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

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 expo...

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Main Authors: Gustav Gerd Bruer, Noömi Lombaert, Arne Burzlaff, Christine Spirlet, Daria Gödecke, Mehmet Ramazanoglu, Otto Creutzenberg
Format: Article
Language:English
Published: MDPI AG 2024-12-01
Series:Toxics
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Online Access:https://www.mdpi.com/2305-6304/13/1/27
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author Gustav Gerd Bruer
Noömi Lombaert
Arne Burzlaff
Christine Spirlet
Daria Gödecke
Mehmet Ramazanoglu
Otto Creutzenberg
author_facet Gustav Gerd Bruer
Noömi Lombaert
Arne Burzlaff
Christine Spirlet
Daria Gödecke
Mehmet Ramazanoglu
Otto Creutzenberg
author_sort Gustav Gerd Bruer
collection DOAJ
description 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.
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issn 2305-6304
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publishDate 2024-12-01
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series Toxics
spelling doaj-art-d274f62d4e74424e8d1889cf1053411f2025-01-24T13:50:59ZengMDPI AGToxics2305-63042024-12-011312710.3390/toxics13010027Considerations and Challenges for Acute Inhalation Toxicity Testing and Classification of Zinc Sulphide Under REACHGustav Gerd Bruer0Noömi Lombaert1Arne Burzlaff2Christine Spirlet3Daria Gödecke4Mehmet Ramazanoglu5Otto Creutzenberg6Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Nikolai-Fuchs-Str. 1, 30625 Hannover, GermanyInternational Zinc Association, 168 Avenue de Tervueren, 1150 Brussels, BelgiumEBRC Consulting GmbH, Kirchhorster Str. 27, 30659 Hannover, GermanyInternational Zinc Association, 168 Avenue de Tervueren, 1150 Brussels, BelgiumFraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Nikolai-Fuchs-Str. 1, 30625 Hannover, GermanyFraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Nikolai-Fuchs-Str. 1, 30625 Hannover, GermanyFraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Nikolai-Fuchs-Str. 1, 30625 Hannover, GermanyZinc 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.https://www.mdpi.com/2305-6304/13/1/27zinc sulphideinhalation toxicologyacute toxicityREACHrats
spellingShingle Gustav Gerd Bruer
Noömi Lombaert
Arne Burzlaff
Christine Spirlet
Daria Gödecke
Mehmet Ramazanoglu
Otto Creutzenberg
Considerations and Challenges for Acute Inhalation Toxicity Testing and Classification of Zinc Sulphide Under REACH
Toxics
zinc sulphide
inhalation toxicology
acute toxicity
REACH
rats
title Considerations and Challenges for Acute Inhalation Toxicity Testing and Classification of Zinc Sulphide Under REACH
title_full Considerations and Challenges for Acute Inhalation Toxicity Testing and Classification of Zinc Sulphide Under REACH
title_fullStr Considerations and Challenges for Acute Inhalation Toxicity Testing and Classification of Zinc Sulphide Under REACH
title_full_unstemmed Considerations and Challenges for Acute Inhalation Toxicity Testing and Classification of Zinc Sulphide Under REACH
title_short Considerations and Challenges for Acute Inhalation Toxicity Testing and Classification of Zinc Sulphide Under REACH
title_sort considerations and challenges for acute inhalation toxicity testing and classification of zinc sulphide under reach
topic zinc sulphide
inhalation toxicology
acute toxicity
REACH
rats
url https://www.mdpi.com/2305-6304/13/1/27
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