Confirmation of in vitro and clinical safety assessment of behentrimonium chloride-containing leave-on body lotions using post-marketing adverse event data.

Behentrimonium chloride (BTC) is a straight-chain alkyltrimonium chloride compound commonly used as an antistatic, hair conditioning, emulsifier, or preservative agent in personal care products. Although the European Union recently restricted the use of alkyltrimonium chlorides and bromides as preservatives to ≤0.1%, these compounds have been safely used for many years at ≤5% in hundreds of cosmetic products for other uses than as a preservative. In vitro, clinical, and controlled consumer usage tests in barrier-impaired individuals were conducted to determine if whole body, leave-on skin care products containing 1-5% BTC cause dermal irritation or any other skin reaction with use. BTC-containing formulations were predicted to be non-irritants by the EpiDerm® skin irritation test and the bovine corneal opacity and permeability (BCOP)/chorioallantoic membrane vascular assay (CAMVA) ocular irritation test battery. No evidence of allergic contact dermatitis or cumulative dermal irritation was noted under the exaggerated conditions of human occlusive patch tests. No clinically assessed or self-reported adverse reactions were noted in adults or children with atopic, eczematous, and/or xerotic skin during two-week and four-week monitored home usage studies. These results were confirmed by post-marketing data for five body lotions, which showed only 0.69 undesirable effects (mostly skin irritation) reported per million shipped consumer units during 2006-2011; a value consistent with a non-irritating body lotion. No serious undesirable effects were reported during in-market use of the products. Therefore, if formulated in appropriate conditions at 1-5%, BTC will not cause dermal irritation or delayed contact sensitization when used in a whole-body, leave-on product.

Cutaneous lesions in swine after decompression: histopathology and ultrastructure.

A detailed histopathologic description of skin lesions from a porcine model of decompression sickness (DCS) is presented. Pigs were dived in a dry chamber on a variety of profiles over an 11-mo period, with a 0.1-0.6 (10-60%) incidence of cutaneous lesions. The clinical appearance of the lesions evolved from irregular, sharply demarcated areas of erythema to violaceous and, eventually, darkly mottled macules. The lesions were biopsied under deep, sedative anesthesia. Histologic abnormalities were found in 91% (20/22) of the biopsies from clinically apparent cutaneous lesions. Vascular congestion was the most common finding. Focal areas of vasculitis were noted in 45% (10/22) of the lesions. Perivascular neutrophil infiltrates, edema, and occasionally, hemorrhage were also noted. Ultrastructural abnormalities were found in all of the lesions studied. Acute inflammation affecting the dermal vasculature was the most common finding. Platelets were rarely observed aggregating within vessels. The clinical and histologic features of cutaneous lesions in pigs after decompression are compared with previous accounts in humans. The model provides a useful tool for the study of cutaneous lesions in DCS and may be a means of exploring interventions in the disease.