*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : XI0368800
CHEMICAL NAME : 5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic
acid,
7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-
8-oxo-3-(((1,2,5,6-te
trahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio)
methyl)-, sodium salt, hydrate (2:4:7)
(6R-(6-alpha,7-beta(Z)))-
CAS REGISTRY NUMBER : 74578-69-1
LAST UPDATED : 199512
DATA ITEMS CITED : 12
MOLECULAR FORMULA : C18-H16-N8-O7-S3.2Na.7/2H2-O
MOLECULAR WEIGHT : 661.63
COMPOUND DESCRIPTOR : Drug
Human
SYNONYMS/TRADE NAMES :
* Cefatriaxone hydrate
* Ceftriaxone sodium hydrate
* Cephtriaxone
* Ro 13-9904
* Ro 13-9904/001
* Rocephin
* X 13-9904
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intramuscular
SPECIES OBSERVED : Human - infant
DOSE/DURATION : 16 mg/kg/3D-I
TOXIC EFFECTS :
Brain and Coverings - meningeal changes
Blood - changes in leukocyte (WBC) count
Nutritional and Gross Metabolic - body temperature increase
REFERENCE :
CPEDAM Clinical Pediatrics (Philadelphia). (Lippincott/Harper, Journal
Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1962-
Volume(issue)/page/year: 32,360,1993
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Multiple routes
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 640 mg/kg/32D-I
TOXIC EFFECTS :
Gastrointestinal - nausea or vomiting
Blood - agranulocytosis
Nutritional and Gross Metabolic - body temperature increase
REFERENCE :
IJMDAI Israel Journal of Medical Sciences. (POB 1435, Jerusalem 91013,
Israel) V.1- 1965- Volume(issue)/page/year: 29,52,1993
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Multiple routes
SPECIES OBSERVED : Human - man
DOSE/DURATION : 800 mg/kg/49D-I
TOXIC EFFECTS :
Blood - agranulocytosis
Blood - changes in leukocyte (WBC) count
REFERENCE :
IJMDAI Israel Journal of Medical Sciences. (POB 1435, Jerusalem 91013,
Israel) V.1- 1965- Volume(issue)/page/year: 29,52,1993
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >10 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
49ZAA4 "Ceftriaxon (Rocephin) ein Neues Parenterales Cephalosporin,
Hahnenklee - Symposion, 9th, 1981," Dettli, L., et al. eds., Harz, Fed. Rep.
Ger., S8-10, 1982 Volume(issue)/page/year: -,91,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >5 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
49ZAA4 "Ceftriaxon (Rocephin) ein Neues Parenterales Cephalosporin,
Hahnenklee - Symposion, 9th, 1981," Dettli, L., et al. eds., Harz, Fed. Rep.
Ger., S8-10, 1982 Volume(issue)/page/year: -,91,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 1900 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
49ZAA4 "Ceftriaxon (Rocephin) ein Neues Parenterales Cephalosporin,
Hahnenklee - Symposion, 9th, 1981," Dettli, L., et al. eds., Harz, Fed. Rep.
Ger., S8-10, 1982 Volume(issue)/page/year: -,91,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >10 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
49ZAA4 "Ceftriaxon (Rocephin) ein Neues Parenterales Cephalosporin,
Hahnenklee - Symposion, 9th, 1981," Dettli, L., et al. eds., Harz, Fed. Rep.
Ger., S8-10, 1982 Volume(issue)/page/year: -,91,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >5 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
49ZAA4 "Ceftriaxon (Rocephin) ein Neues Parenterales Cephalosporin,
Hahnenklee - Symposion, 9th, 1981," Dettli, L., et al. eds., Harz, Fed. Rep.
Ger., S8-10, 1982 Volume(issue)/page/year: -,91,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 2200 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
JANTAJ Journal of Antibiotics. (Japan Antibiotics Research Assoc., 2-20-8
Kamiosaki, Shinagawa-ku, Tokyo, 141, Japan) V.2-5, 1948-52; V.21- 1968-
Volume(issue)/page/year: 33,783,1980
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 51450 mg/kg/42D-I
TOXIC EFFECTS :
Skin and Appendages - dermatitis, other (after systemic exposure)
Related to Chronic Data - death
REFERENCE :
KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda
Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960-
Volume(issue)/page/year: 18,1751,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 42875 mg/kg/5W-I
TOXIC EFFECTS :
Gastrointestinal - other changes
Skin and Appendages - dermatitis, other (after systemic exposure)
Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda
Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960-
Volume(issue)/page/year: 18,1793,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Mammal - dog
DOSE/DURATION : 21840 mg/kg/13W-I
TOXIC EFFECTS :
Liver - change in gall bladder structure or function
Related to Chronic Data - death
REFERENCE :
KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda
Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960-
Volume(issue)/page/year: 18,1855,1984
*** END OF RECORD ***