrosive, along with DOT Packing Groups II and III.
Our Research Mission
Lebrun Labs develops quantitative, cell-free in chemico methods for chemical safety classification. Our goal is to replace animal-based and cell-based safety tests with validated, shelf-stable, high-throughput alternatives that are accessible to any laboratory. Both our ocular and dermal programs are grounded in peer-reviewed science and designed to meet international regulatory acceptance criteria under GHS, DOT, REACH, and OECD test guidelines.
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Cell-Free Methods
No cell culture, no live tissue, no animal use. Shelf-stable reagents, room-temperature incubation, spectrophotometric endpoints.
Regulatory Acceptance
Methods designed to meet OECD test guideline criteria and GHS classification requirements for international regulatory submissions.
17 NIH Grant Awards
Lebrun Labs has received grant awards across 11 unique grants since 2015, funded by NIEHS and NEI. Active awards include SB1 ES038803 (OptiSafe eye irritation test commercialization) and R44ES036065 Year 3 (DermaSafe SCT skin corrosion test). The complete grant portfolio spans SBIR Phase I/II Fast-Track, SB1 commercialization, and NEI CounterAct awards — establishing Lebrun Labs as a continuously NIH-funded developer of nonanimal safety tests for cosmetics and chemicals.
Peer-Reviewed Science
Eight peer-reviewed publications in Toxicology In Vitro and Cutaneous and Ocular Toxicology (2019–2025). The OptiSafe paper was named NIEHS Paper of the Month (2023) and OTSS SOT Paper of the Year (2024). OptiSafe is listed in OECD Test Guideline 496 as an independently validated method.
OptiSafe Eye Irritation Test & DermaSafe SCT Skin Corrosion Test
New approach methodologies (NAMs) for GHS ocular and dermal hazard classification, replacing animal-based and cell-based safety tests.
OptiSafe: In Chemico Eye Irritation Test
The OptiSafe eye irritation test program is supported by eight peer-reviewed publications in Toxicology In Vitro and Cutaneous and Ocular Toxicology (2019–2025), five NIH/NIEHS SBIR grants, OECD TG 496 listing, and five U.S. patents. The 2023 OptiSafe optimisation paper was selected as NIEHS Paper of the Month and awarded OTSS SOT Paper of the Year 2024. Publications cover the formal OptiSafe validation, antioxidant tear chemistry modeling to reduce false positives, application domain expansion, and a same-chemical comparison with BCOP, ICE, EpiOcular, and other accepted nonanimal eye irritation test methods.
The OptiSafe Eye Irritation Test (OptiSafe EIT) is a validated, cell-free in chemico new approach methodology (NAM) for GHS eye irritation and corrosion classification, funded across multiple NIH/NIEHS SBIR awards (R43ES025501, R44ES025501, R44ES031881, SB1 ES025501, SB1 ES038803). OptiSafe uses ocular tissue-relevant macromolecules and spectrophotometric damage measurement to classify test substances as GHS Category 1 (serious eye damage), GHS Category 2 (eye irritation), or Not Classified — with no cell culture, live tissue, or animal use. In June 2024, OptiSafe was added to OECD Test Guideline 496 as an independently validated test method for the identification of ocular irritants.
Research Approach
Identification and characterization of ocular tissue-relevant macromolecular targets that respond quantitatively to eye irritants and corrosives across the GHS classification range.
Incubation of test substance with macromolecular targets under controlled conditions, followed by spectrophotometric measurement of damage extent. Endpoint is quantitative and objective.
Development and optimization of a classification algorithm mapping spectrophotometric damage profiles to GHS eye irritation/corrosion categories (Cat. 1, Cat. 2, Not Classified).
Prospective and retrospective validation against OECD-accepted reference chemical datasets for eye irritation and corrosion, targeting accuracy metrics sufficient for OECD TG submission.
GHS eye irritation and corrosion classification is required for chemical substances under GHS, REACH, and DOT regulations. OptiSafe is listed in OECD Test Guideline 496 (June 2024) as an independently validated method for the identification of ocular irritants — the first fully cell-free, in chemico method to achieve this status. Current OECD-accepted nonanimal methods (BCOP, ICE, RhCE) require animal tissue or cell culture. OptiSafe's OECD TG 496 listing represents a significant advance in the 3Rs (Replacement, Reduction, Refinement) framework.
DermaSafe SCT: In Chemico Skin Corrosion Test
98% global corrosive/non-corrosive accuracy — the highest of any currently validated method. GHS multicategory accuracy on par with RhE (EpiDerm, SkinEthic) and Membrane Barrier (Corrositex) methods.
DermaSafe SCT is a validated, NIH/NIEHS SBIR-funded in chemico skin corrosion test (NAM) for GHS classification, funded under SBIR Fast-Track Award R44ES036065 (2024–2026). The test incubates the test substance with specific epithelial macromolecules, then measures macromolecular damage spectrophotometrically. The measured extent of damage is used to assign the GHS skin corrosion category and DOT packing group. The method is shelf-stable, rapid, and high-throughput, with no cell culture, no live tissue, and no animal use. U.S. Patent US12559784B2 (granted February 2026) covers the in chemico testing platform underpinning DermaSafe SCT.
GHS Classification Output
No significant macromolecular damage. No GHS Category 1 skin corrosion hazard.
Mild corrosive. Irreversible damage within 1 hour, persisting up to 4 hours.
Moderate corrosive. Irreversible damage within 1 hour, persisting up to 14 days.
Severe corrosive. Irreversible damage within 3 minutes, persisting up to 1 hour.
Validated and commercially available. Testing services offered through LebrunLabs.com.
Eye Irritation & Skin Corrosion Testing for Cosmetic Manufacturers
Cosmetic manufacturers, formulators, ingredient suppliers, and contract research organizations (CROs) use OptiSafe and DermaSafe SCT to meet GHS eye irritation and skin corrosion labeling requirements — without animal testing.
Cosmetic Eye Irritation Testing
Test finished cosmetic formulations, rinse-off products, eye-area products, and raw ingredients for GHS eye irritation classification. OptiSafe (OECD TG 496) replaces the Draize rabbit eye test with a validated, cell-free in chemico method.
Cosmetic Skin Corrosion Testing
Classify cosmetic ingredients and formulations for GHS skin corrosion hazard (Category 1A, 1B+1C, Not Corrosive) and DOT packing groups. DermaSafe SCT achieves 98% accuracy — the highest of any validated method.
GHS Regulatory Compliance
Both OptiSafe and DermaSafe SCT generate GHS classification data accepted for regulatory submissions under REACH, GHS, and DOT. OptiSafe is listed in OECD Test Guideline 496 — the international standard for nonanimal eye irritation testing.
Ingredient Safety Screening
Screen new cosmetic ingredients, surfactants, preservatives, and actives for ocular and dermal safety before formulation. High-throughput format tests up to 30 chemicals per run in under 6 hours.
Cruelty-Free & Vegan Formulations
OptiSafe and DermaSafe SCT require no animals, no animal-derived tissue, and no cell culture. Both methods use shelf-stable, vegan reagents — supporting cruelty-free product development and EU cosmetics animal testing ban compliance.
CRO & Contract Lab Testing
Contract research organizations and testing laboratories can offer OptiSafe and DermaSafe SCT services to cosmetic and chemical clients. Test kits are available from InChemico.com. Contract testing and regulatory data packages available from LebrunLabs.com.
OptiSafe vs. Traditional Eye Irritation Tests for Cosmetics
How OptiSafe compares to the Draize test, BCOP, ICE, and EpiOcular for cosmetic safety testing
| Feature | Draize Rabbit Eye Test | BCOP / ICE | EpiOcular (RhCE) | OptiSafe (OECD TG 496) |
|---|---|---|---|---|
| Animal use | ✗ Rabbit eyes | ✗ Bovine/chicken tissue | ✗ Cell culture | ✓ None — fully cell-free |
| OECD accepted | TG 405 | TG 437/438 | TG 492 | ✓ TG 496 (June 2024) |
| GHS categories | NC / Cat 2 / Cat 1 | NC / Cat 1 only | NC / Cat 1 only | ✓ NC / Cat 2 / Cat 1 |
| Turnaround | 21 days | 3–5 days | 5–7 days | ✓ Under 24 hours |
| Cost per test | High | Medium | High | ✓ $1,200–$1,800/kit |
| Cruelty-free | ✗ No | ✗ No | ✗ No | ✓ Yes — vegan reagents |
OptiSafe is the only fully cell-free, in chemico eye irritation test listed in OECD TG 496. Validated by NICEATM with 92% accuracy.
NIH/NIEHS Funded Research — Complete Grant Portfolio
Lebrun Labs has received 17 NIH grant awards across 11 unique grants since 2015, funding the OptiSafe eye irritation test for cosmetics and chemicals (OECD TG 496), the DermaSafe SCT skin corrosion test, and antioxidant eye wash programs. Both the OptiSafe and DermaSafe SCT programs are currently active and funded by the National Institute of Environmental Health Sciences (NIEHS) and the National Eye Institute (NEI).
SB1 ES038803 — IVD EIT Commercialization (2026, NIEHS)
ActiveNIH/NIEHS SB1 Award ES038803 funds commercialization of the IVD EIT (OptiSafe Eye Irritation Test) — a validated nonanimal alternative method for the detection of ocular irritants used by cosmetic manufacturers, chemical companies, and CROs for GHS eye irritation classification. Most recent award in the OptiSafe program.
R44 ES036065 Year 3 — In Chemico Dermal Corrosives (2026, NIEHS)
ActiveNIH/NIEHS SBIR Fast-Track Year 3 continuation 5R44ES036065-03 funds final validation, OECD test guideline submission, and commercial scale-up of DermaSafe SCT — the in chemico skin corrosion test for cosmetic and chemical GHS classification. This is the largest single-year award in the DermaSafe SCT program.
R44 ES036065 Year 2 S1 — Administrative Supplement (2025, NIEHS)
ActiveAdministrative supplement to the DermaSafe SCT SBIR Fast-Track Award R44ES036065, supporting additional validation work for the in chemico skin corrosion test for cosmetics and chemicals.
R44 ES036065 Year 2 — In Chemico Dermal Corrosives (2025, NIEHS)
ActiveNIH/NIEHS SBIR Fast-Track Year 2 continuation 4R44ES036065-02 funded multi-laboratory transferability study, applicability domain expansion, and OECD test guideline data package preparation for DermaSafe SCT — the validated skin corrosion test for cosmetic ingredient safety testing.
R21 EY033713 Year 2 — Antioxidant Eye Wash (2024, NIH/NEI)
CompletedNIH/NEI CounterAct Year 2 continuation 5R21EY033713-02 funded generalizability testing of ascorbate-based emergency eye wash formulations and led to U.S. Patent US12648892B2 for emergency eye wash using buffered vitamin C.
R44 ES031881 Year 3 — IVD EIT Nonanimal Eye Irritation Test: Phase II (2024, NIEHS)
CompletedNIH/NIEHS SBIR Phase II Year 3 continuation 5R44ES031881-03 funded antioxidant tear chemistry modeling, application domain expansion, and same-chemical comparison publications for OptiSafe — the nonanimal eye irritation test for cosmetics and chemicals.
R44 ES031881 Year 3 S1 — Administrative Supplement (2024, NIEHS)
CompletedAdministrative supplement to the IVD EIT SBIR Phase II Award R44ES031881, supporting additional development work for the OptiSafe nonanimal eye irritation test.
R44 ES036065 Year 1 — In Chemico Dermal Corrosives (2024, NIEHS)
CompletedNIH/NIEHS SBIR Fast-Track Year 1 award 1R44ES036065-01 launched the DermaSafe SCT skin corrosion test program — developing a nonanimal, high-throughput, field test to identify dermal corrosives for GHS classification of cosmetic and chemical products.
R44 ES031881 Diversity Supplement — Joana Romero (2024, NIEHS)
CompletedAdministrative supplement to promote diversity in research and development small businesses, supporting Joana Romero's work on the IVD EIT (OptiSafe) nonanimal eye irritation test program.
R21 EY033713 Year 1 — Antioxidant Eye Wash (2023, NIH/NEI)
CompletedNIH/NEI CounterAct Award 1R21EY033713-01A1 launched the antioxidant eye wash program, funding development of ascorbate-based emergency eye wash formulations to reduce ocular damage following chemical exposure.
R44 ES031881 Year 2 — IVD EIT Nonanimal Eye Irritation Test: Phase II (2023, NIEHS)
CompletedNIH/NIEHS SBIR Phase II Year 2 continuation 2R44ES031881-02A1 funded further development of OptiSafe — the nonanimal kit and service for the detection of ocular irritants used by cosmetic manufacturers and chemical companies for GHS eye irritation classification.
SB1 ES025501 Year 5 — OptiSafe Commercialization (2023, NIEHS)
CompletedNIH/NIEHS SB1 Award 5SB1ES025501-05 funded commercialization of the OptiSafe Eye Irritation Test, supporting the transition from validated research method to commercial testing service and kit product for cosmetic and chemical safety testing.
SB1 ES025501 Year 4 — OptiSafe Commercialization (2022, NIEHS)
CompletedNIH/NIEHS SB1 Award 2SB1ES025501-04A1 continued commercialization of the OptiSafe nonanimal eye irritation test for consumer products and chemicals, expanding market access for cosmetic manufacturers and CROs.
R44 ES025501 Year 3 — Nonanimal Ocular Safety Test: Phase II (2020, NIEHS)
CompletedNIH/NIEHS SBIR Phase II Year 3 continuation 5R44ES025501-03 funded further development and validation of the OptiSafe nonanimal eye irritation test for consumer products and chemicals — the method that became OECD TG 496 listed.
R43 ES031881 Year 1 — IVD EIT Nonanimal Eye Irritation Test: Phase I (2020, NIEHS)
CompletedNIH/NIEHS SBIR Phase I Award 1R43ES031881-01 launched the IVD EIT program — a nonanimal kit and service for the detection of reversible ocular irritants, expanding the OptiSafe platform to cover GHS Category 2 eye irritation for cosmetic and chemical safety testing.
R44 ES025501 Year 2 — Nonanimal Ocular Safety Test: Phase II (2019, NIEHS)
CompletedNIH/NIEHS SBIR Phase II Year 2 award 2R44ES025501-02 funded further development of the OptiSafe nonanimal test method to determine the ocular safety of consumer products and chemicals.
R43 ES025501 Year 1 — Nonanimal Ocular Safety Test: Phase I (2015, NIEHS)
CompletedFoundational NIH/NIEHS SBIR Phase I grant 1R43ES025501-01 that launched the OptiSafe research program in 2015 and led to U.S. Patent US10041922B2 — the first patent covering the OptiSafe biochemistry-based ocular toxicity assay for consumer products and chemicals.
For collaboration proposals, licensing inquiries, or partnership discussions, contact Lebrun Labs at [email protected] or (714) 345-4689.
Published Research
Nine peer-reviewed publications in Toxicology In Vitro and Cutaneous and Ocular Toxicology (2019–2025) validating OptiSafe (OECD TG 496 nonanimal eye irritation test for cosmetics), DermaSafe SCT (in chemico skin corrosion test), and the antioxidant eye wash program. All are open-access via PubMed Central.
Washing with buffered vitamin C after corrosive chemical (sodium hypochlorite) exposure reduces ocular depth of injury
Lebrun S, Nguyen L, Romero J, Chan R
Evaluation of a New In Chemico Skin Corrosion Test
Lebrun S, Nguyen L, Ho KV
Expansion of the application domain of a macromolecular ocular irritation test (OptiSafe™)
Lebrun S, Chavez S, Nguyen L, Chan R
Further optimisation of a macromolecular ocular irritation test (OptiSafe™)
Lebrun S, Chavez S, Nguyen L, Chan R
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
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
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
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
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
All publications listed above were supported in part by the National Institute of Environmental Health Sciences under Award R44ES031881. Content does not represent official NIH views.
- Award
- R44ES031881
- Mechanism
- SBIR Fast-Track (Phase I + II)
- Institute
- National Institute of Environmental Health Sciences
- Program
- DermaSafe SCT™: Skin Corrosion
- Status
- Completed and validated
Recognition & Regulatory Milestones
OptiSafe and DermaSafe SCT have earned independent scientific recognition, regulatory acceptance, and intellectual property protection across 17 NIH grant awards, 5 U.S. patents, and 4 registered trademarks.
OptiSafe Added to OECD Test Guideline 496
In June 2024, OptiSafe was added to OECD TG 496 as an independently validated test method for the identification of ocular irritants — the first fully cell-free, in chemico eye irritation test to achieve OECD listing. This makes OptiSafe directly usable for GHS regulatory submissions under REACH, GHS, and DOT frameworks worldwide.
OTSS SOT Paper of the Year 2024
The OptiSafe paper "Further optimisation of a macromolecular ocular irritation test (OptiSafe)" was awarded the OTSS Annual SOT Paper of the Year at the Society of Toxicology 2024 Annual Meeting. The paper demonstrated a 50% reduction in the false-positive rate of the OptiSafe eye irritation test.
NIEHS Paper of the Month
The OptiSafe optimisation paper was selected by the National Institute of Environmental Health Sciences as one of its featured Papers of the Month in 2023 — recognition given to research of exceptional public health significance funded by NIEHS.
U.S. Patent US12648892B2 — Emergency Eye Wash
Granted June 9, 2026. Covers a novel emergency eye wash method using a low-concentration freshly prepared ascorbate solution applied in high volume within 10 minutes of chemical exposure. Inventors: Stewart Lebrun, Linda Nguyen. Supported by NIH/NEI Grant R21 EY033713.
U.S. Patent US12559784B2 — In Chemico Test for Toxicity
Granted February 24, 2026. Covers the in chemico testing platform that measures reduction in enzyme activity as a predictor of in vivo toxicity, underpinning the DermaSafe SCT skin corrosion test. Inventor: Stewart Lebrun. Supported by NIH/NIEHS Grant R44ES036065.
U.S. Patent US12521367B2 — Antioxidant Tear Chemistry
Granted January 13, 2026. Covers the discovery that adding tear-mimicking antioxidants to in vitro ocular irritation tests reduces false-positive rates from ~40% to ~20%. Inventors: Stewart Lebrun, Roxanne Chan, Sara Chavez. Underpins the OptiSafe antioxidant modeling publications.
U.S. Patent US12115147B2 — Antioxidant Formulations for Eye Irritation Tests
Granted October 15, 2024. Covers antioxidant formulations that substantially reduce the false-positive rate of nonanimal ocular irritation tests by modeling the antioxidant properties of human tears. Inventors: Stewart Lebrun, Roxanne Chan, Sara Chavez.
U.S. Patent US10041922B2 — OptiSafe Biochemistry-Based Ocular Toxicity Assay
Granted August 2018. Foundational patent behind OptiSafe — the first in vitro method to combine dual sub-assays for ocular irritation prediction. Independently validated by NICEATM with 92% accuracy. Supported by NIH/NIEHS SBIR Phase I R43ES025501.
Registered Trademarks: OptiSafe EIT, DermaSafe SCT, In Chemico
U.S. trademarks registered in 2024: OPTISAFE EYE IRRITATION TEST, OPTISAFE EIT, IN CHEMICO, and IN CHEMICO LLC — all registered to Lebrun Labs LLC / In Chemico LLC for use in connection with nonanimal toxicity testing products and services.
Eye Irritation & Skin Corrosion Testing: Common Questions for Cosmetic Manufacturers
What eye irritation test should I use for cosmetic products?
How do cosmetic companies comply with GHS eye irritation labeling requirements?
Is there a nonanimal alternative to the Draize eye irritation test for cosmetics?
What is the OptiSafe eye irritation test?
What is DermaSafe SCT and how does the skin corrosion test work?
What is a NAM (new approach methodology) in chemical safety testing?
How does OptiSafe compare to BCOP, ICE, and EpiOcular eye irritation tests?
Is DermaSafe SCT accepted for GHS and DOT regulatory submissions?
Where can I submit samples for OptiSafe or DermaSafe SCT testing?
Partner With Lebrun Labs
We welcome inquiries from funding agencies, industry partners, CROs, and regulatory bodies interested in advancing nonanimal safety testing for eye and skin hazard classification.
Lebrun Labs LLC · 3301 E. Miraloma Ave., Suite 194, Anaheim, CA 92806 · (714) 345-4689 · [email protected]
- Organization
- Lebrun Labs LLC
- Address
- 3301 E. Miraloma Ave., Suite 194, Anaheim, CA 92806
- Phone
- (714) 345-4689
- [email protected]
- Contract testing
- LebrunLabs.com
- Test kits
- InChemico.com
- Submit sample
- inchemico.com/sample-submission
- NIH Award
- R44ES031881 (NIEHS SBIR)