BOMAC FLUXIMINE INJECTION
ChemWatch Material Safety Data Sheet CHEMWATCH 4632-3
Issue Date: Fri 13-May-2005 CD 2005/2 Page 1 of 9
Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
PRODUCT NAME
BOMAC FLUXIMINE INJECTION
SYNONYMS
Product Code: 7804
! 02/04
injectable analgesic
PRODUCT USE
For the treatment of inflammatory and painful conditions in horses, cattle and
dogs.
SUPPLIER
Company: Bomac Laboratories Ltd
Address:
Cnr. Wiri Station Rd & Hobill Avenue
Manukau City
Auckland,
NZL
Telephone: +64 9 262 3169
Fax: +64 9 262 3008
Section 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
NON-HAZARDOUS SUBSTANCE. NON-DANGEROUS GOODS. According to
the Criteria of NOHSC, and the ADG Code.
POISONS SCHEDULE
S4
RISK
SAFETY
Do not breathe gas/fumes/vapour/spray.
Wear eye/face protection.
Take off immediately all contaminated clothing.
In case of contact with eyes, rinse with plenty of water and contact Doctor or
Poisons Information Centre.
Section 3 - COMPOSITION / INFORMATION ON INGREDIENTS
NAME CAS RN %
flunixin meglumine 42461-84-7 8.3
No other ingredient information supplied
Section 4 - FIRST AID MEASURES
SWALLOWED
鈥? If swallowed do NOT induce vomiting.
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BOMAC FLUXIMINE INJECTION
ChemWatch Material Safety Data Sheet CHEMWATCH 4632-3
Issue Date: Fri 13-May-2005 CD 2005/2 Page 2 of 9
Section 4 - FIRST AID MEASURES
鈥? If vomiting occurs, lean patient forward or place on left side (head-down
position, if possible) to maintain open airway and prevent aspiration.
鈥? Observe the patient carefully.
鈥? Never give liquid to a person showing signs of being sleepy or with reduced
awareness; i.e. becoming unconscious.
鈥? Give water to rinse out mouth, then provide liquid slowly and as much as
casualty can comfortably drink.
鈥? Seek medical advice.
EYE
If this product comes in contact with the eyes:
鈥? Immediately hold eyelids apart and flush the eye continuously with running
water.
鈥? 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.
鈥? Continue flushing until advised to stop by the Poisons Information Centre or a
doctor, or for at least 15 minutes.
鈥? Transport to hospital or doctor without delay.
鈥? Removal of contact lenses after an eye injury should only be undertaken by
skilled personnel.
SKIN
If skin contact occurs:
鈥? Immediately remove all contaminated clothing, including footwear
鈥? Flush skin and hair with running water (and soap if available).
鈥? Seek medical attention in event of irritation.
INHALED
鈥? If fumes or combustion products are inhaled remove from contaminated area.
鈥? Lay patient down. Keep warm and rested.
鈥? Prostheses such as false teeth, which may block airway, should be removed,
where possible, prior to initiating first aid procedures.
鈥? 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.
鈥? Transport to hospital, or doctor, without delay.
NOTES TO PHYSICIAN
Treat symptomatically.
Section 5 - FIRE FIGHTING MEASURES
EXTINGUISHING MEDIA
鈥? Foam.
鈥? Dry chemical powder.
鈥? BCF (where regulations permit).
鈥? Carbon dioxide.
鈥? Water spray or fog - Large fires only.
FIRE FIGHTING
鈥? Alert Fire Brigade and tell them location and nature of hazard.
鈥? Wear breathing apparatus plus protective gloves.
鈥? Prevent, by any means available, spillage from entering drains or water
courses.
鈥? Use water delivered as a fine spray to control fire and cool adjacent area.
鈥? DO NOT approach containers suspected to be hot.
鈥? Cool fire exposed containers with water spray from a protected location.
鈥? If safe to do so, remove containers from path of fire.
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BOMAC FLUXIMINE INJECTION
ChemWatch Material Safety Data Sheet CHEMWATCH 4632-3
Issue Date: Fri 13-May-2005 CD 2005/2 Page 3 of 9
Section 5 - FIRE FIGHTING MEASURES
鈥? Equipment should be thoroughly decontaminated after use.
FIRE/EXPLOSION HAZARD
鈥? Combustible.
鈥? Slight fire hazard when exposed to heat or flame.
鈥? Heating may cause expansion or decomposition leading to violent rupture of
containers.
鈥? On combustion, may emit toxic fumes of carbon monoxide (CO).
鈥? May emit acrid smoke.
鈥? Mists containing combustible materials may be explosive.
Combustion products include.
carbon dioxide (CO2).
hydrogen fluoride.
nitrogen oxides (NOx).
other pyrolysis products typical of burning organic material.
May emit poisonous fumes.
FIRE INCOMPATIBILITY
Avoid contamination with oxidising agents i.e. nitrates, oxidising acids,
chlorine bleaches, pool chlorine etc. as ignition may result.
HAZCHEM
None
Personal Protective Equipment
PERSONAL PROTECTION EQUIPMENT
Gloves, boots (chemical resistant).
Section 6 - ACCIDENTAL RELEASE MEASURES
EMERGENCY PROCEDURES
MINOR SPILLS
鈥? Remove all ignition sources.
鈥? Clean up all spills immediately.
鈥? Avoid breathing vapours and contact with skin and eyes.
鈥? Control personal contact by using protective equipment.
鈥? Contain and absorb spill with sand, earth, inert material or vermiculite.
鈥? Wipe up.
鈥? Place in a suitable labelled container for waste disposal.
MAJOR SPILLS
Not applicable.
Personal Protective Equipment advice is contained in Section 8 of the MSDS.
Section 7 - HANDLING AND STORAGE
PROCEDURE FOR HANDLING
鈥? Avoid all personal contact, including inhalation.
鈥? Wear protective clothing when risk of exposure occurs.
鈥? Use in a well-ventilated area.
鈥? Prevent concentration in hollows and sumps.
鈥? DO NOT enter confined spaces until atmosphere has been checked.
鈥? DO NOT allow material to contact humans, exposed food or food utensils.
鈥? Avoid contact with incompatible materials.
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BOMAC FLUXIMINE INJECTION
ChemWatch Material Safety Data Sheet CHEMWATCH 4632-3
Issue Date: Fri 13-May-2005 CD 2005/2 Page 4 of 9
Section 7 - HANDLING AND STORAGE
鈥? When handling, DO NOT eat, drink or smoke.
鈥? Keep containers securely sealed when not in use.
鈥? Avoid physical damage to containers.
鈥? Always wash hands with soap and water after handling.
鈥? Work clothes should be laundered separately. Launder contaminated clothing
before re-use.
鈥? Use good occupational work practice.
鈥? Observe manufacturer's storing and handling recommendations.
鈥? Atmosphere should be regularly checked against established exposure standards
to ensure safe working conditions are maintained.
SUITABLE CONTAINER
50 ml vial.
STORAGE INCOMPATIBILITY
Avoid contamination of water, foodstuffs, feed or seed.
Avoid reaction with oxidising agents.
STORAGE REQUIREMENTS
Protect from light.
鈥? Store in original containers.
鈥? Keep containers securely sealed.
鈥? No smoking, naked lights or ignition sources.
鈥? Store in a cool, dry, well-ventilated area.
鈥? Store away from incompatible materials and foodstuff containers.
鈥? Protect containers against physical damage and check regularly for leaks.
鈥? Observe manufacturer's storing and handling recommendations.
Store below 25 degC.
Shelf Life: 2 years.
Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION
EXPOSURE CONTROLS
No data available for flunixin meglumine as (CAS: 42461-84-7) / (CAS: 38677-85-9)
Not available. Refer to individual constituents.
EXPOSURE STANDARDS FOR MIXTURE
"Worst Case" computer-aided prediction of spray/ mist or fume/ dust components
and concentration:
Composite Exposure Standard for Mixture (TWA) :3 mg/m鲁.
Operations which produce a spray/mist or fume/dust, introduce particulates to
the breathing zone.
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 ppm Breathing Zone mg/m鲁 Mixture Conc (%).
Component Breathing Zone Mixture Conc
(mg/m鲁) (%)
flunixin meglumine 3.0000 8.3
INGREDIENT DATA
FLUNIXIN MEGLUMINE:
Dusts not otherwise classified, as inspirable dust;
ES TWA: 10 mg/m鲁.
Particulate (insoluble or poorly soluble *) Not Otherwise Specified (P.N.O.C)
TLV TWA: 10 mg/m鲁 Inhalable particulate
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BOMAC FLUXIMINE INJECTION
ChemWatch Material Safety Data Sheet CHEMWATCH 4632-3
Issue Date: Fri 13-May-2005 CD 2005/2 Page 5 of 9
Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION
TLV TWA: 3 mg/m鲁 Respirable particulate
OEL-Sweden, United Kingdom: 10 mg/m鲁 total dust, 5 mg/m鲁 respirable dust
These "dusts" have little adverse effect on the lungs and do not produce toxic
effects or organic disease. Although there is no dust which does not evoke some
cellular response at sufficiently high concentrations, the cellular response
caused by P.N.O.C.s has the following characteristics:
路 the architecture of the air spaces remain intact,
路 scar tissue (collagen) is not synthesised to any degree,
路 tissue reaction is potentially reversible.
Extensive concentrations of P.N.O.C.s may:
路 seriously reduce visibility,
路 cause unpleasant deposits in the eyes, ears and nasal passages,
路 contribute to skin or mucous membrane injury by chemical or mechanical action,
per se, or by the rigorous skin cleansing procedures necessary for their
removal. [ACGIH]
This limit does not apply:
路 to brief exposures to higher concentrations
路 nor does it apply to those substances that may cause physiological impairment
at lower concentrations but for which a TLV has as yet to be determined.
This exposure standard applies to particles which
路 are insoluble or poorly soluble* in water or, preferably, in aqueous lung
fluid (if data is available) and
路 have a low toxicity (i.e.. are not cytotoxic, genotoxic, or otherwise
chemically reactive with lung tissue, and do not emit ionizing radiation, cause
immune sensitization, or cause toxic effects other than by inflammation or by a
mechanism of lung overload)
* Notice of intended change.
PERSONAL PROTECTION
EYE
None under normal operating conditions.
HANDS/FEET
Wear general protective gloves, eg. light weight rubber gloves.
OTHER
No special equipment needed when handling small quantities.
OTHERWISE:
鈥? Overalls.
鈥? Barrier cream.
鈥? Eyewash unit.
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:
Protective 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
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BOMAC FLUXIMINE INJECTION
ChemWatch Material Safety Data Sheet CHEMWATCH 4632-3
Issue Date: Fri 13-May-2005 CD 2005/2 Page 6 of 9
Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION
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.
RESPIRATOR
Selection of the Class and Type of respirator will depend upon the level of
breathing zone contaminant and the chemical nature of the contaminant.
Protection Factors (defined as the ratio of contaminant outside and inside the
mask) may also be important.
Breathing Zone Maximum Protection Half-face Full-Face
Level ppm (volume) Factor Respirator Respirator
1000 10 -AUS P -
1000 50 - -AUS P
5000 50 Airline * -
5000 100 - -2 P
10000 100 - -3 P
100+ Airline**
* - Continuous Flow ** - Continuous-flow or positive pressure demand.
The local concentration of material, quantity and conditions of use determine
the type of personal protective equipment required. For further information
consult site specific CHEMWATCH data (if available), or your Occupational
Health and Safety Advisor.
ENGINEERING CONTROLS
General exhaust is adequate under normal operating conditions. If risk of
overexposure exists, wear SAA approved respirator. Correct fit is essential to
obtain adequate protection. Provide adequate ventilation in warehouse or closed
storage areas.
Section 9 - PHYSICAL AND CHEMICAL PROPERTIES
APPEARANCE
Clear, almost colourless liquid with a characteristic odour of phenol.
PHYSICAL PROPERTIES
Liquid.
Molecular Weight: Not Applicable Boiling Range (掳C): Not Available
Melting Range (掳C): Not Available Specific Gravity (water=1): Not Available
Solubility in water (g/L): Not Available pH (as supplied): Not Available
pH (1% solution): Not Available Vapour Pressure (kPa): Not Available
Volatile Component (%vol): Not Available Evaporation Rate: Not Available
Relative Vapour Density (air=1): Not Available Flash Point (掳C): Not Available
Lower Explosive Limit (%): Not Available Upper Explosive Limit (%): Not Available
Autoignition Temp (掳C): Not Available Decomposition Temp (掳C): Not Available
State: Liquid
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BOMAC FLUXIMINE INJECTION
ChemWatch Material Safety Data Sheet CHEMWATCH 4632-3
Issue Date: Fri 13-May-2005 CD 2005/2 Page 7 of 9
Section 10 - CHEMICAL STABILITY AND REACTIVITY INFORMATION
CONDITIONS CONTRIBUTING TO INSTABILITY
鈥? Presence of incompatible materials.
鈥? Product is considered stable.
鈥? Hazardous polymerisation will not occur.
Section 11 - TOXICOLOGICAL INFORMATION
POTENTIAL HEALTH EFFECTS
ACUTE HEALTH EFFECTS
SWALLOWED
Considered an unlikely route of entry in commercial/industrial environments.
Ingestion may result in nausea, abdominal irritation, pain and vomiting.
EYE
The material may be irritating to the eye, with prolonged contact causing
inflammation. Repeated or prolonged exposure to irritants may produce
conjunctivitis.
SKIN
The material may cause skin irritation after prolonged or repeated exposure and
may produce a contact dermatitis (nonallergic). This form of dermatitis is often
characterised by skin redness (erythema) and swelling epidermis. Histologically
there may be intercellular oedema of the spongy layer (spongiosis) and
intracellular oedema of the epidermis.
Entry into the blood-stream, through, for example, cuts, abrasions or lesions,
may produce systemic injury with harmful effects. Examine the skin prior to the
use of the material and ensure that any external damage is suitably protected.
INHALED
Not normally a hazard due to non-volatile nature of product.
Acute effects from inhalation of high vapour concentrations may be chest and
nasal irritation with coughing, sneezing, headache and even nausea.
CHRONIC HEALTH EFFECTS
Substance accumulation, in the human body, may occur and may cause some concern
following repeated or long-term occupational exposure. Prolonged or chronic
exposure to alkanolamines may result in liver, kidney or nervous system injury.
Repeated inhalation may aggravate asthma and inflammatory or fibrotic pulmonary
disease. Results of repeated exposure tests with diethanolamine (DEA) in
laboratory animals include anaemia (rats) and effects on the kidneys (rats and
mice) and liver (mice). DEA produces nervous system injury in dogs and rats.
Heart and salivary gland lesions have also been seen in mice treated cutaneously
with DEA and in mice receiving DEA in drinking water. Rats given high doses of
DEA developed anaemia and testicular lesions. Exaggerated doses of DEA produced
heart and nervous system effects in other animals. Changes in other organs were
judged to be secondary due to the poor health of animals subjected to extremely
high doses of DEA. Rats, rabbits and guinea pigs exposed to high vapour
concentrations of volatile monoethanolamine (MEA) (up to 1250 ppm) for periods
of up to 5 weeks developed pulmonary, hepatic and renal lesions. Dogs, rats and
guinea pigs exposed to 100 ppm MEA for 30 days, became apathetic and developed
poor appetites. Animal tests also indicate that inhalation exposure to MEA may
result in nervous system injury. All species exposed to airborne MEA experienced
dermal effects, varying from ulceration to hair loss probably resulting from
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BOMAC FLUXIMINE INJECTION
ChemWatch Material Safety Data Sheet CHEMWATCH 4632-3
Issue Date: Fri 13-May-2005 CD 2005/2 Page 8 of 9
Section 11 - TOXICOLOGICAL INFORMATION
contact with the cage. An increased incidence of skeletal variations, suggestive
of a slight developmental delay was seen in the foetuses of rats given 1500
mg/kg/day DEA cutaneously; this also produced significant maternal toxicity. No
foetal malformations, however, were seen in rats nor in rabbits receiving
identical treatment. The foetus of rats given high doses of MEA by gavage,
showed an increased rate of embryofoetal death, growth retardation, and some
malformations including hydronephrosis and hydroureter. The high doses required
to produce these effects bring into question the relevance of this finding to
humans. There is some evidence that embryofoetotoxicity and teratogenicity does
not occur in rats when MEA is administered by dermal application to the mother.
The National Toxicology Program (NTP) concluded that there is clear evidence of
liver tumours and some evidence of kidney tumours in mice exposed dermally to
DEA over their lifetime. Chronic skin painting studies in mice of both sexes
produced liver tumours and an increased incidence of kidney tumours in male
mice. The significance of these findings to humans is unclear as DEA is neither
genotoxic, mutagenic nor clastogenic, and did not induce tumours in rats or
transgenic mice similarly treated. Alkanolamines (especially those containing a
secondary amine moiety) may react with nitrites or other nitrosating agents to
form carcinogenic N-nitrosamines. Alkanolamines are metabolised by biosynthetic
routes to ethanolamine and choline and incorporated into phospholipids. They are
excreted predominantly unchanged with a half-life of approximately one week. In
the absence of sodium nitrite, no conversion to carcinogenic N-nitrosamines was
observed. Diethanolamine competitively inhibits the cellular uptake of choline,
in vitro, and hepatic changes in choline homeostasis, consistent with choline
deficiency, are observed in vivo. Many amines are potent skin and respiratory
sensitisers and certain individuals especially those described as "atopic" (i.e.
those predisposed to asthma and other allergic responses) may show allergic
reactions when chronically exposed to alkanolamines. In a study with coconut
diethanolamide, the National Toxicology Program (Technical Report Series 479),
showed clear evidence of carcinogenic activity in male B6C3F1 mice based on
increased incidences of hepatic and renal tubule neoplasms and in female B6C3F1
mice based on increased incidences of hepatic neoplasms. There was equivocal
evidence of carcinogenic activity in female F344/N rats based on a marginal
increase in the incidence of renal tube neoplasms. These increases were
associated with the concentration of free diethanolamine present as a
contaminant in the diethanolamine condensate. Exposure to rats to coconut oil
diethanolamine condensate by dermal application in ethanol for 2 years resulted
in epidermal hyperplasia, sebaceous gland hyperplasia, hyperkeratosis and
parakeratosis in males and females and ulcer in females at the site of
application. There were increases in the incidences of chronic inflammation,
epithelial hyperplasia, and epithelial ulcer in the forestomach of female rats.
The severity of nephropathy in dosed female rats were increased. Exposure of
mice to coconut oil diethanolamine condensate by dermal application for 2 years
resulted in increased incidences of eosinophilic foci of the liver in males.
Increased incidences of epidermal hyperplasia, sebaceous gland hyperplasia, and
hyperkeratosis in males and females, ulcer in males, and parakeratosis and
inflammation in females at the site of application and of follicular cell
hyperplasia in the thyroid gland of males and females, were chemical related.
TOXICITY AND IRRITATION
MATERIAL CARCINOGEN SENSITISER SKIN MUTAGEN REPROTOXIN
______________________________ ____________ __________ __________ __________ __________
Bomac Fluximine Injection
flunixin meglumine
TOXICITY IRRITATION
Oral (Rat) LD50: 120 mg/kg
FLUNIXIN MEGLUMINE:
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BOMAC FLUXIMINE INJECTION
ChemWatch Material Safety Data Sheet CHEMWATCH 4632-3
Issue Date: Fri 13-May-2005 CD 2005/2 Page 9 of 9
Section 11 - TOXICOLOGICAL INFORMATION
No significant acute toxicological data identified in literature search.
Section 12 - ECOLOGICAL INFORMATION
DO NOT discharge into sewer or waterways.
Refer to data for ingredients, which follows:
FLUNIXIN MEGLUMINE:
No data for flunixin meglumine.
Section 13 - DISPOSAL CONSIDERATIONS
Puncture containers to prevent re-use and bury at an authorised landfill.
Section 14 - TRANSPORTATION INFORMATION
Shipping Name:
None
Dangerous Goods Class: None, None
UN/NA Number: None
ADR Number: None
Packing Group: None
Labels Required:
Additional Shipping Information:
International Transport Regulations:
IMO: None
HAZCHEM
None
Section 15 - REGULATORY INFORMATION
POISONS SCHEDULE
S4
REGULATIONS
flunixin meglumine (CAS: 42461-84-7) is found on the following regulatory lists:
Australian Inventory of Chemical Substances (AICS)
Australian Poisons Schedule
Section 16 - OTHER INFORMATION
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.
Issue Date: Fri 13-May-2005
Print Date: Tue 14-Jun-2005
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