Toxicology and digestibility of Chlamydomonas debaryana green algal biomass

There is an economic interest, both for food security and for the non‐meat‐eating population, in the development of novel, sustainable sources of high‐quality protein. The green algae Chlamydomonas reinhardtii has already been developed for this purpose, and the closely related species, Chlamydomona...

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Vydané v:	Journal of applied toxicology Ročník 43; číslo 7; s. 993 - 1012
Hlavní autori:	Murbach, Timothy S., Glávits, Róbert, Jayasena, Shyamali, Moghadam Maragheh, Niloofar, Endres, John R., Hirka, Gábor, Goodman, Richard E., Vértesi, Adél, Béres, Erzsébet, Pasics Szakonyiné, Ilona
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	England Wiley Subscription Services, Inc 01.07.2023
Predmet:	Algae Animals Aquatic plants Biocompatibility Biomass Chlamydomonas Chlamydomonas - metabolism Chlamydomonas debaryana Chlorophyta Chromosome Aberrations Clastogenicity Digestibility Food consumption Food security Genotoxicity Humans In vitro methods and tests In vivo methods and tests Mammals Mice Mutagenicity No-Observed-Adverse-Effect Level NOAEL Production costs Proteins Rats Safety simulated gastric fluid Sustainable development Toxicity Toxicology toxicity Chlamydomonas debaryana simulated gastric fluid digestibility safety NOAEL
ISSN:	0260-437X, 1099-1263, 1099-1263
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Abstract	There is an economic interest, both for food security and for the non‐meat‐eating population, in the development of novel, sustainable sources of high‐quality protein. The green algae Chlamydomonas reinhardtii has already been developed for this purpose, and the closely related species, Chlamydomonas debaryana, is a complementary source that also presents some additional advantages, such as reduced production cost. To determine whether C. debaryana may have a similar safety profile to that of C. reinhardtii, a wild type strain was obtained, designated TS04 after confirmation of its identity, and subjected to a battery of preclinical studies. Genetic toxicity was evaluated using a bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian micronucleus test in a mouse model. No genotoxic potential (e.g., mutagenicity and clastogenicity) was observed in these tests under the employed conditions up to maximum recommended concentrations or doses. To assess general toxicity, a 90‐day repeated‐dose oral toxicity study was conducted in rats. No mortality or adverse effects were observed, and no target organs were identified up to the maximum feasible dose, due to solubility, of 4,000 mg/kg bw/day. The no‐observed‐adverse‐effect level was determined as the highest dose tested. A digestibility study in simulated gastric fluid was conducted and determined that TS04 has low allergenic potential, exhibiting rapid digestion of proteins. Due to the negative results of our evaluation, it is reasonable to proceed with further development and additional investigations to contribute towards a safety assessment of the proposed use in food for human consumption. Due to interest in developing the green algae Chlamydomonas debaryana as a source of food protein, a wild type strain was obtained, designated TS04, and subjected to preclinical safety testing. TS04 did not exhibit allergenic potential in a digestibility study or genotoxic potential in a standard battery of tests. A no‐observed‐adverse‐effect level of 4,000 mg/kg bw/day (the highest dose tested) was determined in a 90‐day repeated‐dose oral toxicity study in rats. Based on these results, further evaluation and development are feasible.
AbstractList	There is an economic interest, both for food security and for the non‐meat‐eating population, in the development of novel, sustainable sources of high‐quality protein. The green algae Chlamydomonas reinhardtii has already been developed for this purpose, and the closely related species, Chlamydomonas debaryana, is a complementary source that also presents some additional advantages, such as reduced production cost. To determine whether C. debaryana may have a similar safety profile to that of C. reinhardtii, a wild type strain was obtained, designated TS04 after confirmation of its identity, and subjected to a battery of preclinical studies. Genetic toxicity was evaluated using a bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian micronucleus test in a mouse model. No genotoxic potential (e.g., mutagenicity and clastogenicity) was observed in these tests under the employed conditions up to maximum recommended concentrations or doses. To assess general toxicity, a 90‐day repeated‐dose oral toxicity study was conducted in rats. No mortality or adverse effects were observed, and no target organs were identified up to the maximum feasible dose, due to solubility, of 4,000 mg/kg bw/day. The no‐observed‐adverse‐effect level was determined as the highest dose tested. A digestibility study in simulated gastric fluid was conducted and determined that TS04 has low allergenic potential, exhibiting rapid digestion of proteins. Due to the negative results of our evaluation, it is reasonable to proceed with further development and additional investigations to contribute towards a safety assessment of the proposed use in food for human consumption. Due to interest in developing the green algae Chlamydomonas debaryana as a source of food protein, a wild type strain was obtained, designated TS04, and subjected to preclinical safety testing. TS04 did not exhibit allergenic potential in a digestibility study or genotoxic potential in a standard battery of tests. A no‐observed‐adverse‐effect level of 4,000 mg/kg bw/day (the highest dose tested) was determined in a 90‐day repeated‐dose oral toxicity study in rats. Based on these results, further evaluation and development are feasible. There is an economic interest, both for food security and for the non-meat-eating population, in the development of novel, sustainable sources of high-quality protein. The green algae Chlamydomonas reinhardtii has already been developed for this purpose, and the closely related species, Chlamydomonas debaryana, is a complementary source that also presents some additional advantages, such as reduced production cost. To determine whether C. debaryana may have a similar safety profile to that of C. reinhardtii, a wild type strain was obtained, designated TS04 after confirmation of its identity, and subjected to a battery of preclinical studies. Genetic toxicity was evaluated using a bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian micronucleus test in a mouse model. No genotoxic potential (e.g., mutagenicity and clastogenicity) was observed in these tests under the employed conditions up to maximum recommended concentrations or doses. To assess general toxicity, a 90-day repeated-dose oral toxicity study was conducted in rats. No mortality or adverse effects were observed, and no target organs were identified up to the maximum feasible dose, due to solubility, of 4,000 mg/kg bw/day. The no-observed-adverse-effect level was determined as the highest dose tested. A digestibility study in simulated gastric fluid was conducted and determined that TS04 has low allergenic potential, exhibiting rapid digestion of proteins. Due to the negative results of our evaluation, it is reasonable to proceed with further development and additional investigations to contribute towards a safety assessment of the proposed use in food for human consumption.There is an economic interest, both for food security and for the non-meat-eating population, in the development of novel, sustainable sources of high-quality protein. The green algae Chlamydomonas reinhardtii has already been developed for this purpose, and the closely related species, Chlamydomonas debaryana, is a complementary source that also presents some additional advantages, such as reduced production cost. To determine whether C. debaryana may have a similar safety profile to that of C. reinhardtii, a wild type strain was obtained, designated TS04 after confirmation of its identity, and subjected to a battery of preclinical studies. Genetic toxicity was evaluated using a bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian micronucleus test in a mouse model. No genotoxic potential (e.g., mutagenicity and clastogenicity) was observed in these tests under the employed conditions up to maximum recommended concentrations or doses. To assess general toxicity, a 90-day repeated-dose oral toxicity study was conducted in rats. No mortality or adverse effects were observed, and no target organs were identified up to the maximum feasible dose, due to solubility, of 4,000 mg/kg bw/day. The no-observed-adverse-effect level was determined as the highest dose tested. A digestibility study in simulated gastric fluid was conducted and determined that TS04 has low allergenic potential, exhibiting rapid digestion of proteins. Due to the negative results of our evaluation, it is reasonable to proceed with further development and additional investigations to contribute towards a safety assessment of the proposed use in food for human consumption. There is an economic interest, both for food security and for the non‐meat‐eating population, in the development of novel, sustainable sources of high‐quality protein. The green algae Chlamydomonas reinhardtii has already been developed for this purpose, and the closely related species, Chlamydomonas debaryana, is a complementary source that also presents some additional advantages, such as reduced production cost. To determine whether C. debaryana may have a similar safety profile to that of C. reinhardtii, a wild type strain was obtained, designated TS04 after confirmation of its identity, and subjected to a battery of preclinical studies. Genetic toxicity was evaluated using a bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian micronucleus test in a mouse model. No genotoxic potential (e.g., mutagenicity and clastogenicity) was observed in these tests under the employed conditions up to maximum recommended concentrations or doses. To assess general toxicity, a 90‐day repeated‐dose oral toxicity study was conducted in rats. No mortality or adverse effects were observed, and no target organs were identified up to the maximum feasible dose, due to solubility, of 4,000 mg/kg bw/day. The no‐observed‐adverse‐effect level was determined as the highest dose tested. A digestibility study in simulated gastric fluid was conducted and determined that TS04 has low allergenic potential, exhibiting rapid digestion of proteins. Due to the negative results of our evaluation, it is reasonable to proceed with further development and additional investigations to contribute towards a safety assessment of the proposed use in food for human consumption.
Author	Goodman, Richard E. Moghadam Maragheh, Niloofar Hirka, Gábor Murbach, Timothy S. Endres, John R. Béres, Erzsébet Glávits, Róbert Pasics Szakonyiné, Ilona Jayasena, Shyamali Vértesi, Adél
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Cites_doi	10.3389/fpls.2021.646498 10.1093/plcell/koab026 10.1016/0165-1161(83)90010-9 10.1002/jat.4293 10.1016/0165-1161(75)90046-1 10.1080/10934529.2019.1672458 10.1093/plcell/koab034 10.1186/s13601-018-0216-9 10.1787/9789264078536-en 10.1128/genomeA.01070-16 10.11646/phytotaxa.362.1.2 10.1016/j.phrs.2017.10.009 10.3390/plants11131770 10.1016/S0027-5107(00)00064-6 10.1016/0165-1110(81)90030-0 10.1007/s00239-017-9826-4 10.1136/jmg.13.2.103 10.1007/978-1-4613-3694-5_4 10.1078/1434-4610-00068 10.1146/annurev.arplant.52.1.363 10.1080/08865140214384 10.1017/S0007114516004189 10.1016/0165-1110(86)90002-3 10.1177/1091581817746109 10.1093/pcp/pcz188 10.1016/j.phytochem.2014.03.011 10.1016/j.fct.2008.05.038 10.1007/s11356-016-7320-y 10.1007/s12010-015-1714-z 10.1016/j.toxrep.2019.08.003 10.1016/j.yrtph.2008.06.006
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Notes	Funding information Richard E. Goodman, Adél Vértesi, Erzsébet Béres, and Ilona Pasics Szakonyiné are co‐senior authors. The authors disclose that financial support for the research described herein was provided by Triton Algae Innovations, San Diego, California 92121, USA. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23
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Snippet	There is an economic interest, both for food security and for the non‐meat‐eating population, in the development of novel, sustainable sources of high‐quality... There is an economic interest, both for food security and for the non-meat-eating population, in the development of novel, sustainable sources of high-quality...
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SubjectTerms	Algae Animals Aquatic plants Biocompatibility Biomass Chlamydomonas Chlamydomonas - metabolism Chlamydomonas debaryana Chlorophyta Chromosome Aberrations Clastogenicity Digestibility Food consumption Food security Genotoxicity Humans In vitro methods and tests In vivo methods and tests Mammals Mice Mutagenicity No-Observed-Adverse-Effect Level NOAEL Production costs Proteins Rats Safety simulated gastric fluid Sustainable development Toxicity Toxicology
Title	Toxicology and digestibility of Chlamydomonas debaryana green algal biomass
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