TYLECO 50 GRANULAR

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
TYLOSIN AS TYLOSIN PHOSPHATE
Available from:
INTERNATIONAL ANIMAL HEALTH PRODUCTS PTY LTD
INN (International Name):
tylosin as phosphate(50g/kg)
Pharmaceutical form:
ORAL POWDER, PRE-MIX
Composition:
TYLOSIN AS TYLOSIN PHOSPHATE ANTIBIOTIC Active 50.0 g/kg
Units in package:
25kg
Class:
VM - Veterinary Medicine
Manufactured by:
IAHP
Therapeutic group:
CATTLE | PIGS | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | GILT | HEI
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
ILEITIS | LIVER ABSCESS | PROMOTE ANIMAL GROWTH | FEED CONVERSION | FINISHING | GROWTH PROMOTION | GROWTH RATE | LIVEWEIGHT GAIN
Product summary:
Poison schedule: 4; Withholding period: WHP:Meat:Nil (at 100g or less tylosin per tonne of final feed). Milk:Nil ESI: This product does not have an ESI esta blished. For advice on the ESI, contact the manufacturer on 02)9672 7944 befor e using this product.; Host/pest details: CATTLE: [LIVER ABSCESS]; PIGS: [ILEITIS]; For increased growth stimulation and improved feed efficiency in pigs. For prevention of ileitis in pigs. For reduction in the incidence of liver abscess in cattle.
Authorization status:
Registered
Authorization number:
54573
Authorization date:
2019-07-01

Product name: Tyleco 50 Granular Page 1 of 3

Company Name:

International Animal Health Products Pty Ltd

Product Name:

TYLECO 50 GRANULAR

APVMA Approval No:

54573/RV0318G

Label Name:

TYLECO 50 GRANULAR

Signal Headings:

PRESCRIPTION

ANIMAL

REMEDY

KEEP

REACH

CHILDREN

ANIMAL

TREATMENT

ONLY

READ

SAFETY

DIRECTIONS

BEFORE

OPENING

USING

Constituent

Statements:

50 g/kg TYLOSlN (as tylosin phosphate)

Claims:

For prevention of ileitis in pigs. For reduction in the incidence of liver abscess

in cattle.

Net Contents:

25kg NET

Directions for Use:

Refer to Page 3.

Restraints:

Prior to prescribing TYLECO 50 GRANULAR investigate the use of non-

antibiotic options. If TYLECO 50 GRANULAR is indicated and selected for use,

prudent prescribing practices (appropriate dose, duration and frequency to

minimise treatment failure while minimising the emergence of antimicrobial

resistance) must be adhered to.

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY

TO THIS LABEL.

Contraindications:

Precautions:

Side

Effects:

RLP

APPROVED

Product name: Tyleco 50 Granular Page 2 of 3

Dosage and

Administration:

Refer to Page 3.

General

Directions:

Withholding

Periods:

MEAT - NIL (at 100 g or less tylosin per tonne of final feed).

MILK - NIL.

Trade

Advice:

EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI

established. For advice on the ESI, contact the manufacturer on (02) 9672 7944

before using this product.

Safety

Directions:

Harmful if swallowed. Will irritate the eyes and skin. Avoid contact with eyes and

skin. Repeated exposure may cause allergic disorders. Do not inhale dust.

When opening the container and mixing into feed, wear cotton overalls

buttoned to the neck and wrist (or equivalent clothing) and a washable hat,

elbow-length chemical resistant gloves and disposable dust face mask covering

mouth and nose. After use and before eating, drinking or smoking, wash hands,

arms and face thoroughly with soap and water. After each day's use, wash

gloves and contaminated clothing.

First

Aid Instructions:

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone

Australia 131 126. Additional information is in the Material Safety Data Sheet

(MSDS).

First

Warnings:

Additional User

Safety:

It is advisable to wear goggles when handling this product. If product in eyes,

wash it out immediately with water. After each day's use, wash goggles.

Environmental

Statements:

Disposal:

Shake and empty contents into medicated feed. Do not dispose of undiluted

chemicals on-site. Puncture or shred and bury empty bags in a local authority

landfill. If no landfill is available, bury the bags below 500 mm in a disposal pit

specifically marked and set up for this purpose clear of waterways, vegetation

and roots. Empty bags and product should not be burnt.

Storage:

STORE BELOW 30

C (Room Temperature) IN A DRY PLACE.

Product name: Tyleco 50 Granular Page 3 of 3

DIRECTIONS FOR USE:

BEFORE USE, THOROUGHLY MIX TYLECO 50 GRANULAR, ACCORDING TO THE

RECOMMENDED DOSAGES DESCRIBED UNDER, "DOSAGES AND ADMINISTRATION,"

UP TO MAXIMUM PROPORTION OF 2.0 Kg (2,000

Grams) TYLECO 50 GRANULAR TO

1 TONNE OF FINAL FEED.

Dosage and Administration:

PIGS:

Tyleco 50 Granular/tonne

of feed

Tylosin equivalent/tonne

of feed

For prevention of ileitis

800 g

40 g

CATTLE:

For reduction in the incidence of liver abscess:

In Complete Feeds:

220 g Tyleco 50 Granular/tonne of feed (equivalent to 11 ppm* tylosin).

Supplementary Feeds:

Calculated on total dry matter intake and supplementary feeding rate of animal. The

level of tylosin should not exceed 11 ppm of total dry matter intake (including supplement and other feed

consumed per day). The following is an example of mixing Tyleco 50 Granular into 1 tonne (1000 kg) of

finished feed to provide 150 mg tylosin/animal/day, depending on Supplementary Feed Rate:

Supplementary Feeding Rate

(kg/animal/day)

Tyleco 50 Granular/tonne of

feed

Tylosin equivalent/tonne of

feed

3 kg

150 g

1.5 kg

75 g

1 kg

50 g

750 g

37.5 g

600 g

30 g

500 g

25 g

430 g

21.5 g

375 g

18.75 g

335 g

16.7 g

300 g

15 g

* ppm (parts per m1lhon) = mg/kg

Increase the level of Tyleco 250 Granular up to the required dose of tylosin over a period of 5 to 7 days.

Dietary changes should be done gradually.

International Animal Health Products Pty Ltd

Chemwatch Hazard Alert Code: 3

Tyleco 50 Granular

Chemwatch: 4856-64

Version No: 3.1.1.1

Material Safety Data Sheet according to NOHSC and ADG requirements

Issue Date: 11/03/2014

Print Date: 26/03/2014

Initial Date: Not Available

S.Local.AUS.EN

SECTION 1 IDENTIFICATION OF THE SUBSTANCE / MIXTURE AND OF THE COMPANY / UNDERTAKING

Product Identifier

Product name

Tyleco 50 Granular

Chemical Name

Not Applicable

Synonyms

Not Available

Proper shipping name

Not Applicable

Chemical formula

Not Applicable

Other means of identification

Not Available

CAS number

Not Applicable

Relevant identified uses of the substance or mixture and uses advised against

Relevant identified uses

Aids in controlling enteric diseases, prevention of swine dysentery and prevention and treatment of ileitis in pigs. It also improves growth rate and

feed conversion efficiency in pigs. Helps in reduction of the incidence of liver abscess in cattle., Thoroughly mix in feed according to

recommended dosages on label.

Details of the supplier of the safety data sheet

Registered company name

International Animal Health Products Pty Ltd

Address

18 Healey Circuit Huntingwood 2148 NSW

Australia

Telephone

+61 2 9672 7944

Fax

+61 2 9672 7988

Website

www.iahp.com.au

Email

info@iahp.com.au

Emergency telephone number

Association / Organisation

Not Available

Emergency telephone numbers

+61 2 9672 7944

Other emergency telephone numbers

131 126 (Poisons Info. Centre Australia)

SECTION 2 HAZARDS IDENTIFICATION

Classification of the substance or mixture

HAZARDOUS SUBSTANCE. NON-DANGEROUS GOODS. According to the Criteria of NOHSC, and the ADG Code.

CHEMWATCH HAZARD RATINGS

Flammability

1

Toxicity

0

Body Contact

3

Reactivity

0

Chronic

2

0 = Minimum

1 = Low

2 = Moderate

3 = High

4 = Extreme

Poisons Schedule

Risk Phrases

[1]

R37/38

Irritating to respiratory system and skin.

R43

May cause SENSITISATION by skin contact.

Continued...

R41

Risk of serious damage to eyes.

Legend:

1. Classified by Chemwatch; 2. Classification drawn from HSIS ; 3. Classification drawn from EC Directive 1272/2008 - Annex VI

GHS Classification

[1]

Skin Corrosion/Irritation Category 2, Serious Eye Damage Category 1, Skin Sensitizer Category 1, STOT - SE (Resp. Irr.) Category 3

Legend:

1. Classified by Chemwatch; 2. Classification drawn from HSIS ; 3. Classification drawn from EC Directive 1272/2008 - Annex VI

Label elements

GHS label elements

SIGNAL WORD

DANGER

Hazard statement(s)

H315

Causes skin irritation

H318

Causes serious eye damage

H317

May cause an allergic skin reaction

H335

May cause respiratory irritation

Supplementary statement(s)

Not Applicable

CLP classification (additional)

Not Applicable

Precautionary statement(s): Prevention

P271

Use only outdoors or in a well-ventilated area.

P280

Wear protective gloves/protective clothing/eye protection/face protection.

P261

Avoid breathing dust/fume/gas/mist/vapours/spray.

P272

Contaminated work clothing should not be allowed out of the workplace.

Precautionary statement(s): Response

P305+P351+P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P310

Immediately call a POISON CENTER/doctor/physician/first aider

P321

Specific treatment (see advice on this label).

P302+P352

IF ON SKIN: Wash with plenty of water and soap

P333+P313

If skin irritation or rash occurs: Get medical advice/attention.

P362+P364

Take off contaminated clothing and wash it before reuse.

P304+P340

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

Precautionary statement(s): Storage

P405

Store locked up.

P403+P233

Store in a well-ventilated place. Keep container tightly closed.

Precautionary statement(s): Disposal

P501

Dispose of contents/container to authorised chemical landfill or if organic to high temperature incineration

Label elements

Relevant risk statements are found in section 2

Indication(s) of danger

SAFETY ADVICE

S24

Avoid contact with skin.

S25

Avoid contact with eyes.

S26

In case of contact with eyes, rinse with plenty of water and contact Doctor or Poisons Information Centre.

S37

Wear suitable gloves.

S39

Wear eye/face protection.

S40

To clean the floor and all objects contaminated by this material, use water and detergent.

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Tyleco 50 Granular

Continued...

S46

If swallowed, seek medical advice immediately and show this container or label.

S56

Dispose of this material and its container at hazardous or special waste collection point.

S64

If swallowed, rinse mouth with water (only if the person is conscious).

Other hazards

Cumulative effects may result following exposure*.

Possible respiratory sensitizer*.

Repeated exposure potentially causes skin dryness and cracking*.

SECTION 3 COMPOSITION / INFORMATION ON INGREDIENTS

Substances

See section below for composition of Mixtures

Mixtures

CAS No

%[weight]

Name

471-34-1

>60

calcium carbonate

1401-69-0

<10

tylosin

NotSpec.

other ingredients not contributing to the classification

SECTION 4 FIRST AID MEASURES

Description of first aid measures

Eye Contact

If this product comes in contact with the eyes:

Immediately hold eyelids apart and flush the eye continuously with running water.

Ensure complete irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionally lifting the upper and

lower lids.

Continue flushing until advised to stop by the Poisons Information Centre or a doctor, or for at least 15 minutes.

Transport to hospital or doctor without delay.

Removal of contact lenses after an eye injury should only be undertaken by skilled personnel.

Skin Contact

If skin contact occurs:

Immediately remove all contaminated clothing, including footwear.

Flush skin and hair with running water (and soap if available).

Seek medical attention in event of irritation.

Inhalation

If fumes or combustion products are inhaled remove from contaminated area.

Lay patient down. Keep warm and rested.

Prostheses such as false teeth, which may block airway, should be removed, where possible, prior to initiating first aid procedures.

Apply artificial respiration if not breathing, preferably with a demand valve resuscitator, bag-valve mask device, or pocket mask as trained.

Perform CPR if necessary.

Transport to hospital, or doctor, without delay.

Ingestion

Immediately give a glass of water.

First aid is not generally required. If in doubt, contact a Poisons Information Centre or a doctor.

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

None known.

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.

Fire/Explosion Hazard

Solid which exhibits difficult combustion or is difficult to ignite.

Avoid generating dust, particularly clouds of dust in a confined or unventilated space as dusts may form an explosive mixture with air, and any

source of ignition, i.e. flame or spark, will cause fire or explosion.

Dust clouds generated by the fine grinding of the solid are a particular hazard; accumulations of fine dust (420 micron or less) may burn

rapidly and fiercely if ignited; once initiated larger particles up to 1400 microns diameter will contribute to the propagation of an explosion.

A dust explosion may release large quantities of gaseous products; this in turn creates a subsequent pressure rise of explosive force

capable of damaging plant and buildings and injuring people.

Chemwatch: 4856-64

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Issue Date: 11/03/2014

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Tyleco 50 Granular

Continued...

SECTION 6 ACCIDENTAL RELEASE MEASURES

Personal precautions, protective equipment and emergency procedures

Minor Spills

Clean up all spills immediately.

Avoid breathing dust and contact with skin and eyes.

Wear protective clothing, gloves, safety glasses and dust respirator.

Use dry clean up procedures and avoid generating dust.

Major Spills

Moderate hazard.

CAUTION: Advise personnel in area.

Alert Emergency Services and tell them location and nature of hazard.

Control personal contact by wearing protective clothing.

Personal Protective Equipment advice is contained in Section 8 of the MSDS.

SECTION 7 HANDLING AND STORAGE

Precautions for safe handling

Safe handling

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.

Other information

Store in original containers.

Keep containers securely sealed.

Store in a cool, dry area protected from environmental extremes.

Store away from incompatible materials and foodstuff containers.

Conditions for safe storage, including any incompatibilities

Suitable container

Multi-ply paper bag with sealed plastic liner or heavy gauge plastic bag.

NOTE: Bags should be stacked, blocked, interlocked, and limited in height so that they are stable and secure against sliding or collapse. Check

that all containers are clearly labelled and free from leaks. Packing as recommended by manufacturer.

|25kg multi-walled paper bag with plastic liner.

Storage incompatibility

Calcium carbonate:

is incompatible with acids, ammonium salts, fluorine, germanium, lead diacetate, magnesium, mercurous chloride, silicon, silver nitrate,

titanium.

Contact with acid generates carbon dioxide gas, which may pressurise and then rupture closed containers

Avoid strong acids, acid chlorides, acid anhydrides and chloroformates.

PACKAGE MATERIAL INCOMPATIBILITIES

SECTION 8 EXPOSURE CONTROLS / PERSONAL PROTECTION

Control parameters

OCCUPATIONAL EXPOSURE LIMITS (OEL)

INGREDIENT DATA

Source

Ingredient

Material

name

TWA

STEL

Peak

Notes

Australia Exposure Standards

calcium

carbonate

Calcium

carbonate

(mg/m3)

Available

Available

This value is for inspirable dust containing no asbestos

and < 1% crystalline silica (see Chapter 14)

EMERGENCY LIMITS

Ingredient

TEEL-0

TEEL-1

TEEL-2

TEEL-3

calcium carbonate

15(ppm)

30 / 45(ppm)

500 / 75(ppm)

500 / 350(ppm)

Ingredient

Original IDLH

Revised IDLH

Tyleco 50 Granular

Not Available

Not Available

Exposure controls

Appropriate engineering controls

None required when handling small quantities.

OTHERWISE:

Engineering controls are used to remove a hazard or place a barrier between the worker and the hazard. Well-designed engineering controls

can be highly effective in protecting workers and will typically be independent of worker interactions to provide this high level of protection.

The basic types of engineering controls are:

Process controls which involve changing the way a job activity or process is done to reduce the risk.

Personal protection

Chemwatch: 4856-64

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Tyleco 50 Granular

Continued...

Eye and face protection

No special equipment for minor exposure i.e. when handling small quantities.

· OTHERWISE:

· Safety glasses with side shields.

· Contact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants. A written policy document, describing the

wearing of lenses or restrictions on use, should be created for each workplace or task.

Skin protection

See Hand protection below

Hand protection

No special equipment needed when handling small quantities.

OTHERWISE: Wear chemical protective gloves, e.g. PVC.

Body protection

See Other protection below

Other protection

No special equipment needed when handling small quantities.

OTHERWISE:

Overalls.

Barrier cream.

Eyewash unit.

Thermal hazards

Recommended material(s)

GLOVE SELECTION INDEX

Glove selection is based on a modified presentation of the:

"Forsberg Clothing Performance Index".

The effect(s) of the following substance(s) are taken into account in the computer-

generated selection:

Tyleco 50 Granular Not Available

Material

CPI

* CPI - Chemwatch Performance Index

A: Best Selection

B: Satisfactory; may degrade after 4 hours continuous immersion

C: Poor to Dangerous Choice for other than short term immersion

NOTE: As a series of factors will influence the actual performance of the glove, a final

selection must be based on detailed observation. -

* Where the glove is to be used on a short term, casual or infrequent basis, factors such as

"feel" or convenience (e.g. disposability), may dictate a choice of gloves which might otherwise

be unsuitable following long-term or frequent use. A qualified practitioner should be consulted.

Respiratory protection

Type A-P Filter of sufficient capacity. (AS/NZS 1716 & 1715, EN 143:2000 & 149:2001, ANSI

Z88 or national equivalent)

Where the concentration of gas/particulates in the breathing zone,

approaches or exceeds the "Exposure Standard" (or ES), respiratory

protection is required.

Degree of protection varies with both face-piece and Class of filter;

the nature of protection varies with Type of filter.

Required

Minimum

Protection

Factor

Half-Face

Respirator

Full-Face

Respirator

Powered Air

Respirator

up to 10 x ES

A-AUS P2

A-PAPR-AUS /

Class 1 P2

up to 50 x ES

A-AUS /

Class 1 P2

up to 100 x ES

A-2 P2

A-PAPR-2 P2 ^

^ - Full-face

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)

SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES

Information on basic physical and chemical properties

Appearance

Light brown free flowing micro-granules; does not mix with water.

Physical state

Divided Solid

Relative density (Water = 1)

Not Available

Odour

Not Available

Partition coefficient n-octanol / water

Not Available

Odour threshold

Not Available

Auto-ignition temperature (°C)

Not Applicable

pH (as supplied)

Not Applicable

Decomposition temperature

Not Available

Melting point / freezing point (°C)

Not Available

Viscosity (cSt)

Not Applicable

Initial boiling point and boiling range

(°C)

Not Applicable

Molecular weight (g/mol)

Not Applicable

Flash point (°C)

Not Applicable

Taste

Not Available

Evaporation rate

Not Applicable

Explosive properties

Not Available

Flammability

Not Available

Oxidising properties

Not Available

Upper Explosive Limit (%)

Not Applicable

Surface Tension (dyn/cm or mN/m)

Not Available

Lower Explosive Limit (%)

Not Applicable

Volatile Component (%vol)

Not Applicable

Vapour pressure (kPa)

Not Applicable

Gas group

Not Available

Solubility in water (g/L)

Immiscible

pH as a solution(1%)

Not Applicable

Vapour density (Air = 1)

Not Applicable

VOC g/L

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Tyleco 50 Granular

Continued...

SECTION 10 STABILITY AND REACTIVITY

Reactivity

See section 7

Chemical stability

Presence of incompatible materials.

Product is considered stable.

Hazardous polymerisation will not occur.

Possibility of hazardous reactions

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

Evidence shows, or practical experience predicts, that the material produces irritation of the respiratory system, in a substantial number of

individuals, following inhalation. In contrast to most organs, the lung is able to respond to a chemical insult by first removing or neutralising the

irritant and then repairing the damage. The repair process, which initially evolved to protect mammalian lungs from foreign matter and antigens,

may however, produce further lung damage resulting in the impairment of gas exchange, the primary function of the lungs. Respiratory tract

irritation often results in an inflammatory response involving the recruitment and activation of many cell types, mainly derived from the vascular

system.

Ingestion

The material has NOT been classified by EC Directives or other classification systems as "harmful by ingestion". This is because of the lack of

corroborating animal or human evidence. The material may still be damaging to the health of the individual, following ingestion, especially where

pre-existing organ (e.g liver, kidney) damage is evident. Present definitions of harmful or toxic substances are generally based on doses

producing mortality rather than those producing morbidity (disease, ill-health).

Skin Contact

The material produces moderate skin irritation; evidence exists, or practical experience predicts, that the material either

produces moderate inflammation of the skin in a substantial number of individuals following direct contact, and/or

produces significant, but moderate, inflammation when applied to the healthy intact skin of animals (for up to four hours), such inflammation

being present twenty-four hours or more after the end of the exposure period.

Skin irritation may also be present after prolonged or repeated exposure; this may result in a form of contact dermatitis (nonallergic). The

dermatitis is often characterised by skin redness (erythema) and swelling (oedema) which may progress to blistering (vesiculation), scaling and

thickening of the epidermis. At the microscopic level there may be intercellular oedema of the spongy layer of the skin (spongiosis) and

intracellular oedema of the epidermis.

Eye

When applied to the eye(s) of animals, the material produces severe ocular lesions which are present twenty-four hours or more after instillation.

Chronic

Long-term exposure to respiratory irritants may result in disease of the airways involving difficult breathing and related systemic problems.

Practical experience shows that skin contact with the material is capable either of inducing a sensitisation reaction in a substantial number of

individuals, and/or of producing a positive response in experimental animals.

Prolonged or repeated skin contact may cause drying with cracking, irritation and possible dermatitis following.

Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involving organs or

biochemical systems.

Tyleco 50 Granular

TOXICITY

IRRITATION

Not Available

Not Available

calcium carbonate

TOXICITY

IRRITATION

Oral (Rat) LD50: 6450 mg/kg

Eye (rabbit): 0.75 mg/24h - SEVERE

Skin (rabbit): 500 mg/24h-moderate

Not Available

Not Available

tylosin

TOXICITY

IRRITATION

Intraperitoneal (Mouse) LD50: 594 mg/kg

Intraperitoneal (Rat) LD50: 600 mg/kg

Intravenous (Mouse) LD50: 400 mg/kg

Intravenous (Rat) LD50: 600 mg/kg

Oral (Dog) LD50: >800 mg/kg

Oral (Mouse) LD50: 10000 mg/kg

Oral (Rat) LD50: >5000 mg/kg

Not Available

Not Available

Not available. Refer to individual constituents.

CALCIUM CARBONATE

Asthma-like symptoms may continue for months or even years after exposure to the material ceases. This may be due to a non-allergenic

condition known as reactive airways dysfunction syndrome (RADS) which can occur following exposure to high levels of highly irritating

compound. Key criteria for the diagnosis of RADS include the absence of preceding respiratory disease, in a non-atopic individual, with

abrupt onset of persistent asthma-like symptoms within minutes to hours of a documented exposure to the irritant. A reversible airflow pattern,

on spirometry, with the presence of moderate to severe bronchial hyperreactivity on methacholine challenge testing and the lack of minimal

lymphocytic inflammation, without eosinophilia, have also been included in the criteria for diagnosis of RADS.

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Tyleco 50 Granular

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No evidence of carcinogenic properties. No evidence of mutagenic or teratogenic effects.

TYLOSIN

The following information refers to contact allergens as a group and may not be specific to this product.

Contact allergies quickly manifest themselves as contact eczema, more rarely as urticaria or Quincke's oedema. The pathogenesis of

contact eczema involves a cell-mediated (T lymphocytes) immune reaction of the delayed type. Other allergic skin reactions, e.g. contact

urticaria, involve antibody-mediated immune reactions.

Acute Toxicity

Carcinogenicity

Skin Irritation/Corrosion

Reproductivity

Serious Eye Damage/Irritation

STOT - Single Exposure

Respiratory or Skin sensitisation

STOT - Repeated Exposure

Mutagenicity

Aspiration Hazard

CMR STATUS

SECTION 12 ECOLOGICAL INFORMATION

Toxicity

DO NOT discharge into sewer or waterways.

Persistence and degradability

Ingredient

Persistence: Water/Soil

Persistence: Air

Not Available

Not Available

Not Available

Bioaccumulative potential

Ingredient

Bioaccumulation

Not Available

Not Available

Mobility in soil

Ingredient

Mobility

Not Available

Not Available

SECTION 13 DISPOSAL CONSIDERATIONS

Waste treatment methods

Product / Packaging disposal

Containers may still present a chemical hazard/ danger when empty.

Return to supplier for reuse/ recycling if possible.

Otherwise:

If container can not be cleaned sufficiently well to ensure that residuals do not remain or if the container cannot be used to store the same

product, then puncture containers, to prevent re-use, and bury at an authorised landfill.

Where possible retain label warnings and MSDS and observe all notices pertaining to the product.

SECTION 14 TRANSPORT INFORMATION

Labels Required

Marine Pollutant

HAZCHEM

Not Applicable

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

SECTION 15 REGULATORY INFORMATION

Safety, health and environmental regulations / legislation specific for the substance or mixture

calcium carbonate(471-34-1) is found on

the following regulatory lists

"Australia Exposure Standards","GESAMP/EHS Composite List - GESAMP Hazard Profiles","Australia Drinking Water Guideline Values For

Physical and Chemical Characteristics","IMO IBC Code Chapter 17: Summary of minimum requirements","FisherTransport

Information","Sigma-AldrichTransport Information","Acros Transport Information","Australia Inventory of Chemical Substances

(AICS)","CODEX General Standard for Food Additives (GSFA) - Additives Permitted for Use in Food in General, Unless Otherwise Specified,

in Accordance with GMP","International Numbering System for Food Additives","International Council of Chemical Associations (ICCA) - High

Production Volume List","OECD List of High Production Volume (HPV) Chemicals","Australia High Volume Industrial Chemical List

(HVICL)","Australia Therapeutic Goods Administration (TGA) Substances that may be used as active ingredients in Listed medicines","IMO

MARPOL 73/78 (Annex II) - List of Noxious Liquid Substances Carried in Bulk","Australia Quarantine and Inspection Service List of chemical

compounds that are accepted solely for use at establishments registered to prepare meat and meat products for the purpose of the Export Control

Act 1982","Australia Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) - Schedule 6","Australia Standard for the

Uniform Scheduling of Medicines and Poisons (SUSMP) - Appendix F (Part 3)","Australia Standard for the Uniform Scheduling of Medicines

Chemwatch: 4856-64

Version No: 3.1.1.1

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Issue Date: 11/03/2014

Print Date: 26/03/2014

Tyleco 50 Granular

Continued...

and Poisons (SUSMP) - Appendix E (Part 2)","Australia Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) - Schedule

5"

tylosin(1401-69-0) is found on the

following regulatory lists

"Australia Inventory of Chemical Substances (AICS)","Australia FAISD Handbook - First Aid Instructions, Warning Statements, and General

Safety Precautions","Australia New Zealand Food Standards Code - Maximum Residue Limits (Australia only) - Schedule 1","Australia

Australian Pesticides and Veterinary Medicines Authority (APVM) Record of approved active constituents","Australia ADI list - Acceptable daily

intakes for agricultural and veterinary chemicals","Australia Approved Active Constituents for Agricultural Chemical Products","Belgium Federal

Public Service Mobility and Transport, Regulations concerning the International Carriage of Dangerous Goods by Rail - Table A: Dangerous

Goods List - RID 2013 (Dutch)","Australia Dangerous Goods Code (ADG Code) - Dangerous Goods List","International Maritime Dangerous

Goods Requirements (IMDG Code) - Substance Index","International Air Transport Association (IATA) Dangerous Goods

Regulations","Australia - New South Wales Protection of the Environment Operations (Waste) Regulation 2005 - Characteristics of trackable

wastes","International Maritime Dangerous Goods Requirements (IMDG Code)","Australia Standard for the Uniform Scheduling of Medicines

and Poisons (SUSMP) - Schedule 4"

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.

A list of reference resources used to assist the committee may be found at:

www.chemwatch.net/references

The (M)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.

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.

Chemwatch: 4856-64

Version No: 3.1.1.1

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Issue Date: 11/03/2014

Print Date: 26/03/2014

Tyleco 50 Granular

end of SDS

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