This case involves a man who purchased a hair relaxer marketed as a ‘no-lye’ product from a retail drug store. The man applied the product in accordance with the packaging instructions and immediately suffered severe chemical burns to his scalp. As he began washing the product out of his hair, large chunks of hair fell out leaving bald patches throughout his scalp. The man suffered permanent hair loss as a result of the incident. An expert in toxicology with specific experience in the hair product chemicals was sought to evaluate whether the product’s safety profile was accurately represented.
Question(s) For Expert Witness
- 1. Please describe the standards and protocols for the development of a product's safety profile.
- 2. Are there specific types of ingredients that would make hair products unsafe for consumers? If so, please describe.
Expert Witness Response E-190567
I am a board-certified toxicologist and have worked in the personal care/cosmetics industry for 12+ years in both the supplier and finished products side of the business. I have performed safety and exposure assessment tests and have served as an expert witness in cases involving industrial chemicals and recreational and prescription drugs. For a finished product, safety data on the ingredients and on the final product is necessary. A cosmetic product should have skin and eye irritation/corrosion, mutagenicity and sensitization data. To test these endpoints, a company should utilize standard models as defined by the Organization for Economic Co-operation and Development (OECD). Information from these studies is used to determine a maximum-use level of a product or ingredient. In addition, a proper safety assessment should be performed using generally accepted consumer-use assumptions. There are specific types of ingredients that would make hair products unsafe. These ingredients can be categorized as potential hazards if inhaled or following topical exposure. These materials can be further subcategorized as acute or chronic irritants/corrosives, sensitizers and mutagens. Specifically for hair relaxer products, there are lye-based (sodium hydroxide), non-lye (calcium hydroxide and guanidine carbonate) and thio-based (thioglycolic acid salts) formulations. The literature demonstrates that hair relaxers can cause burns and lesions on the scalp. The hair relaxing process can also cause breakage of the hair and alopecia. This is a common process I use to support or limit the use of cosmetic ingredients and finished products.
Expert Witness Response E-189796
I have worked in the dermatology field as an expert on hair, a product developer, and an educator to multi-media outlets with a specific emphasis on products for women of color. Chemical hair relaxers of all types can potentially cause harm from superficial erosion, burning, hair thinning, to permanent hair loss and deep scarring. Lye relaxers (sodium hydroxide) are used in professional salons and not for individual retail. In lye relaxers, the full scalp needs to be protected with a base grease/petrolatum. Retail drugstores and beauty supply stores sell ‘no-lye’ relaxers. However, they contain calcium hydroxide, guanine hydroxide, lithium hydroxide, and other active chemicals which can all break the disulfide bonds to permanently straighten the hair strands and are still unsafe. These chemicals are marked as ‘no lye’ and claim to be safer than sodium hydroxide/lye. Packaging states to apply provided petroleum grease base to the hairline only and that there’s no need to apply this to the entire scalp. Therefore, all unprotected non-based scalp can still absorb these ‘no-lye’ chemicals as well as other active ingredients. These chemicals can penetrate the epidermal layers of the scalp into deep dermis which causes burns/scars and severe follicle damage, resulting in permanent hair loss. In other words, whether the product is ‘lye or no-lye’, the entire scalp, ears, and neck should be completely covered to reduce chemical absorption that can potentially result in serious burns and/or hair loss. This should be indicated on the product’s safety packaging instructions.