Topical Safety Testing and Irritation

Patch Testing, Safety In Use, Hypoallergenic Claim Support, Sensitive Skin, HRIPT and Ocular Testing

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Published by our sponsorsSee case studies

Mineral sunscreen whitening study, NCT05565625 ↗

Skin hydration and health study ↗

18-week hyperpigmentation study, NCT07136766 ↗

12-week eye cream study, NCT05807620 ↗

8-week microcurrent device study, NCT07510581 ↗

VCS technicians evaluating a participant for skin response

Preliminary Safety And Erythemal Responses

VCS can help provide you with the assurance that your product won’t cause irritation, clog pores, or cause allergenic/systemic reactions in a sample population ranging from 20-100 test subjects.

Consumer safety is broken down into 2 main categories:

Patch Testing
Consumer in Use Safety

Amazon.com Marketplace Safety Documentation and Compliance

Recently Amazon has changed its marketplace requirements to include more stringent safety testing and patch testing requirements. Amazon also now requires a Certificate of Analysis for all products in the personal care space, and if you’re unfamiliar with clinical testing and claim support it can be quite a lot to digest.

Our team of experts will be happy to walk you through Amazon’s safety guidelines, ensuring that your products are compliant, that consumers are safe, and that your products are back up on the marketplace as quickly as possible. If you get one of the dreaded “takedown” letters contact us and let us help you navigate Amazon’s safety compliance guidelines.

Patch Testing and Safety Assays

Patch testing represents a visual assessment of the capacity of a product to induce redness, scaling, or inflammation when applied directly to the skin.

Patch testing is generally split up into short term or Primary Irritation and long-term Sensitizing or Cumulative irritation practices.

Repeat Insult Patch Testing (RIPT)

HRIPT is an industry standard test for discerning both the immediate irritation and the long term, systemic or allergenic reaction potential of a topical product or treatment. Useful for supporting claims such as “non-sensitizing,” “non-irritating,” “not a primary irritant,” and “Dermatologist Approved.”

Additional Medical Professional review is also available with RIPT, and it is possible to support secondary claims such as “Pediatrician Tested.”

Jordan and King, Schlanski, Kligman methods are available.

Safe for Sensitive Skin

The traditional RIPT panel can be modified to include a panel that has self-perceived sensitive skin. This is often recommended for certain leave-on products, products designed for use around the eye area, or products designed for use in intimate areas.

Sensitive skin claims can also be supported in use as an add on with medical review and a percentage of users with self-perceived or qualified sensitive skin.

48 Hour Patch

Simplified, single application irritation testing for topically applied products. Does not include a measure of sensitization.

These tests often represent a place holder or benchmark irritancy test, and 48 hour results can be made available via report from any standard RIPT for an additional fee.

Cumulative Irritation Testing

A 14 or 21 day protocol to detect the outcome of a continuous product application over an extended period of time.

This method is slightly more aggressive than HRIPT, as products are applied with no breaks, and often this method is recommended for “Leave on” products. It also commonly helps support the claim “Safe for Daily Use.”

20 subject panel

VCS technician checking a participant’s forearm during patch testing

Participant check-in area at the VCS lab in Teaneck, NJ

Nose pores and comedones at baseline and T3

VCS technician recording comedone counts

Comedogenicity and Comedone Testing

Comedones or black heads can be formed when products disrupt the skin’s natural ability to pass waste and normal byproducts.

The claim “non-comedogenic” is both widely used and sought after by consumers who have oil prone skin or suffer from blackheads and acne.

The test is performed on the back, with product applications followed by a follicular biopsy and a comparison to an untreated site. Comedones removed are counted under a microscope and the sites are scored and compared.

This test represents a hybrid safety/efficacy test because the claim is also demonstrative of a form of product efficacy.

ROAT Repeat Open Application Testing

A skin test is used to confirm or rule out the presence of allergic contact dermatitis, often used after initial patch testing for secondary confirmation.

Safety in Use Testing

Aside from basic irritation and safety, there is a wide range of secondary claims that can be supported through “Safety in Use” or User Trials.

Safety in use provides both a measure of irritation as well as the gateway to a number of highly sought-after marketing claims, and as such it is a multifaceted approach that can boost sales and protect the consumer.

Safety Claims Supported

Safe for Use Around the Eye Area
Ophthalmologically Tested
Gynecologist Tested
Safe for Contact Lens Wearers
No Tears
Won’t Irritate the Eyes
Clinically Tested
Safe for Intimate Use
Condom Compatible

Ophthalmological Testing – Non-Instillation Versus Direct Instillation

For products designed for use around the sensitive eye area, secondary safety is often recommended under the care of a medically trained professional.

We generally recommend that some form of In Vitro ocular irritation is conducted prior to direct installation eye area studies, and we can gladly refer you to a laboratory we trust to conduct this work. Contact us and we will make an introduction.

VCS maintains a number of agreements with consulting doctors including Ophthalmologists, and their experience can help ensure that products are both safe while also providing claims that will boost consumer awareness.

Indirect Instillation Under Ophthalmological Supervision

A study in healthy male and female users with a minimum of 50% contact lens wearers.

An Ophthalmologist conducts onsite study assessments with a slit lamp to ensure that products do not cause irritation.

This study helps to support claims such as “Ophthalmologist tested/approved” and “Suitable for contact lens wearers”.

Direct Installation

A study in healthy male & female subjects, to evaluate the comparative eye irritation potential of 1 test article plus control.

In this instance, the product is diluted and installed directly into the eyes via dropper. Scores are compared to baseline to determine redness and irritation.

Panelists also fill out a subjective consumer perception questionnaire with questions about sting, irritation and redness.

Intimate Area Products (Gynecologist Tested)

These “In Use” tests provide a secondary practical assessment of continuous application/use, and they are more akin to “product efficacy” and “claims” studies alongside safety. They also often involve Gynecologist assessments and examinations onsite, and the products are used as directed.

Length of use varies, and usually these studies require a review of additional preliminary safety data.

Recruitment can involve various parameters including sexually active voluteers, users of personal entertainment devices, condom users, etc. in order to support a wide range of real world applicable use possibilities.

These tests are often carried out to boost brand awareness for prestige or premium products once sales, pipelines, and brand recognition is in place. They are not directly recognized by most regulatory authorities.

Anti-Inflammatory and Counter Irritation

Redness, irritation, and scar reduction studies also fall under the blanket of “safety in use.” Once again, these studies provide an approach to documenting and supporting changes that consumers experience while ensuring that products are safe for human use.

Induced Irritation Reduction

Up to 6 sites outlined on volar forearm plus untreated control site.

Induction of inflammation on all skin sites by either:

UV (4x MED)
SLS (0.75% patch for 24-hours)
Friction (super-fine sandpaper – 360-600 grit)

Open application of products with expert visual clinical grading for erythema on sites prior to application of products throughout the study.

ROAT Repeat Open Application Testing

A skin test to confirm or rule out the presence of allergic contact dermatitis, often used after initial patch testing for secondary confirmation.

These tests can be conducted on the forearm, the inner arm, the lower leg or the back depending on the nature of the product. They can provide a slightly more real world “in use” test than standardized patch testing, however the test routine is not quite as rigorous.

Anti-Inflammatory and Counter Irritation

Multiple sites outlined on volar forearm plus untreated control site.

Induction of inflammation on all skin sites by either Ultraviolet Dose (2-3x MED), known primary irritant (SLS or similar), or mechanical friction (super-fine sandpaper).

Includes Open Application conductions along with expert erythemal grading of sites prior to application of products and throughout the study.

Color profile for age spots, dark spots, and hyperpigmentation is common in both beauty and OTC drug-level applications. With our proprietary photography techniques we can shoot spots on the face or body, and follow the treatments to see how skin-tone is evened overtime, how the intensity of the hyperpigmentation is reduced, or the overall area of the spots are diminished. Clinical Photography and Analysis can be done stand-alone, or we can pair the techniques as part of a larger clinical evaluation which includes Expert Grading, User Subjective Feedback, or secondary instrumental assessments of color profiling and L* values.

Inflammation and Redness are two of the most common signs of stress on the skin. VCS can conduct induced redness and irritation studies and compare an untreated site to your product to see if your formulation can help to reduce the symptoms more quickly. Redness and Irritation are generally considered OTC level claims, and as an FDA Registered and Inspected Laboratory you can trust our team to handle your drug level visual claim support. We can induce a wide range of irritation for treatment, including but not limited to UV/sunburn, known primary irritant/positive control, poison oak/poison ivy, bug bites, etc., Acne Lesion inflammation, Dandruff, Psoriasis, and Eczema, and a wide range of other secondary claims.

VCS technician taking a forearm reading during a repeat open application test

Cutometer dual MPA 580 skin measurement system in the VCS laboratory

Clinical photography

Before & After Photography: Custom Teaneck NJ Studio

Clinically Validated, High Resolution Before and After Images and Analysis Over Time. Validated Claim Support offers cutting-edge, high-resolution photography to help document product efficacy over a given treatment timeline or product usage cycle.

See our before and after photography Get a quote See the gallery

BaselineWeek 2

Redness reduction: 44% less redness from baseline to week 2. The lower circle shows the average skin color in the treated area. Drag to compare.

Before and after case studies

Hair Growth Efficacy And Clinical Density Improvement →

Hair Density And Hair Growth Clinical Imaging Side Profile →

Acne lesion, baseline compared with result

Full Face Acne Reduction Lesions With Analysis →

Dry Scalp And Dandruff Improvement Clinical Study Photo →

Anti-Aging, Wrinkle Reduction And Clinical Claim Support Imaging →

Full Face Before And After Anti-Aging And Fine Line Reduction →

Pore Size Reduction Clinical Photograph →

Blemish redness, baseline compared with day 3

High Resolution Redness Reduction →

Expert Clinical Grading

Trained graders score visible change

Supports claims like “Clinically proven to reduce the appearance of fine lines and wrinkles”

Learn more →

Biomarkers and Microbiome

Tape strips, swabs and collections

Supports claims like “Microbiome friendly” and “Won’t disrupt the skin’s natural microbiome”

Learn more →

Biophysical Instrumentation

Hydration, TEWL, elasticity, color

Supports claims like “Hydrates by up to 87% in as little as one use”

Learn more →

Peer-Reviewed Writing

Clinical and scientific publications

Scientifically validated study summaries for publication in peer-reviewed medical journals

Learn more →

Before and After Photography

Controlled, reproducible clinical imaging

Supports claims like “Up to a 44% reduction in redness in as little as 2 weeks”

Learn more →

Consumer Perception

Panelist questionnaires and self-assessment

Supports claims such as “97% of women agreed their skin felt smoother and more supple”

Learn more →

FAQ

Safety and Irritation Testing: frequently asked questions

What safety testing does Validated Claim Support offer?

Validated Claim Support offers patch testing and consumer in use safety testing to show that a product won't cause irritation, clog pores or cause allergic or systemic reactions, in a sample population of 20 to 100 test subjects. Options include HRIPT, 48-hour patch, cumulative irritation, comedogenicity, ROAT, sensitive skin, ophthalmological and gynecologist-tested studies.

What is HRIPT and what claims does it support?

HRIPT, or human repeat insult patch testing, is an industry standard test for both immediate irritation and long-term systemic or allergic reaction potential. It supports claims such as "Non-sensitizing," "Non-irritating," "Not a primary irritant" and "Dermatologist approved," and with additional medical review, "Pediatrician tested." Jordan and King, Schlanski and Kligman methods are available.

Can VCS support a "safe for sensitive skin" claim?

Yes. The standard RIPT panel can be modified to include subjects with self-perceived sensitive skin, which is often recommended for leave-on products and for products used around the eyes or in intimate areas. Sensitive skin claims can also be supported in use, with medical review and a share of users with self-perceived or qualified sensitive skin.

What is the difference between a 48-hour patch test and cumulative irritation testing?

A 48-hour patch is a simplified, single application irritation test that does not measure sensitization. Cumulative irritation testing follows a 14 or 21 day protocol of continuous application with no breaks, on a 20 subject panel. It is slightly more aggressive than HRIPT, is often recommended for leave-on products, and helps support "Safe for daily use."

How is "non-comedogenic" tested?

The comedogenicity test is performed on the back. Product is applied, followed by a follicular biopsy and a comparison with an untreated site, and the comedones removed are counted under a microscope and the sites scored. Validated Claim Support treats it as a hybrid safety and efficacy test.

Can VCS help with Amazon's safety testing requirements?

Yes. Amazon's marketplace now has more stringent safety and patch testing requirements and requires a Certificate of Analysis for personal care products. Validated Claim Support can walk you through Amazon's safety guidelines and help get products compliant and back on the marketplace, including after a takedown letter.

What eye safety testing is available?

Validated Claim Support offers indirect instillation testing under ophthalmologist supervision, with at least 50% contact lens wearers and slit lamp assessments, supporting "Ophthalmologist tested" and "Suitable for contact lens wearers." Direct instillation testing places a diluted product in the eyes by dropper and compares redness and irritation with baseline. VCS recommends in vitro ocular irritation testing first.

What safety claims can VCS help support?

Validated Claim Support can help support claims such as "Safe for use around the eye area," "Ophthalmologically tested," "Gynecologist tested," "Safe for contact lens wearers," "No tears," "Won't irritate the eyes," "Clinically tested," "Safe for intimate use" and "Condom compatible."

Topical Safety Testing and Irritation

Preliminary Safety And Erythemal Responses

Amazon.com Marketplace Safety Documentation and Compliance

Patch Testing and Safety Assays

Repeat Insult Patch Testing (RIPT)

Safe for Sensitive Skin

48 Hour Patch

Cumulative Irritation Testing

Comedogenicity and Comedone Testing

ROAT Repeat Open Application Testing

Safety in Use Testing

Safety Claims Supported

Ophthalmological Testing – Non-Instillation Versus Direct Instillation

Intimate Area Products (Gynecologist Tested)

Anti-Inflammatory and Counter Irritation

Induced Irritation Reduction

ROAT Repeat Open Application Testing

Anti-Inflammatory and Counter Irritation

Hair Growth Efficacy And Clinical Density Improvement →

Hair Density And Hair Growth Clinical Imaging Side Profile →

Full Face Acne Reduction Lesions With Analysis →

Dry Scalp And Dandruff Improvement Clinical Study Photo →

Anti-Aging, Wrinkle Reduction And Clinical Claim Support Imaging →

Full Face Before And After Anti-Aging And Fine Line Reduction →

Pore Size Reduction Clinical Photograph →

High Resolution Redness Reduction →

Expert Clinical Grading

Biomarkers and Microbiome

Biophysical Instrumentation

Peer-Reviewed Writing

Before and After Photography

Consumer Perception

Safety and Irritation Testing: frequently asked questions

What safety testing does Validated Claim Support offer?

What is HRIPT and what claims does it support?

Can VCS support a "safe for sensitive skin" claim?

What is the difference between a 48-hour patch test and cumulative irritation testing?

How is "non-comedogenic" tested?

Can VCS help with Amazon's safety testing requirements?

What eye safety testing is available?

What safety claims can VCS help support?

Explore every test method and claim we support