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在监管风险评估范围内,手部对工业化学品潜在皮肤暴露评估的默认值。

Default values for assessment of potential dermal exposure of the hands to industrial chemicals in the scope of regulatory risk assessments.

作者信息

Marquart Hans, Warren Nicholas D, Laitinen Juha, van Hemmen Joop J

机构信息

TNO Chemistry, Department of Food and Chemical Risk Analysis, PO Box 360, 3700 AJ Zeist, The Netherlands.

出版信息

Ann Occup Hyg. 2006 Jul;50(5):469-89. doi: 10.1093/annhyg/mel012. Epub 2006 Mar 15.

DOI:10.1093/annhyg/mel012
PMID:16540540
Abstract

Dermal exposure needs to be addressed in regulatory risk assessment of chemicals. The models used so far are based on very limited data. The EU project RISKOFDERM has gathered a large number of new measurements on dermal exposure to industrial chemicals in various work situations, together with information on possible determinants of exposure. These data and information, together with some non-RISKOFDERM data were used to derive default values for potential dermal exposure of the hands for so-called 'TGD exposure scenarios'. TGD exposure scenarios have similar values for some very important determinant(s) of dermal exposure, such as amount of substance used. They form narrower bands within the so-called 'RISKOFDERM scenarios', which cluster exposure situations according to the same purpose of use of the products. The RISKOFDERM scenarios in turn are narrower bands within the so-called Dermal Exposure Operation units (DEO units) that were defined in the RISKOFDERM project to cluster situations with similar exposure processes and exposure routes. Default values for both reasonable worst case situations and typical situations were derived, both for single datasets and, where possible, for combined datasets that fit the same TGD exposure scenario. The following reasonable worst case potential hand exposures were derived from combined datasets: (i) loading and filling of large containers (or mixers) with large amounts (many litres) of liquids: 11,500 mg per scenario (14 mg cm(-2) per scenario with surface of the hands assumed to be 820 cm(2)); (ii) careful mixing of small quantities (tens of grams in <1l): 4.1 mg per scenario (0.005 mg cm(-2) per scenario); (iii) spreading of (viscous) liquids with a comb on a large surface area: 130 mg per scenario (0.16 mg cm(-2) per scenario); (iv) brushing and rolling of (relatively viscous) liquid products on surfaces: 6500 mg per scenario (8 mg cm(-2) per scenario) and (v) spraying large amounts of liquids (paints, cleaning products) on large areas: 12,000 mg per scenario (14 mg cm(-2) per scenario). These default values are considered useful for estimating exposure for similar substances in similar situations with low uncertainty. Several other default values based on single datasets can also be used, but lead to estimates with a higher uncertainty, due to their more limited basis. Sufficient analogy in all described parameters of the scenario, including duration, is needed to enable proper use of the default values. The default values lead to similar estimates as the RISKOFDERM dermal exposure model that was based on the same datasets, but uses very different parameters. Both approaches are preferred over older general models, such as EASE, that are not based on data from actual dermal exposure situations.

摘要

在化学品的监管风险评估中,需要考虑皮肤接触问题。到目前为止所使用的模型是基于非常有限的数据。欧盟的RISKOFDERM项目收集了大量关于在各种工作场景下皮肤接触工业化学品的新测量数据,以及有关可能的接触决定因素的信息。这些数据和信息,连同一些非RISKOFDERM数据,被用于推导所谓“TGD接触情景”下手部潜在皮肤接触的默认值。TGD接触情景在一些非常重要的皮肤接触决定因素(如使用的物质数量)方面具有相似的值。它们在所谓的“RISKOFDERM情景”中形成更窄的范围,而“RISKOFDERM情景”是根据产品相同的使用目的对接触情况进行分类的。反过来,RISKOFDERM情景又是在所谓的皮肤接触操作单元(DEO单元)中更窄的范围,这些单元是在RISKOFDERM项目中定义的,用于将具有相似接触过程和接触途径的情况进行分类。针对合理最坏情况和典型情况都推导了默认值,既针对单个数据集,也在可能的情况下针对符合相同TGD接触情景的组合数据集。从组合数据集中得出了以下合理最坏情况的潜在手部接触值:(i) 用大量(数升)液体装载和填充大容器(或混合器):每个情景11500毫克(假设手部表面积为820平方厘米,每个情景为14毫克/平方厘米);(ii) 小心混合少量(小于1升中的几十克):每个情景4.1毫克(每个情景0.005毫克/平方厘米);(iii) 用梳子在大面积上涂抹(粘性)液体:每个情景130毫克(每个情景0.16毫克/平方厘米);(iv) 在表面刷涂和滚动(相对粘性)液体产品:每个情景6500毫克(每个情景8毫克/平方厘米);以及(v) 在大面积上喷洒大量液体(油漆、清洁产品):每个情景12000毫克(每个情景14毫克/平方厘米)。这些默认值被认为对于在低不确定性的类似情况下估计类似物质的接触是有用的。基于单个数据集的其他几个默认值也可以使用,但由于其基础更有限,会导致估计的不确定性更高。情景的所有描述参数(包括持续时间)都需要有足够的相似性,以便能够正确使用默认值。这些默认值得出的估计结果与基于相同数据集但使用非常不同参数的RISKOFDERM皮肤接触模型相似。这两种方法都比旧的通用模型(如EASE)更可取,后者不是基于实际皮肤接触情况的数据。

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