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2. HAZARDS IDENTIFICATION
Appearance: Statement of Hazard: Additional Hazard Information: Short Term: Long Term: Known Clinical Effects: Blue film-coated tablets Non-hazardous in accordance with international standards for workplace safety.
Active ingredient may be harmful if swallowed. May cause eye irritation (based on components) . Animal studies indicate that this material may cause adverse effects on the cardiovascular system. Adverse effects most commonly reported in clinical use include difficult digestion (dyspepsia), nose bleed, headache, flushing, insomnia, abnormal redness of skin (erythema), difficulty breathing, muscle pain, fever, gastrointestinal irritation, tingling/itching (paresthesia), transient changes in light perception and color vision, effects on hearing, and effects on vision. Not classified Non-Hazardous Substance. Non-Dangerous Goods.
This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Hazardous Ingredient Sildenafil citrate CAS Number 171599-83-0 EU EINECS/ELINCS List EU Classification Not Listed Xn;R22 % 23
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3. COMPOSITION/INFORMATION ON INGREDIENTS
Microcrystalline cellulose Titanium dioxide Magnesium stearate 9004-34-6 13463-67-7 557-04-0 232-674-9 236-675-5 209-150-3 Not Listed Not Listed Not Listed * * *
Ingredient FD & C Blue No. 2, Aluminum lake Lactose Monohydrate Triacetin Calcium phosphate dibasic, anhydrous Croscarmellose sodium Hydroxypropyl methylcelluslose Additional Information:
EU EINECS/ELINCS List EU Classification 240-589-3 Not Listed Not Listed Not Listed 203-051-9 Not Listed 231-826-1 Not Listed Not Listed Not Listed Not Listed Not Listed
% * * * * * *
* Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety.
For the full text of the R phrases mentioned in this Section, see Section 16
Ingestion: Inhalation:
Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - Hazards Identification and/or Section 11 - Toxicological Information.
Additional Information:
Not applicable
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Contain the source of spill if it is safe to do so. Collect spilled material by a method that controls dust generation. A damp cloth or a filtered vacuum should be used to clean spills of dry solids. Clean spill area thoroughly. Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release. Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel.
Storage Conditions:
10 mg/m3
350g/m3
10 mg/m3 10 mg/m3 10 mg/m3 10 mg/m3 10 mg/m3 10 mg/m3 4 mg/m3 2 mg/m3 15 mg/m3 10 mg/m3 10 mg/m3 10 mg/m3
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Analytical method available for Sildenafil. Contact Pfizer Inc for further information. Engineering controls should be used as the primary means to control exposures. General room ventilation is adequate unless the process generates dust, mist or fumes. Keep airborne contamination levels below the exposure limits listed above in this section. Refer to specific Member State legislation for requirements under Community environmental legislation. Refer to applicable national standards and regulations in the selection and use of personal protective equipment (PPE). Impervious gloves are recommended if skin contact with drug product is possible and for bulk processing operations. Wear safety glasses or goggles if eye contact is possible. Impervious protective clothing is recommended if skin contact with drug product is possible and for bulk processing operations. If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL.
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Acute Toxicity: (Species, Route, End Point, Dose) Microcrystalline cellulose Rat Oral LD50 > 5000 mg/kg Rabbit Dermal LD50 > 2000 mg/kg Magnesium stearate Rat Oral LD50 > 2000 mg/kg Rat Inhalation LC50 > 2000 mg/m3 Sildenafil citrate Rat Oral LDmin. 300-500 mg/kg Mouse Oral LDmin. 500-1000 mg/kg Rat Dermal LD50 > 2000 mg/kg Hydroxypropyl methylcelluslose Rat Oral LD50 > 10,000 mg/kg Titanium dioxide Rat Oral LD50 > 7500 mg/kg Rat Subcutaneous LD 50 50 mg/kg Lactose Monohydrate Rat Oral LD 50 29700 mg/kg Triacetin Rat Oral LD 50 3000 mg/kg Mouse Oral LD 50 1100 mg/kg A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable Acute Toxicity Comments: at the highest dose used in the test. Irritation / Sensitization: (Study Type, Species, Severity) Microcrystalline cellulose Skin Irritation Rabbit Non-irritating Eye Irritation Rabbit Non-irritating Sildenafil citrate Eye Irritation Rabbit Moderate Skin Irritation Rabbit Non-irritating Skin Sensitization Guinea Pig Negative Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ) Sildenafil citrate 6 Month(s) Rat 6 Month(s) Dog
Oral 3 mg/kg/day NOAEL Adrenal gland, Liver, Thyroid Oral 15 mg/kg/day NOAEL Cardiovascular system
Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s)) _______________________________________________________________________________________________________ 366
Negative
Negative
Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s)) Sildenafil citrate 24 Month(s) Mouse Oral 5 mg/kg/day 24 Month(s) Rat Oral 60 mg/kg/day Carcinogen Status:
NOAEL NOAEL
None of the components present in this material at concentrations equal to or greater than 0.1% are listed by IARC, NTP, OSHA, or ACGIH as a carcinogen.
Aquatic Toxicity: (Species, Method, End Point, Duration, Result) Sildenafil citrate Daphnia magna (Water Flea) TAD EC50 48 Hours 14 mg/L Oncorhynchus mykiss (Rainbow Trout) OECD LC50 96 Hours > 9.5 mg/L 72 Hours 20 mg/L Pseudokirchneriella subcapitata (Green Alga) OECD EC50 A greater than (>) symbol indicates that acute ecotoxicity was not observed at the maximum Aquatic Toxicity Comments: solubility. Since the substance is insoluble in aqueous solutions above this concentration, an acute ecotoxicity value (i.e. LC/EC50) is not achievable. Bacterial Inhibition: (Inoculum, Method, End Point, Result) Sildenafil citrate Activated sludge OECD
EC50
Hours
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OSHA Label: Non-hazardous in accordance with international standards for workplace safety.
Canada - WHMIS: Classifications WHMIS hazard class: None required This product has been classified in accordance with the hazard criteria of the CPR and the MSDS contains all of the information required by the CPR.
FD & C Blue No. 2, Aluminum lake Inventory - United States TSCA - Sect. 8(b) Australia (AICS): EU EINECS/ELINCS List Lactose Monohydrate Australia (AICS): Triacetin Inventory - United States TSCA - Sect. 8(b) Australia (AICS): EU EINECS/ELINCS List
Present
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Present
Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known information at this time. End of Safety Data Sheet
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