A Toxicological Evaluation of Germanium Sesquioxide (Organic Germanium)
A battery of OECD- and GLP-compliant toxicological studies was performed to assess the safety of a highly purified germanium sesquioxide, an organic form of the naturally occurring, nonessential trace element germanium. Germanium dioxide and germanium lactate citrate (inorganic germaniums) have been...
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| Format: | Article |
| Language: | English |
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Wiley
2020-01-01
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| Series: | Journal of Toxicology |
| Online Access: | http://dx.doi.org/10.1155/2020/6275625 |
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| author | Robin A. Reddeman Róbert Glávits John R. Endres Timothy S. Murbach Gábor Hirka Adél Vértesi Erzsébet Béres Ilona Pasics Szakonyiné |
| author_facet | Robin A. Reddeman Róbert Glávits John R. Endres Timothy S. Murbach Gábor Hirka Adél Vértesi Erzsébet Béres Ilona Pasics Szakonyiné |
| author_sort | Robin A. Reddeman |
| collection | DOAJ |
| description | A battery of OECD- and GLP-compliant toxicological studies was performed to assess the safety of a highly purified germanium sesquioxide, an organic form of the naturally occurring, nonessential trace element germanium. Germanium dioxide and germanium lactate citrate (inorganic germaniums) have been shown to induce renal toxicity, whereas germanium sesquioxide (an organic germanium) has been shown to have a more favorable safety profile. However, past toxicity studies on germanium sesquioxide compounds have not clearly stated the purity of the tested compounds. In the studies reported herein, there was no evidence of mutagenicity in a bacterial reverse mutation test or an in vitro mammalian chromosomal aberration test. There was no genotoxic activity observed in an in vivo mammalian micronucleus test at concentrations up to the limit dose of 2000 mg/kg bw/day. In a 90-day repeated-dose oral toxicity study in Han:WIST rats conducted at doses of 0, 500, 1000, and 2000 mg/kg bw/day by gavage, there were no mortalities, treatment-related adverse effects, or target organs identified. The no-observed-adverse-effect-level (NOAEL) was determined to be 2000 mg/kg bw/day. |
| format | Article |
| id | doaj-art-ba8de1f343c24f0682c53535ddb0cdb9 |
| institution | OA Journals |
| issn | 1687-8191 1687-8205 |
| language | English |
| publishDate | 2020-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Toxicology |
| spelling | doaj-art-ba8de1f343c24f0682c53535ddb0cdb92025-08-20T02:19:26ZengWileyJournal of Toxicology1687-81911687-82052020-01-01202010.1155/2020/62756256275625A Toxicological Evaluation of Germanium Sesquioxide (Organic Germanium)Robin A. Reddeman0Róbert Glávits1John R. Endres2Timothy S. Murbach3Gábor Hirka4Adél Vértesi5Erzsébet Béres6Ilona Pasics Szakonyiné7AIBMR Life Sciences, Inc., 2800 E. Madison St., Suite 202, Seattle, WA 98373, USAToxi-Coop Zrt., H-1122 Budapest, Magyar Jakobinusok Tere 4/B, HungaryAIBMR Life Sciences, Inc., 2800 E. Madison St., Suite 202, Seattle, WA 98373, USAAIBMR Life Sciences, Inc., 2800 E. Madison St., Suite 202, Seattle, WA 98373, USAToxi-Coop Zrt., H-1122 Budapest, Magyar Jakobinusok Tere 4/B, HungaryToxi-Coop Zrt., H-1122 Budapest, Magyar Jakobinusok Tere 4/B, HungaryToxi-Coop Zrt., H-1122 Budapest, Magyar Jakobinusok Tere 4/B, HungaryToxi-Coop Zrt., H-1122 Budapest, Magyar Jakobinusok Tere 4/B, HungaryA battery of OECD- and GLP-compliant toxicological studies was performed to assess the safety of a highly purified germanium sesquioxide, an organic form of the naturally occurring, nonessential trace element germanium. Germanium dioxide and germanium lactate citrate (inorganic germaniums) have been shown to induce renal toxicity, whereas germanium sesquioxide (an organic germanium) has been shown to have a more favorable safety profile. However, past toxicity studies on germanium sesquioxide compounds have not clearly stated the purity of the tested compounds. In the studies reported herein, there was no evidence of mutagenicity in a bacterial reverse mutation test or an in vitro mammalian chromosomal aberration test. There was no genotoxic activity observed in an in vivo mammalian micronucleus test at concentrations up to the limit dose of 2000 mg/kg bw/day. In a 90-day repeated-dose oral toxicity study in Han:WIST rats conducted at doses of 0, 500, 1000, and 2000 mg/kg bw/day by gavage, there were no mortalities, treatment-related adverse effects, or target organs identified. The no-observed-adverse-effect-level (NOAEL) was determined to be 2000 mg/kg bw/day.http://dx.doi.org/10.1155/2020/6275625 |
| spellingShingle | Robin A. Reddeman Róbert Glávits John R. Endres Timothy S. Murbach Gábor Hirka Adél Vértesi Erzsébet Béres Ilona Pasics Szakonyiné A Toxicological Evaluation of Germanium Sesquioxide (Organic Germanium) Journal of Toxicology |
| title | A Toxicological Evaluation of Germanium Sesquioxide (Organic Germanium) |
| title_full | A Toxicological Evaluation of Germanium Sesquioxide (Organic Germanium) |
| title_fullStr | A Toxicological Evaluation of Germanium Sesquioxide (Organic Germanium) |
| title_full_unstemmed | A Toxicological Evaluation of Germanium Sesquioxide (Organic Germanium) |
| title_short | A Toxicological Evaluation of Germanium Sesquioxide (Organic Germanium) |
| title_sort | toxicological evaluation of germanium sesquioxide organic germanium |
| url | http://dx.doi.org/10.1155/2020/6275625 |
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