*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : VO1400000
CHEMICAL NAME : Salicylic acid, 5-amino-
CAS REGISTRY NUMBER : 89-57-6
BEILSTEIN REFERENCE NO. : 2090421
REFERENCE : 4-14-00-02058 (Beilstein Handbook Reference)
LAST UPDATED : 199710
DATA ITEMS CITED : 14
MOLECULAR FORMULA : C7-H7-N-O3
MOLECULAR WEIGHT : 153.15
WISWESSER LINE NOTATION : ZR DQ CVQ
COMPOUND DESCRIPTOR : Drug
Human
SYNONYMS/TRADE NAMES :
* 5-Amino-2-hydroxybenzoic acid
* 5-Aminosalicylic acid
* m-Aminosalicylic acid
* p-Aminosalicylsaeure
* 5-ASA
* Asacol
* Benzoic acid, 5-amino-2-hydroxy-
* Claversal
* Mesalamine
* Mesalazine
* Pentasa
* Salofalk
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 6857 mg/kg/17W-I
TOXIC EFFECTS :
Gastrointestinal - nausea or vomiting
Liver - jaundice, cholestatic
REFERENCE :
JOHEEC Journal of Hepathology. (Elsevier Science, 655 Avenue of the
Americas, New York, NY 10010) V.1- 1985- Volume(issue)/page/year:
26,425,1997
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 21800 mg/kg/39W-I
TOXIC EFFECTS :
Lungs, Thorax, or Respiration - fibrosis, focal (pneumoconiosis)
Lungs, Thorax, or Respiration - respiratory depression
Blood - eosinophilia
REFERENCE :
AJGAAR American Journal of Gastroenterology. (American College of
Gastroenterology, Inc., 428 E. Preston St., Baltimore, MD 21202) V.21-
1954- Volume(issue)/page/year: 91,1039,1996
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 51 mg/kg/5D-I
TOXIC EFFECTS :
Gastrointestinal - hypermotility, diarrhea
Skin and Appendages - dermatitis, other (after systemic exposure)
Nutritional and Gross Metabolic - body temperature increase
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 1,917,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 8 mg/kg
TOXIC EFFECTS :
Behavioral - headache
Gastrointestinal - hypermotility, diarrhea
Nutritional and Gross Metabolic - body temperature increase
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 1,917,1984
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 2057 mg/kg/17W-I
TOXIC EFFECTS :
Blood - agranulocytosis
Nutritional and Gross Metabolic - body temperature increase
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 341,1476,1993
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 2800 mg/kg
TOXIC EFFECTS :
Behavioral - somnolence (general depressed activity)
Behavioral - food intake (animal)
Gastrointestinal - other changes
REFERENCE :
NTIS** National Technical Information Service. (Springfield, VA 22161)
Formerly U.S. Clearinghouse for Scientific & Technical Information.
Volume(issue)/page/year: OTS0570511
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 1 gm/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold
Kidney, Ureter, Bladder - other changes in urine composition
Skin and Appendages - hair
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 47,505,1994
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 5 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
ZENBAX Zeitschrift fuer Naturforschung, Teil B: Anorganische Chemie,
Organische Chemie, Biochemie, Biophysik, Biologie. (Tuebingen, Fed. Rep.
Ger.) V.2B-27B, 1947-1972. For publisher information, see ZNCBDA.
Volume(issue)/page/year: 6B,183,1951
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 681 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
PHTOEH Pharmacology and Toxicology (Copenhagen). (Munksgaard International
Pub., POB 2148, DK-1016 Copenhagen K, Denmark) V.60- 1987-
Volume(issue)/page/year: 64,247,1989
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Primate - monkey
DOSE/DURATION : 3 gm/kg
TOXIC EFFECTS :
Sense Organs and Special Senses (Eye) - ptosis
Behavioral - somnolence (general depressed activity)
Kidney, Ureter, Bladder - hematuria
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 47,509,1994
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Administration onto the skin
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : >5 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NTIS** National Technical Information Service. (Springfield, VA 22161)
Formerly U.S. Clearinghouse for Scientific & Technical Information.
Volume(issue)/page/year: OTS0570511
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 36400 mg/kg/13W-I
TOXIC EFFECTS :
Kidney, Ureter, Bladder - urine volume increased
Kidney, Ureter, Bladder - changes in bladder weight
Blood - normocytic anemia
REFERENCE :
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180,
Sendai 980-91, Japan) V.1- 1967- Volume(issue)/page/year: 48,277,1994
*** STATUS IN U.S. ***
EPA TSCA Section 8(b) CHEMICAL INVENTORY
EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JUNE 1998
*** END OF RECORD ***