SAFETY DATA
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SECTION 1: PRODUCT IDENTIFICATION
PRODUCT NAME POLYPEG SUPPOSITORY BASE
PRODUCT CODE 0746
SUPPLIER MEDISCA Inc.
Tel.: 1.800.932.1039 | Fax.: 1.855.850.5855
626 Tom Miller Road, Plattsburgh, NY, 12901
MEDISCA Pharmaceutique Inc.
Tel.: 1.800.665.6334 | Fax.: 514.338.1693
4509 Rue Dobrin, St. Laurent, QC, H4R 2L8
MEDISCA Australia PTY LTD
Tel.: 1.300.786.392 | Fax.: 61.2.9700.9047
Unit 7, Heritage Business Park
5-9 Ricketty Street, Mascot, NSW 2020
EMERGENCY PHONE CHEMTREC Day or Night Within USA and Canada: 1-800-424-9300
NSW Poisons Information Centre: 131 126
National Chemical Emergency Centre 44(0)1235239670
RECOMMENDED USES Pharmaceutical Manufacturing
RESTRICTIONS ON USE Not applicable
SECTION 2: HAZARDS IDENTIFICATION
GHS CLASSIFICATION Based on available data, the classification criteria are not met.
PICTOGRAM Not Applicable
SIGNAL WORD Not applicable
HAZARD STATEMENT(S) Not applicable
ADVERSE PHYSIOCHEMICAL, Not applicable
HUMAN HEALTH AND
ENVIRONMENTAL EFFECTS
PRECAUTIONARY STATEMENT(S) Prevention Not applicable
Response Not applicable
Storage Not applicable
Disposal Not applicable
HMIS CLASSIFICATION Health Hazard 0 Flammability 0
Reactivity 0 Personal Protection A
SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS
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CHEMICAL NAME Not applicable
BOTANICAL NAME Not applicable
SYNONYM Not applicable
CHEMICAL FORMULA Not applicable
CHEMICAL FAMILY Not applicable
CAS NUMBER Not applicable
ALTERNATE CAS NUMBER Not applicable
MOLECULAR WEIGHT Not applicable
COMPOSITION CHEMICAL NAME CAS NUMBER EC NUMBER % BY WEIGHT
Mixture Not applicable Not applicable Not applicable
There are no additional ingredients present which, within the current knowledge of the supplier and in the
concentrations applicable, are classified as health hazards and hence require reporting in this section.
NOTES Blend of different molecular weights of polyethylene glycols.
*Proprietary: Ingredients indicated as hazardous have been assessed under standards for workplace
safety. In accordance with 29 CFR 1910.1200, the exact percentage composition of this mixture has been
withheld as trade secret.
SECTION 4: FIRST-AID MEASURES
IN CASE OF EYE CONTACT Flush with copious amounts of water for 15 minutes, separating eyelids with fingers. If irritation persists
seek medical aid.
IN CASE OF SKIN CONTACT Not expected to be a hazard under anticipated conditions of normal use. Wash with soap and water if
irritation occurs. Seek medical attention if irritation develops and persists.
IF SWALLOWED Call a physician. Wash out mouth with water. Do not induce vomiting without medical advice.
IF INHALED Not expected to be a hazard under anticipated conditions of normal use. Remove to fresh air. If not
breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.
MEDICAL ATTENTION AND Get emergency medical help.
SPECIAL TREATMENT
SYMPTOMS CAUSED BY Not expected to present a significant hazard under anticipated conditions of normal use.
EXPOSURE
SECTION 5: FIREFIGHTING MEASURES
SPECIFIC HAZARDS ARISING Not applicable
FROM THE CHEMICAL
FLAMMABLE PROPERTIES May be combustible at high temperature
HAZARDOUS COMBUSTION Under fire conditions, hazardous fumes will be present.
PRODUCTS
SUITABLE & UNSUITABLE Small fire: dry chemical, CO₂ or water spray. Large fire: dry chemical, CO₂, alcohol resistant foam or
EXTINGUISHING MEDIA water spray. Do not get water inside containers.
PROTECTIVE EQUIPMENT AND Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.
PRECAUTIONS FOR
FIREFIGHTERS
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SECTION 6: ACCIDENTAL RELEASE MEASURES
PERSONAL PRECAUTIONS Wear respiratory protection.Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate
personnel to safe areas. Avoid breathing dust.
METHODS & MATERIAL FOR On land, sweep or shovel into suitable containers. Minimize generation of dust.
CONTAINMENT
CLEANUP PROCEDURE Shut off all sources of ignition. Evacuate the area. Wear respirator, chemical safety goggles, rubber boots
and heavy rubber gloves. If necessary, employ water fog to disperse the vapors. Absorb the matter with
compatible vermiculite or other absorbing material. Place in a suitable container and retain for disposal.
Ventilate and clean the affected area. Do not flush into sewerage system or to drains.
REFERENCE TO OTHER See Section 7 for information on safe handling. See Section 8 for information on personal protection
SECTIONS equipment. See Section 13 for disposal information.
SECTION 7: HANDLING AND STORAGE
PRECAUTIONS FOR SAFE Do not inhale. Avoid contact with eyes, skin and clothing. Avoid prolonged or repeated exposure. Wash
HANDLING thoroughly after handling. Store away from incompatible materials, in a well-ventilated area. Eliminate all
sources of ignition. Store in accordance with local regulations. Do not store in unlabeled containers.
Containers that have been opened must be carefully resealed and kept upright to prevent leakage. Use
appropriate containment to avoid environmental contamination.
CONDITIONS FOR SAFE Store away from incompatible materials, in a well-ventilated area. Eliminate all sources of ignition. Store
STORAGE in accordance with local regulations. Do not store in unlabeled containers. Containers that have been
opened must be carefully resealed and kept upright to prevent leakage. Use appropriate containment to
avoid environmental contamination.
STORAGE CONDITIONS Store in original container, tightly sealed, protected from direct sunlight and moisture.
Store at controlled room temperature indicates a temperature 20° to 25°C (68° to 77°F); that results in a
mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between
15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the
mean kinetic temperature remains in the allowed range, transient spikes up to 40°C (104°F) are permitted
as long as they do not exceed 24 hours.
SECTION 8: EXPOSURE CONTROLS/ PERSONAL PROTECTION
Chemical Name: Not applicable CAS #: Not applicable
Country Limit value-8 hours Limit value-Short Term IDLH REL Advisory Notes
ppm mg/m³ ppm mg/m³
OSHA USA N/L N/L N/L N/L N/L N/L N/A N/A
ACGIH USA N/L N/L N/L N/L N/L N/L N/A N/A
NIOSH USA N/L N/L N/L N/L N/L N/L N/A N/A
WEEL USA N/L N/L N/L N/L N/L N/L N/A N/A
HSIS Australia N/L N/L N/L N/L N/L N/L N/A N/A
HSE UK N/L N/L N/L N/L N/L N/L N/A N/A
GESTIS Add Country N/L N/L N/L N/L N/L N/L N/A N/A
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N/L = Not listed ; N/A = Not Available
PELs are 8-hour TWAs = Limit value - Eight hours
Ceiling or Short-Term TWA = STEL = Limit value - Short term
EXPOSURE GUIDELINES Consult local authorities for provincial or state exposure limits. Particulates not otherwise regulated,
respirable fraction: 5 mg/m³
PERSONAL PROTECTIVE Eyes: Wear appropriate protective eyeglasses or chemical safety goggles as described by WHMIS or
EQUIPMENT OSHA's eye and face protection regulations in 29 CFR 1910.133 or European Standard EN166. Skin:
Wear appropriate gloves to prevent skin exposure. Clothing: Wear appropriate protective clothing to
minimize contact with skin. Respirators: Follow WHMIS or OSHA respirator regulations found in 29 CFR
1910.134 or European Standard EN 149. Use a NIOSH/MSHA or European Standard EN 149 approved
respirator if exposure limits are exceeded or if irritation or other symptoms are experienced. Thermal
Hazards: For products representing a thermal hazard, appropriate Personal Protective Equipment should
be used.
SPECIFIC ENGINEERING Not needed for normal use. Operate according to good working practices.
CONTROLS
BIOLOGICAL MONITORING Not available
CONTROL BANDING Not available
SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES
PHYSICAL Solid
STATE
DESCRIPTION White solid with mild odor.
SOLUBILITY Soluble in water
ODOR Mild Polyethylene Glycol odor
FLAMMABILITY May be combustible at high temperature
AUTO-IGNITION Not available BOILING POINT Not available DECOMPOSITION Not available
TEMPERATURE TEMPERATURE
EVAPORATION RATE Not available EXPLOSIVE LIMIT Not available FLASH POINT Not available
log P Not available LOWER FLAMMABLE/ Not available MELTING/FREEZING (50 - 60)°C,
(OCTANOL-WATER) EXPLOSIVE LIMIT(S) POINT (122-140)°F
PARTICLE Not available OXIDIZING Not available pH 5.3 - 10.3
CHARACTERISTICS PROPERTY
RELATIVE DENSITY Not available SPECIFIC GRAVITY Not available UPPER FLAMMABLE/ Not available
(WATER = 1) EXPLOSIVE LIMIT(S)
VAPOR DENSITY Not available VAPOR PRESSURE Not available VISCOSITY Not available
(AIR = 1)
The physical data presented above are typical values and should not be construed as a specification.
NOTES Density: 1.156 g/mL
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SECTION 10: STABILITY AND REACTIVITY
REACTIVITY Not established
CHEMICAL STABILITY Stable under recommended storage conditions
INCOMPATIBLE MATERIALS Strong oxidants
HAZARDOUS DECOMPOSITION Toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides and other gases may occur
PRODUCTS
HAZARDOUS POLYMERIZATION Will not occur
POSSIBLITY OF HAZARDOUS Not established
REACTION
CONDITIONS TO AVOID Moisture, sunlight and extreme temperatures
SECTION 11: TOXICOLOGICAL INFORMATION
ACUTE TOXICITY Oral: Rat: LD50: (mg/kg): Not available
Dermal: Rabbit LD50: (mg/kg): Not available
Inhalation: Rat: LC50: (mg/L/4hr): Not available
SKIN CORROSION/IRRITATION Based on available data, the classification criteria are not met.
SERIOUS EYE DAMAGE/EYE Based on available data, the classification criteria are not met.
IRRITATION
RESPIRATORY SENSITIZATION Based on available data, the classification criteria are not met.
SKIN SENSITIZATION Based on available data, the classification criteria are not met.
GERM CELL MUTAGENICITY Based on available data, the classification criteria are not met.
CARCINOGENICITY OSHA No component of this product, present at ≥0.1%, is listed.
NTP No component of this product, present at ≥0.1%, is listed.
IARC No component of this product, present at ≥0.1% has been evaluated.
California No component of this product, present at ≥0.1% is known to the State of California to
Proposition cause cancer, birth defects, or any other reproductive harm: .
ADDITIONAL CARCINOGENICITY Based on available data, the classification criteria are not met.
INFORMATION
REPRODUCTIVE TOXICITY Based on available data, the classification criteria are not met.
SPECIFIC TARGET ORGAN Based on available data, the classification criteria are not met.
TOXICITY - SINGLE EXPOSURE
SPECIFIC TARGET ORGAN Based on available data, the classification criteria are not met.
TOXICITY - REPEATED
EXPOSURE
ASPIRATION HAZARDS Based on available data, the classification criteria are not met.
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SIGNS AND SYMPTOMS OF ROUTES OF EXPOSURE:
EXPOSURE Oral, Dermal, Inhalation, Eye contact
EARLY ONSET SYMPTOMS RELATED TO EXPOSURE:
Not available
DELAYED HEALTH EFFECT FROM EXPOSURE:
Not available
Not expected to present a significant hazard under anticipated conditions of normal use.
POTENTIAL HEALTH EFFECTS Inhalation Not expected to present a significant hazard under anticipated conditions of normal use.
Ingestion May be harmful if swallowed.
Skin Not expected to present a significant hazard under anticipated conditions of normal use.
Eyes May cause eye irritation.
SECTION 12: ECOLOGICAL INFORMATION
ECOTOXICITY EC50: 48 Hr: Crustacea: (mg/L): Not available
LC50: 96 Hr: Fish: (mg/L): Not available
EC50: 72 or 96 Hr: Algae (or other aqua plants): (mg/L): Not available
PERSISTENCE AND Not available
DEGRADABILITY
BIOACCUMULATIVE POTENTIAL Not available
MOBILITY IN SOIL Soluble in water
OTHER ADVERSE EFFECTS Not available
This product is not intended to be released into the environment
SECTION 13: DISPOSAL CONSIDERATIONS
DISPOSAL METHODS Dispose of in accordance with federal / local laws and regulations. Avoid release into the environment.
SECTION 14: TRANSPORT INFORMATION
UN PROPER SHIPPING NAME Not dangerous good
UN NUMBER Not applicable
CLASS Not applicable
PACKING GROUP Not applicable
AUSTRALIA
HAZCHEM Not Applicable
EU
TRANSPORT IN BULK ACCORDING
Not Listed
TO ANNEX II OF MARPOL 73/78
AND THE IBC CODE
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ENVIRONMENTAL HAZARDS Not available
SPECIAL SHIPPING Not applicable
INFORMATION
SECTION 15: REGULATORY INFORMATION
UNITED STATES REGULATIONS
CERCLA SARA (Title California
Chemical Name EPA 40 CFR Part 355 Right-to-know
40 CFR III) Prop 65
& CAS Appendix A Appendix B Pennsylvania New Jersey Massachusett
Part 302.4 40 CFR s
Mixture Not applicable N/L N/L N/L N/L N/L N/L N/L N/L
N/L = Not Listed; X = Listed
AUSTRALIAN REGULATIONS
Poisons and Therapeutic Code of Poisons Work Health Inventory of
Chemical Name
Therapeutic Goods Act Practices - Standard and Safety Industrial
& CAS
Goods Illicit Drug Regulations Chemicals
Mixture Not applicable N/L N/L N/L N/L N/L N/L
N/L = Not Listed
EU REGULATIONS
Chemical Name REACH REACH EC EC EC PIC - Prior EC
& CAS ANNEX ANNEX 1005/2009 850/2004 1107/2009 Informed 2012/18
Consent
XVII XIV
Regulation
Mixture Not applicable N/L N/L N/L N/L N/L N/L N/L
N/L = Not Listed; X = Listed
Any EU regulation not listed above is not applicable to this product.
SUBJECT TO INTERNATIONAL Not applicable
AGREEMENT
SECTION 16: OTHER INFORMATION
REFERENCES Available upon request
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ABBREVIATIONS AND ACRONYMS ACGIH - American Conference of Governmental Industrial Hygienists; AIHA WEEL – American
Industrial Hygiene Association Workplace Environment Exposure Levels; CAESAR – Computer Assisted
Evaluation of industrial chemical Substances According to Regulations; CAS – Chemical Abstract
Service; CERCLA – Comprehensive Environmental Response, Compensation, and Liability Act; EC50 –
Effective Concentration, 50%; EPA – Environmental Protection Agency; GHS – Global Harmonized
System; HMIS – Hazardous Materials Information System; HSE – Health and Safety Executive; HSIS –
Hazardous Substances Information System; IARC – International Agency for Research on Cancer; IDLH -
Immediately Dangerous to Life or Health; IRFMN – Ready Biodegradability Model; ISS – Instituto
Superiore Sanità; LC50 – Lethal Concentration, 50%; LD50 – Lethal Dose, 50%; MSHA - Mine Safety
and Health Administration; NIOSH – National Institute for Occupational Safety and Health; NTP –
National Toxicology Program; OSHA PEL – Occupational Safety & Health Administration Permissible
Exposure Limits; QSAR – Quantitative Structure-activity relationship; REL - Recommended Exposure
Limit; SARA – Superfund Amendments and Reauthorization Act; STEL – Short Term Exposure Limit;
TLV – Threshold Limit Value; TWA – Time Weighted Average; WHMIS – Workplace Hazardous Materials
Information System
LAST REVISION 07/2023
SUPERSEDES 05/2021
For a list of changes to the SDS since the last version, please communicate with MEDISCA at
www.medisca.com
DISCLAIMER This document was created in accordance with OSHA, Safe Work Australia and WHMIS regulations. The
above information is believed to be correct but does not purport to be all inclusive and shall be used only
as a guide. The information in this document is based on the present state of our knowledge and is
applicable to the product with regard to appropriate safety precautions. It does not represent any
guarantee of the properties of the product. MEDISCA® shall not be held liable for any damage resulting
from handling or from contact with the above product. Recipients of the product must take responsibility
for observing existing laws and regulations.
SUPPLEMENTARY INFORMATION For all country specific requirements not outlined on this Safety Data Sheet, please request
Supplementary Page to this Safety Data Sheet.
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