Developmental toxicity evaluation of berberine in rats and mice
Identifieur interne : 000F73 ( Main/Exploration ); précédent : 000F72; suivant : 000F74Developmental toxicity evaluation of berberine in rats and mice
Auteurs : Gloria D. Jahnke [États-Unis] ; Catherine J. Price [États-Unis] ; Melissa C. Marr [États-Unis] ; Christina B. Myers [États-Unis] ; Julia D. George [États-Unis]Source :
- Birth Defects Research Part B: Developmental and Reproductive Toxicology [ 1542-9733 ] ; 2006-06.
English descriptors
- Teeft :
- Anesthesia, Aqueous methylcellulose, Berberine, Berberine chloride, Berberine chloride dihydrate, Berberine chloride dihydrate feed, Birth defects research, Body weight, Body weights, Cary, Chemical substances, Chloride, Cleft, Cleft palate, Control group, Developmental effects, Developmental toxicity, Developmental toxicity evaluation, Developmental toxicity loael, Developmental toxicity noael, Developmental toxicity screen, Developmental toxicity study, Dihydrate, Dose group, Dose selection, Dosing, Feed consumption, Feed studies, Feed study, Female swiss mice, Fetal, Fetal body weight, Fetus, Fetuses litters, Gavage, Gavage studies, Gavage study, Gestation, Gestational, Gestational days, Gestational period, Gravid, Gravid uterine weight, Ground feed, Herbal, Herbal remedies, High dose, High dose group, Historic control data, Implant, Implantation, Implantation sites, Jahnke, Laboratory animals, Linear trend, Litter, Litter size, Liver weight, Loael, Malformation, Maternal, Maternal body weight, Maternal body weight gain, Maternal body weights, Maternal feed consumption, Maternal toxicity, Maternal toxicity loael, Maternal weight gain, Misdirected dose, Mouse, National toxicology program, Noael, Oral route, Pairwise comparisons, Palate, Percent fetuses, Pregnant females, Prenatal mortality, Pretreatment, Pretreatment period, Rat, Research triangle park, Resorption, Significant differences, Significant effects, Skeletal malformations, Stratified randomization, Study design, Swiss albino mice, Swiss mice, Test article, Toxic effects, Toxicity, Toxicology, Treatment groups, Treatment period, Uterine, Vehicle control group, Water consumption, Weight gain.
Abstract
BACKGROUND: Berberine, a plant alkaloid, is found in some herbal teas and health‐related products. It is a component of goldenseal, an herbal supplement. Berberine chloride dihydrate (BCD) was evaluated for developmental toxicity in rats and mice. METHODS: Berberine chloride dihydrate was administered in the feed to timed‐mated Sprague–Dawley (CD) rats (0, 3625, 7250, or 14,500 ppm; on gestational days [GD] 6–20), and Swiss Albino (CD‐1) mice (0, 3500, 5250, or 7000 ppm; on GD 6–17). Ingested doses were 0, 282, 531, and 1313 mg/kg/day (rats) and 0, 569, 841, and 1155 mg/kg/day (mice). RESULTS:There were no maternal deaths. The rat maternal lowest observed adverse effect level (LOAEL), based on reduced maternal weight gain, was 7250 ppm. The rat developmental toxicity LOAEL, based on reduced fetal body weight per litter, was 14,500 ppm. In the mouse study, equivocal maternal and developmental toxicity LOAELs were 5250 ppm. Due to scattering of feed in the high dose groups, a gavage study at 1000 mg/kg/day was conducted in both species. CONCLUSIONS: In rats, maternal, but not fetal adverse effects were noted. The maternal toxicity LOAEL remained at 7250 ppm (531 mg/kg/day) based on the feed study and the developmental toxicity NOAEL was raised to 1000 mg/kg/day BCD based on the gavage study. In the mouse, 33% of the treated females died. Surviving animals had increased relative water intake, and average fetal body weight per litter decreased 5–6% with no change in live litter size. The maternal toxicity LOAEL remained at 5250 ppm (841 mg/kg/day) BCD, based on increased water consumption. The developmental toxicity LOAEL was raised to 1000 mg/kg/day BCD based on decreased fetal body weight. Birth Defects Research (Part B) 77:195–206, 2006. Published 2006 Wiley‐Liss, Inc.
Url:
DOI: 10.1002/bdrb.20075
Affiliations:
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Jahnke</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Sciences International Inc., Research Triangle Park</wicri:cityArea></affiliation><affiliation></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Correspondence address: EC‐32, National Institute of Environmental Health Sciences, PO Box 12233, Alexander Drive, Research Triangle Park</wicri:cityArea></affiliation></author><author><name sortKey="Price, Catherine J" sort="Price, Catherine J" uniqKey="Price C" first="Catherine J." last="Price">Catherine J. Price</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>RTI International, Research Triangle Park</wicri:cityArea></affiliation></author><author><name sortKey="Marr, Melissa C" sort="Marr, Melissa C" uniqKey="Marr M" first="Melissa C." last="Marr">Melissa C. Marr</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>RTI International, Research Triangle Park</wicri:cityArea></affiliation></author><author><name sortKey="Myers, Christina B" sort="Myers, Christina B" uniqKey="Myers C" first="Christina B." last="Myers">Christina B. 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George</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>RTI International, Research Triangle Park</wicri:cityArea></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Birth Defects Research Part B: Developmental and Reproductive Toxicology</title><title level="j" type="alt">BIRTH DEFECTS RESEARCH PART B: DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY</title><idno type="ISSN">1542-9733</idno><idno type="eISSN">1542-9741</idno><imprint><biblScope unit="vol">77</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="195">195</biblScope><biblScope unit="page" to="206">206</biblScope><biblScope unit="page-count">12</biblScope><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2006-06">2006-06</date></imprint><idno type="ISSN">1542-9733</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1542-9733</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Anesthesia</term><term>Aqueous methylcellulose</term><term>Berberine</term><term>Berberine chloride</term><term>Berberine chloride dihydrate</term><term>Berberine chloride dihydrate feed</term><term>Birth defects research</term><term>Body weight</term><term>Body weights</term><term>Cary</term><term>Chemical substances</term><term>Chloride</term><term>Cleft</term><term>Cleft palate</term><term>Control group</term><term>Developmental effects</term><term>Developmental toxicity</term><term>Developmental toxicity evaluation</term><term>Developmental toxicity loael</term><term>Developmental toxicity noael</term><term>Developmental toxicity screen</term><term>Developmental toxicity study</term><term>Dihydrate</term><term>Dose group</term><term>Dose selection</term><term>Dosing</term><term>Feed consumption</term><term>Feed studies</term><term>Feed study</term><term>Female swiss mice</term><term>Fetal</term><term>Fetal body weight</term><term>Fetus</term><term>Fetuses litters</term><term>Gavage</term><term>Gavage studies</term><term>Gavage study</term><term>Gestation</term><term>Gestational</term><term>Gestational days</term><term>Gestational period</term><term>Gravid</term><term>Gravid uterine weight</term><term>Ground feed</term><term>Herbal</term><term>Herbal remedies</term><term>High dose</term><term>High dose group</term><term>Historic control data</term><term>Implant</term><term>Implantation</term><term>Implantation sites</term><term>Jahnke</term><term>Laboratory animals</term><term>Linear trend</term><term>Litter</term><term>Litter size</term><term>Liver weight</term><term>Loael</term><term>Malformation</term><term>Maternal</term><term>Maternal body weight</term><term>Maternal body weight gain</term><term>Maternal body weights</term><term>Maternal feed consumption</term><term>Maternal toxicity</term><term>Maternal toxicity loael</term><term>Maternal weight gain</term><term>Misdirected dose</term><term>Mouse</term><term>National toxicology program</term><term>Noael</term><term>Oral route</term><term>Pairwise comparisons</term><term>Palate</term><term>Percent fetuses</term><term>Pregnant females</term><term>Prenatal mortality</term><term>Pretreatment</term><term>Pretreatment period</term><term>Rat</term><term>Research triangle park</term><term>Resorption</term><term>Significant differences</term><term>Significant effects</term><term>Skeletal malformations</term><term>Stratified randomization</term><term>Study design</term><term>Swiss albino mice</term><term>Swiss mice</term><term>Test article</term><term>Toxic effects</term><term>Toxicity</term><term>Toxicology</term><term>Treatment groups</term><term>Treatment period</term><term>Uterine</term><term>Vehicle control group</term><term>Water consumption</term><term>Weight gain</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND: Berberine, a plant alkaloid, is found in some herbal teas and health‐related products. It is a component of goldenseal, an herbal supplement. Berberine chloride dihydrate (BCD) was evaluated for developmental toxicity in rats and mice. METHODS: Berberine chloride dihydrate was administered in the feed to timed‐mated Sprague–Dawley (CD) rats (0, 3625, 7250, or 14,500 ppm; on gestational days [GD] 6–20), and Swiss Albino (CD‐1) mice (0, 3500, 5250, or 7000 ppm; on GD 6–17). Ingested doses were 0, 282, 531, and 1313 mg/kg/day (rats) and 0, 569, 841, and 1155 mg/kg/day (mice). RESULTS:There were no maternal deaths. The rat maternal lowest observed adverse effect level (LOAEL), based on reduced maternal weight gain, was 7250 ppm. The rat developmental toxicity LOAEL, based on reduced fetal body weight per litter, was 14,500 ppm. In the mouse study, equivocal maternal and developmental toxicity LOAELs were 5250 ppm. Due to scattering of feed in the high dose groups, a gavage study at 1000 mg/kg/day was conducted in both species. CONCLUSIONS: In rats, maternal, but not fetal adverse effects were noted. The maternal toxicity LOAEL remained at 7250 ppm (531 mg/kg/day) based on the feed study and the developmental toxicity NOAEL was raised to 1000 mg/kg/day BCD based on the gavage study. In the mouse, 33% of the treated females died. Surviving animals had increased relative water intake, and average fetal body weight per litter decreased 5–6% with no change in live litter size. The maternal toxicity LOAEL remained at 5250 ppm (841 mg/kg/day) BCD, based on increased water consumption. The developmental toxicity LOAEL was raised to 1000 mg/kg/day BCD based on decreased fetal body weight. Birth Defects Research (Part B) 77:195–206, 2006. Published 2006 Wiley‐Liss, Inc.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Caroline du Nord</li></region></list><tree><country name="États-Unis"><region name="Caroline du Nord"><name sortKey="Jahnke, Gloria D" sort="Jahnke, Gloria D" uniqKey="Jahnke G" first="Gloria D." last="Jahnke">Gloria D. Jahnke</name></region><name sortKey="George, Julia D" sort="George, Julia D" uniqKey="George J" first="Julia D." last="George">Julia D. George</name><name sortKey="Jahnke, Gloria D" sort="Jahnke, Gloria D" uniqKey="Jahnke G" first="Gloria D." last="Jahnke">Gloria D. Jahnke</name><name sortKey="Marr, Melissa C" sort="Marr, Melissa C" uniqKey="Marr M" first="Melissa C." last="Marr">Melissa C. Marr</name><name sortKey="Myers, Christina B" sort="Myers, Christina B" uniqKey="Myers C" first="Christina B." last="Myers">Christina B. Myers</name><name sortKey="Price, Catherine J" sort="Price, Catherine J" uniqKey="Price C" first="Catherine J." last="Price">Catherine J. Price</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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