A toxicological evaluation of 8–28 nm gold nanocrystals

Gold nanocrystals (AuNC) are gold nanoparticles (AuNP) relatively homogenous in size at 8–28 nm with clean surfaces and crystalline structures. There are concerns and a lack of consensus in the scientific literature and major regulatory bodies regarding not only the safety of nanoparticles when cons...

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Vydáno v:	Food and chemical toxicology Ročník 161; s. 112844
Hlavní autoři:	Modica, Vickie, Glávits, Róbert, Murbach, Timothy S., Endres, John R., Hirka, Gábor, Vértesi, Adél, Béres, Erzsébet, Szakonyiné, Ilona Pasics
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	England Elsevier Ltd 01.03.2022
Témata:	Animals AuNP body weight Cell Line chromosome aberrations Cricetinae Female Genotoxicity gold Gold - chemistry Gold - toxicity Gold nanoparticles Lung - cytology Male Metal Nanoparticles - chemistry Metal Nanoparticles - toxicity Mice Micronucleus Tests mutagens mutation nanocrystals nanogold No-Observed-Adverse-Effect Level NOAEL Rats Rats, Wistar Safety Toxicity MPCE Toxicity Gold nanoparticles Genotoxicity IP BRMT TSH AuNP GLP OECD ANOVA AuNC NOAEL FOB Safety T3
ISSN:	0278-6915, 1873-6351, 1873-6351
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Abstract	Gold nanocrystals (AuNC) are gold nanoparticles (AuNP) relatively homogenous in size at 8–28 nm with clean surfaces and crystalline structures. There are concerns and a lack of consensus in the scientific literature and major regulatory bodies regarding not only the safety of nanoparticles when consumed by humans, but exactly how to determine their safety and whether evidence from a nanoparticle with one set of physiochemical properties extends to one with a different set. Additionally, there are few general long-term toxicity data on AuNP. To our knowledge, the potential toxicity of AuNC specifically, with the above characteristics, or otherwise, has not been investigated in preclinical studies; thus, we conducted a battery of genetic toxicity tests and an oral repeated-dose toxicity test to further explore their safety. AuNC were not mutagenic or clastogenic in bacterial reverse mutation and in vitro mammalian chromosomal aberration tests, respectively, and did not exhibit in vivo genotoxicity in a micronucleus test in mice. In a 60-day, repeated-dose oral toxicity study, rats were administered 0, 2.5, 5, or 10 mg/kg bw/day of AuNC by gavage. No toxicity was identified. Therefore, a no observed adverse effect level was determined as 10 mg/kg body weight/day. •This is the first preclinical toxicologic evaluation of 8–28 nm gold nanocrystals.•No in vitro or in vivo genotoxic effects were observed in a standard test battery.•No treatment related adverse effects were observed in Wistar rats.•No target organs were identified in Wistar rats.•The NOAEL was 10 mg/kg bw/day, the highest dose tested.
AbstractList	Gold nanocrystals (AuNC) are gold nanoparticles (AuNP) relatively homogenous in size at 8–28 nm with clean surfaces and crystalline structures. There are concerns and a lack of consensus in the scientific literature and major regulatory bodies regarding not only the safety of nanoparticles when consumed by humans, but exactly how to determine their safety and whether evidence from a nanoparticle with one set of physiochemical properties extends to one with a different set. Additionally, there are few general long-term toxicity data on AuNP. To our knowledge, the potential toxicity of AuNC specifically, with the above characteristics, or otherwise, has not been investigated in preclinical studies; thus, we conducted a battery of genetic toxicity tests and an oral repeated-dose toxicity test to further explore their safety. AuNC were not mutagenic or clastogenic in bacterial reverse mutation and in vitro mammalian chromosomal aberration tests, respectively, and did not exhibit in vivo genotoxicity in a micronucleus test in mice. In a 60-day, repeated-dose oral toxicity study, rats were administered 0, 2.5, 5, or 10 mg/kg bw/day of AuNC by gavage. No toxicity was identified. Therefore, a no observed adverse effect level was determined as 10 mg/kg body weight/day. •This is the first preclinical toxicologic evaluation of 8–28 nm gold nanocrystals.•No in vitro or in vivo genotoxic effects were observed in a standard test battery.•No treatment related adverse effects were observed in Wistar rats.•No target organs were identified in Wistar rats.•The NOAEL was 10 mg/kg bw/day, the highest dose tested. Gold nanocrystals (AuNC) are gold nanoparticles (AuNP) relatively homogenous in size at 8–28 nm with clean surfaces and crystalline structures. There are concerns and a lack of consensus in the scientific literature and major regulatory bodies regarding not only the safety of nanoparticles when consumed by humans, but exactly how to determine their safety and whether evidence from a nanoparticle with one set of physiochemical properties extends to one with a different set. Additionally, there are few general long-term toxicity data on AuNP. To our knowledge, the potential toxicity of AuNC specifically, with the above characteristics, or otherwise, has not been investigated in preclinical studies; thus, we conducted a battery of genetic toxicity tests and an oral repeated-dose toxicity test to further explore their safety. AuNC were not mutagenic or clastogenic in bacterial reverse mutation and in vitro mammalian chromosomal aberration tests, respectively, and did not exhibit in vivo genotoxicity in a micronucleus test in mice. In a 60-day, repeated-dose oral toxicity study, rats were administered 0, 2.5, 5, or 10 mg/kg bw/day of AuNC by gavage. No toxicity was identified. Therefore, a no observed adverse effect level was determined as 10 mg/kg body weight/day. Gold nanocrystals (AuNC) are gold nanoparticles (AuNP) relatively homogenous in size at 8-28 nm with clean surfaces and crystalline structures. There are concerns and a lack of consensus in the scientific literature and major regulatory bodies regarding not only the safety of nanoparticles when consumed by humans, but exactly how to determine their safety and whether evidence from a nanoparticle with one set of physiochemical properties extends to one with a different set. Additionally, there are few general long-term toxicity data on AuNP. To our knowledge, the potential toxicity of AuNC specifically, with the above characteristics, or otherwise, has not been investigated in preclinical studies; thus, we conducted a battery of genetic toxicity tests and an oral repeated-dose toxicity test to further explore their safety. AuNC were not mutagenic or clastogenic in bacterial reverse mutation and in vitro mammalian chromosomal aberration tests, respectively, and did not exhibit in vivo genotoxicity in a micronucleus test in mice. In a 60-day, repeated-dose oral toxicity study, rats were administered 0, 2.5, 5, or 10 mg/kg bw/day of AuNC by gavage. No toxicity was identified. Therefore, a no observed adverse effect level was determined as 10 mg/kg body weight/day. Gold nanocrystals (AuNC) are gold nanoparticles (AuNP) relatively homogenous in size at 8-28 nm with clean surfaces and crystalline structures. There are concerns and a lack of consensus in the scientific literature and major regulatory bodies regarding not only the safety of nanoparticles when consumed by humans, but exactly how to determine their safety and whether evidence from a nanoparticle with one set of physiochemical properties extends to one with a different set. Additionally, there are few general long-term toxicity data on AuNP. To our knowledge, the potential toxicity of AuNC specifically, with the above characteristics, or otherwise, has not been investigated in preclinical studies; thus, we conducted a battery of genetic toxicity tests and an oral repeated-dose toxicity test to further explore their safety. AuNC were not mutagenic or clastogenic in bacterial reverse mutation and in vitro mammalian chromosomal aberration tests, respectively, and did not exhibit in vivo genotoxicity in a micronucleus test in mice. In a 60-day, repeated-dose oral toxicity study, rats were administered 0, 2.5, 5, or 10 mg/kg bw/day of AuNC by gavage. No toxicity was identified. Therefore, a no observed adverse effect level was determined as 10 mg/kg body weight/day.Gold nanocrystals (AuNC) are gold nanoparticles (AuNP) relatively homogenous in size at 8-28 nm with clean surfaces and crystalline structures. There are concerns and a lack of consensus in the scientific literature and major regulatory bodies regarding not only the safety of nanoparticles when consumed by humans, but exactly how to determine their safety and whether evidence from a nanoparticle with one set of physiochemical properties extends to one with a different set. Additionally, there are few general long-term toxicity data on AuNP. To our knowledge, the potential toxicity of AuNC specifically, with the above characteristics, or otherwise, has not been investigated in preclinical studies; thus, we conducted a battery of genetic toxicity tests and an oral repeated-dose toxicity test to further explore their safety. AuNC were not mutagenic or clastogenic in bacterial reverse mutation and in vitro mammalian chromosomal aberration tests, respectively, and did not exhibit in vivo genotoxicity in a micronucleus test in mice. In a 60-day, repeated-dose oral toxicity study, rats were administered 0, 2.5, 5, or 10 mg/kg bw/day of AuNC by gavage. No toxicity was identified. Therefore, a no observed adverse effect level was determined as 10 mg/kg body weight/day.
ArticleNumber	112844
Author	Hirka, Gábor Murbach, Timothy S. Endres, John R. Béres, Erzsébet Glávits, Róbert Szakonyiné, Ilona Pasics Modica, Vickie Vértesi, Adél
Author_xml	– sequence: 1 givenname: Vickie surname: Modica fullname: Modica, Vickie email: vickie@aibmr.com organization: AIBMR Life Sciences, Inc., 1425 Broadway, Suite 458, Seattle, WA, 98122, USA – sequence: 2 givenname: Róbert surname: Glávits fullname: Glávits, Róbert email: glavits.robert.dr@gmail.com organization: Toxi-Coop Zrt., Berlini utca 47–49, H-1045, Budapest, Hungary – sequence: 3 givenname: Timothy S. orcidid: 0000-0002-7658-858X surname: Murbach fullname: Murbach, Timothy S. email: tim@aibmr.com organization: AIBMR Life Sciences, Inc., 1425 Broadway, Suite 458, Seattle, WA, 98122, USA – sequence: 4 givenname: John R. surname: Endres fullname: Endres, John R. email: john@aibmr.com organization: AIBMR Life Sciences, Inc., 1425 Broadway, Suite 458, Seattle, WA, 98122, USA – sequence: 5 givenname: Gábor surname: Hirka fullname: Hirka, Gábor email: gabor.hirka@toxicoop.com organization: Toxi-Coop Zrt., Berlini utca 47–49, H-1045, Budapest, Hungary – sequence: 6 givenname: Adél surname: Vértesi fullname: Vértesi, Adél email: adel.vertesi@toxicoop.com organization: Toxi-Coop Zrt., Arácsi út 97, 8230, Balatonfüred, Hungary – sequence: 7 givenname: Erzsébet surname: Béres fullname: Béres, Erzsébet email: erzsebet.beres@toxicoop.com organization: Toxi-Coop Zrt., Arácsi út 97, 8230, Balatonfüred, Hungary – sequence: 8 givenname: Ilona Pasics surname: Szakonyiné fullname: Szakonyiné, Ilona Pasics email: ilona.pasics@toxicoop.com organization: Toxi-Coop Zrt., Berlini utca 47–49, H-1045, Budapest, Hungary
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Cites_doi	10.1016/0165-1161(83)90010-9 10.1016/0165-1110(86)90002-3 10.1016/j.actbio.2017.01.082 10.1016/0165-1110(81)90030-0 10.2147/IJN.S8428 10.1002/jbm.a.35944 10.1007/BF00401402 10.1016/j.nantod.2011.08.001 10.3109/17435390.2013.773464 10.1016/j.yrtph.2013.11.002 10.1007/s12274-014-0697-3 10.1016/j.nantod.2011.10.001 10.1007/s11671-009-9334-6 10.1016/0165-1161(75)90046-1
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Keywords	MPCE Toxicity Gold nanoparticles Genotoxicity IP BRMT TSH AuNP GLP OECD ANOVA AuNC NOAEL FOB Safety T3
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Snippet	Gold nanocrystals (AuNC) are gold nanoparticles (AuNP) relatively homogenous in size at 8–28 nm with clean surfaces and crystalline structures. There are... Gold nanocrystals (AuNC) are gold nanoparticles (AuNP) relatively homogenous in size at 8-28 nm with clean surfaces and crystalline structures. There are... Gold nanocrystals (AuNC) are gold nanoparticles (AuNP) relatively homogenous in size at 8-28 nm with clean surfaces and crystalline structures. There are... Gold nanocrystals (AuNC) are gold nanoparticles (AuNP) relatively homogenous in size at 8–28 nm with clean surfaces and crystalline structures. There are...
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SubjectTerms	Animals AuNP body weight Cell Line chromosome aberrations Cricetinae Female Genotoxicity gold Gold - chemistry Gold - toxicity Gold nanoparticles Lung - cytology Male Metal Nanoparticles - chemistry Metal Nanoparticles - toxicity Mice Micronucleus Tests mutagens mutation nanocrystals nanogold No-Observed-Adverse-Effect Level NOAEL Rats Rats, Wistar Safety Toxicity
Title	A toxicological evaluation of 8–28 nm gold nanocrystals
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