The Threshold of Toxicological Concern (TTC) in risk assessment

The Threshold of Toxicological Concern (TTC) is a level of human intake or exposure that is considered to be of negligible risk, despite the absence of chemical-specific toxicity data. The TTC approach is a form of risk characterisation in which uncertainties arising from the use of data on other compounds are balanced against the low level of exposure. The approach was initially developed by the FDA for packaging migrants, and used a single threshold value of 1.5mug/day (called the threshold of regulation). Subsequent analyses of chronic toxicity data resulted in the development of TTC values for three structural classes with different potentials for toxicity (1,800, 540 and 90mug/day). These TTC values have been incorporated into the procedure that is used internationally for the evaluation of flavouring substances. Further developments included additional TTC values for certain structural alerts for genotoxicity (0.15mug/day), and for the presence of an organophosphate group (18mug/day). All of these TTC values were incorporated into an extended decision tree for chemicals, such as contaminants, which might be present in human foods. The TTC approach has been shown to have potential applications to risk assessments of cosmetic ingredients, household products and impurities in therapeutic drugs.     

洗发类化妆品中4种禁限用去屑剂组分测定方法的研究

采用高效液相色谱法建立洗发类化妆品中四种禁限用去屑剂组分的分离和含量测定方法。样品经有机溶剂超声提取,以C18柱分离,二极管阵列检测器测定,用保留时间定性及外标法定量。结果表明：在所选择的色谱条件下,水杨酸、酮康唑、氯咪巴唑和吡啰克酮乙醇胺盐的理论板数分别为9385、8155、14087和17548,分离度均大于1.5;四种组分的峰面积在一定浓度范围内具有良好的线性关系,最低检出浓度分别为20.0μg/g、20.0μg/g、40.0μg/g和40.0μg/g。该方法简便快速、重现性和分离度好及灵敏度高,为化妆品中四种禁限用去屑组分的测定提供了方法和技术支持。     

安全使用化妆品调查分析

目的了解公众安全使用化妆品的现状和对化妆品不良反应认知度,为药监部门和医疗机构监测化妆品不良反应提供理论依据。方法开展合理用药、安全使用化妆品宣传活动,设计统一的调查表,随机进行化妆品安全使用情况调查,发放调查表480余份,回收420份,有效表415份,并对有效调查表进行汇总分析。结果 415例受访者女性374人(90.12%),男性41人(9.88%);涉及22种职业,300人知晓化妆品不良反应,占72.29%;会留意产品警示信息的有247人,占59.92%,84人有化妆品过敏史,占20.24%;119人选择出现不良反应后自认倒霉,不会找相关部门解决,占28.67%。结论公众对化妆品安全使用和不良反应相关知识认识不足,应加强普及化妆品不良反应知识,及时公布化妆品安全信息,提高公众科学、安全使用化妆品意识。     

The Cosmetics Europe strategy for animal-free genotoxicity testing: Project status up-date

The Cosmetics Europe (formerly COLIPA) Genotoxicity Task Force has driven and funded three projects to help address the high rate of misleading positives in in vitro genotoxicity tests:The completed “False Positives” project optimized current mammalian cell assays and showed that the predictive capacity of the in vitro micronucleus assay was improved dramatically by selecting more relevant cells and more sensitive toxicity measures.The on-going “3D skin model” project has been developed and is now validating the use of human reconstructed skin (RS) models in combination with the micronucleus (MN) and Comet assays. These models better reflect the in use conditions of dermally applied products, such as cosmetics. Both assays have demonstrated good inter- and intra-laboratory reproducibility and are entering validation stages.The completed “Metabolism” project investigated enzyme capacities of human skin and RS models. The RS models were shown to have comparable metabolic capacity to native human skin, confirming their usefulness for testing of compounds with dermal exposure.The program has already helped to improve the initial test battery predictivity and the RS projects have provided sound support for their use as a follow-up test in the assessment of the genotoxic hazard of cosmetic ingredients in the absence of in vivo data.     

动物模型评价化妆品原料美白功效的研究

目的 建立化妆品原料美白功效评价动物模型并应用.方法 紫外线连续照射7 d造成花色豚鼠皮肤黑化模型,在褐色无毛部位连续涂抹样品30 d.Maxmeter仪检测皮肤黑色素指数（MI）和红色素指数（EI）的变化.安乐处死动物后取皮肤组织,多聚甲醛固定、石蜡切片,多巴胺染色和氨银染色,对组织切片进行图像分析.结果 UV照射豚鼠皮肤后,MI指数升高,组织学观察显示黑色素颗粒增大和表皮层分布增多.经白藜芦醇-熊果苷复配美白原料测试,皮肤颜色MI指数显著下降,EI指数升高.组织学显示呈多巴染色阳性的黑素颗粒明显抑制,氨银染色区域在表皮内的分布下降.结论 利用紫外线造成实验动物皮肤黑化模型,运用皮肤生物物理学检测和组织学染色分析技术可以用于美白化妆品原料的功效评价和机制研究.     

Blotting paper as a disposable tool for sampling chemical residues from skin surface

1. Download : Download high-res image (168KB)
2. Download : Download full-size image

     

Claim substantiation and efficiency of hydrating body lotions and protective creams

In the present work a practical claim substantiation study is shown by the example of 5 commercially available body lotions. Their efficacy with respect to effects on transepidermal water loss (TEWL) and stratum corneum (SC) hydration of ageing skin has been examined. Results were obtained after single and repeated application (14 days, 2 x a day). The best performing product was then selected and further tested for its potential effects on sodium lauryl sulfate (SLS)-damaged skin. This was done in a younger population and the recovery of the impaired barrier function was followed by TEWL measurements. The selected body lotion had a high efficacy, improving both the TEWL and SC hydration of ageing skin by more than 30%. When applied to SLS-damaged skin, the product was able to improve skin barrier repair in comparison with physiological barrier repair. The results of this study show that a combination of non-invasive objective measurements can be used to substantiate product claims. Claims can be made with respect to protective and preventive properties of products, but also as to effectiveness of topical skin treatment in the case of abnormal barrier function or barrier restoration.     

Aufgabe und Bedeutung einer ästhetischen Dermatologie

Ohne Zusammenfassung

---

     

ICP-MS测定化妆品中硼

目的 建立化妆品中硼的电感耦合等离子体-质谱检测方法.方法 以硝酸-过氧化氢体系微波消解处理样品;以Sc作为内标元素,电感耦合等离子体-质谱法测定(射频功率1000w,雾化器流速1.00 L/min,透镜电压6.0 V,进样速度26 r/min).结果 方法线性范围为0～500 μg/L,按取样1.00 g定容至50.0 ml计算,方法检出限可达151μg/kg;相对标准偏差为3.7％,加标回收率在99.0％～102％.结论 方法灵敏度高、操作简便,用于化妆品中硼的测定,结果满意.