化妆品原料吡硫鎓锌毒理学及风险评估研究进展

Research progress on toxicology and risk assessment of zinc pyrithione as cosmetics ingredient

吡硫鎓锌(Zinc Pyrithione,ZPT)是化妆品中常用的去屑剂,因欧盟ZPT禁令引起化妆品行业高度关注。ZPT急性经口/吸入毒性为中等毒性,对眼睛有严重刺激性和腐蚀性,未见皮肤致敏性,口服吸收率较高,在体内代谢较快,生物蓄积能力较低,不具有致突变性/遗传毒性和致癌潜力,具有一定生殖毒性,对水域生态环境存在较大负面影响。欧盟SCCS评估认为ZPT作为去屑剂在淋洗类发用产品最大用量1%是安全的,课题组初步评估认为在其作为去屑剂我国发用产品中最大用量1.5%是安全的。鉴于欧盟ZPT禁令对我国化妆品行业的影响,建议相关部门积极关注吡硫鎓锌国际法规调整及其安全性,做好技术储备,完善我国化妆品监管体系。同时,多途径开展风险交流以引导行业进行配方调整,综合考虑对产品过渡期的设置,鼓励行业积极开展去屑新原料的研究开发工作,增加可选原料的品种,推动化妆品行业健康发展。

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.