Superiority:

SAFETY DATA SHEETS

According to the UN GHS revision 10

Version: 1.0

Creation Date: July 15, 2019

Revision Date: July 15, 2019

SECTION 1: Identification

1.1GHS Product identifier

Product name	Erythromycin

1.2Other means of identification

Product number	-
Other names	Ergel; USP; E.E.S

1.3Recommended use of the chemical and restrictions on use

Identified uses	Industrial and scientific research use.
Uses advised against	no data available

 

SECTION 2: Hazard identification

 

2.1Classification of the substance or mixture

Not classified.

2.2GHS label elements, including precautionary statements

Pictogram(s)	No symbol.
Signal word	No signal word
Hazard statement(s)	none
Precautionary statement(s)
Prevention	none
Response	none
Storage	none
Disposal	none

2.3Other hazards which do not result in classification

no data available

SECTION 3: Composition/information on ingredients

3.1Substances

Chemical name	Common names and synonyms	CAS number	EC number	Concentration
Erythromycin	Erythromycin	114-07-8	204-040-1	100%

SECTION 4: First-aid measures

4.1Description of necessary first-aid measures

If inhaled

Move the victim into fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration and consult a doctor immediately. Do not use mouth to mouth resuscitation if the victim ingested or inhaled the chemical.

Following skin contact

Take off contaminated clothing immediately. Wash off with soap and plenty of water. Consult a doctor.

Following eye contact

Rinse with pure water for at least 15 minutes. Consult a doctor.

Following ingestion

Rinse mouth with water. Do not induce vomiting. Never give anything by mouth to an unconscious person. Call a doctor or Poison Control Center immediately.

4.2Most important symptoms/effects, acute and delayed

SYMPTOMS: Symptoms of exposure to this compound include nausea, vomiting, diarrhea and abdominal cramps. Chronic overexposure may cause jaundice. This may be accompanied by fever, leukocytosis, eosinophilia and elevated activities of transaminases in plasma. Allergic reactions to this compound may include fever, eosinophilia, skin eruptions, urticaria and anaphylaxis. Cholestatic hepatitis occurs rarely. Epigastric distress, possibly severe may also occur. Intramuscular injections of large quantities of this compound may cause extremely severe pain that persists for hours. Intravenous infusions of 1 gram doses have reportedly been followed by thrombophlebitis. Prolonged use may result in an overgrowth of nonsusceptible bacteria or fungi. There have been isolated reports of reversible hearing loss occurring after exposure to this chemical, chiefly in persons with renal insufficiency. ACUTE/CHRONIC HAZARDS: When heated to decomposition, this compound may emit toxic fumes of NOx. (NTP, 1992)

4.3Indication of immediate medical attention and special treatment needed, if necessary

Decontamination: Administer activated charcoal orally if conditions are appropriate. Gastric lavage is not necessary after small to moderate ingestions if activated charcoal can be given promptly. Antibacterial agents

SECTION 5: Fire-fighting measures

5.1Suitable extinguishing media

As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.

5.2Specific hazards arising from the chemical

Flash point data for this chemical are not available; however, it is probably combustible. (NTP, 1992)

5.3Special protective actions for fire-fighters

Wear self-contained breathing apparatus for firefighting if necessary.

SECTION 6: Accidental release measures

6.1Personal precautions, protective equipment and emergency procedures

Avoid dust formation. Avoid breathing mist, gas or vapours.Avoid contacting with skin and eye. Use personal protective equipment.Wear chemical impermeable gloves. Ensure adequate ventilation.Remove all sources of ignition. Evacuate personnel to safe areas.Keep people away from and upwind of spill/leak.

6.2Environmental precautions

Prevent further spillage or leakage if it is safe to do so. Do not let the chemical enter drains. Discharge into the environment must be avoided.

6.3Methods and materials for containment and cleaning up

Wear approved respiratory protection, chemically compatible gloves, and protective clothing. Wipe up spillage or collect spillage using a high-efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriate labeled container for disposal. Wash spill site.

SECTION 7: Handling and storage

7.1Precautions for safe handling

Handling in a well ventilated place. Wear suitable protective clothing. Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Use non-sparking tools. Prevent fire caused by electrostatic discharge steam.

7.2Conditions for safe storage, including any incompatibilities

Commercially available erythromycin topical solutions and gels should be stored at 15 - 30 deg C; exposure to heat or open flames should be avoided. The topical ointment should be stored at a temperature less than 27 deg C.

SECTION 8: Exposure controls/personal protection

8.1Control parameters

Occupational Exposure limit values

no data available

Biological limit values

no data available

8.2Appropriate engineering controls

Ensure adequate ventilation. Handle in accordance with good industrial hygiene and safety practice. Set up emergency exits and the risk-elimination area.

8.3Individual protection measures, such as personal protective equipment (PPE)

Eye/face protection

Wear tightly fitting safety goggles with side-shields conforming to EN 166(EU) or NIOSH (US).

Skin protection

Wear fire/flame resistant and impervious clothing. Handle with gloves. Gloves must be inspected prior to use. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.

Respiratory protection

If the exposure limits are exceeded, irritation or other symptoms are experienced, use a full-face respirator.

Thermal hazards

no data available

SECTION 9: Physical and chemical properties and safety characteristics

Physical state	PHYSICAL DESCRIPTION: Fluffy colorless powder or fine white powder. (NTP, 1992)
Colour	Hydrated crystals from water
Odour	Odorless
Melting point/freezing point	360°C(lit.)
Boiling point or initial boiling point and boiling range	359°C(lit.)
Flammability	no data available
Lower and upper explosion limit/flammability limit	no data available
Flash point	64°C(lit.)
Auto-ignition temperature	no data available
Decomposition temperature	no data available
pH	pH (saturated solution): 8 to 10.5; pH <4 is destructive
Kinematic viscosity	no data available
Solubility	less than 1 mg/mL at 72° F (NTP, 1992)
Partition coefficient n-octanol/water	no data available
Vapour pressure	4.94E-31mmHg at 25°C
Density and/or relative density	1.2g/cm3
Relative vapour density	no data available
Particle characteristics	no data available

SECTION 10: Stability and reactivity

10.1Reactivity

no data available

10.2Chemical stability

no data available

10.3Possibility of hazardous reactions

This material is assumed to be combustible.A base. Readily forms salts with acids. (NTP, 1992)

10.4Conditions to avoid

no data available

10.5Incompatible materials

no data available

10.6Hazardous decomposition products

When heated to decomp it emits toxic fumes of nitric oxides.

SECTION 11: Toxicological information

Acute toxicity

• Oral: LD50 - Mice and rats (male/female) - > 5 000 mg/kg bw. Remarks:Rats.
• Inhalation: no data available
• Dermal: no data available

Skin corrosion/irritation

no data available

Serious eye damage/irritation

no data available

Respiratory or skin sensitization

no data available

Germ cell mutagenicity

no data available

Carcinogenicity

no data available

Reproductive toxicity

no data available

STOT-single exposure

no data available

STOT-repeated exposure

no data available

Aspiration hazard

no data available

SECTION 12: Ecological information

12.1Toxicity

• Toxicity to fish: no data available
• Toxicity to daphnia and other aquatic invertebrates: no data available
• Toxicity to algae: no data available
• Toxicity to microorganisms: no data available

12.2Persistence and degradability

AEROBIC: Erythromycin was 0, 75, 100% degraded at 4, 20, and 30 deg C, respectively, in sandy loam soil plus cattle feces in 30 days; a half-life of 11 days was reported in feces-amended soil at 20 deg C(1). Degradation of erythromycin has been reported at 25% in 30 days using a sandy loam mixed with manure(2). Using the closed bottle test, erythromycin, present at 3 ug/L and 2.46 mg/L exhibited theoretical BODs of -3 and -3% after 14 and 28 days incubation, respectively, using an inoculum of municipal sewage treatment plant effluent and maintained at 20 deg C(3). Addition of a readily biodegradable source of organic carbon such as sodium acetate increased the theoretical BOD to 23.1% after 28 days(3). Using a sandy loam soil (pH 6.0-6.3, clay 16.3%; sand 60.0%; silt 23.7%) amended with chicken feces, 3% and 75% activity was lost in 30 days at 4 and 20 deg C, respectively, corresponding to a half-life of 11 days; 100% activity was observed at 30 deg C after 18 days, corresponding to a half-life of 8.5 days(4).

12.3Bioaccumulative potential

An estimated BCF of 49 was calculated in fish for erythromycin(SRC), using a log Kow of 3.06(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is moderate(SRC).

12.4Mobility in soil

The Koc of erythromycin is estimated as 570(SRC), using a log Kow of 3.06(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that erythromycin is expected to have low mobility in soil. Freundlich adsorption coefficients for erythromycin A of 3.1X10-23, 0.86, 1.9X10-14, 2.0X10-5, 0.50, 2.57, 0.94 and 4.95 have been reported using HK, KK, CaK, FeK, HM, KM, CaM and FeM homoionic clays, respectively, at 25 deg C(4). The pKa of erythromycin is 8.9(5), indicating that this compound will exist almost entirely in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(6).

12.5Other adverse effects

no data available

SECTION 13: Disposal considerations

13.1Disposal methods

Product

The material can be disposed of by removal to a licensed chemical destruction plant or by controlled incineration with flue gas scrubbing. Do not contaminate water, foodstuffs, feed or seed by storage or disposal. Do not discharge to sewer systems.

Contaminated packaging

Containers can be triply rinsed (or equivalent) and offered for recycling or reconditioning. Alternatively, the packaging can be punctured to make it unusable for other purposes and then be disposed of in a sanitary landfill. Controlled incineration with flue gas scrubbing is possible for combustible packaging materials.

SECTION 14: Transport information

14.1UN Number

ADR/RID: Not dangerous goods. (For reference only, please check.)

IMDG: Not dangerous goods. (For reference only, please check.)

IATA: Not dangerous goods. (For reference only, please check.)

14.2UN Proper Shipping Name

ADR/RID: Not dangerous goods. (For reference only, please check.)

IMDG: Not dangerous goods. (For reference only, please check.)

IATA: Not dangerous goods. (For reference only, please check.)

14.3Transport hazard class(es)

ADR/RID: Not dangerous goods. (For reference only, please check.)

IMDG: Not dangerous goods. (For reference only, please check.)

IATA: Not dangerous goods. (For reference only, please check.)

14.4Packing group, if applicable

ADR/RID: Not dangerous goods. (For reference only, please check.)

IMDG: Not dangerous goods. (For reference only, please check.)

IATA: Not dangerous goods. (For reference only, please check.)

14.5Environmental hazards

ADR/RID: No

IMDG: No

IATA: No

14.6Special precautions for user

no data available

14.7Transport in bulk according to IMO instruments

no data available

SECTION 15: Regulatory information

15.1Safety, health and environmental regulations specific for the product in question

Chemical name	Common names and synonyms	CAS number	EC number
Erythromycin	Erythromycin	114-07-8	204-040-1
European Inventory of Existing Commercial Chemical Substances (EINECS)			Listed.
EC Inventory			Listed.
United States Toxic Substances Control Act (TSCA) Inventory			Not Listed.
China Catalog of Hazardous chemicals 2015			Not Listed.
New Zealand Inventory of Chemicals (NZIoC)			Listed.
Philippines Inventory of Chemicals and Chemical Substances (PICCS)			Listed.
Vietnam National Chemical Inventory			Listed.
Chinese Chemical Inventory of Existing Chemical Substances (China IECSC)			Listed.
Korea Existing Chemicals List (KECL)			Listed.

SECTION 16: Other information

Information on revision

Creation Date	July 15, 2019
Revision Date	July 15, 2019

Abbreviations and acronyms

• CAS: Chemical Abstracts Service
• ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road
• RID: Regulation concerning the International Carriage of Dangerous Goods by Rail
• IMDG: International Maritime Dangerous Goods
• IATA: International Air Transportation Association
• TWA: Time Weighted Average
• STEL: Short term exposure limit
• LC50: Lethal Concentration 50%
• LD50: Lethal Dose 50%
• EC50: Effective Concentration 50%

 

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