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关于《化学品注册、评估、授权和限制法规》(REACH)下硫化锌急性吸入毒性测试及分类的考量与挑战

Considerations and Challenges for Acute Inhalation Toxicity Testing and Classification of Zinc Sulphide Under REACH.

作者信息

Bruer Gustav Gerd, Lombaert Noömi, Burzlaff Arne, Spirlet Christine, Gödecke Daria, Ramazanoglu Mehmet, Creutzenberg Otto

机构信息

Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Nikolai-Fuchs-Str. 1, 30625 Hannover, Germany.

International Zinc Association, 168 Avenue de Tervueren, 1150 Brussels, Belgium.

出版信息

Toxics. 2024 Dec 31;13(1):27. doi: 10.3390/toxics13010027.

DOI:10.3390/toxics13010027
PMID:39853026
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11768892/
Abstract

Zinc sulphide is a widely used inorganic powder, and its production has reached quantities greater than 1000 t/year. Therefore, in accordance with OECD guideline 436, an acute inhalation test was implemented to provide more accurate data. This study is crucial for ensuring the safety of workers exposed to zinc sulphide dust and complying with regulatory requirements for REACH. Due to particle-specific properties, the maximum attainable concentration of zinc sulphide for an inhalation study was not certain. Two dry dispersion systems were used to aerosolize the zinc sulphide powder, and the generated aerosol was supplied to a nose-only inhalation exposure system. The results showed a maximum attainable concentration of 0.82 mg/L at an MMAD of 1.5 µm over a 4 h exposure. In the inhalation study, all six rats showed no specific symptoms and good health status and survived a post-exposure observation period of up to 14 days. From the results observed, the status of Not classified was derived according to CLP. Based on the experimental results, an LC50 was not determined but is considered to be higher than 0.82 mg/L (the maximum achievable aerosol concentration). These findings highlight the importance of documenting efforts to achieve aerosol conditions when concentrations required by OECD test guidelines cannot be reached.

摘要

硫化锌是一种广泛使用的无机粉末,其产量已超过1000吨/年。因此,根据经合组织准则436,进行了急性吸入试验以提供更准确的数据。本研究对于确保接触硫化锌粉尘的工人的安全以及符合REACH法规要求至关重要。由于颗粒的特定性质,吸入研究中硫化锌的最大可达到浓度并不确定。使用两种干式分散系统将硫化锌粉末雾化,并将产生的气溶胶供应到仅经鼻吸入暴露系统。结果显示,在4小时暴露期间,MMAD为1.5 µm时最大可达到浓度为0.82 mg/L。在吸入研究中,所有六只大鼠均未表现出特定症状,健康状况良好,并且在长达14天的暴露后观察期内存活。根据观察结果,根据CLP得出未分类的状态。基于实验结果,未确定LC50,但认为其高于0.82 mg/L(最大可达到的气溶胶浓度)。这些发现突出了在无法达到经合组织试验准则要求的浓度时记录实现气溶胶条件的努力的重要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a06b/11768892/7d93fe89965f/toxics-13-00027-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a06b/11768892/b7f78daf65dd/toxics-13-00027-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a06b/11768892/396440c21cf2/toxics-13-00027-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a06b/11768892/831caebcec16/toxics-13-00027-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a06b/11768892/7d93fe89965f/toxics-13-00027-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a06b/11768892/b7f78daf65dd/toxics-13-00027-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a06b/11768892/396440c21cf2/toxics-13-00027-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a06b/11768892/831caebcec16/toxics-13-00027-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a06b/11768892/7d93fe89965f/toxics-13-00027-g004.jpg

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本文引用的文献

1
Alternatives to Acute Inhalation Toxicity Studies in Animal Models-A Perspective.动物模型急性吸入毒性研究的替代方法——一种观点
Front Bioeng Biotechnol. 2020 Jun 3;8:549. doi: 10.3389/fbioe.2020.00549. eCollection 2020.