Developmental toxicity study of CBLB502 in Wistar rats
•We determined the potential developmental toxicity of CBLB502.•Significantly decreased gestation body, body weight changes and food consumption were observed in all dose groups.•No external, visceral and skeletal malformations were observed.•Based on the results of this study, the NOAEL for develop...
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| Veröffentlicht in: | Reproductive toxicology (Elmsford, N.Y.) N.Y.), 2014-07, Vol.46, p.12-19 |
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| creator | Chow, C. Paul Faqi, Ali S. |
| description | •We determined the potential developmental toxicity of CBLB502.•Significantly decreased gestation body, body weight changes and food consumption were observed in all dose groups.•No external, visceral and skeletal malformations were observed.•Based on the results of this study, the NOAEL for developmental toxicity was estimated to be ≥300μg/kg/day.
CBLB502 is a derivative of a microbial protein that binds to Toll-like receptor 5. It is demonstrated to reduce inflammatory response from acute stresses, such as radiation in animal models. We determined the potential developmental toxicity of CBLB502 in rats. Four groups of 25 time-mated female Wistar rats/group received subcutaneously 0, 30, 100, or 300μg/kg/day of CBLB502 from Gestation Days (GD) 6 to 17 at a dose volume of 1.0mL/kg. Toxicokinetic evaluation was performed on GD 6 and 17. On GD 20 C-section was performed for uterine evaluation and blood samples collected from each dam for immunogenicity assay.
Significant decrease in gestation body weight, weight changes and food consumption indicative of maternal toxicity were observed in all dose groups. Also adjusted body weight and weight changes were seen at 300μg/kg/day. No external, visceral and skeletal abnormalities were observed. The NOAEL for developmental toxicity was estimated to be ≥300μg/kg/day. |
| doi_str_mv | 10.1016/j.reprotox.2014.02.007 |
| format | Article |
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CBLB502 is a derivative of a microbial protein that binds to Toll-like receptor 5. It is demonstrated to reduce inflammatory response from acute stresses, such as radiation in animal models. We determined the potential developmental toxicity of CBLB502 in rats. Four groups of 25 time-mated female Wistar rats/group received subcutaneously 0, 30, 100, or 300μg/kg/day of CBLB502 from Gestation Days (GD) 6 to 17 at a dose volume of 1.0mL/kg. Toxicokinetic evaluation was performed on GD 6 and 17. On GD 20 C-section was performed for uterine evaluation and blood samples collected from each dam for immunogenicity assay.
Significant decrease in gestation body weight, weight changes and food consumption indicative of maternal toxicity were observed in all dose groups. Also adjusted body weight and weight changes were seen at 300μg/kg/day. No external, visceral and skeletal abnormalities were observed. The NOAEL for developmental toxicity was estimated to be ≥300μg/kg/day.</description><identifier>ISSN: 0890-6238</identifier><identifier>EISSN: 1873-1708</identifier><identifier>DOI: 10.1016/j.reprotox.2014.02.007</identifier><identifier>PMID: 24602561</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Animals ; Antibodies - analysis ; Body Weight - drug effects ; Bone and Bones - abnormalities ; Bone and Bones - pathology ; CBLB502 ; Developmental toxicity ; Dose-Response Relationship, Drug ; Eating - drug effects ; Female ; Male ; No-Observed-Adverse-Effect Level ; Peptides - immunology ; Peptides - pharmacokinetics ; Peptides - toxicity ; Pregnancy ; Rats ; Rats, Wistar ; Teratogens - toxicity ; Toll-Like Receptor 5 - drug effects ; Wistar rats</subject><ispartof>Reproductive toxicology (Elmsford, N.Y.), 2014-07, Vol.46, p.12-19</ispartof><rights>2014 Elsevier Inc.</rights><rights>Copyright © 2014 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c401t-29f9ece9d83ac219cbe430d86b10edcfff026f1af773565cab039a664e3ff6983</citedby><cites>FETCH-LOGICAL-c401t-29f9ece9d83ac219cbe430d86b10edcfff026f1af773565cab039a664e3ff6983</cites><orcidid>0000-0002-6533-5982</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0890623814000410$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24602561$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chow, C. Paul</creatorcontrib><creatorcontrib>Faqi, Ali S.</creatorcontrib><title>Developmental toxicity study of CBLB502 in Wistar rats</title><title>Reproductive toxicology (Elmsford, N.Y.)</title><addtitle>Reprod Toxicol</addtitle><description>•We determined the potential developmental toxicity of CBLB502.•Significantly decreased gestation body, body weight changes and food consumption were observed in all dose groups.•No external, visceral and skeletal malformations were observed.•Based on the results of this study, the NOAEL for developmental toxicity was estimated to be ≥300μg/kg/day.
CBLB502 is a derivative of a microbial protein that binds to Toll-like receptor 5. It is demonstrated to reduce inflammatory response from acute stresses, such as radiation in animal models. We determined the potential developmental toxicity of CBLB502 in rats. Four groups of 25 time-mated female Wistar rats/group received subcutaneously 0, 30, 100, or 300μg/kg/day of CBLB502 from Gestation Days (GD) 6 to 17 at a dose volume of 1.0mL/kg. Toxicokinetic evaluation was performed on GD 6 and 17. On GD 20 C-section was performed for uterine evaluation and blood samples collected from each dam for immunogenicity assay.
Significant decrease in gestation body weight, weight changes and food consumption indicative of maternal toxicity were observed in all dose groups. Also adjusted body weight and weight changes were seen at 300μg/kg/day. No external, visceral and skeletal abnormalities were observed. The NOAEL for developmental toxicity was estimated to be ≥300μg/kg/day.</description><subject>Animals</subject><subject>Antibodies - analysis</subject><subject>Body Weight - drug effects</subject><subject>Bone and Bones - abnormalities</subject><subject>Bone and Bones - pathology</subject><subject>CBLB502</subject><subject>Developmental toxicity</subject><subject>Dose-Response Relationship, Drug</subject><subject>Eating - drug effects</subject><subject>Female</subject><subject>Male</subject><subject>No-Observed-Adverse-Effect Level</subject><subject>Peptides - immunology</subject><subject>Peptides - pharmacokinetics</subject><subject>Peptides - toxicity</subject><subject>Pregnancy</subject><subject>Rats</subject><subject>Rats, Wistar</subject><subject>Teratogens - toxicity</subject><subject>Toll-Like Receptor 5 - drug effects</subject><subject>Wistar rats</subject><issn>0890-6238</issn><issn>1873-1708</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkMtOwzAQRS0EoqXwC1WWbBLGTuLEO2h5SpXYgFhajjOWXOVRbKeif0-qtmxZzebMvbqHkDmFhALld-vE4cb1of9JGNAsAZYAFGdkSssijWkB5TmZQikg5iwtJ-TK-zUAZIUoLsmEZRxYzumU8EfcYtNvWuyCaqIxz2obdpEPQ72LehMtF6tFDiyyXfRlfVAucir4a3JhVOPx5nhn5PP56WP5Gq_eX96WD6tYZ0BDzIQRqFHUZao0o0JXmKVQl7yigLU2xgDjhipTFGnOc60qSIXiPMPUGC7KdEZuD7nj1u8BfZCt9RqbRnXYD15SzgqR8XHWiPIDql3vvUMjN862yu0kBbl3Jtfy5EzunUlgcnQ2Ps6PHUPVYv33dpI0AvcHAMelW4tOem2x01hbhzrIurf_dfwCTIOAbw</recordid><startdate>20140701</startdate><enddate>20140701</enddate><creator>Chow, C. Paul</creator><creator>Faqi, Ali S.</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U7</scope><scope>C1K</scope><orcidid>https://orcid.org/0000-0002-6533-5982</orcidid></search><sort><creationdate>20140701</creationdate><title>Developmental toxicity study of CBLB502 in Wistar rats</title><author>Chow, C. Paul ; Faqi, Ali S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c401t-29f9ece9d83ac219cbe430d86b10edcfff026f1af773565cab039a664e3ff6983</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Animals</topic><topic>Antibodies - analysis</topic><topic>Body Weight - drug effects</topic><topic>Bone and Bones - abnormalities</topic><topic>Bone and Bones - pathology</topic><topic>CBLB502</topic><topic>Developmental toxicity</topic><topic>Dose-Response Relationship, Drug</topic><topic>Eating - drug effects</topic><topic>Female</topic><topic>Male</topic><topic>No-Observed-Adverse-Effect Level</topic><topic>Peptides - immunology</topic><topic>Peptides - pharmacokinetics</topic><topic>Peptides - toxicity</topic><topic>Pregnancy</topic><topic>Rats</topic><topic>Rats, Wistar</topic><topic>Teratogens - toxicity</topic><topic>Toll-Like Receptor 5 - drug effects</topic><topic>Wistar rats</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chow, C. Paul</creatorcontrib><creatorcontrib>Faqi, Ali S.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Reproductive toxicology (Elmsford, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chow, C. Paul</au><au>Faqi, Ali S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Developmental toxicity study of CBLB502 in Wistar rats</atitle><jtitle>Reproductive toxicology (Elmsford, N.Y.)</jtitle><addtitle>Reprod Toxicol</addtitle><date>2014-07-01</date><risdate>2014</risdate><volume>46</volume><spage>12</spage><epage>19</epage><pages>12-19</pages><issn>0890-6238</issn><eissn>1873-1708</eissn><abstract>•We determined the potential developmental toxicity of CBLB502.•Significantly decreased gestation body, body weight changes and food consumption were observed in all dose groups.•No external, visceral and skeletal malformations were observed.•Based on the results of this study, the NOAEL for developmental toxicity was estimated to be ≥300μg/kg/day.
CBLB502 is a derivative of a microbial protein that binds to Toll-like receptor 5. It is demonstrated to reduce inflammatory response from acute stresses, such as radiation in animal models. We determined the potential developmental toxicity of CBLB502 in rats. Four groups of 25 time-mated female Wistar rats/group received subcutaneously 0, 30, 100, or 300μg/kg/day of CBLB502 from Gestation Days (GD) 6 to 17 at a dose volume of 1.0mL/kg. Toxicokinetic evaluation was performed on GD 6 and 17. On GD 20 C-section was performed for uterine evaluation and blood samples collected from each dam for immunogenicity assay.
Significant decrease in gestation body weight, weight changes and food consumption indicative of maternal toxicity were observed in all dose groups. Also adjusted body weight and weight changes were seen at 300μg/kg/day. No external, visceral and skeletal abnormalities were observed. The NOAEL for developmental toxicity was estimated to be ≥300μg/kg/day.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>24602561</pmid><doi>10.1016/j.reprotox.2014.02.007</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-6533-5982</orcidid></addata></record> |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Animals Antibodies - analysis Body Weight - drug effects Bone and Bones - abnormalities Bone and Bones - pathology CBLB502 Developmental toxicity Dose-Response Relationship, Drug Eating - drug effects Female Male No-Observed-Adverse-Effect Level Peptides - immunology Peptides - pharmacokinetics Peptides - toxicity Pregnancy Rats Rats, Wistar Teratogens - toxicity Toll-Like Receptor 5 - drug effects Wistar rats |
| title | Developmental toxicity study of CBLB502 in Wistar rats |
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