*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : VO6250000
CHEMICAL NAME : Salicylic acid,
5-((p-(2-pyridylsulfamoyl)phenyl)azo)-
CAS REGISTRY NUMBER : 599-79-1
BEILSTEIN REFERENCE NO. : 0356241
REFERENCE : 5-22-08-00433 (Beilstein Handbook Reference)
LAST UPDATED : 199803
DATA ITEMS CITED : 38
MOLECULAR FORMULA : C18-H14-N4-O5-S
MOLECULAR WEIGHT : 398.42
WISWESSER LINE NOTATION : T6NJ BSWMR DNUNR DQ CVQ
COMPOUND DESCRIPTOR : Tumorigen
Drug
Mutagen
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* Accucol
* Asulfidine
* Azopyrin
* Azulfidine
* Benzoic acid, 2-hydroxy-5-((4-((2-pyridinylamino)sulfonyl)phenyl)azo)-
* Benzosulfa
* Colo-Pleon
* 2-Hydroxy-5-((4-((2-pyridinylamino)sulfonyl)phenyl)azo)benzoic acid
* 4-(Pyridyl-2-amidosulfonyl)-3'-carboxy-4'-hydroxyazobenzene
* 5-(4-(2-Pyridylsulfamoyl)phenylazo)-2-hydroxybenzoic acid
* 5-(p-(2-Pyridylsulfamoyl)phenylazo)salicylic acid
* Reupirin
* Salazopyrin
* Salazosulfapyridine
* Salicylazosulfapyridine
* Salisulf
* S.A.S.-500
* SASP
* SI-88
* Sulcolon
* Sulfasalazine
* Sulphasalazine
* W-T Sasp Oral
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 1286 mg/kg/30D-I
TOXIC EFFECTS :
Lungs, Thorax, or Respiration - other changes
Blood - eosinophilia
Blood - changes in cell count (unspecified)
REFERENCE :
IEDIEP Internal Medicine. (The Japanese Society of Internal Medicine, 34-3,
3-chome, Hongo, Bunkyo-ku, Tokyo 113, Japan) V.31- 1992-
Volume(issue)/page/year: 31,108,1992
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 570 mg/kg/11D-I
TOXIC EFFECTS :
Blood - leukopenia
Blood - thrombocytopenia
Blood - other changes
REFERENCE :
CEDEDE Clinical and Experimental Dermatology. (Blackwell Scientific Pub.
Ltd., POB 88, Oxford, UK) V.1- 1976- Volume(issue)/page/year:
19,419,1994
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - child
DOSE/DURATION : 3800 mg/kg/19D-I
TOXIC EFFECTS :
Liver - hepatitis (hepatocellular necrosis), diffuse
REFERENCE :
AJDDAL American Journal of Digestive Diseases. (New York, NY) V.5-22,
1938-55; New series: V.1-23, 1956-78. For publisher information, see
DDSCDJ. Volume(issue)/page/year: 23,956,1978
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 7143 ug/kg
TOXIC EFFECTS :
Gastrointestinal - hypermotility, diarrhea
Gastrointestinal - nausea or vomiting
REFERENCE :
NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10
Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year:
306,409,1982
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 143 mg/kg/10D-I
TOXIC EFFECTS :
Blood - thrombocytopenia
REFERENCE :
AIMEAS Annals of Internal Medicine. (American College of Physicians, 4200
Pine St., Philadelphia, PA 19104) V.1- 1927- Volume(issue)/page/year:
102,277,1985
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 3200 mg/kg/31D-I
TOXIC EFFECTS :
Blood - agranulocytosis
Blood - other changes
Skin and Appendages - dermatitis, allergic (after systemic exposure)
REFERENCE :
JRSMD9 Journal of the Royal Society of Medicine. (Oxford Univ. Press,
Walton St., Oxford OX2 6DP, UK) V.71- 1978- Volume(issue)/page/year:
73,587,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human
DOSE/DURATION : 429 mg/kg/10D-I
TOXIC EFFECTS :
Blood - other hemolysis with or without anemia
REFERENCE :
NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10
Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year:
289,491,1973
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - man
DOSE/DURATION : 357 mg/kg
TOXIC EFFECTS :
Behavioral - hallucinations, distorted perceptions
Behavioral - headache
REFERENCE :
JTCTDW Journal of Toxicology, Clinical Toxicology. (Marcel Dekker, 270
Madison Ave., New York, NY 10016) V.19- 1982- Volume(issue)/page/year:
29,543,1991
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 140 mg/kg/2W-I
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 : Unreported
SPECIES OBSERVED : Human - man
DOSE/DURATION : 1300 mg/kg/4W-I
TOXIC EFFECTS :
Behavioral - hallucinations, distorted perceptions
Behavioral - ataxia
Gastrointestinal - nausea or vomiting
REFERENCE :
PRACAK Practitioner. (Morgan-Grampian Ltd., 40 Beresford St., Woolwich,
London SE18 6BQ, UK) V.1- 1868- Volume(issue)/page/year: 204,850,1970
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Human - woman
DOSE/DURATION : 2700 mg/kg/13W-I
TOXIC EFFECTS :
Skin and Appendages - dermatitis, other (after systemic exposure)
Immunological Including Allergic - uncharacterized
REFERENCE :
BMJOAE British Medical Journal. (British Medical Assoc., BMA House,
Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- Volume(issue)/page/year:
286,1547,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Rectal
SPECIES OBSERVED : Human - man
DOSE/DURATION : 7143 ug/kg
TOXIC EFFECTS :
Gastrointestinal - hypermotility, diarrhea
Gastrointestinal - nausea or vomiting
REFERENCE :
NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10
Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year:
306,409,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 15600 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: -,420,1990
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 3870 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: -,420,1990
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 1520 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: -,420,1990
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 12500 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: -,420,1990
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 3 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: -,420,1990
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intravenous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 1096 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo,
Japan) Volume(issue)/page/year: -,420,1990
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rabbit
DOSE/DURATION : >7500 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
IYKEDH Iyakuhin Kenkyu. Study of Medical Supplies. (Nippon Koteisho
Kyokai, 12-15, 2-chome, Shibuya, Shibuya-ku, Tokyo 150, Japan) V.1- 1970-
Volume(issue)/page/year: 26,953,1995
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 32400 mg/kg/16D-I
TOXIC EFFECTS :
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol)
Endocrine - changes in thymus weight
Nutritional and Gross Metabolic - weight loss or decreased weight gain
REFERENCE :
NTPTR* National Toxicology Program Technical Report Series. (Research
Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-457,1997
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 32400 mg/kg/16D-I
TOXIC EFFECTS :
Gastrointestinal - other changes
REFERENCE :
NTPTR* National Toxicology Program Technical Report Series. (Research
Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-457,1997
** TUMORIGENIC DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 177 mg/kg/2Y-I
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Kidney, Ureter, Bladder - tumors
REFERENCE :
NTPTR* National Toxicology Program Technical Report Series. (Research
Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-457,1997
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 141 mg/kg/2Y-I
TOXIC EFFECTS :
Tumorigenic - Carcinogenic by RTECS criteria
Liver - tumors
REFERENCE :
NTPTR* National Toxicology Program Technical Report Series. (Research
Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-457,1997
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Human - woman
DOSE : 8100 mg/kg
SEX/DURATION : female 1-40 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - craniofacial
(including nose and tongue)
Reproductive - Specific Developmental Abnormalities - cardiovascular
(circulatory) system
REFERENCE :
NEJMAG New England Journal of Medicine. (Massachusetts Medical Soc., 10
Shattuck St., Boston, MA 02115) V.198- 1928- Volume(issue)/page/year:
318,1128,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 5460 mg/kg
SEX/DURATION : male 13 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
REFERENCE :
NTPTR* National Toxicology Program Technical Report Series. (Research
Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-457,1997
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 8400 mg/kg
SEX/DURATION : male 28 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - male fertility index (e.g. # males impregnating
females per # males exposed to fertile nonpregnant females)
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 28,273,1983
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 16800 mg/kg
SEX/DURATION : male 28 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in
number of implants per female; total number of implants per corpora lutea)
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 37,539,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 7 gm/kg
SEX/DURATION : male 35 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material,
sperm morphology, motility, and count)
REFERENCE :
CCPTAY Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1-
1970- Volume(issue)/page/year: 37,539,1988
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - rat
DOSE : 8400 mg/kg
SEX/DURATION : male 14 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - testes, epididymis, sperm duct
Reproductive - Fertility - male fertility index (e.g. # males impregnating
females per # males exposed to fertile nonpregnant females)
REFERENCE :
REPTED Reproductive Toxicology. (Pergamon Press Inc., Maxwell House,
Fairview Park, Elmsford, NY 10523) V.1- 1987- Volume(issue)/page/year:
9,315,1995
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE : 43875 mg/kg
SEX/DURATION : male 13 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - testes, epididymis, sperm duct
REFERENCE :
NTPTR* National Toxicology Program Technical Report Series. (Research
Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-457,1997
** MUTATION DATA **
TYPE OF TEST : Micronucleus test
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 40 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 222,27,1989
TYPE OF TEST : Sister chromatid exchange
TEST SYSTEM : Human Lymphocyte
DOSE/DURATION : 20 mg/L
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 222,27,1989
TYPE OF TEST : Micronucleus test
ROUTE OF EXPOSURE : Oral
TEST SYSTEM : Rodent - mouse
DOSE/DURATION : 5634 mg/kg
REFERENCE :
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE
Amsterdam, Netherlands) V.1- 1964- Volume(issue)/page/year: 283,53,1992
*** REVIEWS ***
TOXICOLOGY REVIEW
DPIRDU Dangerous Properties of Industrial Materials Report. (Van Nostrand
Reinhold, 115 Fifth Ave., New York, NY 10003) V.1- 1981-
Volume(issue)/page/year: 1(8),8,1981
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X5355
No. of Facilities: 48 (estimated)
No. of Industries: 1
No. of Occupations: 1
No. of Employees: 704 (estimated)
No. of Female Employees: 435 (estimated)
*** STATUS IN U.S. ***
EPA GENETOX PROGRAM 1988, Positive: Sperm morphology-human
NTP Carcinogenesis Studies (gavage);clear evidence:mouse
NTPTR* National Toxicology Program Technical Report Series. (Research
Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-457,1997
NTP Carcinogenesis Studies (gavage);some evidence:rat
NTPTR* National Toxicology Program Technical Report Series. (Research
Triangle Park, NC 27709) No.206- Volume(issue)/page/year: NTP-TR-457,1997
*** END OF RECORD ***