NTP CHEMICAL REPOSITORY (RADIAN CORPORATION, AUGUST 29, 1991)
IDENTIFIERS
CATALOG ID NUMBER: 001667
CAS NUMBER: 50-07-7
BASE CHEMICAL NAME: MITOMYCINC
PRIMARY NAME: MITOMYCIN C
CHEMICAL FORMULA: C15H18N4O5
STRUCTURAL FORMULA: Not printable
WLN: Not available
SYNONYMS:
6-AMINO-1,1A,2,8,8A,8B-HEXAHYDRO-8-(HYDROXYMETHYL)-8A-METHOXY-5-METHYLAZIRINO-
(2',3':3,4)PYRROLO(1,2-A)INDOLE-4,7-DIONE, CARBAMATE (ESTER)
7-AMINO-9-ALPHA-METHOXYMITOSANE
AMETYCIN
(1AR)-6-AMINO-8-(((AMINOCARBONYL)OXY)METHYL)-1,1A,2,8,8A,8B-HEXAHYDRO-8A-
METHOXY-5-METHYLAZIRINO(2',3':3,4)PYRROLO(1,2-A)INDOLE-4,7-DIONE
AMETYCINE
MIT-C
MITO-C
MITOCIN-C
MITOMYCIN
MITOMYCINUM
MMC
MUTAMYCIN
MUTAMYCIN(MITOMYCIN FOR INJECTION)
MYTOMYCIN
NCI-C04706
NSC-26980
RCRA WASTE NUMBER U010
PHYSICAL CHEMICAL DATA
PHYSICAL DESCRIPTION: LITERATURE: Blue-violet crystals
REPOSITORY: Dark gray powder
MOLECULAR WEIGHT: 334.33
SPECIFIC GRAVITY: Not available
DENSITY: Not available
MP (DEG C): >360 C [025,031,365,395]
BP (DEG C): Not available
SOLUBILITIES:
WATER : Soluble [025,031,295,365]
DMSO : Not available
95% ETHANOL : Not available
METHANOL : Soluble [025,031,295,365]
ACETONE : Soluble [025,031,295,365]
TOLUENE : Not available
OTHER SOLVENTS:
Butyl acetate: Soluble [031,295,365,395]
Cyclohexanone: Soluble [031,295,365,395]
Carbon tetrachloride: Slightly soluble [031,365,395]
Ether: Slightly soluble [031,295,365,395]
Benzene: Slightly soluble [031,365,395]
Petroleum ether: Practically insoluble [031]
Organic solvents: Freely soluble [159]
VOLATILITY:
Vapor pressure: Not available
Vapor density : Not available
FLAMMABILITY(FLASH POINT):
Flash point data for this chemical are not available; however, it is
probably combustible. Fires involving this material can be controlled with
a dry chemical, carbon dioxide or Halon extinguisher.
UEL: Not available LEL: Not available
REACTIVITY:
This chemical is incompatible with strong oxidizing agents, strong acids
and strong bases [269]. Calcium salts may cause decomposition [900].
STABILITY:
This chemical is sensitive to prolonged exposure to light [295,900].
It may be sensitive to prolonged exposure to air [295]. Solutions of this
chemical in water, DMSO, 95% ethanol or acetone should be stable for 24 hours
under normal lab conditions (RAD). Solutions in water are most stable at a
pH of 6 to 9 [295].
OTHER PHYSICAL DATA:
Lambda max (in methanol): 216 nm, 360 nm, 560 nm (epsilon = 742, 742, 0.06)
Odorless [900]
TOXICITY
NIOSH REGISTRY NUMBER: CN0700000
TOXICITY:
typ. dose mode specie amount units other
TDLo ivn wmn 1800 ug/kg
LD50 orl rat 30 mg/kg
LD50 ipr rat 2 mg/kg
LD50 scu rat 3250 ug/kg
LD50 ivn rat 3 mg/kg
LD50 orl mus 23 mg/kg
LD50 ipr mus 5 mg/kg
LD50 scu mus 7800 ug/kg
LD50 ivn dog 1 mg/kg
LDLo ivn mky 1 mg/kg
LDLo ivn cat 2500 ug/kg
LD50 unr mus 12 mg/kg
TDLo unr wmn 2100 ug/kg/40W-I
TDLo unr man 1350 ug/kg/21W-I
LD50 orl bwd 7500 ug/kg
LDLo itr mus 4 mg/kg
LD50 ivn mus 4700 ug/kg
AQTX/TLM96: Not available
SAX TOXICITY EVALUATION:
THR: MUTATION data. An experimental teratogen, neoplastigen and carcinogen.
HIGH via oral, intraperitoneal, intravenous and unknown routes.
CARCINOGENICITY:
Tumorigenic Data:
TDLo: ipr-rat 3000 ug/kg/26W-I
TDLo: ivn-rat 2600 ug/kg/8W-I
TDLo: scu-mus 280 ug/kg/18W-I
Review: IARC Cancer Review: Animal Sufficient Evidence
IARC possible human carcinogen (Group 2B) [610]
Status: EPA Carcinogen Assessment Group [610]
MUTATION DATA:
test lowest dose | test lowest dose
----------- ----------------- | ----------- -----------------
dnd-hmn:oth 10 umol/L | cyt-grh:oth 10 umol/L
dnr-sat 1000 ppm | dns-sat 2 ug
dni-sat 5 mg/L | pic-sat 10 pmol/plate
cyt-dmg:oth 500 ug/L | cyt-ham:lng 30 ug/L
cyt-grh:emb 100 nmol/L | dnd-esc 1 mg/L
dns-esc 1 mmol/L | dni-esc 100 ug/L
dnd-bcs 20 ug/disc | dni-bcs 10 mg/L
oms-bcs 10 mg/L | dnd-hmi 5 mg/L
dni-hmi 500 ug/L | pic-hmi 15 umol/L
cyt-ham:fbr 50 nmol/L | mma-omi 80 umol/L
dnr-omi 20 mg/L | dnd-omi 20 mg/L
dns-omi 1200 umol/L | dni-omi 80 ug/L
cyt-dmg-par 100 mg/L | sln-dmg-orl 125 ppm
dlt-oin-par 500 mg/L | mrc-smc 10 mg/L
sln-smc 4 mg/L | cyt-mus/ast 110 mg/kg
cyt-nml:kdy 2500 ug/L | sce-ofs:emb 10 nmol/L
dnd-hmn:bmr 15 umol/L | dns-hmn:oth 100 umol/L
dns-hmn:hla 300 nmol/L | dns-hmn:fbr 160 ug/L
dns-hmn:lym 1 mg/L | dni-hmn:hla 1 umol/L/30M-C
dni-hmn:lym 1 mg/L | oms-hmn:leu 1 mg/L
dns-hmn:oth 100 mg/L | cyt-hmn:lym 10 ug/L/24H
cyt-hmn:leu 100 ug/L/24H | sce-hmn-ivn 228 ug/kg/2W-I
sce-hmn:lng 20 ug/L | msc-hmn:lym 1 nmol/L
sce-hmn:ovr 20 ug/L | sce-hmn:tes 10 ug/L
cyt-hmn:hla 10 umol/L | cyt-rat-ivn 2 mg/kg
cyt-mam:lym 20 ug/L | cyt-mky-unr 1 mg/kg
mnt-mus-ihl 65 mg/m3 | cyt-mus-scu 3 mg/kg
slt-mus-ipr 5250 ug/kg | dnd-mus:leu 150 mg/L
dni-mus:mmr 10 mg/L | cyt-mus:fbr 100 ug/L
sce-mus-ipr 300 ug/kg | sce-mus-ivn 5 mg/kg
sce-mus:lym 1500 ug/kg | dlt-mus-ipr 2 mg/kg
msc-mus:lym 20 ug/L/4H | hma-mus/sat 200 mg/kg
cyt-mus:lym 2500 ug/L | sce-mus:ovr 20 ug/L
dnd-ham:ovr 1 mg/L | cyt-ham-ipr 2 mg/kg
sce-ham:lng 15 nmol/L | cyt-mus-ivn 5 mg/kg
mnt-mky-ivn 500 ug/kg | cyt-mky-ivn 1 mg/kg
mnt-dog:lym 400 nmol/L | dni-rbt:kdy 750 ug/L
cyt-ckn-par 847 ng/kg | cyt-mam:lng 600 ug/L
cyt-mam:kdy 10 mg/L/8H-C | cyt-mus-ipr 2 mg/kg
sce-mam:lym 20 ug/L | sce-ckn-par 847 ng/kg
cyt-hmn:lym 60 nmol/L | cyt-hmn:fbr 100 ug/L
cyt-hmn:lng 2500 ug/L | dni-hmn:fbr 10 umol/L
cyt-rat-unr 750 ug/kg | msc-hmn:fbr 1 mg/L
cyt-mus-unr 2500 ug/kg | cyt-mus:oth 100 ug/L
cyt-nml-orl 6 nmol/L | cyt-nml:oth 500 umol/L/5H-C
cyt-nml:lym 2 pmol/L | cyt-ofs:oth 5 ug/L/24H
cyt-ofs:lym 500 pmol/L | cyt-oin-par 1 ug
cyt-rat-ipr 6670 ug/kg | cyt-rat-scu 670 ug/kg
dnd-mus-ipr 7500 ug/kg | dnd-mus:mmr 2 umol/L
dnd-omi 500 ug/L | dnd-omi 2 mmol/L
dnd-omi 670 nmol | dnd-rat:lvr 300 nmol/L
dni-hmn:hla 100 ug/L | dni-omi 3 mg/L
dnr-bcs 20 ng/plate | dnr-esc 25 nmol/L
dns-hmn:oth 2 iu/L | mma-sat 5 ug/plate
dns-mus:lvr 2 umol/L | dns-mus:tes 1 umol/L/5H
dns-mus:lym 500 ug/L | dns-mus-ipr 8 mg/kg
dns-rat-ipr 4 mg/kg | dns-rat:oth 2 mmol/L
dlt-mus-unr 1 mg/kg | dlt-ofs-mul 2500 ug/L/24H
dlt-slw-par 100 umol/kg | mrc-asn 1190 umol/L
mrc-clr 200 mg/L | trn-dmg-unr 300 umol/L
trn-mus-unr 2500 ug/kg | trn-rat-ipr 6670 ug/kg
hma-mky/esc 5 ug/L | hma-mus/esc 1 mg/kg
hma-mus/bcs 3 mg/kg | msc-ham:lng 1 mg/L/1H
msc-ham:ovr 75 ug/L | msc-mus-unr 1 mg/kg
mnt-mky-unr 500 ug/kg | mnt-mus-scu 3 mg/kg
mnt-mus:lym 100 nmol/L | mnt-ipr 650 ug/kg
mnt-mus-unr 2 mg/kg | mnt-mus-ivn 5 mg/kg
mnt-rat-ipr 1 mg/kg | mmo-bcs 25 ug/L
mmo-esc 100 ug/L | mmo-omi 1 ug/L/15M
mmo-omi 5 mg/L | mmo-omi 1 mg/plate
mmo-omi 50 mg/L | mmo-sat 50 ng/plate
mma-asn 1190 umol/L | mma-esc 15 umol/L
mma-ham:ovr 750 nmol/L | mma-mus:lym 500 ug/L/4H
otr-ham:kdy 1 ug/L | pic-esc 1 ng/well
pic-omi 500 ng/plate | pic-omi 1 mg/L
sln-dmg-unr 150 umol/L | sln-dmg-par 300 umol/L
sln-oin-par 1 gm/L | sln-slw-par 100 umol/kg
sce-ham-ipr 100 ug/kg | sce-ham:ovr 12500 ng/L
sce-ham:fbr 5 nmol/L | sce-ham:kdy 20 mg/L
sce-ham-unr 100 ug/kg | sce-ham:emb 50 ug/L
sce-ham:oth 480 nmol/L | sce-hmn:leu 100 ug/L
sce-hmn:lym 6 ug/L | sce-hmn:emb 3 nmol/L
sce-hmn:fbr 5 nmol/L | sce-hmn:oth 30 ug/L
sce-mam:fbr 330 ug/L | oms-mus/ast 2500 ppm
sce-mus:emb 15 ug/L | sce-mus-par 2500 ug/kg
sce-mus:fbr 10 ug/L | sce-mus/ast 3 mg/kg
sce-mus:lym 5 gm/L | sce-mus:oth 25 ug/L
sce-mus:lng 10 ug/L | sce-nml-orl 6 nmol/L
sce-nml-skn 1250 nmol/L | sce-nml:lym 10 pmol/L
sce-ofs-mul 5400 pmol/L | sce-ofs:lym 5 nmol/L
sce-rat-ivn 3 mg/kg | sce-rat:lym 10 nmol/L
sce-rat:bmr 10 nmol/L | sce-rat-ipr 1 mg/kg
sce-rat-scu 500 ug/kg | sce-rbt-ipr 4 mg/kg/8W
slt-dmg-orl 625 umol/L/6H | slt-mus-par 2 mg/kg
slt-mus-unr 2 mg/kg | slt-mus-unr 5250 ug/kg
slt-slw-par 25 mg/L | spm-mky-ivn 500 ug/kg
spm-mus-par 5250 ug/kg | spm-mus-unr 2500 ug/kg
spm-mus-scu 2500 ug/kg | oms-esc 5 pmol/tube
oms-grh:oth 100 umol/L | oms-ham:fbr 600 ug/L
oms-hmn:hla 100 ug/L | oms-hmn:lym 100 ug/L
cyt-ham:ovr 2500 ug/L |
TERATOGENICITY:
Reproductive Effects Data:
TDLo: ipr-mus 10 mg/kg (5D male)
TDLo: ipr-rat 3700 ug/kg (1D male)
TDLo: ipr-rat 7500 ug/kg (15D male)
TDLo: scu-rat 2 mg/kg (6-10D preg)
TDLo: ipr-mus 3 mg/kg (10D preg)
TDLo: ipr-mus 5 mg/kg (10D preg)
TDLo: ipr-mus 4 mg/kg (6D preg)
TDLo: ipr-mus 1875 ug/kg (12-14D preg)
TDLo: ipr-mus 1750 ug/kg (1D male)
TDLo: scu-mus 5 mg/kg (1D male)
TDLo: scu-mus 1 mg/kg (1D male)
TDLo: ivn-mus 5 mg/kg (12D preg)
TDLo: ivn-mus 5 mg/kg (10D preg)
TDLo: iut-mus 1600 ng/kg (1D preg)
TDLo: ipr-ham 2 mg/kg (2D preg)
TDLo: scu-mus 2500 ug/kg (1D male)
STANDARDS, REGULATIONS & RECOMMENDATIONS:
OSHA: None
ACGIH: None
NIOSH Criteria Document: None
NFPA Hazard Rating: Health (H): None
Flammability (F): None
Reactivity (R): None
OTHER TOXICITY DATA:
Review: Toxicology Review-3
Status: EPA TSCA Chemical Inventory, 1986
EPA Genetox Program 1986, Positive: Carcinogenicity-mouse/rat; In
vitro cytogenetics-nonhuman
EPA Genetox Program 1986, Positive: In vivo cytogenetics-nonhuman bone
marrow
EPA Genetox Program 1986, Positive: In vivo cytogenetics-mammalian
oocyte
EPA Genetox Program 1986, Positive: Cytogenetics-male germ cell;
Rodent dominant lethal
EPA Genetox Program 1986, Positive: Host mediated assay; Rodent heri-
table translocation
EPA Genetox Program 1986, Positive: L5178Y cells in vitro-TK test
EPA Genetox Program 1986, Positive: Mammalian micronucleus
EPA Genetox Program 1986, Positive: In vitro human lymphocyte
micronucleus; Mouse spot test
EPA Genetox Program 1986, Positive: N crassa-forward mutation
EPA Genetox Program 1986, Positive: B subtilis rec assay
EPA Genetox Program 1986, Positive: E coli polA without S9; Mouse
specific locus
EPA Genetox Program 1986, Positive: Sperm morphology-mouse: D
melanogaster Sex-linked lethal
EPA Genetox Program 1986, Positive: In vitro UDS-human fibroblast;
TRP reversion
EPA Genetox Program 1986, Positive: S cerevisiae gene conversion;
S cerevisiae-homozygosis
EPA Genetox Program 1986, Positive: S cerevisiae-aneuploidy;
S cerevisiae-reverion
EPA Genetox Program 1986, Positive/dose response: In vitro SCE-human
lymphocytes
EPA Genetox Program 1986, Positive/dose response: In vitro SCE-WI-38
cells; In vitro SCE-human
EPA Genetox Program 1986, Positive/dose response: In vitro SCE-non-
human; In vivo SCE-nonhuman
EPA Genetox Program 1986, Negative: N crassa-aneuploidy; UDS in mouse
germ cells
EPA Genetox Program 1986, Negative: TRP reversion
EPA Genetox Program 1986, Inconclusive: Histidine reversion-Ames test
EPA Genetox Program 1986, Inconclusive: Sperm morphology-mouse F1
EPA TSCA Test Submission (TSCATS) Data Base, March 1988
Meets criteria for proposed OSHA Medical Records Rule
OTHER DATA (Regulatory)
PROPER SHIPPING NAME (IATA): Poisonous solids, n.o.s.
(Mitomycin C)
UN/ID NUMBER: UN2811
HAZARD CLASS: 6.1 SUBSIDIARY RISK: None PACKING GROUP: II
LABELS REQUIRED: Poison label
PACKAGING: PASSENGER: PKG. INSTR.: 613, Y613 MAXIMUM QUANTITY: 25 kg, 1 kg
CARGO : PKG. INSTR.: 615 MAXIMUM QUANTITY: 100 kg
SPECIAL PROVISIONS: None
USES:
This compound is used as an antineoplastic, antibiotic, bioreductive
alkylating agent and cancer research tool.
COMMENTS:
This compound is derived from Streptomyces [062].
HANDLING PROCEDURES
ACUTE/CHRONIC HAZARDS:
This compound may be fatal if inhaled, ingested or absorbed through
the skin. It may cause irritation [269]. When heated to decomposition it
emits toxic fumes of carbon monoxide, carbon dioxide and nitrogen oxides
[042,269].
MINIMUM PROTECTIVE CLOTHING:
If Tyvek-type disposable protective clothing is not worn during
handling of this chemical, wear disposable Tyvek-type sleeves taped to
your gloves.
RECOMMENDED GLOVE MATERIALS:
Permeation Test Results For The Neat (Undiluted) Chemical:
The permeation test results for the neat (undiluted) chemical are given
below. The breakthrough times of this chemical are given for each glove type
tested. The table is a presentation of actual test results, not specific
recommendations or suggestions. Avoid glove types which exhibit breakthrough
times of less than the anticipated task time plus an adequate safety factor.
If this chemical makes direct contact with your glove, or if a tear, puncture
or hole develops, replace them at once.
Glove Type Model Number Thickness Breakthrough Time
No information available
RECOMMENDED RESPIRATOR:
Where the neat test chemical is weighed and diluted, wear a NIOSH-
approved half face respirator equipped with a combination filter cartridge,
i.e. organic vapor/acid gas/HEPA (specific for organic vapors, HCl, acid
gas, SO2 and a high efficiency particulate filter).
OTHER:
Since this chemical is a known or suspected carcinogen you should contact
a physician for advice regarding the possible long term health effects and
potential recommendation for medical monitoring. Recommendations from the
physician will depend upon the specific compound, its chemical, physical and
toxicity properties, the exposure level, length of exposure, and the route
of exposure.
STORAGE PRECAUTIONS:
You should keep this material in a tightly closed container
under an inert atmosphere, and store it at refrigerated temperatures.
SPILLS AND LEAKAGE:
If you spill this chemical, you should dampen the solid spill material
with water, then transfer the dampened material to a suitable container. Use
absorbent paper dampened with water to pick up any remaining material. Seal
your contaminated clothing and the absorbent paper in a vapor-tight plastic
bag for eventual disposal. Wash all contaminated surfaces with a soap
and water solution. Do not reenter the contaminated area until the Safety
Officer (or other responsible person) has verified that the area has been
properly cleaned.
DISPOSAL AND WASTE TREATMENT: Not available
EMERGENCY PROCEDURES
SKIN CONTACT:
IMMEDIATELY flood affected skin with water while removing and isolating
all contaminated clothing. Gently wash all affected skin areas thoroughly
with soap and water.
IMMEDIATELY call a hospital or poison control center even if no symptoms
(such as redness or irritation) develop.
IMMEDIATELY transport the victim to a hospital for treatment after
washing the affected areas.
INHALATION:
IMMEDIATELY leave the contaminated area; take deep breaths of fresh air.
IMMEDIATELY call a physician and be prepared to transport the victim to a
hospital even if no symptoms (such as wheezing, coughing, shortness of breath,
or burning in the mouth, throat, or chest) develop.
Provide proper respiratory protection to rescuers entering an unknown
atmosphere. Whenever possible, Self-Contained Breathing Apparatus (SCBA)
should be used; if not available, use a level of protection greater than or
equal to that advised under Respirator Recommendation.
EYE CONTACT:
First check the victim for contact lenses and remove if present. Flush
victim's eyes with water or normal saline solution for 20 to 30 minutes while
simultaneously calling a hospital or poison control center.
Do not put any ointments, oils, or medication in the victim's eyes without
specific instructions from a physician.
IMMEDIATELY transport the victim after flushing eyes to a hospital even if
no symptoms (such as redness or irritation) develop.
INGESTION:
If the victim is conscious and not convulsing, give 1 or 2 glasses of
water to dilute the chemical and IMMEDIATELY call a hospital or poison control
center.
Generally, the induction of vomiting is NOT recommended outside of a
physician's care due to the risk of aspirating the chemical into the victim's
lungs. However, if the victim is conscious and not convulsing and if medical
help is not readily available, consider the risk of inducing vomiting because
of the high toxicity of the chemical ingested. Ipecac syrup or salt water may
be used in such an emergency. IMMEDIATELY transport the victim to a hospital.
If the victim is convulsing or unconscious, do not give anything by mouth,
ensure that the victim's airway is open and lay the victim on his/her side with
the head lower than the body. DO NOT INDUCE VOMITING. IMMEDIATELY transport
the victim to a hospital.
SYMPTOMS:
Symptoms of exposure to this compound may include myelosuppression,
leukopenia, thrombocytopenia, nausea, vomiting, diarrhea, stomatitis, fever,
dermatitis, malaise, interstitial pneumonia and glomerular damage resulting in
renal failure [406]. Other symptoms include delayed erythema and/or ulcera-
tion, cellulitis at the injection site, alopecia, rise in creatinine, dyspnea,
anorexia, headache, blurring of vision, confusion, drowsiness, fatigue, edema,
syncope, thrombophlebitis, hematemesis and abdominal pain [159]. It may also
cause fibrosing alveolitis [015]. Eye exposure may cause irritation and pos-
sible corneal damage. Skin contact may cause irritation, dermatitis or an
allergic reaction. Inhalation can cause irritation or an allergic reaction.
Ingestion can cause gastrointestinal irritation, central nervous system dis-
orders, bone marrow disease, liver damage and kidney damage [900]. Pulmonary
damage may also occur [301].
SOURCES
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[025] Buckingham, J., Ed. Dictionary of Organic Compounds. 5th Ed.
Chapman and Hall. New York. 1982. Vol. 4, p. 410, #M-03985.
[031] Windholz, M., Ed. The Merck Index. 10th Ed. Merck and Co.
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[062] Sax, N.I. and R.J. Lewis Sr., Eds. Hawley's Condensed Chemical
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[099] Grant, W. Morton, M.D. Toxicology of the Eye. 3rd Ed. Charles
C. Thomas, Publisher. Springfield, IL. 1986. p. 638.
[107] Occupational Health Services, Inc. Hazardline. Occupational
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[110] Oak Ridge National Laboratory. Environmental Mutagen Information
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[159] Huff, B.B., Ed. Physicians' Desk Reference. 41st Ed. Medical
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[295] Reynolds, James E.F., Ed. Martindale The Extra Pharmacopoeia. 28th Ed.
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[301] Dreisbach, R.H. Handbook of Poisoning: Prevention, Diagnosis
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[395] International Agency for Research on Cancer, World Health
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[406] Goodman, L.S., A. Gilman, F. Murad and T.W. Rall, Eds. The
Pharmacological Basis of Therapeutics. 7th Ed. Macmillan
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[610] Clansky, Kenneth B., Ed. Suspect Chemicals Sourcebook: A Guide to
Industrial Chemicals Covered Under Major Federal Regulatory and
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Not listed.
[900] United States Biochemical Corporation. Material Safety Data Sheet for
Mitomycin C. July 8, 1986.
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