MATERIAL SAFETY DATA SHEET
FMOM No.: 9101-1MM-0.03 DATE: 5/21/99
PRODUCT NAME: Ethambutol HCl Tablet Cores
POTENCY: 400 mg
BATCH SIZE: 1,000,000 Cores
ETHAMBUTOL HYDROCHLORIDE CAS #74-55-5
Threshold Limit
Value Signs and
Symptoms of
Overexposure: None established
TDL0: 45 mg/Kg/3D-I oral-man;
TDL0: 46 mg/Kg/3D-I oral-man;
TDL0: 720 mg/Kg/48D unreported-woman
LD50: 6800 mg/Kg oral/rats
LD50: 1200 mg/Kg intraperitoneal-rat;
LD50: 300 mg/Kg intravenous-rat;
LD50: 8890 mg/Kg oral-mouse;
LD50: 1800 mg/Kg subcutaneous-mouse;
LD50: 230 mg/Kg intravenous-mouse;
Mutation data (RTECS)
TDL0: 900 mg/Kg56OD-(oral-woman)
TDL0: 600 mg/Kg oral-man;
TDL0: 1200 mg/Kg- oral-man;
LD50: 8700 mg/Kg oral mouse;
LD50: 1075 mg/Kg intraperitoneal-mouse
LD50: 240 mg/Kg intravenous-mouse;
LD50: 890 mg/Kg subcutaneous-mammal;
LD50: 300 mg/Kg intravenous-mammal;
Possible allergic reaction to dust if inhaled, ingested or in contact with skin.
Adverse effects include blurred vision, eye pain, red7green color blindness, or
any loss of vision.
ACUTE: Eye, skin and/or respiratory tract irritation.
CHRONIC: Possible hypersensitization
PRECAUTION TO
CONSIDER: Persons developing hypersensitivity (anaphylactic) reactions must receive
immediate medical attention. Material may be irritation to mucous membranes
and respiratory tract. As a general rule, when handling USP Reference Standards
avoid all contact and inhalation of dust, fumes, mists, and/or vapors associated
with the material. Keep container tightly closed and use with adequate
ventilation; wash thoroughly after handling. Individuals working with chemicals
should consider all chemicals to be potentially hazardous even if their individual
hazards may be uncharacterized or unknown. Ethambutol crosses the placenta,
resulting in fetal plasma concentrations approximately 30% of material plasma
concentrations. Problems in humans have not been documented. However,
studies in mice given high doses have shown that Ethambutol causes low
incidence of cleft palate etc. (USP DI, 10th Edition).
Emergency and First
Aid Procedures: Remove from exposure. Remove contaminated clothing. Person developing
serious hypersensitivity reactions must receive immediate attention. Upon eye or
skin contact, flush affected area with copious quantities of water. Obtain medical
attention. If not breathing give artificial respiration. If breathing is difficult, give
oxygen.
1. Inhalation: May cause irritation of respiratory tract. Avoid inhalation. Remove to fresh air.
2. Eyes: May cause irritation. Flush with copious quantities of water.
3. Skin: May cause irritation. Flush with copious amounts of water.
4. Ingestion: May cause irritation. Flush out mouth with water.
COMPRESSIBLE SUGAR (DIPAC):
Routes of Entry: Inhalation.
Acute or Chronic
Health Hazards: Nuisance dust.
Signs and Symptoms
Of Exposure: Overexposure may irritate eyes, nose, throat and/or lungs. Continued
overexposure may lead to increased sensitivity, which is reversible.
Medical Conditions
Generally Aggravated
By Exposure: Any pre-existing upper respiratory ailment or allergic sensitivity.
Emergency and First
Aid Procedures:
Flush eyes with water; provide adequate ventilation, e.g., fresh air; in case of
respiratory difficulty obtain immediate medical attention.
CROSCARMELLOSE SODIUM (AC-DI-SOL): CAS #74811-65-7
Hazards Identification:
Emergency Overview: Accumulation of overhead settled dust my form explosive concentrations in air
when disturbed and dispersed.
Potential Health
Effects: Minimally irritating to the eyes and skin.
First Aid Measures:
1. Eyes: Flush with water for at least 15 minutes. If irritation occurs and persists, obtain
medical attention.
2. Skin: Wash with plenty of soap and water. Get medical attention of irritation occurs
and persists.
3. Inhalation: Remove to fresh air. If breathing difficulty or discomfort occurs and persists,
obtain medical attention.
4. Ingestion: Drink plenty of water. Never give anything by mouth to an unconscious person.
If any discomfort persists, obtain medical attention.
Notes to Medical
Doctor: AC-DI-Sol Croscarmellose Sodium has a very low toxicity. Treatment is
symptomatic and supportive only.
Fire Fighting
Measures:
Extinguishing
Media: Water.
Unusual Fire and
Explosion Hazard: Accumulation of overhead settled dust may form explosive concentrations in air
when disturbed and dispersed. The propagation of flame through air-floated dusts
takes place usually following a small explosion which shakes down accumulated
dust.
Special Fire Fighting
Procedures: For fires involving this material, do not enter any enclosed or confined fire space
without wearing full protective clothing and self-contained breathing apparatus
(SCBA) approved for firefighting. This is necessary to protect against the
hazards of heat, products of combustion and oxygen deficiency. Do not breathe
smoke, gases or vapors generated.
Hazardous
Decomposition
Products: None known.
Exposure Controls/
Personal Protection:
1. Respiratory: Whenever dust in the worker's breathing zone cannot be controlled with
ventilation, workers should wear respirators which are approved by
NIOSH/MSHA (or equivalent agency) for protection against airborne dust.
2. Eyes: Whenever airborne dust concentrations are high, appropriate protective eyewear,
such as monogoggles, should be worn to prevent eye contact.
3. Gloves: Not required.
4. Special Clothing
& Equipment: Not required.
5. Exposure Limits: None known.
TECHNOLOGICAL INFORMATION
Eye Contact: Minimally irritating (Rabbit). FMC study number I82-603.
Skin Contact: Minimally irritating. Primary Irritation Index (Rabbit) = 0.1/8.0 FMC Study
Number I82-602. Non-sensitizing (Guinea Pig). FMC Study Number I91-1186.
Skin Absorption: Dermal LD50 (Rabbit) > 2 g/kg. FMC Study Number I82-601.
Inhalation: No mortality in rats at maximum a concentration. 4 hour LC50 > 0.13 mg/l.
FMC Study Number I82-604.
Ingestion: Oral LD50 (Rat) > 5050 mg/kg. FMC Study Number I80-433.
Acute Effects for
Overexposure: No significant hazard in animal toxicity tests.
Chronic Effects
from Overexposure: AC-DI-SOL SD-711 was negative (nonmutagenic) in the Ames test (FMC Study
Number I87-960) and did not induce chromosome aberrations in rats (FMC
Study Number I87-979), A 90 day animal study showed no adverse effects when
administered in the diet (FMC Study Number I80-434). No adverse human
effects known.
COLLOIDAL SILICON DIOXIDE (CAB-O-SIL): CAS # 112945-52-5
Effects of Overexposure:
ACUTE: None known other than possible temporary discomfort due to inhalation of dust
concentration above the permissible exposure limit.
CHRONIC: None Known.
Emergency and First
Aid Procedures: Flush eyes with plenty of water. For inhalation discomfort, move victim to fresh
air.
STEARIC ACID: CAS # 57-11-4
Signs and Symptoms
of Over Exposure
1. Inhalation Nuisance dust may cause coughing, sneezing or labored breathing if large
amount are inhaled.
2. Ingestion No adverse effects expected.
3. Skin Mild irritant, possibly causing surface inflammation, especially on prolonged
contact with oily skin.
4. Eyes May cause mechanical irritation.
Emergency and First
Aid Procedures
1. Inhalation Remove to fresh air. Get medical attention for any breathing difficulty.
2. Ingestion If large amounts were swallowed, give water to drink and get medical advise.
3. Skin Not expected to require first aid measures.
4. Eyes Wash thoroughly with running water. Get medical advise if irritation develops.
MAGNESIUM STEARATE: CAS # 557-04-0
Signs and Symptoms of Overexposure:
1. Inhalation: Symptoms from excessive inhalation of dust may include coughing and difficult
breathing.
2. Ingestion: Low level of toxicity by ingestion.
3. Skin Contact: No information found. Not expected to be a hazard.
4. Eye Contact: May cause mechanical irritation.
5. Chronic Exposure: Grossly excessive and chronic inhalation of the dust may cause a progressive
chemical pneumonitis.
6. Aggravation of
Pre-existing
Conditions: Persons with pre-existing skin disorders, impaired respiratory function, or a
history of pulmonary disease should not be exposed to dusts.
MATERIAL SAFETY DATA SHEET
FMOM No.: 90-0006-2.22 DATE: 1/14/00
PRODUCT NAME: Ethambutol HCl Pre-mix
POTENCY: N/A
BATCH SIZE: 183.6 kg
ETHAMBUTOL HYDROCHLORIDE CAS #74-55-5
Threshold Limit
Value Signs and
Symptoms of
Overexposure: None established
TDL0: 45 mg/Kg/3D-I oral-man;
TDL0: 46 mg/Kg/3D-I oral-man;
TDL0: 720 mg/Kg/48D unreported-woman
LD50: 6800 mg/Kg oral/rats
LD50: 1200 mg/Kg intraperitoneal-rat;
LD50: 300 mg/Kg intravenous-rat;
LD50: 8890 mg/Kg oral-mouse;
LD50: 1800 mg/Kg subcutaneous-mouse;
LD50: 230 mg/Kg intravenous-mouse;
Mutation data (RTECS)
TDL0: 900 mg/Kg56OD-(oral-woman)
TDL0: 600 mg/Kg oral-man;
TDL0: 1200 mg/Kg- oral-man;
LD50: 8700 mg/Kg oral mouse;
LD50: 1075 mg/Kg intraperitoneal-mouse
LD50: 240 mg/Kg intravenous-mouse;
LD50: 890 mg/Kg subcutaneous-mammal;
LD50: 300 mg/Kg intravenous-mammal;
Possible allergic reaction to dust if inhaled, ingested or in contact with skin.
Adverse effects include blurred vision, eye pain, red7green color blindness, or
any loss of vision.
ACUTE: Eye, skin and/or respiratory tract irritation.
CHRONIC: Possible hypersensitization
PRECAUTION TO
CONSIDER: Persons developing hypersensitivity (anaphylactic) reactions must receive
immediate medical attention. Material may be irritation to mucous membranes
and respiratory tract. As a general rule, when handling USP Reference Standards
avoid all contact and inhalation of dust, fumes, mists, and/or vapors associated
with the material. Keep container tightly closed and use with adequate
ventilation; wash thoroughly after handling. Individuals working with chemicals
should consider all chemicals to be potentially hazardous even if their individual
hazards may be uncharacterized or unknown. Ethambutol crosses the placenta,
resulting in fetal plasma concentrations approximately 30% of material plasma
concentrations. Problems in humans have not been documented. However,
studies in mice given high doses have shown that Ethambutol causes low
incidence of cleft palate etc. (USP DI, 10th Edition).
Emergency and First
Aid Procedures: Remove from exposure. Remove contaminated clothing. Person developing
serious hypersensitivity reactions must receive immediate attention. Upon eye or
skin contact, flush affected area with copious quantities of water. Obtain medical
attention. If not breathing give artificial respiration. If breathing is difficult, give
oxygen.
1. Inhalation: May cause irritation of respiratory tract. Avoid inhalation. Remove to fresh air.
2. Eyes: May cause irritation. Flush with copious quantities of water.
3. Skin: May cause irritation. Flush with copious amounts of water.
4. Ingestion: May cause irritation. Flush out mouth with water.
LACTOSE MONOHYDRATE: CAS 163-42-3
Signs and Symptoms
of Overexposure: None - Not a Health Hazard.
CORN STARCH (Purity 21): CAS #9005-25-8
Effects of
Overexposure
Acute Overexposure: NONE
Chronic
Overexposure: NONE
Emergency and First
Aid Procedures
Eyes: Flush with water.
Skin: N/A
Inhalation: N/A
Ingestion: N/A
CROSCARMELLOSE SODIUM (AC-DI-SOL): CAS #74811-65-7
Hazards Identification:
Emergency Overview: Accumulation of overhead settled dust my form explosive concentrations in air
when disturbed and dispersed.
Potential Health
Effects: Minimally irritating to the eyes and skin.
First Aid Measures:
1. Eyes: Flush with water for at least 15 minutes. If irritation occurs and persists, obtain
medical attention.
2. Skin: Wash with plenty of soap and water. Get medical attention of irritation occurs
and persists.
3. Inhalation: Remove to fresh air. If breathing difficulty or discomfort occurs and persists,
obtain medical attention.
4. Ingestion: Drink plenty of water. Never give anything by mouth to an unconscious person.
If any discomfort persists, obtain medical attention.
Notes to Medical
Doctor: AC-DI-Sol Croscarmellose Sodium has a very low toxicity. Treatment is
symptomatic and supportive only.
Fire Fighting
Measures:
Extinguishing
Media: Water.
Unusual Fire and
Explosion Hazard: Accumulation of overhead settled dust may form explosive concentrations in air
when disturbed and dispersed. The propagation of flame through air-floated dusts
takes place usually following a small explosion which shakes down accumulated
dust.
Special Fire Fighting
Procedures: For fires involving this material, do not enter any enclosed or confined fire space
without wearing full protective clothing and self-contained breathing apparatus
(SCBA) approved for firefighting. This is necessary to protect against the
hazards of heat, products of combustion and oxygen deficiency. Do not breathe
smoke, gases or vapors generated.
Hazardous
Decomposition
Products: None known.
Exposure Controls/
Personal Protection:
1. Respiratory: Whenever dust in the worker's breathing zone cannot be controlled with
ventilation, workers should wear respirators which are approved by
NIOSH/MSHA (or equivalent agency) for protection against airborne dust.
2. Eyes: Whenever airborne dust concentrations are high, appropriate protective eyewear,
such as monogoggles, should be worn to prevent eye contact.
3. Gloves: Not required.
4. Special Clothing
& Equipment: Not required.
5. Exposure Limits: None known.
TECHNOLOGICAL INFORMATION
Eye Contact: Minimally irritating (Rabbit). FMC study number I82-603.
Skin Contact: Minimally irritating. Primary Irritation Index (Rabbit) = 0.1/8.0 FMC Study
Number I82-602. Non-sensitizing (Guinea Pig). F'MC Study Number I91-1186.
Skin Absorption: Dermal LD50 (Rabbit) > 2 g/kg. FMC Study Number I82-601.
Inhalation: No mortality in rats at maximum a concentration. 4 hour LC50 > 0.13 mg/l.
FMC Study Number I82-604.
Ingestion: Oral LD50 (Rat) > 5050 mg/kg. FMC Study Number I80-433.
Acute Effects for
Overexposure: No significant hazard in animal toxicity tests.
Chronic Effects
from Overexposure: AC-DI-SOL SD-711 was negative (nonmutagenic) in the Ames test (FMC Study
Number I87-960) and did not induce chromosome aberrations in rats (FMC
Study Number I87-979), A 90 day animal study showed no adverse effects when
administered in the diet (FMC Study Number I80-434). No adverse human
effects known.
POVIDONE: CAS # 9003-35-8
Signs and Symptoms
of Exposure
Symptoms of
Ingestion: No effects of exposure expected.
Symptoms of
Inhalation: If misted, no effects of exposure expected.
Symptoms of Skin
Contact: No effects of exposure expected due to absorption or contact. May possibly
cause irritation or dermatitis in some individuals upon prolonged contact.
Symptoms of Eye
Contact: No effects of exposure expected with the exception of possible irritation.
Emergency and First
Aid Procedure
First Aid for
Ingestion: General precautionary measures suggest inducing vomiting immediately by
giving two glasses of water and sticking finger down throat. Never give anything
by mouth to an unconscious person. Call a physician.
First Aid for
Inhalation: None required.
First Aid for Skin
Contact: For all foreign materials, wash after exposure.
First Aid for Eye
Contact: For all foreign materials, immediately flush eyes with plenty of water.
Medical Conditions
Aggravated by
Exposure: No Data Found.
DOCUSATE SODIUM (DIOCTYL SODIUM SULFOSUCCINATE): CAS #577-11-7
HEALTH HAZARD DATA
ACUTE EFFECTS: Harmful if swallowed. May be harmful if inhaled. May be harmful if absorbed
through the skin. Causes eye and skin irritation. Material is irritating to mucous
membranes and upper respiratory tract. To the best of our knowledge, the
chemical, physical, and toxicological properties have not been thoroughly
investigated.
FIRST AID: In case of contact, immediately flush eyes with copious amounts of water for at
least 15 minutes.
In case of contact, immediately wash skin with soap and copious amounts of
water.
If inhaled, remove to fresh air. If not breathing give artificial respiration. If
breathing is difficult, give oxygen. call a physician.
Wash contaminated clothing before reuse.
FIRE AND EXPLOSION HAZARD DATA
Extinguishing
Media: Water spray.
Carbon Dioxide, Dry Chemical Powder, Alcohol or Polymer Foam.
Fire Fighting
Procedures: Wear self-contained breathing apparatus and protective clothing to prevent
contact with skin and eyes.
Unusual Fire and
Explosion Hazard: Emits toxic fumes under fire conditions.
MATERIAL SAFETY DATA SHEET
FMOM No.: 9101C-1MM-0.13 DATE: 7/8/99
PRODUCT NAME: Ethambutol HCl F/C Tablet Cores
POTENCY: 400 mg
BATCH SIZE: 1,000,000 Tablets
ETHAMBUTOL HYDROCHLORIDE: CAS #74-55-5
Threshold Limit Value
Signs and Symptoms
of Overexposure: None established
TDLo: 45 mg/Kg/3D-I oral-man;
TDLo: 46 mg/Kg/3D-( oral-man;
TDLo: 720 mg/Kg/48D unreported-woman
LD50: 6800 mg/Kg oral/rats
LD50: 1200 mg/Kg intraperitoneal-rat;
LD50: 300 mg/Kg intravenous-rat;
LD50: 8890 mg/Kg oral-mouse;
LD50: 1800 mg/Kg subcutaneous-mouse;
LD50: 230 mg/Kg intervenous-mouse; Mutation data (RTECS))
TDLo: 900 mg/Kg56OD-(oral-woman)
TDLo: 600 mg/Kg oral-man;
TDLo: 1200 mg/Kg- oral-man;
LD50: 8700 mg/Kg oral mouse;
LD50: 1075 mg/Kg intraperitoneal-mouse
LD50: 240 mg/Kg intravenous-mouse;
LD50: 890 mg/Kg subcutaneous-mammal;
LD50: 300 mg/Kg intravenous-mammal;
Possible allergic reaction to dust if inhaled, ingested or in contact with
skin. Adverse effects include blurred vision, eye pain, red 7green color
blindness, or any loss of vision.
ACUTE: Eye, skin and/or respiratory tract irritation.
CHRONIC: Possible hypersensitization
PRECAUTION TO
CONSIDER: Persons developing hypersensitivity (anaphylactic) reactions must receive
immediate medical attention. Material may be irritation to mucous membranes and
respiratory tract. As a general rule, when handling USP Reference Standards avoid
all contact and inhalation of dust, fumes, mists, and/or vapors associated with the
material. Keep container tightly closed and use with adequate ventilation; wash
thoroughly after handling. Individuals working with chemicals should consider all
chemicals to be potentially hazardous even if their individual hazards may be
uncharacterized or unknown. Ethambutol crosses the placenta, resulting in fetal
plasma concentrations approximately 30% of material plasma concentrations.
Problems in humans have not been documented. However, studies in mice given
high doses have shown that Ethambutol causes low incidence of cleft palate etc.
(USP DI, 10th Edition).
Emergency And First
Aid Procedures: Remove from exposure. Remove contaminated clothing. Person developing serious
hypersensitivity reactions must receive immediate attention. Upon eye or skin
contact, flush affected area with copious quantities of water. Obtain medical
attention. If not breathing give artificial respiration. If breathing is difficult, give
oxygen.
1. Inhalation: May cause irritation of respiratory tract. Avoid inhalation. Remove to fresh air.
2. Eyes: May cause irritation. Flush with copious quantities of water.
3. Skin: May cause irritation. Flush with copious amounts of water.
4. Ingestion: May cause irritation. Flush out mouth with water.
F/C SOLUTION CONTAINS:
OPADRY WHITE YS 1-7003: CAS # N/A
Unusual Fire and
Explosion Hazards: None
Effects of
Overexposure: None
Primary Route(s)
of Entry: Inhalation
Emergency and First
Aid Procedures: In case of accidental eye contact, flush eyes with water. If irritation exists, obtain
medical attention.
Ventilation: Sufficient to prevent inhalation of dust.
Respiratory
Protection: An approved dust respirator should be worn.
Protective Clothing: Gloves and coveralls recommended to protect from dust.
Eye Protection: Safety goggles.
POLISHING SOLUTION CONTAINS:
POLYETHYLENE GLYCOL 400: CAS #25322-68-3
Signs and Symptoms
of Overexposure:
1. Ingestion No evidence of adverse effects from available information.
2. Skin Absorption No evidence of adverse effects from available information.
3. Inhalation No evidence of adverse effects from available information.
4. Skin Contact No evidence of adverse effects from available information.
5. Eye Contact No evidence of adverse effects from available information.
Effects of Repeated
Over Exposure No evidence of adverse effects from available information.
Other Effects of
Over Exposure: This material may contribute to nuisance dusts and possibly to respirable dusts;
avoid breathing dusts. overexposure to vapors generated at high temperatures may
result in eye and respiratory tract irritation and the inhalation of harmful amounts of
material.
Emergency and First
Aid Procedures
1. Ingestion No harmful effects expected.
2. Skin Wash with soap and water.
3. Inhalation No emergency care anticipated.
4. Eyes Flush with water.
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