OECD TG 496 Validated

OptiSafe EIT™

The only nonanimal eye irritation test with 100% sensitivity for nonirritants. Shelf-stable, vegan, OECD TG 496 accepted. Results in under 24 hours.

100%

Sensitivity for nonirritants

>90%

Overall accuracy

<24 h

Time to results

None

Animal ingredients

The Science

How OptiSafe EIT™ works

The OptiSafe EIT™ is an in chemico nonanimal eye irritation test that identifies ocular nonirritants with 100% sensitivity; the highest of any new alternative method (NAM) currently available. It uses a shelf-stable, vegan macromolecular test matrix that mimics the biochemical environment of the anterior segment of the eye.

The method is based on the principle that ocular irritants must pass through the tear film to interact with and disrupt the macromolecular components of the cornea. When a test material is added to the OptiSafe matrix, irritants cause a measurable change in optical density that correlates with their irritation potential. Nonirritants produce no significant change.

Unlike cell-based methods such as EpiOcular or SkinEthic RHC, OptiSafe requires no aseptic technique, no live tissue, and no specialized cell culture equipment. A standard laboratory spectrophotometer is all that is needed beyond the kit contents. This makes OptiSafe accessible to any analytical chemistry laboratory — not just those with cell culture infrastructure.

OptiSafe is suitable for cosmetics, personal care products, industrial chemicals, pharmaceuticals, and agrochemicals. It is accepted under OECD Test Guideline 496 for GHS Not Classified (NC) determination, and is recognized by regulatory agencies in the EU, US, Canada, and internationally.

OECD Test Guideline 496

OptiSafe Procedure

Run Pretest Kit

Measure solubility, buffering, and foaming to select the right assay.

Run OptiSafe Test

No aseptic technique. Standard lab bench setup.

Incubate

Overnight (18 hour) incubation with the OptiSafe matrix.

Measure

Read absorbance on spectrophotometer.

Classify

Apply decision criteria and classify as nonirritant or irritant.

Application domains

Cosmetics & Personal Care

Shampoos, conditioners, cleansers, makeup

Industrial Chemicals

Solvents, cleaning agents, process chemicals

Pharmaceuticals

Ophthalmic excipients, topical formulations

Agrochemicals

Pesticides, herbicides, formulation ingredients

What is outside of the OptiSafe application domain?

Metal Oxides

Many sunscreens and eye shadows contain high levels of metal oxides and are outside the OptiSafe application domain.

What do I do if my formulation contains metal oxides?

The IVD EIT™ is compatible with metal oxides and sunscreens. View IVD EIT™ kits

Which kit do I need?

1

Run the Pretest Kit first

OSPT2903 measures solubility, buffering capacity, and foaming. Results determine which assay kit is appropriate.

2

Standard or Surfactant?

Surfactant materials → Surfactant Assay (OSSA2489). All other materials → Main Assay (OSMA2796).

3

Extreme buffering?

Extreme buffering → H Kit (OSHA2815). Middle buffering → HMA Kit (OSHM2612).

Order Online

OptiSafe EIT™ Kits

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Each kit row below includes a Full kit details button that opens tabbed support content — protocol steps, materials list, downloadable documents, and gallery images.

OptiSafe EIT™ Pretest KitPCHP Selection

OptiSafe EIT™ Pretest Kit

SKU OSPT2903

Measures physicochemical properties (solubility, buffering capacity, foaming) to select the correct OptiSafe assay kit for your material.

One pretest kit tests 10 samples.

$600

per kit (10 test articles)

Ships within 3–5 business days

OptiSafe EIT™ Main Assay
OECD 496

OptiSafe EIT™ Main Assay

SKU OSMA2796

Nonanimal NAM to identify ocular irritants with 90% accuracy. OECD TG 496 accepted. Shelf-stable, vegan. Results in <24 hours.

One kit tests 3 samples. Additional equipment required. See kit Instructions and Lab Set-Up PDFs.

$1,800

per kit (3 test articles)

Ships within 3–5 business days

OptiSafe EIT™ Surfactant Assay
Surfactant PCHP

OptiSafe EIT™ Surfactant Assay

SKU OSSA2489

Shelf-stable in chemico test for surfactant materials. Includes a dilution series to account for unexpected increased toxicity of some surfactants after dilution.

One kit tests 3 samples. Use when Pretest Kit indicates surfactant character.

$1,800

per kit (3 test articles)

Ships within 3–5 business days

OptiSafe EIT™ H Kit
Extreme buffering

OptiSafe EIT™ H Kit

SKU OSHA2815

For test samples with extreme buffering values. Evaluates potential to disrupt, denature, and degrade biological molecules via extreme pH buffering.

Use when Pretest Kit indicates extreme buffering. Tests 1 test article per kit.

$600

per kit (1 test article)

Ships within 3–5 business days

OptiSafe EIT™ HMA Kit
Mid-range pH buffering

OptiSafe EIT™ HMA Kit

SKU OSHM2612

OptiSafe EIT test kit for test samples with middle buffering values. Extends coverage to materials in the intermediate buffering range.

Use when Pretest Kit indicates middle buffering values. Tests 1 sample per kit.

$600

per kit (1 test article)

Ships within 3–5 business days

Free shipping on orders over $500 · Volume discounts available · Contact us

OptiSafe Full Protocols
Surfactant Assay protocol cover

Surfactant Assay

Completely Insoluble / Floats or Aggregates protocol cover

Completely Insoluble / Floats or Aggregates

Peer-Reviewed Science

Publications

1

Lebrun S, Chavez S, Nguyen L, Chan R. Further optimisation of a macromolecular ocular irritation test (OptiSafe™). Cutan Ocul Toxicol. 2023;42(1):38-48.

PubMed
2

Lebrun S, Chavez S, Nguyen L, Chan R. Expansion of the application domain of a macromolecular ocular irritation test (OptiSafe™). Toxicol In Vitro. 2023;86:105515.

PubMed
3

Lebrun S et al. Ascorbic acid specifically reduces the misclassification of nonirritating reactive chemicals in the OptiSafe™ macromolecular eye irritation test. Toxicol In Vitro. 2022;80:105313.

PubMed
4

Lebrun SJ et al. Modeling the antioxidant properties of the eye reduces the false-positive rate of a nonanimal eye irritation test (OptiSafe). Toxicol In Vitro. 2021;76:105208.

PubMed
5

Lebrun S et al. Same-chemical comparison of nonanimal eye irritation test methods. Toxicol In Vitro. 2021;72:105070.

PubMed

Patents

Lebrun, S., Chan, R., Chavez, S. (2024, Oct 15). Formulations and methods related to eye irritation (U.S. Patent No. 12,115,147).

Lebrun, S. (2018, Aug 7). Biochemistry based ocular toxicity assay (U.S. Patent No. 10,041,922).

Need contract testing?

LebrunLabs.co offers contract testing using OptiSafe EIT™ and other InChemico methods.