How Do We Know the OS-01 Peptide is Safe?

8 min read

May 09,2024
FROM THE ONESKIN LAB

How Do We Know the OS-01 Peptide is Safe?

8 min read

May 09,2024
FROM THE ONESKIN LAB
Safety is our top priority, especially when it comes to the ingredients in your skincare products. Unlike medications, which must be FDA-approved before hitting the shelves, cosmetics often don't face such rigorous checks before they're sold. (1) That's why at OneSkin, we take our commitment to safety very seriously. We only select ethically sourced ingredients that are verified as safe for topical use.
Safety is our top priority, especially when it comes to the ingredients in your skincare products. Unlike medications, which must be FDA-approved before hitting the shelves, cosmetics often don't face such rigorous checks before they're sold. (1) That's why at OneSkin, we take our commitment to safety very seriously. We only select ethically sourced ingredients that are verified as safe for topical use.
01

Safety Testing

Now, let's talk about our unique OS-01 peptide. Since it's exclusive to our products, we extensively verified its safety before including it in our formulations. This was especially important given the class of molecules that our peptide falls within - senotherapeutics. Many senotherapeutic molecules have displayed the ability to reduce senescence in tissues, but their toxicity has prevented them from being clinically applicable. (2) Knowing this, we took extra precautions to ensure the safety of the OS-01 peptide before introducing it into our products. The OS-01 peptide’s effect on skin was evaluated using the following 4 methods. The results support the peptide's safety and have been peer reviewed and published. (2)
  1. In vitro toxicity and irritation tests.
  2. Genotoxicity testing.
  3. Repeated insult patch test (RIPT).
  4. Effect on cancer cells.

Irritation and Toxicity Tests

Because of the potential challenges with senotherapeutics, we conducted extensive assessments to ensure cell viability and confirm that the OS-01 peptide is not toxic or irritating to skin (2):Cell Viability Tests:During testing, we exposed human dermal fibroblasts and keratinocytes to various concentrations of OS-01 peptide (0.01–100 μM). Our findings were encouraging; after 24 hours there was no significant reduction in cell viability even at concentrations up to 100 μM. Considering the peptide's effectiveness occurs at much lower concentrations (0.5–12.5 μM), these results were strong indicators of its non-toxic nature.3D Human Skin Models:To further test for potential irritation, we applied the OS-01 peptide to 3D human skin models. Instead of compromising skin viability, the OS-01 peptide enhanced it. Moreover, microscopic examination of the treated skin revealed that the peptide maintained crucial skin characteristics like epidermal thickness and stratification, further confirming its safety and beneficial effects on skin health.
01

Safety Testing

Now, let's talk about our unique OS-01 peptide. Since it's exclusive to our products, we extensively verified its safety before including it in our formulations. This was especially important given the class of molecules that our peptide falls within - senotherapeutics. Many senotherapeutic molecules have displayed the ability to reduce senescence in tissues, but their toxicity has prevented them from being clinically applicable. (2) Knowing this, we took extra precautions to ensure the safety of the OS-01 peptide before introducing it into our products. The OS-01 peptide’s effect on skin was evaluated using the following 4 methods. The results support the peptide's safety and have been peer reviewed and published. (2)
  1. In vitro toxicity and irritation tests.
  2. Genotoxicity testing.
  3. Repeated insult patch test (RIPT).
  4. Effect on cancer cells.

Irritation and Toxicity Tests

Because of the potential challenges with senotherapeutics, we conducted extensive assessments to ensure cell viability and confirm that the OS-01 peptide is not toxic or irritating to skin (2):Cell Viability Tests:During testing, we exposed human dermal fibroblasts and keratinocytes to various concentrations of OS-01 peptide (0.01–100 μM). Our findings were encouraging; after 24 hours there was no significant reduction in cell viability even at concentrations up to 100 μM. Considering the peptide's effectiveness occurs at much lower concentrations (0.5–12.5 μM), these results were strong indicators of its non-toxic nature.3D Human Skin Models:To further test for potential irritation, we applied the OS-01 peptide to 3D human skin models. Instead of compromising skin viability, the OS-01 peptide enhanced it. Moreover, microscopic examination of the treated skin revealed that the peptide maintained crucial skin characteristics like epidermal thickness and stratification, further confirming its safety and beneficial effects on skin health.

Genotoxicity Testing

To evaluate the safety of the OS-01 peptide further, we conducted a series of genotoxicity tests. (2) Genotoxicity refers to the ability of a chemical to damage genetic information within a cell, causing mutations that may lead to cancer.Ames Test for Mutagenicity:The Ames Test assesses whether a given compound can cause mutations in the DNA of cells. In our Ames test on bacteria, we found that the OS-01 peptide is not mutagenic even in the highest concentration tested, which far exceeds the concentrations that would be found in our products.Micronuclei Test for Genotoxicity:Micronuclei are small membrane-bound fragments of chromosomal DNA that are linked to chromosome instability, genome rearrangements, and mutagenesis. (3) Genotoxic compounds are known to induce the formation of micronuclei. Measuring the level of cells that present micronuclei is an effective way to test whether a compound is toxic to the genetic material (i.e. the chromosomes). Our results showed that the OS-01 peptide did not increase the frequency of micronuclei-containing cells suggesting that OS-01 does not cause genotoxic harm.Karyotyping for Genome Stability:Karyotyping tests the effects of compounds on the chromosomes of cells. This evaluates their toxicity to genetic material based on the presence of abnormalities. We analyzed the chromosomes of cells treated with OS-01 to check for abnormalities. The results were normal, indicating no genotoxic effects from the peptide.

Genotoxicity Testing

To evaluate the safety of the OS-01 peptide further, we conducted a series of genotoxicity tests. (2) Genotoxicity refers to the ability of a chemical to damage genetic information within a cell, causing mutations that may lead to cancer.Ames Test for Mutagenicity:The Ames Test assesses whether a given compound can cause mutations in the DNA of cells. In our Ames test on bacteria, we found that the OS-01 peptide is not mutagenic even in the highest concentration tested, which far exceeds the concentrations that would be found in our products.Micronuclei Test for Genotoxicity:Micronuclei are small membrane-bound fragments of chromosomal DNA that are linked to chromosome instability, genome rearrangements, and mutagenesis. (3) Genotoxic compounds are known to induce the formation of micronuclei. Measuring the level of cells that present micronuclei is an effective way to test whether a compound is toxic to the genetic material (i.e. the chromosomes). Our results showed that the OS-01 peptide did not increase the frequency of micronuclei-containing cells suggesting that OS-01 does not cause genotoxic harm.Karyotyping for Genome Stability:Karyotyping tests the effects of compounds on the chromosomes of cells. This evaluates their toxicity to genetic material based on the presence of abnormalities. We analyzed the chromosomes of cells treated with OS-01 to check for abnormalities. The results were normal, indicating no genotoxic effects from the peptide.

Repeated Insult Patch Test (RIPT)

Our RIPT results demonstrate that the OS-01 peptide shows no signs of irritation, allergic response, or increased skin sensitization. (2) The RIPT is a critical test for assessing the potential of topical substances to cause allergic reactions or skin sensitization. We used this test to determine the allergenic potential of the OS-01 peptide. We tested the OS-01 peptide in 54 individuals over three weeks with repeated applications. No negative reactions were identified.

Repeated Insult Patch Test (RIPT)

Our RIPT results demonstrate that the OS-01 peptide shows no signs of irritation, allergic response, or increased skin sensitization. (2) The RIPT is a critical test for assessing the potential of topical substances to cause allergic reactions or skin sensitization. We used this test to determine the allergenic potential of the OS-01 peptide. We tested the OS-01 peptide in 54 individuals over three weeks with repeated applications. No negative reactions were identified.

Effects of the OS-01 Peptide on Cancer Cells

Given the peptide's role in influencing cell behaviors, we had to ensure the OS-01 peptide wouldn't encourage cancer growth in tissues. We exposed several cancerous cell lines including melanoma (MeWo), cervical cancer (HeLa), pancreatic cancer (SW1990), and lung cancer (H358) to the OS-01 peptide and observed no increase in cancer cell proliferation. (2) This suggests that the peptide is effective in its intended role of reducing senescence without promoting cancer cell growth, assuring further safety in its use.Note: The OS-01 peptide is not intended to treat, cure, or diagnose any disease including cancer. Tests on cancer cell lines were performed to evaluate the safety of the OS-01 peptide only.

Effects of the OS-01 Peptide on Cancer Cells

Given the peptide's role in influencing cell behaviors, we had to ensure the OS-01 peptide wouldn't encourage cancer growth in tissues. We exposed several cancerous cell lines including melanoma (MeWo), cervical cancer (HeLa), pancreatic cancer (SW1990), and lung cancer (H358) to the OS-01 peptide and observed no increase in cancer cell proliferation. (2) This suggests that the peptide is effective in its intended role of reducing senescence without promoting cancer cell growth, assuring further safety in its use.Note: The OS-01 peptide is not intended to treat, cure, or diagnose any disease including cancer. Tests on cancer cell lines were performed to evaluate the safety of the OS-01 peptide only.
02

Penetrates but Doesn’t Absorb

After confirming the peptide's safety for topical application, we conducted a 12-week clinical study to investigate any systemic effects when applied extensively (daily application of OS-01 BODY across the entire body). We specifically looked for the presence of the peptide in the bloodstream and confirmed the OS-01 peptide does not enter the bloodstream when applied topically. While the peptide is small enough to penetrate the skin barrier, it mustn't enter the bloodstream. After 12 weeks we found no peptide present in the participants' bloodstreams indicating that the OS-01 peptide's action is limited to the site of application, the skin, without affecting other organs. Furthermore, the peptide was found clinically effective at reversing signs of skin aging.
02

Penetrates but Doesn’t Absorb

After confirming the peptide's safety for topical application, we conducted a 12-week clinical study to investigate any systemic effects when applied extensively (daily application of OS-01 BODY across the entire body). We specifically looked for the presence of the peptide in the bloodstream and confirmed the OS-01 peptide does not enter the bloodstream when applied topically. While the peptide is small enough to penetrate the skin barrier, it mustn't enter the bloodstream. After 12 weeks we found no peptide present in the participants' bloodstreams indicating that the OS-01 peptide's action is limited to the site of application, the skin, without affecting other organs. Furthermore, the peptide was found clinically effective at reversing signs of skin aging.
03

Summary

The extensive testing and rigorous evaluation of the OS-01 peptide underlines our commitment to safety. By performing in-depth toxicity, genotoxicity, and sensitization tests, alongside clinical evaluations for systemic effects, we ensure that our products are safe for consumer use. Our ongoing monitoring and testing regime maintains this assurance as our products reach consumers. If you’re interested in our products, check out this article on how to integrate these products into your skincare regimen.
03

Summary

The extensive testing and rigorous evaluation of the OS-01 peptide underlines our commitment to safety. By performing in-depth toxicity, genotoxicity, and sensitization tests, alongside clinical evaluations for systemic effects, we ensure that our products are safe for consumer use. Our ongoing monitoring and testing regime maintains this assurance as our products reach consumers. If you’re interested in our products, check out this article on how to integrate these products into your skincare regimen.
Key Takeaways:
  • OneSkin prioritizes safety by selecting only ethically sourced ingredients verified as safe for topical use. Given the absence of rigorous FDA requirements for cosmetics, OneSkin independently verified the safety of the proprietary OS-01 peptide.
  • The OS-01 peptide underwent thorough toxicity assessments, including in vitro tests and irritation evaluations on human skin samples and models, to ensure its safety. These tests showed no significant toxicity or irritation, even at high concentrations.
  • OneSkin conducted comprehensive genotoxicity testing, including the Karyotyping, Ames and Micronuclei Tests, to confirm that the OS-01 peptide does not cause DNA damage or mutations.
  • The Repeated Insult Patch Test (RIPT) was utilized to ascertain that the OS-01 peptide does not cause allergic reactions or skin sensitization.
  • Tests on various cancer cell lines, such as melanoma and lung cancer, affirming that it acts safely within its intended role of reducing senescence.
  • Clinical studies confirmed that the OS-01 peptide, while able to penetrate the skin barrier, does not enter the bloodstream, ensuring that its rejuvenating effects are confined to the skin without impacting other organs.
Key Takeaways:
  • OneSkin prioritizes safety by selecting only ethically sourced ingredients verified as safe for topical use. Given the absence of rigorous FDA requirements for cosmetics, OneSkin independently verified the safety of the proprietary OS-01 peptide.
  • The OS-01 peptide underwent thorough toxicity assessments, including in vitro tests and irritation evaluations on human skin samples and models, to ensure its safety. These tests showed no significant toxicity or irritation, even at high concentrations.
  • OneSkin conducted comprehensive genotoxicity testing, including the Karyotyping, Ames and Micronuclei Tests, to confirm that the OS-01 peptide does not cause DNA damage or mutations.
  • The Repeated Insult Patch Test (RIPT) was utilized to ascertain that the OS-01 peptide does not cause allergic reactions or skin sensitization.
  • Tests on various cancer cell lines, such as melanoma and lung cancer, affirming that it acts safely within its intended role of reducing senescence.
  • Clinical studies confirmed that the OS-01 peptide, while able to penetrate the skin barrier, does not enter the bloodstream, ensuring that its rejuvenating effects are confined to the skin without impacting other organs.

Reviewed by Alessandra Zonari, PhD, Chief Scientific Officer (CSO) and Co-Founder of OneSkin

Alessandra earned her Master’s degree in stem cell biology, and her PhD in skin regeneration and tissue engineering at the Federal University of Minas Gerais in Brazil in collaboration with the 3B’s Research Group in Portugal. Alessandra did a second post-doctoral at the University of Coimbra in Portugal. She is a co-inventor of three patents and has published 20 peer-reviewed papers in scientific journals.

Reviewed by Alessandra Zonari, PhD, Chief Scientific Officer (CSO) and Co-Founder of OneSkin

Alessandra earned her Master’s degree in stem cell biology, and her PhD in skin regeneration and tissue engineering at the Federal University of Minas Gerais in Brazil in collaboration with the 3B’s Research Group in Portugal. Alessandra did a second post-doctoral at the University of Coimbra in Portugal. She is a co-inventor of three patents and has published 20 peer-reviewed papers in scientific journals.

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