SAFETY DATA SHEET

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Product Name: Metacam 20 mg/mL Solution for Injection Reviewed on: 7 February 2020
SECTION 1: IDENTIFICATION OF THE SUBSTANCE AND SUPPLIER
Metacam 20 mg/mL Solution for Injection
Product name:
Product code: A007982
Recommended use: Meloxicam is a non- steroidal anti- inflammatory drug (NSAID) of
the oxicam class which acts by inhibition of prostaglandin synthesis,
thereby inserting anti-inflammatory, anti-endotoxic, anti-exudative,
analgesic and antipyretic properties. For use in cattle, sheep, pigs
and horses.
Company details: Boehringer Ingelheim Animal Health New Zealand Limited
Address: Level 3, Boehringer Ingelheim Building
2 Osterley Way
Manukau City
Auckland 2104
New Zealand
Telephone number: Phone: +64 9 263 1400
Emergency telephone Boehringer Ingelheim Freephone: 0800 800 822
number: National Poisons Centre : 0800 764 766 (0800 POISON)
Fire Service, Ambulance : Dial 111
Date of issue: 17 May 2018
Date of review: 7 February 2020

SECTION 2: COMPOSITION/INFORMATION ON INGREDIENTS

Chemical characterization: Liquid

Product components:
Name CAS Proportion
Ethanol 64-17-5 10-30%
Meloxicam (4-hydroxy-2-methyl-N-(5-methyl-2- 71125-38-7 2%
thiazolyl)- 2H-1,2-benzothiazine-3-carboxamide-
1,1-dioxide)
Ingredients determined not to be hazardous, N/A Balance
including water.

SECTION 3: HAZARDS IDENTIFICATION

3.1C, 6.1E, 6.4A, 6.8B, 6.9B, 9.1D
Hazard classifications:
Priority and secondary WARNING
identifiers:
Risk and safety phrases: 3.1C Flammable liquids: medium hazard
6.1E (Oral) - Substance that is acutely toxic
6.4A Substance that is irritating to the eyes
6.8B Substance that is suspected to be a human reproductive or
developmental toxicant
6.9B (Single exposure) - Substance that is harmful to human target
organs or systems
6.9B (Repeated exposure) - Substance that is harmful to human
target organs or systems
9.1D Substance that is slightly harmful to the aquatic environment
or is otherwise designed for biocidal action

Hazard Statements
H226 Flammable liquid and vapour.
H303 May be harmful if swallowed.
H319 Causes serious eye irritation.
H361 Suspected of damaging fertility or the unborn child.
H371 May cause damage to organs by oral.
H373 May cause damage to organs through prolonged or repeated
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Product Name: Metacam 20 mg/mL Solution for Injection Reviewed on: 7 February 2020

exposure by oral.
H401 Toxic to aquatic life.

Precautionary statement – Prevention

P102 Keep out of reach of children.
P103 Read label before use.
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been read and
understood.
P210 Keep away from heat/sparks/open flames/hot surfaces. – No
smoking.
P233 Keep container tightly closed.
P240 Ground/bond container and receiving equipment.
P241 Use explosion-proof electrical/ventilating/lighting/equipment.
P242 Use only non-sparking tools.
P243 Take precautionary measures against static discharge.
P260 Do not breathe dust/fume/gas/mist/vapours/spray.
P264 Wash contaminated skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P273 Avoid release to the environment.
P280 Wear protective gloves/protective clothing/eye protection/face
protection.
Precautionary statement – Response
P101 If medical advice is needed, have product container or label at
hand.
P303+P361+P353 IF ON SKIN (or hair): Remove/Take off
immediately all contaminated clothing. Rinse skin with
water/shower.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for
several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing.
P308+P313 IF exposed or concerned: Get medical advice/attention.
P309+P311 IF exposed or if you feel unwell: Call a POISON CENTER
or doctor/physician.
P312 Call a POISON CENTER or doctor/physician if you feel unwell.
P314 Get medical advice/attention if you feel unwell.
P337+P313 If eye irritation persists: Get medical advice/attention.
P370+P378 In case of fire: Use carbon dioxide, dry chemical, foam,
water fog or water mist.
Precautionary statement – Storage
P403+P235 Store in a well-ventilated place. Keep cool.
P405 Store locked up.
Precautionary statement – Disposal
P501 In the case of a substance that is in compliance with a HSNO
approval other than a Part 6A (Group Standards) approval, a label
must provide a description of one or more appropriate and
achievable methods for the disposal of a substance in accordance
with the Hazardous Substances (Disposal) Regulations 2001. This
may also include any method of disposal that must be avoided. See
Section 13 for disposal details.

SECTION 4: FIRST AID MEASURES

For advice, contact the National Poisons Centre on 0800 POISON
Necessary first aid
(0800 764 766), or a doctor immediately.
measures:
Ingestion: If swallowed, seek immediate medical attention. Do NOT
induce vomiting. Wash out mouth thoroughly with water.
Eyes: If in eyes, hold eyelids apart and flush the eyes continuously
with running water. Remove contact lenses. Continue flushing for
several minutes until all contaminants are washed out completely.
Seek medical attention.
Skin: Wash affected area thoroughly with soap and water. If
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Product Name: Metacam 20 mg/mL Solution for Injection Reviewed on: 7 February 2020

symptoms develop, seek medical attention.

In case of accidental injection, wash the site thoroughly. Contact a
physician immediately and show the packet insert or label to the
physician.
Inhalation: If inhaled, remove affected person from contaminated
area to fresh air. Keep at rest until recovered. If symptoms develop
and/or persist, seek medical attention.
Workplace facilities: No special facilities required.
Required instructions: Observe good work practices and avoid skin contact. Wash hands
and exposed skin before meals and after use. Do not eat or drink
while using. Launder protective clothing separately from other
clothing, and before each reuse.
Notes for medical personnel: Treat symptomatically.
Note to Physician: For animal injection only. Not for human use.
Antidote: Epinephrine is indicated for anaphylactoid reactions

SECTION 5: FIRE FIGHTING MEASURES

Type of hazard: Flammable liquid and vapour.
Fire hazard properties: Vapour/air mixtures may ignite explosively. Flashback along the
vapour trail may occur. Runoff to sewer may create fire or explosion
hazard. Under fire conditions this product may emit toxic and/or
irritating fumes including carbon monoxide and carbon dioxide.
Extinguishing media and Use carbon dioxide, dry chemical, foam, water fog or water mist.
methods:
Hazchem code: N/A
Recommended protective Fire fighters should wear Self-Contained Breathing Apparatus and
clothing: full protective clothing to prevent exposure to vapours, fumes or
products of combustion. Water spray may be used to cool down
heat-exposed material.

SECTION 6: ACCIDENTAL RELEASE MEASURES

For minor spills: refer to product label for specific instructions.
Emergency procedures:
Avoid inhalation of fumes, and skin or eye contact. Absorb with an
inert material and place in an appropriate waste disposal container.
In the event of a major spill: Wear appropriate personal protective
equipment and clothing to prevent exposure. Extinguish or remove
all sources of ignition and stop leak if safe to do so. Increase
ventilation. Evacuate all unprotected personnel. If possible, contain
the spill. Place inert absorbent, non- combustible material onto
spillage. Use clean non-sparking tools to collect the material and
place into suitable labelled containers for subsequent recycling or
disposal. Dispose of waste according to the applicable local and
national regulations. If contamination of sewers or waterways
occurs, inform the local water and waste management authorities
in accordance with local regulations.

SECTION 7: HANDLING AND STORAGE

Avoid contact with skin and eyes. Wear overalls, impervious gloves
Precautions for safe
and safety glasses. Use in designated areas with local exhaust
handling:
ventilation, away from sparks, flames and other ignition sources.
Use approved flammable liquid storage containers in the work area.
Prevent release of vapours and mists into workplace air. Keep
containers tightly closed. Take precautionary measures against
static discharges. Do not empty into drains. Ensure a high level of
personal hygiene is maintained when using this product, that is,
always wash hands before eating, drinking, smoking or using the
toilet facilities. Use as directed on label or package insert.
Avoid exposure. Do not handle until all safety precautions have
been read and understood. It is recommended that pregnant or
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Product Name: Metacam 20 mg/mL Solution for Injection Reviewed on: 7 February 2020

breastfeeding women should not handle this product unless

adequate exposure protection can be assured at all times. Female
personnel planning pregnancy should be made aware of the
potential risks.
Approved handlers: Not required
Conditions for safe storage: Store in a cool, dry, well-ventilated area away from sources of
ignition, oxidising agents, strong acids, foodstuffs, and clothing.
Keep containers closed when not in use, securely sealed and
protected against physical damage. Inspect regularly for
deficiencies such as damage or leaks. Have appropriate fire
extinguishers available in and near the storage area. Take
precautions against static electricity discharges. Use proper
grounding procedures. Protect from freezing. Ensure that storage
conditions comply with applicable local and national regulations. For
information on the design of the storeroom, reference should be
made to Australian Standard AS1940 - The storage and handling of
flammable and combustible liquids. Not to be used after 28 days of
opening.
Store site requirements: Store below 25 °C.

SECTION 8: EXPOSURE CONTROL/PERSONAL PROTECTION

No exposure standards have been established for this material.
Workplace exposure
However, the available exposure limits for ingredients are listed
standards:
below:
Ethanol:
TWA: 1000 ppm, 1880 mg/m³
TWA (Time Weighted Average): The average airborne concentration
of a particular substance when calculated over a normal eight- hour
working day, for a five-day week.
Application in the workplace: Prevent exposure by using engineering controls, personal protective
equipment and work practices that prevent skin contact.
Engineering controls: Industrial application: This substance is hazardous and should be
used with a local exhaust ventilation system, drawing vapours away
from workers' breathing zone. A flame-proof exhaust ventilation
system is required. If the engineering controls are not sufficient to
maintain concentrations of vapours/mists below the exposure
standards, suitable respiratory protection must be worn. Refer to
relevant regulations for further information concerning ventilation
requirements.
Personal protection: Respiratory Protection
Industrial application: If engineering controls are not effective in
controlling airborne exposure then an approved respirator with a
replaceable vapour/mist filter should be used.1
Eye Protection
Industrial application: glasses with side shields, full face shield or
chemical goggles should be worn. Final choice of appropriate eye/
face protection will vary according to individual circumstances.2
Hand Protection
Wear impervious chemical resistant gloves such as butyl rubber or
nitrile rubber. Final choice of appropriate gloves will vary according
to individual circumstances, i.e. methods of handling or according to
risk assessments undertaken.3
Body Protection
Suitable protective workwear, e.g. cotton overalls buttoned at neck
and wrist. When large quantities are handled the use of plastic
aprons and rubber boots is recommended.

References: 1. Reference should be made to Australian/New Zealand

Standards AS/NZS 1715, Selection, Use and Maintenance of
Respiratory Protective Devices; and AS/NZS 1716,
Respiratory Protective Devices, in order to make any
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Product Name: Metacam 20 mg/mL Solution for Injection Reviewed on: 7 February 2020

necessary changes for individual circumstances.

2. Eye protection devices should conform with Australian/ New
Zealand Standard AS/NZS 1337 - Eye Protectors for
Industrial Applications.
3. Reference should be made to AS/NZS 2161.1: Occupational
protective gloves - Selection, use and maintenance.

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES

Formulation type: Liquid
Specify product data:
Appearance: Colourless glass injection vials of 20 mL, 50 mL, 100
mL and 250 mL
Specific gravity: Not available
Boiling Point: 78 °C (approximate) (related to solvents)
Vapour Pressure: Not available
Solubility in Water: Soluble (20 °C)
Odour: Alcohol-like
Flash Point: 36.6 °C (literature)
Auto-ignition Temperature: 425 °C (related to solvents)
Flammability: Flammable
Explosion properties: Not explosive

SECTION 10: STABILITY AND REACTIVITY

Stability of the substance: Stable under normal conditions of use and storage.
Conditions to avoid: Heat, open flames and other sources of ignition.
Material to avoid: Strong oxidizing agents.
Hazardous decomposition Under fire conditions this product may emit toxic and/or irritating
products: fumes including carbon monoxide and carbon dioxide
Hazardous polymerization: Will not occur.
Specific data: N/A

SECTION 11: TOXICOLOGICAL INFORMATION

Acute Toxicity - Oral
Data:
Meloxicam
LD50 (rat): 83.5 mg/kg Ethanol
LD50 (rat): 6200 mg/kg
Acute Toxicity - Inhalation
Ethanol
LC50 (rat): 95.6 mg/l/4h
Acute Toxicity - Dermal
Ethanol
LD50 (rat): >2000 mg/kg
Ingestion
May be harmful if swallowed. Ingestion of this product may cause
irritation to the mouth, throat, oesophagus and stomach with
symptoms of nausea, abdominal discomfort, vomiting and
diarrhoea.
Inhalation
Inhalation of product vapours may cause irritation of the nose,
throat and respiratory system.
Skin
May be irritating to skin. The symptoms may include redness,
itching and swelling. Meloxicam:
Species: Rabbit Exposure time: 4 h
Method: OECD Test Guideline 404 Result: No skin irritation
Ethanol:
Species: Rabbit
Method: OECD Test Guideline 404 Result: No skin irritation
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Product Name: Metacam 20 mg/mL Solution for Injection Reviewed on: 7 February 2020

Eye
Causes serious eye irritation. On eye contact this product will cause
tearing, stinging, blurred vision, and redness. Serious eye
damage/eye irritation
Meloxicam:
Species: Rabbit
Result: No eye irritation Ethanol:
Species: Rabbit Result: Eye irritation
Method: OECD Test Guideline 405
Respiratory sensitisation
Not expected to be a respiratory sensitiser.
Skin Sensitisation
Not expected to be a skin sensitiser.
Germ cell mutagenicity
Not considered to be a mutagenic hazard. Meloxicam:
Genotoxicity in vitro:
Test Type: Ames-test, Species: Salmonella typhimurium, Result:
negative
Test Type: HGPRT assay, Species: V79 cells (Chinese hamster),
Result: negative
Test Type: Chromosomal aberration test, Species: Human
lymphocytes, Result: negative Genotoxicity in vivo :
Test Type: Micronucleus test, Species: Mouse (oral), Dose: 300
mg/kg Remarks: In vivo tests did not show any chromosomal
changes.
Ethanol:
Genotoxicity in vitro: Test Type: Ames-test, Species: Salmonella
typhimurium, Result: negative
Carcinogenicity
Not considered to be a carcinogenic hazard. Meloxicam
Species: Mouse, Application Route: Oral, Exposure time: 48
month(s), Dose: 8 mg/kg Remarks: Did not show carcinogenic
effects in animal experiments.
Species: Rat, Application Route: Oral, Exposure time: 48 month(s),
Dose: 0,8 mg/kg Remarks: Did not show carcinogenic effects in
animal experiments
Reproductive Toxicity
Suspected of damaging fertility or the unborn child. Classified as a
suspected human reproductive or developmental toxicant.
Meloxicam:
Effects on fertility:
Test Type: Study of Fertility and Early Embryonic Development,
Species: Rat, Dose: 4 mg/kg, Application Route: Oral Remarks: Did
not show teratogenic effects in animal experiments
Test Type: Study for Effects on Embryo-Fetal Development,
Species: Rabbit, Dose: 80 mg/kg, Application Route: Oral Remarks:
Did not show teratogenic effects in animal experiments
Test Type: Pre- and Postnatal development study, Species: Rat,
NOAEL: < 0.125 mg/kg, F1: < 0.125 mg/kg
STOT-single exposure
May cause damage to organs by oral.
STOT-repeated exposure
May cause damage to organs through prolonged or repeated
exposure by oral. Meloxicam:
Species: Rat
NOAEL: = 0.4 mg/kg, Application Route: Oral, Exposure time: 52
weeks Species: Rat
NOAEL: < 1 mg/kg, Application Route: Oral, Exposure time: 18
months Species: guinea pig
NOAEL: = 1 mg/kg, Application Route: Oral, Exposure time: 52
weeks
Aspiration Hazard
Not expected to be an aspiration hazard.
Other Information
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Product Name: Metacam 20 mg/mL Solution for Injection Reviewed on: 7 February 2020

Meloxicam:
Test Type: Maximisation Test Species: Guinea pig
Result: Did not cause sensitisation on laboratory animals. Ethanol:
Species: Guinea pig
Method: OECD Test Guideline 406
Result: Did not cause sensitisation on laboratory animals.

SECTION 12: ENVIRONMENTAL INFORMATION

Potential environmental
Toxic to aquatic life.
interactions:
Data organisation : Persistence and degradability
Meloxicam:
Biodegradability : Result: Not rapidly biodegradable
Biodegradation: 31.3%, Exposure time: 28 d
Method: OECD Test Guideline 301B
Remarks: According to the results of tests of biodegradability this
product is not readily biodegradable.
Ethanol:
Biodegradability : Result: Readily biodegradable
Biodegradation: 94%
Biochemical Oxygen Demand (5d) : 930 - 1,670 mg/g
Chemical Oxygen Demand (COD): 1.99 mg/g
ThOD : 2,100 mg/g
Mobility
Not available
Bioaccumulative Potential
Meloxicam:
Bioaccumulation : Remarks: No appreciable bioaccumulation
potential is to be expected (log Pow) 1-3).
Partition coefficient: n-octanol/water: log Pow: = 1.7
Method: OECD Test Guideline 107 log Pow: = 0.2
Method: OECD Test Guideline 107 log Pow: = -0.3
Method: OECD Test Guideline 107
Ethanol:
Bioaccumulation : Remarks: No bioaccumulation is to be expected
(log Pow)<1).
Partition coefficient: n-octanol/water: log Pow: -0.32
Other Adverse Effects
Not available
Environmental Protection
Prevent this material entering waterways, drains and sewers.
Acute Toxicity - Fish
Meloxicam:
LC50 (Brachydanio rerio (zebrafish)): = 50 mg/l/96h
Test Type: static test, Method: OECD Test Guideline 203
Ethanol:
LC50 (golden orfe): = 8,140 mg/l/48h
Acute Toxicity - Daphnia
Meloxicam
EC50 (Daphnia magna (Water flea)): > 13 mg/l/48h
Test Type: static test, Method: OECD Test Guideline 202
Remarks: No toxicity at the limit of solubility
Ethanol:
EC50 (Daphnia magna (Water flea)): = 9,268 - 14,221 mg/l/48h
Acute Toxicity - Algae
Meloxicam
EC50 (Desmodesmus subspicatus): > 100.1 mg/l/72h
Method: OECD Test Guideline 201
NOEC (Desmodesmus subspicatus): = 100.1 mg/l/72h
Method: OECD Test Guideline 201
Ethanol:
Lowest Observed Effect Concentration (Scenedesmus quadricauda
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Product Name: Metacam 20 mg/mL Solution for Injection Reviewed on: 7 February 2020

(Green algae)): = 5,000 mg/l/7d

Acute Toxicity - Bacteria
Meloxicam
NOEC (activated sludge, industrial): > 1,000 mg/l Method: OECD
209
Ethanol:
EC5 (Pseudomonas putida): = 6,500 mg/l/16h
Environmental risk and
safety phrases:
Prevent this material entering waterways, drains and sewers.

SECTION 13: DISPOSAL CONSIDERATIONS

Dispose of waste according to applicable local and national
Disposal information :
regulations. Do not allow into drains or watercourses or dispose of
where ground or surface waters may be affected. Wastes including
emptied containers are controlled wastes and should be disposed of
in accordance with all applicable local and national regulations.

Product Disposal:
Product wastes are controlled wastes and should be disposed of in
accordance with all applicable local and national regulations. This
product can be disposed through a licensed commercial waste
collection service. In this specific case the product is a flammable
substance and therefore can be sent to an approved high
temperature incineration plant for disposal.

Personal protective clothing and equipment as specified in Section 8

of this SDS must be worn during handling and disposal of this
product. The ventilation requirements as specified in the same
section must also be followed, and the precautions given in Section
7 of this SDS regarding handling must also be followed.

Do not dispose into the sewerage system. Do not discharge into

drains or watercourses or dispose where ground or surface waters
may be affected.

In New Zealand, the disposal agency or contractor must comply

with the New Zealand Hazardous Substances (Disposal) Regulations
2001. Further details regarding disposal can be obtained on the EPA
New Zealand website under specific group standards.

Container Disposal:
The container or packaging must be cleaned and rendered incapable
of holding any substance. It can then be disposed of in a manner
consistent with that of the substance it contained. In this instance
the packaging can be disposed through a commercial waste
collection service.
Alternatively, the container or packaging can be recycled if the
hazardous residues have been thoroughly cleaned or rendered non-
hazardous.

In New Zealand, the packaging (that may or may not hold any
residual substance) that is lawfully disposed of by householders or
other consumers through a public or commercial waste collection
service is a means of compliance with regulations.

SECTION 14: TRANSPORT INFORMATION

Not classified as dangerous for rail, road, air or sea transport.
Relevant information:
Note: This product is exempted from being classified as Dangerous
Goods Class 3, UN 1170 ETHANOL SOLUTION (ETHYL ALCOHOL
SOLUTION), packing group III, since the Special Provision (SP) 'An
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Product Name: Metacam 20 mg/mL Solution for Injection Reviewed on: 7 February 2020

aqueous solution containing not more than 24% alcohol by volume

is not subject to the provisions of this Standard (SP 144 in NZS
5433:2012 and IMDG and SP A58 in IATA) is applicable to this
product.
Other requirements: N/A

SECTION 15: REGULATORY INFORMATION

Registered pursuant to the ACVM Act 1997, No. A007982
Regulatory status:
See www.foodsafety.govt.nz for registration conditions

Restricted Veterinary Medicine

For use only under the authority or prescription of a veterinarian.

Approved pursuant to the HSNO Act, Approval Code HSR002068

See www.epa.govt.nz for approval conditions

Classified as Hazardous according to the New Zealand Hazardous

Substances (Minimum Degrees of Hazard) Regulations 2001. HSNO
name: Flammable liquid containing 16 - 30 g/litre meloxicam

HSNO and ACVM controls: Refer to Section 3

SECTION 16: OTHER INFORMATION

Additional information: For product information visit the Boehringer Ingelheim website
www.boehringer-ingelheim.co.nz
While the information set forth is believed to be accurate as of the
date hereof, BOEHRINGER INGELHEIM makes no warranty with
respect hereto and disclaims all liability from reliance thereon.