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Approaches to Safety Evaluation of Baby Wipes
Ning Li1, Swatee Dey1, Robert O'Connor1
1Winton Hill Business Center, Cincinnati, OH, USA.
Insights
Procter & Gamble developed a rigorous safety assessment process for baby wipes, ensuring skin compatibility through comprehensive testing and in-market monitoring. This systematic approach confirms the mildness and safety of baby wipes for infant skin.
Area of Science:
- Dermatology
- Toxicology
- Consumer Product Safety
Background:
- Baby wipes are widely used for infant hygiene.
- Ensuring the safety and gentleness of baby wipes on delicate infant skin is paramount.
- Previous safety assessments may not have been sufficiently comprehensive.
Purpose of the Study:
- To develop and describe a rigorous safety assessment process for disposable baby wipes.
- To ensure baby wipes are safe and gentle for infant skin from product development through market release.
- To validate the skin compatibility and mildness of baby wipes.
Main Methods:
- Implementing an exposure-based safety assessment for all raw materials.
- Conducting in vitro and clinical studies for irritation and sensitization, comparing to benchmark products.
- Performing prospective, randomized in-use studies in babies.
- Establishing continuous in-market monitoring for ongoing safety assessment.
Main Results:
- The implemented safety assessment approaches, individually and combined, demonstrated the mildness of the tested baby wipes.
- In-market monitoring confirmed the positive skin compatibility of the baby wipes.
- The developed methods provide robust evidence of baby wipe safety and efficacy.
Conclusions:
- The described safety assurance program and testing strategies effectively demonstrate baby wipe skin compatibility.
- Baby wipes offer a safe and beneficial alternative for infant cleansing.
- This comprehensive safety assessment process ensures product safety and consumer confidence.
Abstract:
Disposable baby wipes manufactured by Procter & Gamble, soft sheets bearing lotion that is balanced to maintain natural skin pH, are convenient for cleaning the diaper area and a quick cleanup on baby's face and hands.
Objective:
Develop a rigorous safety assessment process to ensure that baby wipes are safe and gentle to skin. This process is built-in from the start of product research and development.
Methods:
A systematic, iterative approach that includes (1) exposure-based safety assessment of all raw materials for systemic and local effects, which are consistent with established risk assessment paradigms; (2) when needed, testing of finished wipes in in vitro and/or clinical studies for skin and eye irritation, contact sensitization, or mechanical effects on skin in comparison to benchmark products that have a long history of wipe safety in marketplace; (3) prospective and randomized in-use studies in babies; and (4) in-market monitoring that is an integral part of the on-going product safety assessment.
Results:
Individual approaches and/or their combination show mildness of the test wipes. Further, in-market monitoring is testimony to baby skin compatibility of baby wipes.
Conclusion:
The approaches that have been developed demonstrate the skin compatibility and/or benefits of baby wipes relative to other modes of cleaning if needed. This article describes our safety assurance program, exposure-based safety assessment, and the range of robust testing strategies and approaches that can be employed to assure the safety of baby wipes.
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