Ranvet Chemwatch Hazard Alert Code: 1 Chemwatch: 4787-61 Safety Data Sheet according to WHS and ADG requirements S.GHS.AUS.EN SECTION 1 IDENTIFICATION OF THE SUBSTANCE / MIXTURE AND OF THE COMPANY / UNDERTAKING Product Identifier Product name Synonyms Other means of identification Relevant identified uses of the substance or mixture and uses advised against Relevant identified uses For the treatment of all gastrointestinal worms in large dogs. Details of the supplier of the safety data sheet Registered company name Ranvet Address 10-12 Green Street Banksmeadow NSW 2019 Australia Telephone +61 2 9666 1744 Fax +61 2 9666 1755 Website https://www.ranvet.com.au/other_msds.htm Email info@ranvet.com.au Emergency telephone number Association / Organisation Emergency telephone numbers Other emergency telephone numbers +61 425 061 584 SECTION 2 HAZARDS IDENTIFICATION Classification of the substance or mixture Poisons Schedule Classification S5 Label elements Hazard pictogram(s) SIGNAL WORD NOT APPLICABLE Hazard statement(s) Precautionary statement(s) Prevention Precautionary statement(s) Response
Page 2 of 8 Precautionary statement(s) Storage Precautionary statement(s) Disposal SECTION 3 COMPOSITION / INFORMATION ON INGREDIENTS Substances See section below for composition of Mixtures Mixtures CAS No %[weight] Name 68813-55-8 30-60 22204-24-6 10-30 55268-74-1 <10 balance oxantel pamoate [1084 mg/tab] pyrantel pamoate [286 mg/tab] praziquantel [100 mg/tab] Ingredients determined not to be hazardous SECTION 4 FIRST AID MEASURES Description of first aid measures Eye Contact Skin Contact Inhalation Ingestion Generally not applicable. If skin or hair contact occurs: Flush skin and hair with running water (and soap if available). Seek medical attention in event of irritation. If fumes, aerosols or combustion products are inhaled remove from contaminated area. Other measures are usually unnecessary. If swallowed do NOT induce vomiting. If vomiting occurs, lean patient forward or place on left side (head-down position, if possible) to maintain open airway and prevent aspiration. Observe the patient carefully. Never give liquid to a person showing signs of being sleepy or with reduced awareness; i.e. becoming unconscious. Give water to rinse out mouth, then provide liquid slowly and as much as casualty can comfortably drink. Seek medical advice. Indication of any immediate medical attention and special treatment needed Treat symptomatically. SECTION 5 FIREFIGHTING MEASURES Extinguishing media There is no restriction on the type of extinguisher which may be used. Use extinguishing media suitable for surrounding area. Special hazards arising from the substrate or mixture Fire Incompatibility Avoid contamination with oxidising agents i.e. nitrates, oxidising acids, chlorine bleaches, pool chlorine etc. as ignition may result Advice for firefighters Fire Fighting Alert Fire Brigade and tell them location and nature of hazard. Wear breathing apparatus plus protective gloves in the event of a fire. Prevent, by any means available, spillage from entering drains or water courses. Use fire fighting procedures suitable for surrounding area. Slight hazard when exposed to heat, flame and oxidisers.
Page 3 of 8 Fire/Explosion Hazard HAZCHEM Non combustible. considered a significant fire risk, however containers may burn. Decomposition may produce toxic fumes of:, carbon dioxide (CO2), nitrogen oxides (NOx), other pyrolysis products typical of burning organic material. May emit poisonous fumes. May emit corrosive fumes. SECTION 6 ACCIDENTAL RELEASE MEASURES Personal precautions, protective equipment and emergency procedures See section 8 Environmental precautions See section 12 Methods and material for containment and cleaning up Minor Spills Major Spills Clean up all spills immediately. Secure load if safe to do so. Bundle/collect recoverable product. Collect remaining material in containers with covers for disposal. Clean up all spills immediately. Wear protective clothing, safety glasses, dust mask, gloves. Secure load if safe to do so. Bundle/collect recoverable product. Personal Protective Equipment advice is contained in Section 8 of the SDS. SECTION 7 HANDLING AND STORAGE Precautions for safe handling Safe handling Other information Avoid all personal contact, including inhalation. Wear protective clothing when risk of exposure occurs. Use in a well-ventilated area. Prevent concentration in hollows and sumps. Store away from incompatible materials. Conditions for safe storage, including any incompatibilities Suitable container Storage incompatibility Glass container is suitable for laboratory quantities Polyethylene or polypropylene container. Packing as recommended by manufacturer. Check all containers are clearly labelled and free from leaks. Avoid reaction with oxidising agents SECTION 8 EXPOSURE CONTROLS / PERSONAL PROTECTION Control parameters OCCUPATIONAL EXPOSURE LIMITS (OEL) INGREDIENT DATA EMERGENCY LIMITS Ingredient Material name TEEL-1 TEEL-2 TEEL-3 Ranvet's Allwormer Dogs (Large Dogs) Ingredient Original IDLH Revised IDLH
Page 4 of 8 oxantel pamoate pyrantel pamoate praziquantel Exposure controls Enclosed local exhaust ventilation is required at points of dust, fume or vapour generation. Appropriate engineering controls HEPA terminated local exhaust ventilation should be considered at point of generation of dust, fumes or vapours. Barrier protection or laminar flow cabinets should be considered for laboratory scale handling. A fume hood or vented balance enclosure is recommended for weighing/ transferring quantities exceeding 500 mg. Personal protection Eye and face protection Skin protection Hands/feet protection Body protection Other protection Thermal hazards When handling very small quantities of the material eye protection may not be required. For laboratory, larger scale or bulk handling or where regular exposure in an occupational setting occurs: Chemical goggles. Face shield. Full face shield may be required for supplementary but never for primary protection of eyes. See Hand protection below Rubber gloves (nitrile or low-protein, powder-free latex, latex/ nitrile). Employees allergic to latex gloves should use nitrile gloves in preference. Double gloving should be considered. PVC gloves. See Other protection below For quantities up to 500 grams a laboratory coat may be suitable. For quantities up to 1 kilogram a disposable laboratory coat or coverall of low permeability is recommended. Coveralls should be buttoned at collar and cuffs. For quantities over 1 kilogram and manufacturing operations, wear disposable coverall of low permeability and disposable shoe covers. Respiratory protection Particulate. (AS/NZS 1716 & 1715, EN 143:2000 & 149:001, ANSI Z88 or national equivalent) Selection of the Class and Type of respirator will depend upon the level of breathing zone contaminant and the chemical nature of the contaminant. Protection Factors (defined as the ratio of contaminant outside and inside the mask) may also be important. Required minimum protection factor Maximum gas/vapour concentration present in air p.p.m. (by volume) Half-face Respirator up to 10 1000 -AUS / Class1 P2 - Full-Face Respirator up to 50 1000 - -AUS / Class 1 P2 up to 50 5000 Airline * - up to 100 5000 - -2 P2 up to 100 10000 - -3 P2 100+ Airline** * - Continuous Flow ** - Continuous-flow or positive pressure demand A(All classes) = Organic vapours, B AUS or B1 = Acid gasses, B2 = Acid gas or hydrogen cyanide(hcn), B3 = Acid gas or hydrogen cyanide(hcn), E = Sulfur dioxide(so2), G = Agricultural chemicals, K = Ammonia(NH3), Hg = Mercury, NO = Oxides of nitrogen, MB = Methyl bromide, AX = Low boiling point organic compounds(below 65 degc) Respirators may be necessary when engineering and administrative controls do not adequately prevent exposures. The decision to use respiratory protection should be based on professional judgment that takes into account toxicity information, exposure measurement data, and frequency and likelihood of the worker's exposure - ensure users are not subject to high thermal loads which may result in heat stress or distress due to personal protective equipment (powered, positive flow, full face apparatus may be an option). Published occupational exposure limits, where they exist, will assist in determining the adequacy of the selected respiratory protection. These may be government mandated or vendor recommended. Certified respirators will be useful for protecting workers from inhalation of particulates when properly selected and fit tested as part of a complete respiratory protection program. Use approved positive flow mask if significant quantities of dust becomes airborne. Try to avoid creating dust conditions.
Page 5 of 8 SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES Information on basic physical and chemical properties Appearance Yellow capsule - shaped tablet; partially miscible with water. Physical state Odour Odour threshold ph (as supplied) Melting point / freezing point ( C) Initial boiling point and boiling range ( C) Manufactured Relative density (Water = 1) Partition coefficient n-octanol / water Auto-ignition temperature ( C) Decomposition temperature Viscosity (cst) Molecular weight (g/mol) Flash point ( C) Taste Evaporation rate Explosive properties Flammability Oxidising properties Upper Explosive Limit (%) Lower Explosive Limit (%) Surface Tension (dyn/cm or mn/m) Volatile Component (%vol) Negligible Vapour pressure (kpa) Negligible Gas group Solubility in water (g/l) Immiscible ph as a solution (1%) Vapour density (Air = 1) VOC g/l SECTION 10 STABILITY AND REACTIVITY Reactivity See section 7 Chemical stability Possibility of hazardous reactions Product is considered stable and hazardous polymerisation will not occur. See section 7 Conditions to avoid See section 7 Incompatible materials See section 7 Hazardous decomposition products See section 5 SECTION 11 TOXICOLOGICAL INFORMATION Information on toxicological effects Inhaled Ingestion Skin Contact Eye Chronic normally a hazard due to non-volatile nature of product Accidental ingestion of the material may be damaging to the health of the individual. Ingestion may result in sore throat, abdominal pain, with central nervous system effects, headache, dizziness, drowsiness The material is not thought to produce adverse health effects or skin irritation following contact (as classified by EC Directives using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting. Open cuts, abraded or irritated skin should not be exposed to this material Entry into the blood-stream, through, for example, cuts, abrasions or lesions, may produce systemic injury with harmful effects. Examine the skin prior to the use of the material and ensure that any external damage is suitably protected. There is some evidence to suggest that this material can cause eye irritation and damage in some persons. Long-term exposure to the product is not thought to produce chronic effects adverse to the health (as classified by EC Directives using animal models); nevertheless exposure by all routes should be minimised as a matter of course. Ranvet's Allwormer Dogs (Large Dogs) TOXICITY IRRITATION
Page 6 of 8 oxantel pamoate TOXICITY IRRITATION pyrantel pamoate TOXICITY Oral (rat) LD50: >4000 mg/kg [2] IRRITATION praziquantel TOXICITY Oral (rat) LD50: 2840 mg/kg [2] IRRITATION Legend: 1. Value obtained from Europe ECHA Registered Substances - Acute toxicity 2.* Value obtained from manufacturer's SDS. Unless otherwise specified data extracted from RTECS - Register of Toxic Effect of chemical Substances PYRANTEL PAMOATE PRAZIQUANTEL Ranvet's Allwormer Dogs (Large Dogs) & OXANTEL PAMOATE For pyrantel: Animal testing shows that pyrantel may cause liver changes. Long term exposure may also affect blood cells, and high doses may cause vomiting and salivation. Pyrantel has not been observed to cause adverse effects on fertility, reproduction or lactation. It also has not been observed to cause birth defects or toxicity to the embryo. NOAEL rat, rabbit 250 mg/kg/day. * [* = PFIZER] Somnolence, convulsions, respiratory stimulation, foetotoxicity, maternal effects, effects on newborn recorded. NOTE: Substance has been shown to be mutagenic in at least one assay, or belongs to a family of chemicals producing damage or change to cellular DNA. * Bayer ADI: 0.02 mg/kg/day NOEL: 20 mg/kg/day No significant acute toxicological data identified in literature search. Acute Toxicity Skin Irritation/Corrosion Serious Eye Damage/Irritation Respiratory or Skin sensitisation Mutagenicity Carcinogenicity Reproductivity STOT - Single Exposure STOT - Repeated Exposure Aspiration Hazard Legend: Data available but does not fill the criteria for classification Data available to make classification Data to make classification SECTION 12 ECOLOGICAL INFORMATION Toxicity Ranvet's Allwormer Dogs (Large Dogs) ENDPOINT TEST DURATION (HR) SPECIES VALUE SOURCE oxantel pamoate ENDPOINT TEST DURATION (HR) SPECIES VALUE SOURCE pyrantel pamoate ENDPOINT TEST DURATION (HR) SPECIES VALUE SOURCE praziquantel Legend: ENDPOINT TEST DURATION (HR) SPECIES VALUE SOURCE Extracted from 1. IUCLID Toxicity Data 2. Europe ECHA Registered Substances - Ecotoxicological Information - Aquatic Toxicity 3. EPIWIN Suite V3.12 (QSAR) - Aquatic Toxicity Data (Estimated) 4. US EPA, Ecotox database - Aquatic Toxicity Data 5. ECETOC Aquatic Hazard Assessment Data 6. NITE (Japan) - Bioconcentration Data 7. METI (Japan) - Bioconcentration Data 8. Vendor Data
Page 7 of 8 DO NOT discharge into sewer or waterways. Persistence and degradability Ingredient Persistence: Water/Soil Persistence: Air No Data available for all ingredients No Data available for all ingredients Bioaccumulative potential Ingredient Bioaccumulation No Data available for all ingredients Mobility in soil Ingredient Mobility No Data available for all ingredients SECTION 13 DISPOSAL CONSIDERATIONS Waste treatment methods Product / Packaging disposal DO NOT allow wash water from cleaning or process equipment to enter drains. It may be necessary to collect all wash water for treatment before disposal. In all cases disposal to sewer may be subject to local laws and regulations and these should be considered first. Where in doubt contact the responsible authority. Recycle wherever possible or consult manufacturer for recycling options. Consult State Land Waste Authority for disposal. Bury or incinerate residue at an approved site. Recycle containers if possible, or dispose of in an authorised landfill. SECTION 14 TRANSPORT INFORMATION Labels Required Marine Pollutant HAZCHEM NO Land transport (ADG): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS Air transport (ICAO-IATA / DGR): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS Sea transport (IMDG-Code / GGVSee): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS Transport in bulk according to Annex II of MARPOL and the IBC code SECTION 15 REGULATORY INFORMATION Safety, health and environmental regulations / legislation specific for the substance or mixture OXANTEL PAMOATE(68813-55-8) IS FOUND ON THE FOLLOWING REGULATORY LISTS Australia Inventory of Chemical Substances (AICS) PYRANTEL PAMOATE(22204-24-6) IS FOUND ON THE FOLLOWING REGULATORY LISTS Australia Inventory of Chemical Substances (AICS) PRAZIQUANTEL(55268-74-1) IS FOUND ON THE FOLLOWING REGULATORY LISTS Australia Inventory of Chemical Substances (AICS) National Inventory Australia - AICS Canada - DSL Canada - NDSL China - IECSC Status Y N (pyrantel pamoate; praziquantel; oxantel pamoate) N (pyrantel pamoate; praziquantel; oxantel pamoate) N (pyrantel pamoate; oxantel pamoate)
Page 8 of 8 Europe - EINEC / ELINCS / NLP Japan - ENCS Korea - KECI New Zealand - NZIoC Philippines - PICCS USA - TSCA Legend: Y N (pyrantel pamoate; praziquantel; oxantel pamoate) N (praziquantel; oxantel pamoate) Y N (pyrantel pamoate) N (pyrantel pamoate; praziquantel; oxantel pamoate) Y = All ingredients are on the inventory N = determined or one or more ingredients are not on the inventory and are not exempt from listing(see specific ingredients in brackets) SECTION 16 OTHER INFORMATION Other information Classification of the preparation and its individual components has drawn on official and authoritative sources as well as independent review by the Chemwatch Classification committee using available literature references. The SDS is a Hazard Communication tool and should be used to assist in the Risk Assessment. Many factors determine whether the reported Hazards are Risks in the workplace or other settings. Risks may be determined by reference to Exposures Scenarios. Scale of use, frequency of use and current or available engineering controls must be considered. Definitions and abbreviations PC TWA: Permissible Concentration-Time Weighted Average PC STEL: Permissible Concentration-Short Term Exposure Limit IARC: International Agency for Research on Cancer ACGIH: American Conference of Governmental Industrial Hygienists STEL: Short Term Exposure Limit TEEL: Temporary Emergency Exposure Limit IDLH: Immediately Dangerous to Life or Health Concentrations OSF: Odour Safety Factor NOAEL :No Observed Adverse Effect Level LOAEL: Lowest Observed Adverse Effect Level TLV: Threshold Limit Value LOD: Limit Of Detection OTV: Odour Threshold Value BCF: BioConcentration Factors BEI: Biological Exposure Index This document is copyright. Apart from any fair dealing for the purposes of private study, research, review or criticism, as permitted under the Copyright Act, no part may be reproduced by any process without written permission from CHEMWATCH. TEL (+61 3) 9572 4700. end of SDS