关键词: 吡硫鎓锌, 毒理学, 风险评估, 化妆品, 法规

Abstract:

Zinc pyrithione （ZPT） is a commonly used anti-dandruff ingredient in cosmetics, which have attracted great attention in the cosmetic industry because of the ban on ZPT in the EU. It could be demonstrated that the acute as well as the sub-chronic toxicity of both ZPT alone or incorporated in market formulation is moderate to low in animal experiments or after practical application to humans. ZPT is-at least-a mild skin irritant but a severe eye irritant and corrosive. ZPT is considered not to be a skin sensitizer based on guinea pig studies. Concerning human data, ZPT （or PT moiety part） has a low potential to induce contact hypersensitivity when tested per se or as part of a cosmetic formulation. ZPT is rapidly and extensively absorbed after oral dosing, is distributed throughout the body, and is not concentrated in any particular tissue. The primary route of excretion of ZPT is via the urine. In a combined chronic toxicity/carcinogenicity study, the dose of 0.5 mg/kg bw/d is considered as NOAEL by the SCCS. It considers ZPT as a non-genotoxic and non-mutagenic compound in vivo. From the studies performed by the oral or dermal route with ZPT, there is no evidence of carcinogenic potential up to dermal doses of 100 mg/kg bw/d and up to oral doses of 2.5 mg/kg bw/d.It is not indicated any potential concern to humans regarding adverse effects on fertility but on development which is most likely attributable to maternal toxicity. It is under a significant adverse impact on the aquatic ecological environment. The SCCS considers ZPT as safe when used as an anti-dandruff in rinse-off hair products up to a maximum content of 1%, while the preliminary evaluation of the research group believes that the maximum content of 1.5% in hair products in China as an anti-dandruff agent is safe. In view of the impact of the EU ZPT ban on China’s cosmetics industry, it is suggested to continuously track the legislative formulation and safety of ZPT in cosmetics and to make good technical reserves, so as to provide reference for perfecting the supervision system of cosmetics in China. Meanwhile, multi-channel risk communication should be made to guide the improvement of the product formula, and the setting of product transition period should be comprehensively considered. The industry should be encouraged to carry out research and development of new cosmetic ingredients and increase the variety of optional cosmetics ingredients to promote the healthy development of the cosmetics industry.

Key words: zinc pyrithione, toxicology, risk assessment, cosmetics, supervision