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Issued by: Jurox Pty Limited Phone: 1800 023 312

Poisons Information Centre: 13 1126 from anywhere in Australia

Section 1: IDENTIFICATION of CHEMICAL PRODUCT and COMPANY

Product Names: Lutogeston® Long Acting Progesterone Product Code: 60890 (5 mL) Recommended Use: For the maintenance of pregnancy in horses with a history of abortion

due to low progesterone levels. Company Identification: Jurox Pty Limited Address: 85 Gardiner Street

Rutherford NSW 2320 Australia

Email: customerservice@jurox.com.au Customer Centre: 1800 023 312 National Poisons Information Centre: 131126 (Australia-wide) Emergency Telephone Number: 1800 023 312 (Monday – Friday, 9 a.m. – 5 p.m).

Section 2: HAZARDS IDENTIFICATION Hazard Classifications: Considered a Hazardous Substance according to the criteria of GHS.

Not considered a Dangerous Good according to the criteria of the Australian Dangerous Goods (ADG) Code.

GHS Hazard Classification:*

GHS Category Hazard code

Hazard Statement

Skin Corrosion/Irritation Category 2 H315 Causes skin irritation

Eye Irritation Category 2A H319 Causes serious eye irritation

Respiratory Sensitizer Category 1* H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled.*

Skin Sensitizer Category 1 H317 May cause an allergic skin reaction

Reproductive Toxicity Category 1B* H360 May damage fertility or the unborn child*

Specific target organ toxicity - single exposure Category 3 (respiratory tract irritation)

H335 May cause respiratory irritation

Acute Aquatic Hazard Category 2 H411 Toxic to aquatic life with long lasting effects.

Chronic Aquatic Hazard Category 2 H411 Toxic to aquatic life with long lasting effects.

* LIMITED EVIDENCE

Signal word:* DANGER GHS Pictograms:

Exclamation mark Health hazard Ecotoxic

Document:

Effective Date:Issue Date:

Rev:

Review Date:Status:

Title: LUTOGESTON® LONG ACTING PROGESTERONE

26-Aug-2019

SDS-AU051

26-Aug-2019

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SAFETY DATA SHEET

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Precautionary Statements:* Prevention P201 Obtain special instructions before use. P261 Avoid breathing mist/vapours/spray. P271 Use only outdoors or in a well-ventilated area. P280 Wear protective gloves/protective clothing/eye protection/face

protection. P281 Use personal protective equipment as required. P285 In case of inadequate ventilation wear respiratory protection.

Response P304+P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. P308+P313 IF exposed or concerned: Get medical advice/attention. P342+P311 If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. P362 Take off contaminated clothing and wash before reuse. P302+P352 IF ON SKIN: Wash with plenty of soap and water. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Storage P405 Store locked up. P403+P233 Store in a well-ventilated place. Keep container tightly closed.

* N.B.: These statements are determined by Work Health and Safety regulations and may not reflect Signal Headings and First Aid and Safety statements on product labelling, which are determined by a competent authority during assessment for registration.

Section 3: COMPOSITION / INFORMATION on INGREDIENTS

INGREDIENT CAS No. CONTENT

Hydroxyprogesterone hexanoate/ Hydroxyprogesterone caproate

630-56-8 25%

Benzyl alcohol 100-51-6 < 10%

Benzyl benzoate 120-51-4 30–60%

Other non-hazardous ingredients 30-60%

Section 4: FIRST AID MEASURES General information: Consult the National Poisons Centre on 13 1126 or a doctor immediately in every case of

suspected chemical poisoning. Never give fluids or induce vomiting if a patient is unconscious or convulsing regardless of cause of injury. If medical advice/attention is needed, have product container or label at hand.

Inhalation: Unlikely to present an inhalation hazard under normal conditions of use. If fumes, aerosols or

combustion products are inhaled remove from contaminated area. Ingestion: May result in nausea, diarrhoea and possible convulsions. Thoroughly rinse mouth with water.

Give plenty of water or bland fluids to drink. Seek medical advice. Show this SDS to a medical practitioner.

Skin: May produce mild irritation. Absorbed through the skin. May lead to skin sensitisation.

Remove all contaminated clothing. Wash well with soap and water. Eye: Mild irritant. Irrigate with plenty of water for at least 20 minutes.

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Injected: Effects will vary in severity according to the quantity involved, from localised site reaction

(pain, redness, swelling), to acute systemic reaction. Treat as for needlestick injury. Wash area well and disinfect. If other symptoms are evident, seek medical advice.

Chronic: Prolonged or repeated exposure may result in acne, oedema, weight gain, headache,

depression and alteration in liver function. Advice to Doctor: Contains hydroxyprogesterone hexanoate, which is a progesterone compound, rapidly

inactivated in the liver. Treat symptomatically.

Flash Point: Not flammable. Non combustible. Hazardous Combustion: If involved in a fire, may emit noxious or irritating fumes. Extinguishing Media: There is no restriction on the type of extinguisher which may be used. Use extinguishing

media suitable for surrounding area. Protective Equipment: Protective gloves and breathing apparatus. A gas tight chemical resistant suit may be

required for large fires. HAZCHEM Code: None specified. Special hazards: Avoid contamination with oxidising agents i.e. nitrates, oxidising acids, chlorine bleaches as

ignition may result.

Spills and Disposal: Avoid inhalation and contact with skin and eyes when cleaning up any spills. Wear

appropriate protective clothing. Exclude non-essential people from the area and move upwind. Neutralise small spills with sodium hypochlorite solution. Contain spill and sweep up / absorb with inert material such as soil, sand or absorbent granules and place in a sealable waste container. Ventilate area and wash spill site after pick-up complete. Dispose of waste safely in an approved landfill. For large spills, alert Fire Brigade and tell them location and nature of hazard.

Protective Clothing: For appropriate personal protective equipment see section 8. Environmental Prevent from entering drains, waterways or sewers. If spill does enter waterways contact Precautions: local authority.

Handling: Keep out of reach of children. Avoid contact with skin and eyes. Care is required to avoid self-

injection. Use personal protective equipment as required. When handling, DO NOT eat, drink or smoke. DO NOT allow clothing wet with material to stay in contact with skin.

Storage: Keep out of reach of children. Store below 30ºC, locked up. Protect from light Other Information: Always read the APVMA-approved label before use. See label for further information on

handling and storage.

Section 5: FIRE FIGHTING MEASURES

Section 6: ACCIDENTAL RELEASE MEASURES

Section 7: HANDLING AND STORAGE

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This SDS describes personal protective measures relating to long term industrial and manufacturing exposure and emergency situations, such as accidents and spills. See product label for personal protective measures during normal use of the marketed product.

Exposure Limits: No exposure limits have been assigned for this product. Do not handle until all safety

precautions have been read and understood. Due to the small volumes involved, and the methods of administration, exposure under normal conditions of use would likely be limited to splashing on to skin or in to eyes, or accidental self injection.

Protective Equipment: Chemical protective gloves (e.g. PVC). Avoid inhalation and eye and skin contact. Wash

hands thoroughly after using. When handling the bulk product, wear chemical protective gloves (e.g. PVC), safety footwear or safety gumboots (e.g. rubber), protective clothing and safety glasses with side shields and chemical goggles.

Engineering Controls: Handle in a well ventilated area. Local exhaust ventilation may be required in specific

circumstances. Hygiene Precautions: Do not drink, eat or smoke when handling this product. Wash hands after use. Care is required to avoid accidental self-injection.

Appearance: Pale yellow clear oily liquid Upper / Lower Flammability or Explosive Limits: Combustible Odour: Not available Vapour Pressure: Not applicable Odour Threshold: Not available Vapour Density: Not applicable pH: Not available Relative Density: 1.040-1.055 Melting Point / Solubility in Water: Does not mix with water Freezing point: Not available Partition Coefficient: Not available Initial Boiling Point and Boiling Range: Not applicable Auto-Ignition Temperature: Not available Flashpoint: Not applicable Decomposition Not applicable Temperature: Evaporation Rate: Not available Viscosity: Not applicable

Stability: When stored appropriately this product should show no significant degradation for at least 24

months from the date of manufacture. Hazardous Not known to occur. Polymerisation: Materials to Avoid: None known.

Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

Section 9: PHYSICAL AND CHEMICAL PROPERTIES

Section 10: STABILITY AND REACTIVITY

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Acute Toxicity: Ingestion: No data for the mixture is available. The material has not been classified by EC

Directives or other classification systems as “harmful by ingestion”. This is because of lack of corroborating animal or human evidence.

Benzyl alcohol: Oral LD50 (rat) 1230 mg / kg. Benzyl benzoate: Oral LD50 (mouse) 1600 mg / kg.

Inhalation: No data for the mixture is available. Based on available data for the ingredients, the mixture is not thought to produce either adverse health effects or irritation of the respiratory tract following inhalation.

Injection: Localised site reaction may occur. Skin Corrosion / Irritation: Skin irritant. Serious Eye Damage / Irritation: Mild irritant. Respiratory or

Skin Sensitisation: There is limited evidence that, skin contact with this mixture is more likely to cause a

sensitisation reaction in some persons compared to the general population. Mutagenicity: No data for the mixture is available. Based on available data for the ingredients, the mixture is

not considered to be mutagenic. Carcinogenicity: No data for the mixture is available. Based on available data for the ingredients, the mixture is

not considered to be carcinogenic. Reproductivity: There is some evidence from animal testing that exposure to Hydroxyprogesterone may result

in toxic effects to the foetus. STOT - Single Exposure: May cause respiratory tract irritation. Aspiration Hazard: No data available.

Ecotoxicity: Slightly harmful in the aquatic environment. Do not empty into drains. Hydroxyprogesterone hexanoate: Aquatic (fish): LC50 (96 hr): 0.163mg/L

Benzyl benzoate: Aquatic (fish): LC50 (96 hr): 2.7 mg/L (Brachydanio rerio – Zebra fish) Aquatic crustacean): LC50 (96hr): 4.8 mg/L (Scud)

Benzyl alcohol: Aquatic (fish): LC50 (96 hr): 10 mg/L (Lepomis macrochirus – Fish, freshwater) Aquatic crustacean): LC50 (96hr): 55 mg/L (Scud) Soil: EC50: 50 mg/L (Photobacterium phosphoreum – Bacteria)

Soil: DT50 > 30 days

Ingredient Persistence: Water/Soil

Persistence: Air

Bioaccumulation potential

Mobility

Hydroxyprogesterone hexanoate High High High Low

Benzyl alcohol Low Low Low Low

Benzyl benzoate High High Medium Low

Section 11: TOXICOLOGICAL INFORMATION

Section 12: ECOLOGICAL INFORMATION

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Product Disposal: Dispose of container by wrapping in paper and putting in garbage.

Dangerous Goods Not classed as a Dangerous Good for transport purposes by road, sea or air. Classification:

Poisons Schedule (SUSMP): S4 APVMA Registration Nos: 36254

AICS: All of the significant ingredients in this formulation are compliant with NICNAS regulations. The following ingredient, Hydroxyprogesterone, is mentioned in SUSMP.

This information is based on data believed by Jurox Pty Limited to be accurate at the time of writing but is subject to change without notice. It is given in good faith, but no warranty expressed or implied is made as to its accuracy, completeness otherwise and no assumption of liability from

howsoever arising is made by Jurox Pty Limited by reason of the provision of this information. Every person dealing with the materials referred to

herein does so at his/her own risk absolutely and must make independent determinations of suitability and completeness of information from all

sources to ensure their proper use.

Legend: ADG Australian Code for the Transport of Dangerous Goods by Road & Rail, 7th Edition. AICS Australian Inventory of Chemical Substances. APVMA Australian Pesticides and Veterinary Medicines Authority. CAS No. Chemical Abstracts Service Registry Number. GHS Globally Harmonized System of Classification and Labelling of Chemicals. Hazchem Code Emergency action code of numbers and letters that provide information to emergency services especially firefighters. LD50 The median lethal dose, being a statistically derived single dose of a substance that

can be expected to cause death in 50% of animals. NICNAS National Industrial Chemicals Notification and Assessment Scheme. PPE Personal Protective Equipment. PVC Polyvinyl Chloride. SDS Safety Data Sheet. STOT Specific Target Organ Toxicity. SUSMP Standard for the Uniform Scheduling of Medicines and Poisons. References: ChemID Plus EPA New Zealand Chemical Classification and Information Database (CCID) HSDB (Hazardous Substances Data Bank) Veterinary Substances DataBase.

Section 13: DISPOSAL INFORMATION

Section 14: TRANSPORT INFORMATION

Section 15: REGULATORY INFORMATION

Section 16: OTHER INFORMATION

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Revision History:

Date of Revision Reason

12 July 2017 Addition of GHS pictograms in Section 2. Updates to Section 5, 8, 9, 11, 12 & 15; Addition of Legend, References and Revision History in Section 16.

END OF SDS

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