SAFETY DATA SHEET
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Section 1: Identification of the Substance and Supplier
Product name
Posatex
Recommended use
For the treatment of acute otitis externa and acute exacerbations of recurrent
otitis externa.
Company details
Schering-Plough Animal Health Ltd
33 Whakatiki Street, Upper Hutt 5018, New Zealand
Phone: 0800 800 543 Fax: 0800 808 100
Website: www.msd-animal-health.co.nz
Hours: 8 am – 5 pm, Mon – Fri
Emergency telephone
0800 764 766 (0800 POISON) 24 hours human health
0800 243 622 (0800 CHEMCALL) 24 hours
Date of preparation
April 2019
Section 2: Hazards Identification
Hazard classifications
6.8B: Reproductive/developmental toxicant
6.9B: Target organ systemic toxicant
9.1C: Aquatic ecotoxicant
GHS Pictogram:
Signal word
Warning
Hazard statement
H361: Suspected of damaging fertility or the unborn child from repeated oral
exposure.
H373: May cause damage to nervous system, through prolonged or repeated
oral or inhalation exposure.
H412: Harmful to aquatic life with long lasting effects.
Prevention statement
P102: Keep out of the reach of children.
P202: Do not handle until all safety precautions have been read and understood.
P260: Do not breathe mist.
P273: Avoid release to the environment.
P281: Use personal protective equipment as required.
Response statement
Storage
P308 + P313: IF exposed or concerned: Get medical advice/ attention.
P405: Store locked up.
Disposal
P501: Dispose of product, packaging and waste at an approved landfill or other
approved facility.
Section 3: Composition/Information on Ingredients
Chemical name
CAS number
Concentration
Mometasone furoate monohydrate
141646-00-6
0.1%
Posaconazole
171228-49-2
0.1%
Orbifloxacin
113617-63-3
1%
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Section 4: First Aid Measures
SKIN CONTACT While wearing protective gloves, carefully remove any
contaminated clothing, including shoes, and wash skin thoroughly with soap and
water. If irritation or symptoms occur or persist, consult a doctor.
EYE CONTACT Immediately rinse eyes thoroughly with plenty of water. If
wearing contact lenses, remove only after initial rinse, and continue rinsing eyes
for at least 15 minutes. If irritation occurs or persists, consult a doctor.
INGESTION Rinse mouth and drink a glass of water. Do not induce vomiting
unless under the direction of a qualified medical professional or National Poisons
Centre. If symptoms persist, consult a doctor.
INHALATION Remove to fresh air. If any trouble breathing, get immediate
medical attention. Administer artificial respiration if breathing has ceased. If
irritation or symptoms occur or persist, consult a doctor.
For advice contact the National Poisons Centre 0800 POISON (0800 764 766)
or a doctor.
Inhalation: Remove to fresh air & provide oxygen if breathing is difficult.
Skin contact: Symptoms: Tingling and pruritus with blotchy erythema on the
face or other exposed areas, exacerbated by sweating or touching. Symptoms
usually resolve within 24 hours without specific treatment.
Treatment: Topical vitamin E (tocopherol acetate) has been shown to reduce
skin irritation if applied soon after exposure.
Emergency showers and eyewashes may be warranted depending on quantity
and type of use.
Section 5: Fire Fighting Measures
Type of hazard
Not classified as flammable
Fire hazard properties
Not applicable
Regulatory requirements
Not applicable
Extinguishing media
and methods
Carbon dioxide (CO
2
), extinguishing powder or water spray
Hazchem code
Not applicable
Recommended protective
clothing
Wear self-contained breathing apparatus (SCBA) plus protective gloves.
Section 6: Accidental Release Measures
Personal Precautions
Avoid contact with skin, eyes and clothing. Do not touch damaged containers or
spilled material unless wearing appropriate protective clothing.
Environmental
Precautions
Prevent spilled material from flowing onto adjacent land or into streams, ponds,
or lakes. Avoid release to the environment.
Emergency procedures
Wear chemical resistant gloves and overalls, face mask or goggles. Prevent
further spillage. Adsorb spilled product and place in sealable container for
disposal. Wash down affected area with water plus detergent. Absorb and
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collect washings and place in the same sealable container for disposal. Seek
advice from the local authority regarding disposal. Avoid contamination of any
water source or soil with product or empty container.
Section 7: Handling and Storage
Precautions for safe
handling
Avoid contact with skin, eyes, and mucosa. Keep containers adequately sealed
during material transfer, transport, or when not in use. See Section 8 (Exposure
Controls) for additional guidance.
Regulatory requirements
Signage required where quantities greater than 1000 L are present.
Emergency Plan required where quantities greater than 1000 L are present.
Handling practices
Avoid contact with skin. Keep containers adequately sealed during material
transfer, transport, or when not in use.
Certified handlers
Not required.
Conditions for safe
storage
Store in original container in a cool, dry, ventilated place away from direct heat or
direct sunlight. Keep container sealed when not in use. Keep out of reach of
children.
Store site requirements
Store in the original bottle and carton at room temperature. Once opened use
within 7 days.
Packaging
Schedule 4
Section 8: Exposure Control/Personal Protection
Occupational exposure
limits
No WES is set for this substance at this time.
Application in the
workplace
Ensure adequate ventilation. Keep container sealed when not in use.
Exposure standards
outside the workplace
No TEL or EEL is set for this substance at this time.
Personal protection
Wear chemical resistant gloves, facemask or goggles.
Engineering controls
The health hazard risks of handling this material are dependent on many factors,
including physical form, duration and frequency of process or task, and
effectiveness of engineering controls. Site-specific risk assessments should be
conducted to determine the feasibility and the appropriateness of all exposure
control measures. Exposure controls for normal operating or routine procedures
follow a tiered strategy. Engineering controls are the preferred means of long-
term or permanent exposure control. If engineering controls are not feasible,
appropriate use of personal protective equipment (PPE) may be considered as
alternative control measures. Exposure controls for non-routine operations must
be evaluated and addressed as part of the site-specific risk assessment.
Section 9: Physical and Chemical Properties
Appearance
White to off white cream
Boiling Point
Not determined
Melting/Softening point
Not determined
Vapour Pressure
Not determined
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Specific Gravity
0.8-0.9
Solubility (H
2
O)
Not applicable
Percent Volatiles
Not determined
Evaporation Rate
Not determined
Section 10: Stability and Reactivity
Stability of the substance
Stable under normal conditions.
Conditions to avoid
Avoid high temperatures
Material to avoid
Avoid food products
Hazardous decomposition
products
Carbon oxides (COx), Sulphur oxides (SOx), and Nitrogen oxides (NOx).
Section 11: Toxicological Information
Acute effects for individual ingredients only
ORAL
LD50 > 2000 mg/kg rat
TEL
No TEL is set for this substance at this time.
Chronic/long term effects for individual ingredients only
Reproductive / Developmental Toxicity
Mometasone furoate – Oral doses of 700 mcg MF/kg in rabbits caused increased incidences of resorptions, cleft
palate and head malformations. Following oral doses of 2800 mcg MF/kg, rabbits failed to become pregnant.
In reproductive and developmental studies, posaconazole increases gestation duration, causes fetotoxicity
(reduced number of live pups and decreased mean pup weights), and causes increases in skeletal variations and
malformations.
Mutagenicity /Genotoxicity
Orbifloxacin was positive in a mouse lymphoma assay and in an in vitro assay in human peripheral blood
lymphocytes.
At cytotoxic doses, mometasone furoate produced an increase in chromosome aberrations in vitro but not in the
presence of microsomal activation (rat liver S9 fraction).
In the mouse micronucleus assay, bone marrow toxicity was observed in male and female mice indicating that
posaconazole can reach and affect the bone marrow; however, increases in micronucleus frequency was not
observed in test animals at any dose administered.
Section 12: Ecological Information
Effects for individual ingredients only
AQUATIC
Posaconazole: 96-hr EC50 (rainbow trout):0.95 mg/L
96-hr EC50 (algae): >0.119 mg/L (growth rate)
48-hr EC50 (daphnid): 0.276 mg/L
EEL
No EEL is set for this substance at this time.
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Section 13: Disposal Considerations
Disposal information
Reference
Disposal
Dispose of unused product through AgRecovery Chemicals. Avoid
contamination of any water source or the environment with product or empty
container.
Container Disposal
Triple rinse empty container, puncture and recycle through AgRecovery. Do NOT
burn.
Current version of NZS 8409 Management of Agrichemicals.
Section 14: Transport Information
Relevant information
Not considered a Dangerous Good for transport
Section 15: Regulatory Information
Regulatory status
HSNO Approval Code: HSR100642
For full listings of controls see www.epa.govt.nz
ACVM registration number: A010701
For conditions of registration see www.foodsafety.govt.nz
Section 16: Other Information
Additional information
Posatex is a registered trademark
Schering-Plough Animal Health Ltd known as MSD Animal Health, is a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA.
Schering-Plough urges each user or recipient of this SDS to read the entire data sheet to become aware of the potential hazards associated
with this material. This SDS summarises, at the date of issue, our best knowledge of the health and safety hazard information. Although
reasonable care has been taken in the preparation of this document, Schering-Plough Animal Health Ltd extend no warranties and make no
representations as to the accuracy or completeness of the information contained therein, and assume no responsibility regarding the suitability
of this information for the user's intended purposes or for the consequence of its use. Each individual should make a determination as to the
suitability of the information for their particular purpose(s).