*** CHEMICAL IDENTIFICATION ***
RTECS NUMBER : WP1950000
CHEMICAL NAME : Sulfanilamide, N(sup 1)-2-pyrimidinyl-,
monosilver(1+) salt
CAS REGISTRY NUMBER : 22199-08-2
LAST UPDATED : 199712
DATA ITEMS CITED : 34
MOLECULAR FORMULA : C10-H10-N4-O2-S.Ag
MOLECULAR WEIGHT : 358.17
WISWESSER LINE NOTATION : T6N CNJ BMSWR DZ &-AG-
COMPOUND DESCRIPTOR : Drug
Mutagen
Reproductive Effector
Human
SYNONYMS/TRADE NAMES :
* 4-Amino-N-(2-pyrimidinyl)benzenesulfonamide silver salt
* Benzenesulfonamide, 4-amino-N-2-pyrimidinyl-, monosilver(1+) salt
* Dermazine
* Flamazine
* Geben
* Silvadene
* Silver sulfadiazine
* Silver sulphadiazine
* Sulfadiazine silver
* Sulfadiazine silver salt
*** HEALTH HAZARD DATA ***
** ACUTE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Administration onto the skin
SPECIES OBSERVED : Human - man
DOSE/DURATION : 536 mg/kg/21W-I
TOXIC EFFECTS :
Peripheral Nerve and Sensation - flaccid paralysis without anesthesia
(usually neuromuscular blockage)
REFERENCE :
LANCAO Lancet. (7 Adam St., London WC2N 6AD, UK) V.1- 1823-
Volume(issue)/page/year: 340,126,1992
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 :
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: 13,637,1982
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 126 mg/kg
TOXIC EFFECTS :
Liver - other changes
Blood - changes in spleen
Skin and Appendages - dermatitis, other (after systemic exposure)
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: 14,2850,1980
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : >10 gm/kg
TOXIC EFFECTS :
Liver - other changes
Blood - changes in spleen
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: 14,2850,1980
TYPE OF TEST : LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE : Unreported
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 160 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
USXXAM United States Patent Document. (U.S. Patent Office, Box 9,
Washington, DC 20231) Volume(issue)/page/year: #4535078
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Oral
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >10 gm/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex)
Behavioral - somnolence (general depressed activity)
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: 14,2850,1980
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Intraperitoneal
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : 550 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
REFERENCE :
USXXAM United States Patent Document. (U.S. Patent Office, Box 9,
Washington, DC 20231) Volume(issue)/page/year: #4020150
TYPE OF TEST : LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - mouse
DOSE/DURATION : >10 gm/kg
TOXIC EFFECTS :
Liver - other changes
Blood - changes in spleen
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: 14,2850,1980
** OTHER MULTIPLE DOSE TOXICITY DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 240 mg/kg/30D-C
TOXIC EFFECTS :
Endocrine - other changes
Blood - changes in spleen
Biochemical - Effect on specific coenzyme - not otherwise specified
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: 14,2856,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 1456 mg/kg/13W-C
TOXIC EFFECTS :
Liver - other changes
Blood - changes in spleen
Biochemical - Enzyme inhibition, induction, or change in blood or tissue
levels - phosphatases
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: 14,2913,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE/DURATION : 728 mg/kg/26W-C
TOXIC EFFECTS :
Liver - other changes
Blood - changes in spleen
Biochemical - Enzyme inhibition, induction, or change in blood or tissue
levels - phosphatases
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: 14,2913,1980
** REPRODUCTIVE DATA **
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 44 gm/kg
SEX/DURATION : female 7-17 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in
number of implants per female; total number of implants per corpora lutea)
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 8,3637,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 11 gm/kg
SEX/DURATION : male 70 day(s) pre-mating
female 2 week(s) pre-mating - 7 day(s) after
conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or
resorbed implants per total number of implants)
Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured
before birth)
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 8,3637,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rat
DOSE : 11 gm/kg
SEX/DURATION : female 7-17 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
Reproductive - Effects on Newborn - viability index (e.g., # alive at day 4
per # born alive)
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 8,3637,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 26 gm/kg
SEX/DURATION : female 6-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured
before birth)
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 8,3637,1980
TYPE OF TEST : TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE : Subcutaneous
SPECIES OBSERVED : Rodent - rabbit
DOSE : 6500 mg/kg
SEX/DURATION : female 6-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - musculoskeletal system
REFERENCE :
YACHDS Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu
Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan) V.1- 1972-
Volume(issue)/page/year: 8,3637,1980
** MUTATION DATA **
TYPE OF TEST : DNA damage
TEST SYSTEM : Microorganism - not otherwise specified
DOSE/DURATION : 5 mg/L
REFERENCE :
AMACCQ Antimicrobial Agents and Chemotherapy. (American Soc. for
Microbiology, 1913 I St., NW, Washington, DC 20006) V.1- 1972-
Volume(issue)/page/year: 2,367,1972
TYPE OF TEST : Unscheduled DNA synthesis
TEST SYSTEM : Microorganism - not otherwise specified
DOSE/DURATION : 4 mg/L
REFERENCE :
PAMIAD Pathologica et Microbiologia. (Basel, Switzerland) V.23-43,
1960-75. For publisher information, see ECEBDI. Volume(issue)/page/year:
39,434,1973
TYPE OF TEST : DNA inhibition
TEST SYSTEM : Microorganism - not otherwise specified
DOSE/DURATION : 2500 ug/L
REFERENCE :
AMACCQ Antimicrobial Agents and Chemotherapy. (American Soc. for
Microbiology, 1913 I St., NW, Washington, DC 20006) V.1- 1972-
Volume(issue)/page/year: 2,367,1972
*** REVIEWS ***
ACGIH TLV-TWA 0.01 mg(Ag)/m3
DTLVS* The Threshold Limit Values (TLVs) and Biological Exposure Indices
(BEIs) booklet issues by American Conference of Governmental Industrial
Hygienists (ACGIH), Cincinnati, OH, 1996 Volume(issue)/page/year:
TLV/BEI,1997
*** U.S. STANDARDS AND REGULATIONS ***
MSHA STANDARD-air:TWA 0.01 mg(Ag)/m3
DTLVS* The Threshold Limit Values (TLVs) and Biological Exposure Indices
(BEIs) booklet issues by American Conference of Governmental Industrial
Hygienists (ACGIH), Cincinnati, OH, 1996 Volume(issue)/page/year:
3,231,1971
*** OCCUPATIONAL EXPOSURE LIMITS ***
OEL-ARAB Republic of Egypt:TWA 0.01 mg(Ag)/m3 JAN 1993
OEL-AUSTRALIA:TWA 0.01 mg(Ag)/m3 JAN 1993
OEL-BELGIUM:TWA 0.01 mg(Ag)/m3 JAN 1993
OEL-DENMARK:TWA 0.01 mg(Ag)/m3 JAN 1993
OEL-FINLAND:TWA 0.01 mg(Ag)/m3;STEL 0.03 mg(Ag)/m3;Skin JAN 1993
OEL-THE NETHERLANDS:TWA 0.01 mg(Ag)/m3 JAN 1993
OEL-THE PHILIPPINES:TWA 0.01 mg(Ag)/m3 JAN 1993
OEL-SWITZERLAND:TWA 0.01 mg(Ag)/m3 JAN 1993
OEL-UNITED KINGDOM:TWA 0.01 mg(Ag)/m3 JAN 1993
OEL IN BULGARIA, COLOMBIA, JORDAN, KOREA check ACGIH TLV
OEL IN NEW ZEALAND, SINGAPORE, VIETNAM check ACGIH TLV
*** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA ***
NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA :
NOES - National Occupational Exposure Survey (1983)
NOES Hazard Code - X5603
No. of Facilities: 944 (estimated)
No. of Industries: 9
No. of Occupations: 10
No. of Employees: 87352 (estimated)
No. of Female Employees: 71312 (estimated)
*** STATUS IN U.S. ***
EPA GENETOX PROGRAM 1988, Negative: E coli polA without S9
*** END OF RECORD ***