SAFETY DATA SHEET A18298/04/AUS SCOURBAN ORAL ANTI ...

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SAFETY DATA SHEET A18298/04/AUS

SCOURBAN ORAL ANTI-DIARRHOEAL SUSPENSION

SECTION 1 – IDENTIFICATION, CONTACTS

Bayer Australia Ltd Emergency Telephone Number
875 Pacific Highway 1800 033 111
Pymble NSW 2073 24 hour Emergency Service Australia Wide, Toll Free

Contact Point (for non-emergency calls)
Animal Health Division
(02) 9391 6000

Full Product Name SCOURBAN ORAL ANTI-DIARRHOEAL SUSPENSION

Other Names Nil.

Product Use FOR ANIMAL TREATMENT ONLY
Creation Date For treatment of bacterial diarrhoea in horses, calves, dogs and cats.
10th January 2012

Revision Date 26 May 2015

SECTION 2 – HAZARDS IDENTIFICATION

Hazard Classification CLASSIFIED AS A HAZARDOUS SUBSTANCE
NOT CLASSIFIED AS DANGEROUS GOODS when transported by
road or rail within Australia under Special Provision AU01 of the
Australian Dangerous Goods Code, 7th Edition.

CLASSIFIED AS DANGEROUS GOODS when transported by sea or
air.

Poison Schedule S4

Risk Phrases R50/53 Very toxic to aquatic organisms, may cause long term adverse
effects in the aquatic environment.

Safety Phrases S60 This material and its container must be disposed of as hazardous
waste. S61 Avoid release to the environment. Refer to special
instructions/ Safety Data Sheet.

RISK & SAFETY PHRASES ARE NOT REQUIRED ON PACKAGES
INTENDED FOR END USERS. APPROPRIATE SAFETY DIRECTIONS AND
FIRST AID STATEMENTS ARE SHOWN ON THE PRODUCT LABEL.

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SECTION 3 – COMPOSITION CAS No. Proportion
(% w/v)
Ingredients 57-68-1 <5%
68-35-9 <5%
Sulfadimidine (sulfamethazine) 3810-74-0 <1%
Sulfadiazine 1405-10-3 <1%
Streptomycin sulphate 7647-14-5 <1%
Neomycin sulphate 299-28-5 <1%
Sodium chloride 10034-99-8 <1%
Calcium gluconate 7447-40-7 <1%
Magnesium sulphate, heptahydrate 114-49-8 <1%
Potassium chloride 9000-69-5 <1%
Hyoscine hydrobromide 1332-58-7 10%
Pectin 56-40-6 <5%
Kaolin
Glycine - balance to 100%
Water and other inert ingredients of a non-hazardous
nature

SECTION 4 – FIRST AID MEASURES

Label Regulated First If poisoning occurs contact a doctor or the Poisons Information

Aid Statement Centre (Phone 13 11 26).

Scheduled Poisons Poison Schedule S4.

Poisons Information Centres in each State capital city can provide
additional assistance for scheduled poisons. Phone 131126.

Inhalation Inhalation exposure to this product is unlikely. In event of aerosol
exposure remove from further exposure and into fresh air.

Skin contact Remove contaminated clothing and wash affected areas thoroughly
with soap and water.

Eye contact Flush gently with large quantities of clean tap water for at least 15
minutes. Seek medical advice if required.

Ingestion Do not induce vomiting. Rinse mouth with water. Give water to
drink. Seek medical advice.

Advice to doctor No specific antidote exists. Aminoglycoside antibiotics may be
removed by haemodialysis or to a lesser extent by peritoneal
dialysis. Calcium salts given intravenously have been used to
counter neuromuscular blockade. The effectiveness of neostigmine
has been variable.

In cases of recent sulfonamide overdose the stomach should be
emptied by aspiration and lavage. If kidney function is adequate, a
saline purgative, such as sodium sulphate may be given to promote
peristalsis and elimination of sulphonamide and elimination in the
urine may be assisted by alkalinising the urine. Treatment should be
continued until it can be assumed that the sulphonamide has been
eliminated. The majority of the sulfonamides are metabolised to
acetylated derivatives which retain the toxicity of the parent
compound and thus may indicate more active removal when
adverse effects are very severe.

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SECTION 5 – FIRE FIGHTING MEASURES

Flammability Non flammable. Not considered a significant fire risk, however
container can burn.

Extinguishing Media If involved in a fire use water spray, carbon dioxide or dry
chemicals powder.

Fire and Explosion Keep away from extreme heat and open flames.
Hazards

Hazardous Non-combustible. If heated to decomposition may give rise to toxic
Combustion Products and choking fumes of carbon dioxide, nitrogen oxides, sulphur
oxides and other pyrolysis product typical of burning organic
material.

Fire Fighting Wear self-contained breathing apparatus and protective clothing.

SECTION 6 – ACCIDENTAL RELEASE MEASURES

Accidental Release Emergency Procedures: Contact emergency response personnel for
large spills. Keep unnecessary persons away.

Method of Containment and Clean up Procedures: Wear overalls,
eye protection and impervious gloves to prevent skin and eye
contamination. In the event of a major spill, prevent the spillage
from entering drains or waterways. If safe to do so, stop the leak
and contain the spill using sand or soil. Absorb onto inert material
(sand, soil or other inert material). Collect and seal in properly
labelled drums for disposal. After a spill, wash the area, preventing
the run-off entering drains. Wash all contaminated clothing and
equipment before re-use.

SECTION 7 – HANDLING AND STORAGE

Safe Handling Avoid eye and skin contact. During normal product use no special
precautions are required.

In other situations wear protective clothing to minimize skin
contact. Do not smoke, eat or drink while handling the product.
Observe good personal hygiene by washing hands before and after
use. Containers should always be kept closed in storage and stored
in original labeled container. Keep out of reach of children.

Storage Store below 25°C (Air conditioning) in the closed, original
container, tightly closed in a dry, well-ventilated area.

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SECTION 8 – EXPOSURE CONTROLS AND PERSONAL PROTECTION

Exposure Limits Composite Exposure Standard for Mixture (TWA): 2.7551 mg/m3.

If the breathing zone concentration of any of the components listed
below is exceeded, worst case considerations deem the individual to
be overexposed.

Component Breathing zone (mg/m3) Mixture
Conc (%)
Kaolin 0.6200 10
Sulfamethazine 1.8607 <5
Hyoscine hydrobrom. 0.0001 <1
Calcium gluconate 0.0132 <1
Pectin 0.0426 <1
Glycine 0.1254 <5
Potassium chloride 0.0216 <1
Sodium chloride 0.0678 1
Magnesium sulphate 0.0036 <1

Ventilation Natural ventilation should be adequate under normal use conditions.
Eye Protection If the air concentration of vapour or mist is high, the process should
be modified to reduce the problem. Keep containers closed when
not in use.

Avoid contact with eyes. Wear face visor of goggles if accidental
eye contact can occur.

Skin Protection No special equipment is required if handling small amounts. Wear
Respirator chemical protective clothing, PVC gloves and safety footwear when
dealing with major spills.

No special respiratory protection is recommended under normal
conditions of use. Respiratory protection may be required when any
worst case aerosol of vapour phase concentration is exceeded.

Thermal protection Non flammable product. Wear self-contained breathing apparatus to
protect from emissions and toxic fumes.

SECTION 9 – PHYSICAL & CHEMICAL PROPERTIES

Physical State Aqueous suspension

Colour Pale pink

Odour Sweet, characteristic odour

pH 4.5-5.4

Boiling point Approx. 100°C

Specific Gravity 1.12-1.14

Vapour pressure Not available

Viscosity 2000-5000 cps

Flash point Not relevant. Does not burn

Solubility Miscible in water.

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SECTION 10 – STABILITY & REACTIVITY

Chemical Stability Stable under normal ambient and anticipated storage conditions of
temperature and pressure

Conditions to Avoid Do not heat to decomposition. Keep away from extreme heat and
open flames.

Incompatible Avoid contamination with oxidising agents, eg nitrates, oxidising
Materials acids, chlorine bleaches, pool chlorine, etc

Hazardous If heated to decomposition may give rise to toxic and choking
Decomposition fumes of carbon dioxide, nitrogen oxides, sulphur oxides and other
pyrolysis product typical of burning organic material.

Hazardous Reactions Hazardous polymerisation will not occur.

SECTION 11 – TOXICOLOGICAL INFORMATION

Acute Toxicity SODIUM CHLORIDE:

Toxicity
Oral (rat) LD50: 3000 mg/kg
Oral (human) TDLo: 12357 mg/kg/23d
Oral Lowest Toxic Dose (Human): 8.2 mg/kg
Irritation
Skin (rabbit): 500 mg/24h - mild
Eye (rabbit): 10 mg - moderate
Eye (rabbit):100 mg/24h - moderate

STREPTOMYCIN SULFATE:
Toxicity
Subcutaneous (mouse) LD50: 500 mg/kg
Intravenous (mouse) LD50: 90.2 mg/kg
Oral (hamster) LD50: 400 mg/kg
Bacterial mutagen.
Reproductive effector in rats.
Irritation
None reported

NEOMYCIN SULFATE:
Toxicity
Oral (woman) TDLo: 12,600 mg/kg/7d
Irritation
Skin (human): 6 mg/3d – mild

HYOSCINE HYDROBROMIDE:
Toxicity
Oral (rat) LD50: 1270 mg/kg Subcutaneous (rat) LD50: 3800
mg/kg
Irritation
None reported

CALCIUM GLUCONATE:
No significant acute toxicological data identified in literature
search.

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SECTION 11 – TOXICOLOGICAL INFORMATION (cont.)

MAGNESIUM SULFATE:
Toxicity Oral (man) TDLo: 183 mg/kg/4h
Irritation None reported

POTASSIUM CHLORIDE:
Toxicity Oral (man) LDLo: 20 mg/kg
Oral (woman) TDLo: 60 mg/kg
Oral (rat) LD50: 2,600 mg/kg
Irritation Eye (rabbit): 500 mg/24h - mild

PECTIN:
Toxicity Subcutaneous rat LD50 6,400 mg/kg

GLYCINE:
Toxicity Oral (rat) LD50: 7930 mg/kg
Irritation None reported

Other Toxic Effects ACUTE
Swallowed:
Considered an unlikely route of entry in commercial/industrial
environments. Sulfonamides and their derivatives may
precipitate in kidney tubules causing extensive damage.
Haemolytic anaemia may also result from use or exposure.
Overdose may cause acidosis or hypoglycaemia with
confusion and coma resulting. Hypersensitivity reactions may
occur in predisposed individuals including those who have
been sensitised by topical application. Deaths associated with
therapies based on sulfonamide appear to be a result of
hypersensitivity reaction, agranulocytosis, aplastic anaemia,
other blood dyscrasias and renal and hepatic failure. Doses of 2
to 5 gms have produced toxicity and fatalities.

Inhaled:
Not normally a hazard due to non-volatile nature of product.
The material is not thought to produce either adverse health
effects or irritation of the respiratory tract following
inhalation (as classified by EC Directives using animal
models). Nevertheless, adverse systemic effects have been
produced following exposure of animals by at least one other
route and good hygiene practice requires that exposure be
kept to a minimum and that suitable control measures be
used in an occupational setting.

Eye:
Ophthalmic solutions containing sulfonamides are reported to
produce local irritation, reactive hyperaemia, burning and
transient stinging, blurred vision and temporary impairment of
depth perception. Hypersensitivity reactions may occur in
predisposed individuals. The material may produce moderate eye
irritation leading to inflammation. Repeated or prolonged
exposure to irritants may produce conjunctivitis.

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SECTION 11 – TOXICOLOGICAL INFORMATION (cont.)

Skin: The material may cause skin irritation after prolonged or
repeated exposure and may produce a contact dermatitis (non-
allergic).

CHRONIC
Principal routes of exposure are by accidental skin and eye
contact and by inhalation of vapours especially at higher
temperatures. Repeated ingestion of sulfonamides used for
therapeutic purposes has caused nausea, vomiting, abdominal
pain, diarrhoea, anorexia, stomatitis, impaired folic acid
absorption, exacerbation of porphyria, acidosis, liver injury
with jaundice and hypoprothrombinaemia, and pancreatitis.
Hepatitis has been reported and may be fatal. Renal effects are
often prominent and may include crystalluria, haematuria,
proteinuria, pain and frequent urination, necrosis of the tubules,
nephritic syndrome, and toxic necrosis with oliguria or anuria
with azotaemia. Neurologic effects include headache,
drowsiness, insomnia, vertigo, tinnitus, hearing loss, mental
depression, hallucinations, ataxia, muscular paralysis, peripheral
neuropathy, transient lesions of the posterior spinal column,
transverse myelitis, convulsions and unconsciousness.
Haematological effects include eosinophilia, thrombocytopenia,
leukopenia, neutropenia, agranulocytosis, pancytopenia,
megaloblastic anaemia, Heinz body anaemia and aplastic
anaemia; petechiae and purpura may result.

SECTION 12 – ECOLOGICAL INFORMATION

Ecotoxicity DO NOT discharge into sewer or waterways.

SODIUM CHLORIDE: TLm 96 >1000 ppm.

SECTION 13 – DISPOSAL INFORMATION

Spills and disposal Triple rinse or preferably pressure rinse containers before disposal.
Dispose of rinsings in a disposal pit away from vegetation and
watercourses. If recycling, replace cap and return clean containers
to recycler or designated collection point.

If not recycling, break, crush or puncture and bury empty containers
in a local authority landfill. If no local landfill is available, bury the
containers to a depth of 500 mm or more in a disposal pit
specifically marked and set up for this purpose clear of waterways,
desirable vegetation and tree roots. Empty containers and product
should not be burnt. Do not re-use empty container for any other
purpose. Dispose of waste product through a reputable waste
contractor.

After spill or accident Dispose of sealed containers at an approved local waste disposal
site.

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SECTION 14 – TRANSPORT INFORMATION

UN No 3082

UN Proper Shipping Environmentally Hazardous Substance, Liquid, NOS

Name (Sulphadiazine, Streptomycin Sulphate)

Class & Subsidiary 9
Risk

Packaging Group III

Hazchem Code 3Z

SECTION 15 – REGULATORY INFORMATION

Poisons Schedule Schedule 4

APVMA Registration The product is registered by the APVMA.

Registration Number 36026

Labelling All necessary directions, precautions and warnings for normal use
of the product are included on the product label.

SECTION 16 – OTHER INFORMATION

Summary of Changes Update storage temperature.
from Last Edition

Acronyms ADG Code Australian Code for the Transport of Dangerous Goods
by Road and Rail

APVMA Australian Pesticides and Veterinary Medicines Authority

AS Australian Standard

NZS New Zealand Standard

CAS Chemical Abstracts Service Registry Number

NOHSC National Occupational Health & Safety Commission

UN Number United Nations number

Disclaimer This Safety Data Sheet has been developed according to the
NOHSC National Code of Practice for the Preparation of MSDS
[NOHSC:2011(2003)]. The data, information and recommendations
herein ("information") are represented in good faith and believed to
be correct as of the date hereof. The purpose of this Safety Data
Sheet is to describe product in terms of their safety requirements.
Bayer Australia Limited makes no representation of
merchantability, fitness for a particular purpose or application, or of
any other nature with respect to the information or the product to
which the information refers ("the product"). The information is
supplied upon the condition that the persons receiving same will
make their own determination as to its suitability for their purposes
prior to use of the product. The physical data shown herein are
typical values based on material tested. These values should not be
construed as a guaranteed analysis of any specific lot or as
guaranteed specification for the product or specific lots thereof.
Due care should be taken to make sure that the use or disposal of
this product and / or its packaging is in compliance with relevant
Federal, State and Local Government regulations.

END OF SDS