One-month parenteral toxicity study of recombinant human basic fibroblast growth factor in dogs

Min Young Kim, Min Ki Shin, Jang Won Son, Hyung Kwak, Ming Zu Fang, Mi Ok Bae, Jung Hyon Kim, Myung Haing Cho, Kyung Koo Kang, Won Bae Kim, Byung Ok Ahn

Research output: Contribution to journalArticle

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Abstract

A 1-mo toxicity study followed by a 1-mo recovery period of recombinant human basic fibroblast growth factor (bFGF) was performed using Beagle dogs at doses of 30, 120 or 480 mg/kg/d to estimate the no observed adverse effect level (NOAEL). Subcutaneous thickening was seen and its incidence, as well as that of stiffness of the injection sites, increased with dose. There were neither dead animals nor significant changes of body weight during the experimental period. In addition, no significant bFGF-related changes were found in ophthalmologic and histopathological examination, urinalysis and hematological, biochemical and organ weight parameters. At necropsy, red- brownish spots and/or nodule formations were recognized in a dose-dependent manner. Splenomegaly was noted in the 480 mg/kg group, but these findings had a low incidence in all dose groups. The findings in the dosing period disappeared or were ameliorated during the recovery period. The above data suggests the NOAEL of bFGF in Beagle dogs is >480 mg/kg/d.

Original languageEnglish (US)
Pages (from-to)234-235
Number of pages2
JournalVeterinary and Human Toxicology
Volume42
Issue number4
StatePublished - Aug 1 2000
Externally publishedYes

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No-Observed-Adverse-Effect Level
fibroblast growth factor 2
Fibroblast Growth Factor 2
toxicity testing
Toxicity
Dogs
no observed adverse effect level
Recovery
Body Weight Changes
Urinalysis
Organ Size
dogs
Splenomegaly
Incidence
dosage
Beagle
Animals
Stiffness
incidence
splenomegaly

All Science Journal Classification (ASJC) codes

  • Toxicology
  • veterinary(all)
  • Health, Toxicology and Mutagenesis

Cite this

Kim, M. Y., Shin, M. K., Son, J. W., Kwak, H., Fang, M. Z., Bae, M. O., ... Ahn, B. O. (2000). One-month parenteral toxicity study of recombinant human basic fibroblast growth factor in dogs. Veterinary and Human Toxicology, 42(4), 234-235.
Kim, Min Young ; Shin, Min Ki ; Son, Jang Won ; Kwak, Hyung ; Fang, Ming Zu ; Bae, Mi Ok ; Kim, Jung Hyon ; Cho, Myung Haing ; Kang, Kyung Koo ; Kim, Won Bae ; Ahn, Byung Ok. / One-month parenteral toxicity study of recombinant human basic fibroblast growth factor in dogs. In: Veterinary and Human Toxicology. 2000 ; Vol. 42, No. 4. pp. 234-235.
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Kim, MY, Shin, MK, Son, JW, Kwak, H, Fang, MZ, Bae, MO, Kim, JH, Cho, MH, Kang, KK, Kim, WB & Ahn, BO 2000, 'One-month parenteral toxicity study of recombinant human basic fibroblast growth factor in dogs', Veterinary and Human Toxicology, vol. 42, no. 4, pp. 234-235.

One-month parenteral toxicity study of recombinant human basic fibroblast growth factor in dogs. / Kim, Min Young; Shin, Min Ki; Son, Jang Won; Kwak, Hyung; Fang, Ming Zu; Bae, Mi Ok; Kim, Jung Hyon; Cho, Myung Haing; Kang, Kyung Koo; Kim, Won Bae; Ahn, Byung Ok.

In: Veterinary and Human Toxicology, Vol. 42, No. 4, 01.08.2000, p. 234-235.

Research output: Contribution to journalArticle

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AU - Kim, Min Young

AU - Shin, Min Ki

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AU - Bae, Mi Ok

AU - Kim, Jung Hyon

AU - Cho, Myung Haing

AU - Kang, Kyung Koo

AU - Kim, Won Bae

AU - Ahn, Byung Ok

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N2 - A 1-mo toxicity study followed by a 1-mo recovery period of recombinant human basic fibroblast growth factor (bFGF) was performed using Beagle dogs at doses of 30, 120 or 480 mg/kg/d to estimate the no observed adverse effect level (NOAEL). Subcutaneous thickening was seen and its incidence, as well as that of stiffness of the injection sites, increased with dose. There were neither dead animals nor significant changes of body weight during the experimental period. In addition, no significant bFGF-related changes were found in ophthalmologic and histopathological examination, urinalysis and hematological, biochemical and organ weight parameters. At necropsy, red- brownish spots and/or nodule formations were recognized in a dose-dependent manner. Splenomegaly was noted in the 480 mg/kg group, but these findings had a low incidence in all dose groups. The findings in the dosing period disappeared or were ameliorated during the recovery period. The above data suggests the NOAEL of bFGF in Beagle dogs is >480 mg/kg/d.

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