Erythromycin Estolate

Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.
Potential Acute Health
Effects
CARCINOGENIC EFFECTS: Not available.
Potential Chronic Health
MUTAGENIC EFFECTS: Not available.
Effects
TERATOGENIC EFFECTS: Not available.
DEVELOPMENTAL TOXICITY: Not available.
The substance may be toxic to liver.
Repeated or prolonged exposure to the substance can produce target organs damage.

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Section 4. First Aid Measures
Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least
Eye Contact
15 minutes. Get medical attention if irritation occurs.
Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.
Skin Contact
Not available.
Serious Skin Contact
InhalationIf inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get
medical attention.
Serious InhalationNot available.
Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an
Ingestion
unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight
clothing such as a collar, tie, belt or waistband.
Not available.
Serious Ingestion

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Section 5. Fire and Explosion Data
Flammability of the Product May be combustible at high temperature.
Auto-Ignition Temperature Not available.
Not available.
Flash Points
Not available.
Flammable Limits
These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...).
Products of Combustion
Fire Hazards in Presence of Slightly flammable to flammable in presence of heat.
Various Substances
Risks of explosion of the product in presence of mechanical impact: Not available.
Explosion Hazards in
Risks of explosion of the product in presence of static discharge: Not available.
Presence of Various
Substances
SMALL FIRE: Use DRY chemical powder.
Fire Fighting Media
LARGE FIRE: Use water spray, fog or foam. Do not use water jet.
and Instructions
Material in powder form, capable of creating a dust explosion. As with most organic solids, fire is possible at elevated
Special Remarks on
temperatures
Fire Hazards
Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential dust
Special Remarks on
explosion hazard.
Explosion Hazards
Erythromycin Estolate

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Section 6. Accidental Release Measures
Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading
Small Spill
water on the contaminated surface and dispose of according to local and regional authority requirements.
Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on
Large Spill
the contaminated surface and allow to evacuate through the sanitary system.

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Section 7. Handling and Storage
Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not
Precautions
ingest. Do not breathe dust. Wear suitable protective clothing. If ingested, seek medical advice immediately and
show the container or the label.
Keep container tightly closed. Keep container in a cool, well-ventilated area.
Storage

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Section 8. Exposure Controls/Personal Protection
Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below
Engineering Controls
recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to
airborne contaminants below the exposure limit.
Personal ProtectionSafety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.
Personal Protection in Case Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used to
avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE
of a Large Spill
handling this product.
Exposure LimitsNot available.

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Section 9. Physical and Chemical Properties
Solid. (Crystalline powder.)Odorless.
Physical state andO dor
appearance
Not available.
Taste
1056.39 g/mole
Molecular Weight
White.
Color
Not applicable.
pH (1% soln/water)
Not available.
Boiling Point
Decomposition temperature: 135°C (275°F) - 140 C.
Melting Point
Not available.
Critical Temperature
Not available.
Specific Gravity
Not applicable.
Vapor Pressure
Not available.
Vapor Density
Not available.
Volatility
Not available.
Odor Threshold
Not available.
Water/Oil Dist. Coeff.
Not available.
Ionicity (in Water)
Not available.
Dispersion Properties
Insoluble in cold water.
Solubility
Erythromycin Estolate

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Section 10. Stability and Reactivity Data
The product is stable.
Stability
Not available.
Instability Temperature
Conditions of Instability Excess heat, dust generation
Incompatibility with various Not available.
substances
Not available.
Corrosivity
Not available.
Special Remarks on
Reactivity
Not available.
Special Remarks on
Corrosivity
Will not occur.
Polymerization

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Section 11. Toxicological Information
Inhalation. Ingestion.
Routes of Entry
Acute oral toxicity (LD50): 1447 mg/kg [Rat].
Toxicity to Animals
Chronic Effects on Humans May cause damage to the following organs: liver.
Other Toxic Effects onSlightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.
Humans
Not available.
Special Remarks on
Toxicity to Animals
May cause adverse reproductive effects.
Special Remarks on
Chronic Effects on Humans
Special Remarks on otherAcute Potential Health Effects:
Toxic Effects on HumansSkin: May cause skin irritation.
Eyes: May cause eye irritation.
Inhalation: May cause respiratory tract irritation.
Ingestion: May cause nausea, vomiting, abdominal cramps, diarrhea. May affect the liver. May cause hearing loss.
Chronic Potential Health Effects:
Ingestion: May cause symtoms similar to acute ingestion. May cause weight loss. May affect the liver.
Medical Conditions Aggravated by Exposure: Hypersensitivity to material; impaired liver function; hearing loss;
history of cardiac arrhythmias or QT prolongation.

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Section 12. Ecological Information
Not available.
Ecotoxicity
Not available.
BOD5 and COD
Products of Biodegradation Possibly hazardous short term degradation products are not likely. However, long term degradation products may
arise.
The products of degradation are less toxic than the product itself.
Toxicity of the Products
of Biodegradation
Not available.
Special Remarks on the
Products of Biodegradation
Erythromycin Estolate

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Section 13. Disposal Considerations
Waste must be disposed of in accordance with federal, state and local environmental control
Waste Disposal
regulations.

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Section 14. Transport Information
Not a DOT controlled material (United States).
DO T Cl assi fi cati on
Not applicable.
Identification
Not applicable.
Special Provisions for
Transport
DO T (Pi ctograms)

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Section 15. Other Regulatory Information and Pictograms
No products were found.
Federal and State
Regulations
California prop. 65: This product contains the following ingredients for which the State of California has found to
California
cause cancer which would require a warning under the statute: No products were found.
Proposition 65
Warnings
California prop. 65: This product contains the following ingredients for which the State of California has found to
cause birth defects which would require a warning under the statute: No products were found.
Other RegulationsEINECS: This product is on the European Inventory of Existing Commercial Chemical Substances (EINECS No.
222-532-4).
Canada: Not listed on Canadian Domestic Substance List (DSL) or Candian Non-Domestic Substances List (NDSL)
China: Not listed on National Inventory.
Japan: Not listed on National Inventory (ENCS).
Korea: Listed on National Inventory (KECI).
Philippines: Not listed on National Inventory (PICCS).
Australia: Listed on AICS.
WHMIS (Canada) Not controlled under WHMIS (Canada).
Other Classifications
R22- Harmful if swallowed.S46- If swallowed, seek medical advice
DSCL (EEC)
immediately and show this container or label.
Health Hazard
HMIS (U.S.A.)1 National Fire Protection
1 Flammability
1 Association (U.S.A.)
Fire Hazard
1 0 Reactivity
Health
Reactivity0
Specific hazard
Personal Protection
E
WHMIS (Canada)
(Pictograms)
DSCL (Europe)
(Pictograms)
Erythromycin Estolate
TDG(Canada)
(Pictograms)
ADR (Europe)
(Pictograms)
Protective Equipment
Gloves.
Lab coat.
Dust respirator. Be sure to use an
approved/certified respirator or equivalent.

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SECTION 16 - ADDITIONAL INFORMATION
N/A

MOLECULAR WEIGHT :

1056.56

WISWESSER LINE NOTATION :

T-14-VO GVTJ C2 DQ D1 EQ F1 H1 JQ J1 L1 N1 KO- BT6OTJ CQ DN1&1 F1& MO- FT6OTJ B1 CQ DO1 D1

HEALTH HAZARD DATA

ACUTE TOXICITY DATA

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Oral

SPECIES OBSERVED :

Rodent - rat

DOSE/DURATION :

1447 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- Volume(issue)/page/year: 18,185,1971

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Subcutaneous

SPECIES OBSERVED :

Rodent - rat

DOSE/DURATION :

>6450 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo, Japan) Volume(issue)/page/year: -,211,1990

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Oral

SPECIES OBSERVED :

Rodent - mouse

DOSE/DURATION :

>6450 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo, Japan) Volume(issue)/page/year: -,211,1990

TYPE OF TEST :

LD50 - Lethal dose, 50 percent kill

ROUTE OF EXPOSURE :

Subcutaneous

SPECIES OBSERVED :

Rodent - mouse

DOSE/DURATION :

>6450 mg/kg

TOXIC EFFECTS :

Details of toxic effects not reported other than lethal dose value

REFERENCE :

NIIRDN Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo, Japan) Volume(issue)/page/year: -,211,1990 ** OTHER MULTIPLE DOSE TOXICITY DATA **

TYPE OF TEST :

TDLo - Lowest published toxic dose

ROUTE OF EXPOSURE :

Oral

SPECIES OBSERVED :

Rodent - rat

DOSE/DURATION :

48488 mg/kg/6W-I

TOXIC EFFECTS :

Skin and Appendages - hair Nutritional and Gross Metabolic - weight loss or decreased weight gain Related to Chronic Data - death

REFERENCE :

APTOA6 Acta Pharmacologica et Toxicologica. (Copenhagen, Denmark) V.1-59, 1945-86. For publisher information, see PHTOEH Volume(issue)/page/year: 25,435,1967 *** NIOSH STANDARDS DEVELOPMENT AND SURVEILLANCE DATA *** NIOSH OCCUPATIONAL EXPOSURE SURVEY DATA : NOES - National Occupational Exposure Survey (1983) NOES Hazard Code - X5545 No. of Facilities: 39 (estimated) No. of Industries: 1 No. of Occupations: 3 No. of Employees: 1088 (estimated) No. of Female Employees: 542 (estimated)