MITOMYCIN

Editor's Note: This material is not listed in the Emergency Response Guidebook. Based on the material's physical and chemical properties, toxicity, or chemical group, a guide has been assigned. For additional technical information, contact one of the emergency response telephone numbers listed under Public Safety Measures.

DESIGNATIONS

NSC NUMBER:26980

MOLECULAR FORMULA

C15-H18-N4-O5

ERG GUIDE NUMBER

151-SUBSTANCES - TOXIC (NON-COMBUSTIBLE)

SYNONYM REFERENCE

(EPA, 1985; HSDB , 1990; RTECS , 1991; Sax & Lewis, 1989)

USES/FORMS/SOURCES

USES

Mitomycin is indicated for disseminated adenocarcinoma of the stomach and pancreas, in combination with other chemotherapy agents (Prod Info MITOMYCIN intravenous injection, 2009). It has also been used for other cancers, such as cervical, breast, colorectal, or head and neck cancers (Wheelock et al, 1990; Gupta, 1982; Doyle et al, 1984).
Mitomycin ophthalmic topical solution is indicated as an adjunct to ab externa glaucoma surgery (Prod Info MITOSOL(R) topical solution powder, 2012).

FORMS

Mitomycin is available in 5 mg, 20 mg, and 40 mg intravenous powder for solution (Prod Info MITOMYCIN intravenous injection, 2009).
Mitomycin (Mitosol(R)) is available as vials containing 0.2 mg mitomycin and 0.4 mg mannitol; the solution contains 0.2 mg/mL mitomycin when reconstituted with sterile water for injection. This product is used topically (Prod Info MITOSOL(R) topical solution powder, 2012).

-CLINICAL EFFECTS

GENERAL CLINICAL EFFECTS

USES: Mitomycin is indicated for disseminated adenocarcinoma of the stomach and pancreas, in combination with other chemotherapy agents. It has also been used for other cancers, such as cervical, breast, colorectal, or head and neck cancers. Mitomycin ophthalmic topical solution is indicated as an adjunct to ab externa glaucoma surgery.

PHARMACOLOGY: Mitomycin ophthalmic solution is isolated from Streptomyces verticillus Yingtangensis and mitomycin solution for injection is isolated from Streptomyces caespitosus. Mitomycin is an antibiotic with antimetabolite activity. It causes cross-linking of DNA and inhibits DNA synthesis. It may also inhibit cellular RNA and protein synthesis.

EPIDEMIOLOGY: Overdose is rare.

WITH POISONING/EXPOSURE

Limited data are available on mitomycin overdose. The clinical effects reported are those noted during therapeutic use of mitomycin, including high-dose therapy.

WITH THERAPEUTIC USE

INTRAVENOUS: COMMON: Nausea, vomiting, anorexia, mucositis, fever, and myelosuppression (eg, leukopenia, thrombocytopenia). Leukopenia and thrombocytopenia may occur anytime within 8 weeks after onset of therapy with an average time of 4 weeks. Recovery after cessation of therapy was within 10 weeks. Approximately 25% of leukopenia or thrombocytopenic episodes did not recover. OTHER EFFECTS: Alopecia, diarrhea, ileus, confusion, drowsiness, fatigue, lethargy, headache, syncope, weakness, skin findings (eg, extravasation, desquamation, induration, pruritus, pain on injection, paresthesias, contact dermatitis, necrosis, cellulitis, ulceration, and tissue sloughing at the injection site), renal dysfunction, thrombophlebitis, hepatotoxicity, pulmonary toxicity (eg, hemoptysis, dyspnea, cough, pneumonitis, alveolitis, and pulmonary fibrosis). Hemolytic uremic syndrome, consisting mainly of microangiopathic hemolytic anemia (hematocrit equal to or less than 25%), thrombocytopenia (equal to or less than 100,000/mm(3)), and irreversible renal failure (serum creatinine equal to or greater than 1.6 mg/dL) has been reported in patients receiving systemic mitomycin. Approximately 98% of patients with this syndrome developed microangiopathic hemolysis with fragmented red blood cells on peripheral blood smears. Congestive heart failure has rarely been reported in patients receiving mitomycin. Almost all patients with CHF had previously received doxorubicin.
OPHTHALMIC: Chronic bleb leak, hypotony, hypotony maculopathy, blebitis, endophthalmitis, lenticular changes, cataract formation, corneal reactions (eg, endothelial damage, epithelial defects, anterior synechiae, superficial punctuate keratitis), and vascular reactions (eg, hyphema, central retinal vein occlusion, and retinal hemorrhage) have been reported.

POTENTIAL HEALTH HAZARDS - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)

Highly toxic, may be fatal if inhaled, swallowed or absorbed through skin.
Avoid any skin contact.
Effects of contact or inhalation may be delayed.
Fire may produce irritating, corrosive and/or toxic gases.
Runoff from fire control or dilution water may be corrosive and/or toxic and cause pollution.

ACUTE CLINICAL EFFECTS

SUMMARY

PHARMACOLOGY: Mitomycin ophthalmic solution is isolated from Streptomyces verticillus Yingtangensis and mitomycin solution for injection is isolated from Streptomyces caespitosus. Mitomycin is an antibiotic with antimetabolite activity. It causes cross-linking of DNA and inhibits DNA synthesis. It may also inhibit cellular RNA and protein synthesis.
EPIDEMIOLOGY: Overdose is rare.
ADVERSE EFFECTS: INTRAVENOUS: COMMON: Nausea, vomiting, anorexia, mucositis, fever, and myelosuppression (eg, leukopenia, thrombocytopenia). Leukopenia and thrombocytopenia may occur anytime within 8 weeks after onset of therapy with an average time of 4 weeks. Recovery after cessation of therapy was within 10 weeks. Approximately 25% of leukopenia or thrombocytopenic episodes did not recover. OTHER EFFECTS: Alopecia, diarrhea, ileus, confusion, drowsiness, fatigue, lethargy, headache, syncope, weakness, skin findings (eg, extravasation, desquamation, induration, pruritus, pain on injection, paresthesias, contact dermatitis, necrosis, cellulitis, ulceration, and tissue sloughing at the injection site), renal dysfunction, thrombophlebitis, hepatotoxicity, pulmonary toxicity (eg, hemoptysis, dyspnea, cough, pneumonitis, alveolitis, and pulmonary fibrosis). Hemolytic uremic syndrome, consisting mainly of microangiopathic hemolytic anemia (hematocrit equal to or less than 25%), thrombocytopenia (equal to or less than 100,000/mm(3)), and irreversible renal failure (serum creatinine equal to or greater than 1.6 mg/dL) has been reported in patients receiving systemic mitomycin. Approximately 98% of patients with this syndrome developed microangiopathic hemolysis with fragmented red blood cells on peripheral blood smears. Congestive heart failure has rarely been reported in patients receiving mitomycin. Almost all patients with CHF had previously received doxorubicin.
OPHTHALMIC: Chronic bleb leak, hypotony, hypotony maculopathy, blebitis, endophthalmitis, lenticular changes, cataract formation, corneal reactions (eg, endothelial damage, epithelial defects, anterior synechiae, superficial punctuate keratitis), and vascular reactions (eg, hyphema, central retinal vein occlusion, and retinal hemorrhage) have been reported.
OVERDOSE: Limited data are available on mitomycin overdose. The clinical effects reported are those noted during therapeutic use of mitomycin, including high-dose therapy.

CARDIOVASCULAR

HEART FAILURE: Congestive heart failure has rarely occurred in patients receiving mitomycin therapy. Almost all patients that develop CHF had previously received doxorubicin (Prod Info MITOMYCIN intravenous injection, 2009).

DERMATOLOGIC

ALOPECIA: Hair loss has occurred in approximately 4% of patients receiving mitomycin therapy (Dorr & Fritz, 1980; EPA, 1985; HSDB , 2000).
NAIL DISCOLORATION: Purple-colored bands occur in nail beds corresponding to repeated doses of mitomycin (Dorr & Fritz, 1980).
Desquamation, induration, pruritus, pain on injection, paresthesias, and necrosis occurs in approximately 4% of patients (HSDB , 2000).
DERMATITIS: Vesicular hand, feet, and groin dermatitis has been reported in approximately 9% of patients receiving mitomycin C via intravesicular instillation (Christensen, 1990; DeGroot & Conemans, 1990; Giorgini et al, 1991), and 2 patients developed a pruritic rash of the palms, legs, and soles of the feet along with fever, chills, and edema of the eyelids(Arregui et al, 1991).
EXTRAVASATION: Extravasation following injection leading to necrosis and sloughing of the tissue has occurred in patients receiving mitomycin therapy (Prod Info MITOMYCIN intravenous injection, 2009; HSDB , 2000)

GASTROINTESTINAL

NAUSEA AND VOMITING: Nausea, vomiting, and loss of appetite has occurred in patients receiving mitomycin therapy (Prod Info MITOMYCIN intravenous injection, 2009) with symptoms developing within 1 to 2 hours. These symptoms may persist for several hours following therapy (Dorr & Fritz, 1980).
DIARRHEA: Diarrhea has been associated with mitomycin administration (Prod Info MITOMYCIN intravenous injection, 2009; Tannir et al, 1984).
STOMATITIS: Stomatitis has been reported with therapy (Dorr & Fritz, 1980).
MUCOSITIS: Mucositis occurred in 20% of patients after the first course of high-dose mitomycin (30 to 50 mg/m(2)) and in 40% after the second course (Tannir et al, 1984).

GENITOURINARY

IMPAIRED RENAL FUNCTION: Development of renal impairment due to mitomycin therapy has occurred (Ravikumar et al, 1984; Dorr & Fritz, 1980; Early et al, 1973) and appears related to total-dose with most patients developing renal symptoms after receiving at least 60 mg of mitomycin C (Ravikumar et al, 1984). It is reported that 10% of patients who receive mitomycin develop renal failure, and increases in BUN, creatinine, and glomerular degeneration are occasionally seen (Dorr & Fritz, 1980; Early et al, 1973).
HEMOLYTIC UREMIC SYNDROME: Hemolytic uremic syndrome consisting of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure have been reported in patients receiving systemic mitomycin. Approximately 98% of patients with this syndrome developed microangiopathic hemolysis with fragmented blood cells on peripheral blood smears (Prod Info MITOMYCIN intravenous injection, 2009; Cantrell et al, 1985; Giroux et al, 1985; Liu et al, 1971).
BLADDER CONTRACTURE: There have been several reports of bladder contracture following intravesical therapy with mitomycin (Wajsman et al, 1983; Farha & Krauss, 1989).
INCREASED URINARY FREQUENCY: Urinary frequency and urgency have been reported following intravesical therapy with mitomycin C (Farha & Krauss, 1989).

HEENT

In open-angle glaucoma patients treated with 0.2 mg/mL mitomycin applied topically to the eye, the following were the most frequent adverse reactions reported: chronic bleb leak, hypotony, hypotony maculopathy, blebitis, endophthalmitis, lenticular changes, cataract formation, corneal reactions (eg, endothelial damage, epithelial defects, anterior synechiae, superficial punctuate keratitis), and vascular reactions (eg, hyphema, central retinal vein occlusion, and retinal hemorrhage) (Prod Info MITOSOL(R) topical solution powder, 2012).
CONJUNCTIVITIS: Reversible blepharo-conjunctivitis has been reported following instillation of a 0.04% solution of mitomycin eyedrops 3 to 6 times daily for one week following surgical treatment of pterygium. Degeneration of the sclera, later iridocyclitis, and secondary glaucoma have been reported following more extensive use (Grant, 1986).

HEMATOLOGIC

MYELOSUPPRESSION: Bone marrow suppression occurred in 605 of 937 patients (64.4%), the most common adverse effect observed during clinical trials (Prod Info MITOMYCIN intravenous injection, 2009) and it becomes more profound and prolonged after repeated doses of mitomycin (Dorr & Fritz, 1980a). Leukopenia and thrombocytopenia may occur anytime within 8 weeks after onset of therapy with an average time of 4 weeks. Recovery after cessation of therapy was within 10 weeks. About 25% of leukopenia or thrombocytopenic episodes did not recover (Prod Info MITOMYCIN intravenous injection, 2009). Mitomycin 30 to 50 mg/m(2)/course produced irreversible thrombocytopenia in some patients (Tannir et al, 1984).
DISSEMINATED INTRAVASCULAR COAGULATION: Disseminated intravascular coagulation (DIC) was reported as a complication associated with high-dose mitomycin (30 to 50 mg/m(2)/course) (Tannir et al, 1984).
THROMBOPHLEBITIS: Thrombophlebitis has been associated with mitomycin administration (Prod Info MITOMYCIN intravenous injection, 2009).

HEPATIC

VENO-OCCLUSIVE DISEASE: Hepatic veno-occlusive disease was reported in patients who received high-dose mitomycin and autologous bone marrow transplantation therapy (Lazarus, 1982; Gottfried & Sudilovsky, 1982).

NEUROLOGIC

Confusion, drowsiness, fatigue, lethargy, headache, syncope, and weakness may occur during therapy (Prod Info MITOMYCIN intravenous injection, 2009; Dorr & Fritz, 1980). These symptoms do not appear to be dose related (Prod Info MITOMYCIN intravenous injection, 2009).

RESPIRATORY

Mitomycin has the potential to cause pneumonitis, alveolitis, and pulmonary fibrosis during therapeutic use (HSDB , 2000).
INTERSTITIAL PNEUMONIA: Several patients developed interstitial pneumonia thought to be secondary to mitomycin therapy. Resulting signs and symptoms on presentation were cough, dyspnea, and occasionally fever (Dorr & Fritz, 1980; Tannir et al, 1984; HSDB , 2000).

VITAL SIGNS

FEVER: Fever may occur with therapy and was reported in 14% (n=1281) of patients treated with mitomycin (Prod Info MITOMYCIN intravenous injection, 2009).

CHRONIC CLINICAL EFFECTS

WITH THERAPEUTIC USE

Congestive heart failure has been reported (Tannir et al, 1984) Sivanesaratnam, 1989). Pulmonary toxicity has occurred in approximately 1 to 1.5 percent of patients. Signs and symptoms include cough, dyspnea, rales, hemoptysis, and fever. Reticular infiltrates may be noted on chest x-ray. Alveolitis, interstitial pneumonia, and pulmonary fibrosis have also been reported (Dorr & Fritz, 1980; Tannir et al, 1984; HSDB , 1996). Pulmonary toxicity has also been reported with combination therapy.
Veno-occlusive disease of the liver was reported by Lazarus et al (1982) and Gottfried et al (1982) in patients who received high-dose mitomycin and autologous bone marrow transplantation therapy. Mitomycin has hepatotoxic potential similar to that of mithramycin, although reports occur only infrequently in the literature (Knoben, 1979).
Increasing BUN, increasing creatinine, and glomerular degeneration are occasionally seen (Dorr & Fritz, 1980; Early et al, 1973; HSDB , 1995). Evidence from the literature indicates that renal impairment appears to be total-dose related and that most patients develop renal symptoms after receiving at least 60 mg of mitomycin C (Ravikumar et al, 1984; Valavaara & Nordman, 1985).
Case reports have described patients who developed renal microangiopathy involving the small arterioles and glomerular capillaries, microangiopathic hemolytic anemia, and a consumptive thrombocytopenia (Pavy et al, 1982; Rabadi et al, 1982).
Approximately 10 percent of patients who receive mitomycin develop renal failure; 98.8 percent of patients who develop cancer-associated hemolytic-uremic syndrome have received mitomycin. There is frequently a delay between treatment and onset, suggesting that a combination of factors is required (Cordonnier et al, 1985; Acheson & Donohue-Rolfe, 1989). Some evidence indicates that early detection and withdrawal of therapy may halt further progression of renal failure (Ravikumar et al, 1984).
Bladder fibrosis and contracture with resultant renal failure has been reported (Wajsman, 1983; (Farha & Krauss, 1989). Bladder wall calcification has also been noted after instillation therapy (Megias Garrigos et al, 1991). Patch testing with mitomycin has led to generalized dermatitis (Echechipia et al, 1995).
Myelosuppression may occur 3 to 8 weeks after treatment and becomes more profound and prolonged after repeated doses (Crooke & Bradner, 1976; Dorr & Fritz, 1980). Bone marrow depression, disseminated intravascular coagulation, and microangiopathic hemolytic anemia have been reported (Tigges et al, 1982; (Tannir et al, 1984; HSDB , 1996).

ANIMAL STUDIES: In experimental animal studies, a significant decrease in alanine aminopeptidase excretion was noted after exposure to mitomycin C. It was concluded that mitomycin causes tubular damage with acute leakage of enzyme from the cells and enzyme depletion during chronic treatment (Verweij et al, 1988).

-MEDICAL TREATMENT

LIFE SUPPORT

Support respiratory and cardiovascular function.

SUMMARY

FIRST AID - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)

Move victim to fresh air.
Call 911 or emergency medical service.
Give artificial respiration if victim is not breathing.
Do not use mouth-to-mouth method if victim ingested or inhaled the substance;give artificial respiration with the aid of a pocket mask equipped with a one-way valve or other proper respiratory medical device.
Administer oxygen if breathing is difficult.
Remove and isolate contaminated clothing and shoes.
In case of contact with substance, immediately flush skin or eyes with running water for at least 20 minutes.
For minor skin contact, avoid spreading material on unaffected skin.
Keep victim warm and quiet.
Effects of exposure (inhalation, ingestion or skin contact) to substance may be delayed.
Ensure that medical personnel are aware of the material(s) involved and take precautions to protect themselves.

FIRST AID

INHALATION EXPOSURE

INHALATION: Move patient to fresh air. Monitor for respiratory distress. If cough or difficulty breathing develops, evaluate for respiratory tract irritation, bronchitis, or pneumonitis. Administer oxygen and assist ventilation as required. Treat bronchospasm with an inhaled beta2-adrenergic agonist. Consider systemic corticosteroids in patients with significant bronchospasm.

DERMAL EXPOSURE

DECONTAMINATION: Remove contaminated clothing and jewelry and place them in plastic bags. Wash exposed areas with soap and water for 10 to 15 minutes with gentle sponging to avoid skin breakdown. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).

EYE EXPOSURE

DECONTAMINATION: Remove contact lenses and irrigate exposed eyes with copious amounts of room temperature 0.9% saline or water for at least 15 minutes. If irritation, pain, swelling, lacrimation, or photophobia persist after 15 minutes of irrigation, the patient should be seen in a healthcare facility.

-RANGE OF TOXICITY

MINIMUM LETHAL EXPOSURE

Minimum lethal exposure has not been established.

CASE REPORTS

ADULTS: A 57-year-old woman with cancer of the cervix received 5 courses of mitomycin C (15 milligrams/square meter at 3 weekly intervals) and 3 weeks after the last course developed acute congestive heart failure and died (Sivanesaratnam & Jayalakshmi, 1989).

MAXIMUM TOLERATED EXPOSURE

GENERAL/SUMMARY

Increased toxicity without enhanced efficacy has been reported with total doses greater than 20 mg/m(2)/day (Dorr & Fritz, 1980).
Reports of pulmonary toxicity have occurred at total dosages as low as 40 mg, but the average cumulative dose resulting in pulmonary toxicity is 78 mg (JEF Reynolds , 2000).
When the total cumulative mitomycin dose exceeds 120 mg, the incidence of renal toxicity significantly increases (JEF Reynolds , 2000).

CASE REPORT

Only one case of overdose has been reported to the manufacturer. The patient received 70 mg mitomycin and recovered with good supportive care only (Personal Communication, 1988).

Carcinogenicity Ratings for CAS50-07-7 :

ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
EPA (U.S. Environmental Protection Agency, 2011): Not Listed
IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): 2B ; Listed as: Mitomycin C

2B : The agent (mixture) is possibly carcinogenic to humans. The exposure circumstance entails exposures that are possibly carcinogenic to humans. This category is used for agents, mixtures and exposure circumstances for which there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals. It may also be used when there is inadequate evidence of carcinogenicity in humans but there is sufficient evidence of carcinogenicity in experimental animals. In some instances, an agent, mixture or exposure circumstance for which there is inadequate evidence of carcinogenicity in humans but limited evidence of carcinogenicity in experimental animals together with supporting evidence from other relevant data may be placed in this group.

NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
MAK (DFG, 2002): Not Listed
NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

TOXICITY AND RISK ASSESSMENT VALUES

EPA IRIS

EPA Risk Assessment Values for CAS50-07-7 (U.S. Environmental Protection Agency, 2011):

Not Listed

TOXICITY VALUES

LD50- (INTRAVENOUS)DOG:
- 1 mg/kg ((RTECS, 2000))
LD50- (INTRAPERITONEAL)MOUSE:
- 4 mg/kg ((RTECS, 2000))
LD50- (INTRAVENOUS)MOUSE:
- 4 mg/kg ((RTECS, 2000))
LD50- (ORAL)MOUSE:
- 23 mg/kg ((RTECS, 2000))
LD50- (SUBCUTANEOUS)MOUSE:
- 7300 mcg/kg ((RTECS, 2000))
LD50- (INTRAPERITONEAL)RAT:
- 2 mg/kg ((RTECS, 2000))
LD50- (INTRAVENOUS)RAT:
- 3 mg/kg ((RTECS, 2000))
LD50- (ORAL)RAT:
- 30 mg/kg ((RTECS, 2000))
LD50- (SUBCUTANEOUS)RAT:
- 3250 mcg/kg ((RTECS, 2000))
LDLo- (INTRAVENOUS)CAT:
- 2500 mcg/kg ((RTECS, 2000))
LDLo- (INTRATRACHEAL)MOUSE:
- 4 mg/kg ((RTECS, 2000))
LDLo- (INTRAVENOUS)PRIMATE:
- 1 mg/kg ((RTECS, 2000))
TDLo- (INTRAVENOUS)HUMAN:
- 1800 mcg/kg ((RTECS, 2000))

-STANDARDS AND LABELS

WORKPLACE STANDARDS

ACGIH TLV Values for CAS50-07-7 (American Conference of Governmental Industrial Hygienists, 2010):

Not Listed

AIHA WEEL Values for CAS50-07-7 (AIHA, 2006):

Not Listed

NIOSH REL and IDLH Values for CAS50-07-7 (National Institute for Occupational Safety and Health, 2007):

Not Listed

OSHA PEL Values for CAS50-07-7 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):

Not Listed

OSHA List of Highly Hazardous Chemicals, Toxics, and Reactives for CAS50-07-7 (U.S. Occupational Safety and Health Administration, 2010):

Not Listed

ENVIRONMENTAL STANDARDS

EPA CERCLA, Hazardous Substances and Reportable Quantities for CAS50-07-7 (U.S. Environmental Protection Agency, 2010):

Listed as: Mitomycin C
Final Reportable Quantity, in pounds (kilograms):

10 (4.54)

Additional Information:
Listed as: Azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b- hexahydro-8a-methoxy-5-methyl-,[1aS- (1aalpha,8beta,8aalpha,8balpha)]-
Final Reportable Quantity, in pounds (kilograms):

10 (4.54)

Additional Information:

EPA CERCLA, Hazardous Substances and Reportable Quantities, Radionuclides for CAS50-07-7 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA RCRA Hazardous Waste Number for CAS50-07-7 (U.S. Environmental Protection Agency, 2010b):

Listed as: Azirino[2[prime],3[prime]:3,4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl-, [1aS-(1aalpha,8beta,8aalpha,8balpha)]-
P or U series number: U010
Footnote:
Listed as: Mitomycin C
P or U series number: U010
Footnote:
Editor's Note: The D, F, and K series waste numbers and Appendix VIII to Part 261 -- Hazardous Constituents were not included. Please refer to 40 CFR Part 261.

EPA SARA Title III, Extremely Hazardous Substance List for CAS50-07-7 (U.S. Environmental Protection Agency, 2010):

Listed as: Mitomycin C
Reportable Quantity, in pounds: 10

Only the statutory or final RQ is shown. For more information, see 40 CFR table 302.4.

Threshold Planning Quantity, in pounds:

500/10,000
Amount necessary to be covered by this standard. See 40 CFR 355.30.

Note(s): Not Listed

EPA SARA Title III, Community Right-to-Know for CAS50-07-7 (40 CFR 372.65, 2006; 40 CFR 372.28, 2006):

Not Listed

DOT List of Marine Pollutants for CAS50-07-7 (49 CFR 172.101 - App. B, 2005):

Not Listed

EPA TSCA Inventory for CAS50-07-7 (EPA, 2005):

Listed as: Azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl-, (1aS,8S,8aR,8bS)-

SHIPPING REGULATIONS

SURFACE

DOT -- Table of Hazardous Materials and Special Provisions (49 CFR 172.101, 2005):

Not Listed

ICAO International Shipping Name (ICAO, 2002):

Not Listed

LABELS

NFPA

NFPA Hazard Ratings for CAS50-07-7 (NFPA, 2002):

Not Listed

-HANDLING AND STORAGE

SUMMARY

INDUSTRIAL CHEMICALS

Occupational exposure from handling mitomycin C by healthcare personnel can be hazardous without proper protection. Improper handling can lead to sensitization and subsequent allergic contact dermatitis (Fisher, 1991).

-PERSONAL PROTECTION

SUMMARY

RECOMMENDED PROTECTIVE CLOTHING - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)

Wear positive pressure self-contained breathing apparatus (SCBA).
Wear chemical protective clothing that is specifically recommended by the manufacturer. It may provide little or no thermal protection.
Structural firefighters' protective clothing provides limited protection in fire situations ONLY; it is not effective in spill situations where direct contact with the substance is possible.

RESPIRATORY PROTECTION

Refer to "Recommendations for respirator selection" in the NIOSH Pocket Guide to Chemical Hazards on TOMES Plus(R) for respirator information.

PROTECTIVE CLOTHING

CHEMICAL PROTECTIVE CLOTHING. Search results for CAS 50-07-7.

Specific recommendations and test data for this chemical were not found in the available manufacturers' product literature. A complete list of consulted manufacturers and references is presented below.

-PHYSICAL HAZARDS

FIRE HAZARD

SUMMARY

Editor's Note: This material is not listed in the Emergency Response Guidebook. Based on the material's physical and chemical properties, toxicity, or chemical group, a guide has been assigned. For additional technical information, contact one of the emergency response telephone numbers listed under Public Safety Measures.
POTENTIAL FIRE OR EXPLOSION HAZARDS - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)
- Non-combustible, substance itself does not burn but may decompose upon heating to produce corrosive and/or toxic fumes.
- Containers may explode when heated.
- Runoff may pollute waterways.

FLAMMABILITY CLASSIFICATION

NFPA Flammability Rating for CAS50-07-7 (NFPA, 2002):

Not Listed

FIRE CONTROL/EXTINGUISHING AGENTS

SMALL FIRE PRECAUTIONS - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)

Dry chemical, CO2 or water spray.

LARGE FIRE PRECAUTIONS - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)

Water spray, fog or regular foam.
Move containers from fire area if you can do it without risk.
Dike fire control water for later disposal; do not scatter the material.
Use water spray or fog; do not use straight streams.

TANK OR CAR/TRAILER LOAD FIRE PRECAUTIONS - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)

Fight fire from maximum distance or use unmanned hose holders or monitor nozzles.
Do not get water inside containers.
Cool containers with flooding quantities of water until well after fire is out.
Withdraw immediately in case of rising sound from venting safety devices or discoloration of tank.
ALWAYS stay away from tanks engulfed in fire.
For massive fire, use unmanned hose holders or monitor nozzles; if this is impossible, withdraw from area and let fire burn.

NFPA Extinguishing Methods for CAS50-07-7 (NFPA, 2002):

Not Listed

REACTIVITY HAZARD

Solutions of mitomycin are inactivated slowly by visible light (Dorr & Fritz, 1980).

EVACUATION PROCEDURES

SUMMARY

Editor's Note: This material is not listed in the Table of Initial Isolation and Protective Action Distances.

SPILL - PUBLIC SAFETY EVACUATION DISTANCES - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)

Increase, in the downwind direction, as necessary, the isolation distance of at least 25 to 50 meters (80 to 160 feet) in all directions.

FIRE - PUBLIC SAFETY EVACUATION DISTANCES - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)

If tank, rail car or tank truck is involved in a fire, ISOLATE for 800 meters (1/2 mile) in all directions; also, consider initial evacuation for 800 meters (1/2 mile) in all directions.

PUBLIC SAFETY MEASURES - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)

CALL Emergency Response Telephone Number on Shipping Paper first. If Shipping Paper not available or no answer, refer to appropriate telephone number:

MEXICO:

SETIQ:

01-800-00-214-00 in the Mexican Republic;
For calls originating in Mexico City and the Metropolitan Area: 5559-1588;
For calls originating elsewhere, call: 011-52-555-559-1588.

CENACOM:

01-800-00-413-00 in the Mexican Republic;
For calls originating in Mexico City and the Metropolitan Area: 5550-1496, 5550-1552, 5550-1485, or 5550-4885;
For calls originating elsewhere, call: 011-52-555-550-1496, or 011-52-555-550-1552; 011-52-555-550-1485, or 011-52-555-550-4885.

ARGENTINA:

CIQUIME:

0-800-222-2933 in the Republic of Argentina;
For calls originating elsewhere, call: +54-11-4613-1100.

BRAZIL:

PRÓ-QUÍMICA:

0-800-118270 (Toll-free in Brazil);
For calls originating elsewhere, call: +55-11-232-1144 (Collect calls are accepted).

COLUMBIA:

CISPROQUIM:

01-800-091-6012 in Colombia;
For calls originating in Bogotá, Colombia, call: 288-6012;
For calls originating elsewhere, call: 011-57-1-288-6012.

CANADA:

CANUTEC:

613-996-6666 (Collect calls are accepted);
*666 cellular (in Canada only).

UNITED STATES:

CHEMTREC®:

1-800-424-9300 (Toll-free in the U.S., Canada, and the U.S. Virgin Islands);
703-527-3887 for calls originating elsewhere (Collect calls are accepted).

CHEM-TEL, INC.:

1-800-255-3924 (Toll-free in the U.S., Canada, and the U.S. Virgin Islands);
813-248-0585 for calls originating elsewhere (Collect calls are accepted).

INFOTRAC:

1-800-535-5053 (Toll-free in the U.S., Canada, and the U.S. Virgin Islands);
352-323-3500 for calls originating elsewhere (Collect calls are accepted).

3E COMPANY:

1-800-451-8346 (Toll-free in the U.S., Canada, and the U.S. Virgin Islands);
760-602-8703 for calls originating elsewhere (Collect calls are accepted).

NATIONAL RESPONSE CENTER (NRC):

1-800-424-8802 - (24 hours) (Toll-free in the U.S., Canada, and the U.S. Virgin Islands);
202-267-2675 for calls in the District of Columbia.

MILITARY SHIPMENTS:

703-697-0218 - Explosives/ammunition incidents (Collect calls are accepted);
1-800-851-8061 - All other dangerous goods incidents.

NATIONWIDE POISON CONTROL CENTER (United States only):

1-800-222-1222 (Toll-free in the U.S.).

For additional details see the section entitled "WHO TO CALL FOR ASSISTANCE" under the ERG Instructions.
As an immediate precautionary measure, isolate spill or leak area in all directions for at least 50 meters (150 feet) for liquids and at least 25 meters (75 feet) for solids.
Keep unauthorized personnel away.
Stay upwind.
Keep out of low areas.

AIHA ERPG Values for CAS50-07-7 (AIHA, 2006):

Not Listed

DOE TEEL Values for CAS50-07-7 (U.S. Department of Energy, Office of Emergency Management, 2010):

Listed as Mitomycin C
TEEL-0 (units = mg/m3): 4
TEEL-1 (units = mg/m3): 12.5
TEEL-2 (units = mg/m3): 23
TEEL-3 (units = mg/m3): 23
Definitions:

TEEL-0: The threshold concentration below which most people will experience no adverse health effects.
TEEL-1: The airborne concentration (expressed as ppm [parts per million] or mg/m(3) [milligrams per cubic meter]) of a substance above which it is predicted that the general population, including susceptible individuals, could experience notable discomfort, irritation, or certain asymptomatic, nonsensory effects. However, these effects are not disabling and are transient and reversible upon cessation of exposure.
TEEL-2: The airborne concentration (expressed as ppm or mg/m(3)) of a substance above which it is predicted that the general population, including susceptible individuals, could experience irreversible or other serious, long-lasting, adverse health effects or an impaired ability to escape.
TEEL-3: The airborne concentration (expressed as ppm or mg/m(3)) of a substance above which it is predicted that the general population, including susceptible individuals, could experience life-threatening adverse health effects or death.

AEGL Values for CAS50-07-7 (National Research Council, 2010; National Research Council, 2009; National Research Council, 2008; National Research Council, 2007; NRC, 2001; NRC, 2002; NRC, 2003; NRC, 2004; NRC, 2004; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; United States Environmental Protection Agency Office of Pollution Prevention and Toxics, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; 62 FR 58840, 1997; 65 FR 14186, 2000; 65 FR 39264, 2000; 65 FR 77866, 2000; 66 FR 21940, 2001; 67 FR 7164, 2002; 68 FR 42710, 2003; 69 FR 54144, 2004):

Not Listed

NIOSH IDLH Values for CAS50-07-7 (National Institute for Occupational Safety and Health, 2007):

Not Listed

CONTAINMENT/WASTE TREATMENT OPTIONS

SUMMARY

SPILL OR LEAK PRECAUTIONS - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)
- Do not touch damaged containers or spilled material unless wearing appropriate protective clothing.
- Stop leak if you can do it without risk.
- Prevent entry into waterways, sewers, basements or confined areas.
- Cover with plastic sheet to prevent spreading.
- Absorb or cover with dry earth, sand or other non-combustible material and transfer to containers.
- DO NOT GET WATER INSIDE CONTAINERS.
RECOMMENDED PROTECTIVE CLOTHING - EMERGENCY RESPONSE GUIDEBOOK, GUIDE 151 (ERG, 2004)
- Wear positive pressure self-contained breathing apparatus (SCBA).
- Wear chemical protective clothing that is specifically recommended by the manufacturer. It may provide little or no thermal protection.
- Structural firefighters' protective clothing provides limited protection in fire situations ONLY; it is not effective in spill situations where direct contact with the substance is possible.

-ENVIRONMENTAL HAZARD MANAGEMENT

POLLUTION HAZARD

NATURAL SOURCES

Mitomycin C is produced by Streptommyces caespitosus, a Japanese soil organism (HSDB, 2004).

OCCUPATIONAL EXPOSURE

Healthcare workers may encounter mitomycin C through various work-related duties. Exposure routes include unintentional ingestion (from contaminated food), inhalation, and skin contact (HSDB, 2004).

ENVIRONMENTAL FATE AND KINETICS

Mitomycin C's estimated atmospheric photooxidation half-life ranges from 0.2 hours (13 minutes) - to 2.1 hours (Howard et al, 1991).

WATER

SURFACE WATER
- The estimated half-life of mitomycin C in surface waters is 168 - 672 hours (1 - 4 weeks) (Howard et al, 1991).
- The first-order hydrolysis half-life for mitomycin C has been estimated at 1872 hours (78 days), based upon a neutral rate constant of 3.7 x 10(-3)/hr (at pH 7 and 25 degrees C) (Howard et al, 1991).
GROUND WATER
- The estimated half-life of mitomycin C in ground water is 336 - 8640 hours (2 - 8 weeks) (Howard et al, 1991)

SOIL

TERRESTRIAL
- The estimated half-life of mitomycin C in soil is 168 - 672 hours (1 - 4 weeks) (Howard et al, 1991).

ABIOTIC DEGRADATION

Although no specific environmental degradation pathway data are available for mitomycin C, biodegradation, photooxidation, and hydrolysis are all potential degradation mechanisms (Howard et al, 1991).

BIODEGRADATION

The aerobic half-life for mitomycin C in unacclimated aqueous environments is estimated to be 168 - 672 hours (1 - 4 weeks). The anaerobic half-life is estimated at 672 - 2688 hours (4 - 16 weeks) (Howard et al, 1991).

ENVIRONMENTAL TOXICITY

No information found at the time of this review.

-PHYSICAL/CHEMICAL PROPERTIES

MOLECULAR WEIGHT

334.33 (Prod Info MITOSOL(R) topical solution powder, 2012; Prod Info MITOMYCIN intravenous injection, 2009)

DESCRIPTION/PHYSICAL STATE

Mitomycin is a blue-violet crystalline powder (Prod Info MITOMYCIN intravenous injection, 2009; Prod Info MITOSOL(R) topical solution powder, 2012) which is soluble in acetone, butyl acetate, cyclohexanone, and methyl alcohol (JEF Reynolds , 2000); slightly soluble in benzene, carbon tetrachloride, ether (Windholz et al, 1983), and water (JEF Reynolds , 2000); and practically insoluble in petroleum ether (Windholz et al, 1983).

6 to 8 (reconstituted injection solution) (Prod Info MITOMYCIN intravenous injection, 2009); 5 to 8 (reconstituted topical solution) (Prod Info MITOSOL(R) topical solution powder, 2012)

FREEZING/MELTING POINT

MELTING POINT

360 degrees C; greater than 680 degrees F (Windholz et al, 1983)

SOLUBILITY

IN WATER

Slightly soluble in water (JEF Reynolds , 2000)

IN ORGANIC SOLVENTS

Soluble in acetone, butyl acetate, cyclohexanone, methyl alcohol (JEF Reynolds , 2000)
Practically insoluble in petroleum ether (Windholz et al, 1983).
Slightly soluble in benzene, carbon tetrachloride, and ether (Windholz et al, 1983).

HENRY'S CONSTANT

2.5x10(-10) atm-m(3)/mol (Ehrenfeld et al, 1986)

-REFERENCES

GENERAL BIBLIOGRAPHY

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65 FR 77866: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2000.

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67 FR 7164: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2002.

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National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances: Acute Exposure Guideline Levels (AEGLs) for Selenium Hexafluoride (Proposed). United States Environmental Protection Agency. Washington, DC. 2006f. Available from URL: http://www.regulations.gov/search/Regs/contentStreamer?objectId=090000648020ec55&disposition=attachment&contentType=pdf. As accessed 2010-08-16.

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Information to evaluate chemical incidents

Information to evaluate chemical incidents

Information to evaluate chemical incidents