ISOFLO INHALATION ANAESTHETIC

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

Buy It Now

Active ingredient:
ISOFLURANE
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
isoflurane(100%)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
ISOFLURANE ANAESTHETIC Active 100.0 %
Units in package:
100mL; 250mL
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
BIRDS - ORNAMENTAL | CAT | DOG | HORSE | REPTILE | SMALL MAMMALS | AMAZON PARROT | BITCH | CAGED BIRD | CANARY | CASTRATE | CAT
Therapeutic area:
ANAESTHETICS/ANALGESICS
Therapeutic indications:
ANAESTHETIC - LOCAL/GENERAL | GENERAL ANAESTHETIC | IMMOBILISER | LOCAL ANAESTHETIC | PREMEDICATION | SEDATIVE | TRANQUILLISER | TRAVEL SICKNESS
Product summary:
Poison schedule: 4; Withholding period: WHP: MEAT: Not to be used in horses in tended for human consumption.; Host/pest details: BIRDS - ORNAMENTAL: [ANAESTHETIC - LOCAL/GENERAL]; CAT: [ANAESTHETIC - LOCAL/GENERAL]; DOG: [ANAESTHETIC - LOCAL/GENERAL]; HORSE: [ANAESTHETIC - LOCAL/GENERAL]; REPTILE: [ANAESTHETIC - LOCAL/GENERAL]; SMALL MAMMALS: [ANAESTHETIC - LOCAL/GENERAL]; General anaesthetic for use in horses, cats, dogs, ornamental birds, reptiles, and small mammals.Treated animals MUST NOT be used or processed for human consumption. DO NOT use in animals with a known sensitivity to isoflurane or with a known susceptibility to malignant hyperthermia.
Authorization status:
Registered
Authorization number:
50140
Authorization date:
2019-07-01

TEXT

LABEL:

lsoFio'

lnhalation anaesthetic

Immediate Container Label:

ANCILLARY

PANEL

Text

appearing above the Header and below the Footer lines is

included

the label

PRESCRIPTION ANIMAL REMEDY

KEEP OUT

REACH

CHILDREN

READ SAFETY DIRECTIONS

FOR ANIMAL TREATMENT ONLY

lsoFio

Inhalation anaesthetic

100%

lsoflurane

For use in horses, cats, dogs, ornamental birds, reptiles and small mammals

mL[250 mL]

22 July 2013

50140_xxxxx_RLP

Approved

Page 1

TEXT

LABEL: lsoflo"' Inhalation anaesthetic

Immediate Container Label:

ANCILLARY PANEL

Text appearing above the Header

and

below the Footer lines

is

not

included

in

the label

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

DIRECTIONS FOR USE:

Restraint:

Treated animals MUST NOT be used or processed for human consumption.

Dosage and Administration: Refer to enclosed leaflet.

MEAT WITHHOLDING PERIOD: Treated animals MUST NOT be used or processed for

human consumption.

SAFETY DIRECTIONS: May irritate the eyes. Avoid contact with the eyes and skin. Ensure

adequate ventilation during use.

ADDITIONAL USER SAFETY INFORMATION:

Potentially pregnant theatre staff should minimise exposure to the vapours.

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

Australia

126.

Disposal: Dispose of empty container by wrapping with paper and putting

garbage.

Abbott Australasia Pty Ltd

ACN 000 180 389

32-34 Lord Street

Botany NSW 2019

(02) 9384 9700; Fax (02) 9384 9800

Store below 25°C (Air conditioning)

Protect from direct sunlight and direct heat.

Store

tightly closed original container

APVMA:

50140/60545

Batch No:

Expiry Date:

July 2013

5014Q_)()()()(X_RLP

Page 2

TEXT LABEL: lsoFlo"" Inhalation anaesthetic

Carton Label:

MAIN PANEL

Text appearing above the Header and below the Footer lines

not included

the label

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING

USING

FOR ANIMAL TREATMENT ONLY

lsoFio

Inhalation anaesthetic

100%

lsoflurane

For use

horses, cats, dogs, ornamental birds, reptiles and small mammals

ml[250

22 July 2013

50140_xxxxx_RLP

Page 3

TEXT

LABEL

lsoFio'~

Inhalation anaesthetic

Carton Label:

ANCILLARY PANEL

Text appearing above the Header

and

below the Footer lines

is

not

included

in

the label

lsoFio Inhalation Anaesthetic

1 00% lsoflurane

For full product indications, directions for use, restraints and disposal instructions, READ

THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

DIRECTIONS FOR USE:

RESTRAINT: Treated animals MUST NOT be used or processed for human

consumption.

Contraindications:

This product

contraindicated for use

animals with known sensitivity to isoflurane or with

a known susceptibility to malignant hypothermia.

MEAT WITHHOLDING PERIOD: Treated animals MUST NOT be used or processed for

human consumption.

SAFETY DIRECTIONS: May irritate the eyes. Avoid contact with the eyes and skin. Ensure

adequate ventilation during use.

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

Australia

126.

Abbott Australasia Ply Ltd

ACN 000 180 389

32-34 Lord Street

Botany NSW 2019

(02) 9384 9700; Fax (02) 9384 9800

Disposal: Dispose

empty container

wrapping with paper and putting

garbage.

Store below 25°C (Air conditioning)

Protect from direct sunlight and direct heat.

Store in tightly closed original container

APVMA:

140/60545

Batch No:

Expiry Date:

22 July 2013

50140_xxxxx_RLP

Page4of7

TEXT

LABEL:

lsoflo"'

Inhalation

anaesthetic

Leaflet

Text

appearing

above

the

Header

and

below

the

Footer

lines

is

not

included

in

the

label

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH

OF

CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

lsoFio

TM

Inhalation anaesthetic

100%

lsoflurane

100

mL

[250

mL]

A potent non-irritant, inhalant anaesthetic. It can

used for all types of veterinary surgery

horses,

cats, dogs, ornamental birds, reptiles and small mammals.

READ THIS LEAFLET BEFORE USING

Presentation

A clear, colourless volatile liquid for the generation of gaseous anaesthetic, with a mildly pungent

odour, containing 100% lsoflurane. Chemically it is 1-chloro-2,2,2-trifluoroethyldifluoromethyl ether.

DIRECTIONS FOR USE

RESTRAINT: Treated animals MUST NOT

be

used or processed for human consumption.

Contra indications:

This product is contraindicated for use

animals with a known sensitivity

isoflurane

with a known

susceptibility to malignant hypothermia.

Precautions:

When using lsoflurane to anaesthetise

animal with a head injury, consideration should be given as

whether artificial ventilation is appropriate

maintain normal

levels, so that cerebral blood flow

does not increase.

man, the action

muscle relaxants, especially those of the non-depolarising type such as

atracurium, pancuronium or vecuronium is enhanced

lsoflurane. Similar potentiation might be

expected to occur

the target species, although there is little direct evidence

this effect.

The concurrent use of sedative or analgesic drugs

likely

reduce the level of lsoflurane required to

induce and maintain anaesthesia. For example, opiates, alpha-2-agonists, acepromazine, and

benzodiazepines have been reported to reduce the MAC values. Particular caution should

exercised if administering a midazolam-ketamine combination to

animal already anaesthetised with

lsoflurane.

lsoflurane has been reported

interact with dry carbon dioxide absorbents to form carbon monoxide.

order

minimise the risk of formation of carbon monoxide

breathing circuits and the possibility of

elevated carboxyhaemoglobin levels, carbon dioxide absorbents should not

allowed to dry out.

lsoFio has been safely used for anaesthesia during Caesarean section

the dog and the cat.

Reproduction studies have been performed

mice, rats, and rabbits with no evidence

foetal

malformation attributable to lsoflurane at clinically relevant concentrations. However, fully

July 2013

50140_xxxxx_RLP

Page 5

TEXT

LABEL:

I

so

Flo"'

Inhalation

anaesthetic

Leaflet Text appearing

above

the

Header

and

below

the

Footer

lines

is

not

included

in

the

label

comprehensive data concerning its use

pregnant, breeding

lactating animals of all target species

have not been obtained.

Side Effects:

lsoFio causes dose-related respiratory and cardiovascular depression. It is important that respiration

and pulse should

monitored for both rate and character. Respiratory arrest should

treated

assisted ventilation with air or, preferably, with oxygen supplementation. It

important that a patent

airway be maintained and adequate tissue oxygenation achieved throughout the period of

anaesthesia. Should cardiac arrest occur, full cardiopulmonary resuscitation methods should be

applied. Cardiac arrhythmias have been reported very occasionally. However, I so Flo has a weaker

sensitising action on the myocardium,

the effects

dysrhythmogenic circulating catecholamines,

than halothane.

DOSAGE

Dosage and Administration

lsoFio should

used only

lsoflurane specific vaporiser.

lsoFio should

administered using

accurately calibrated vaporiser

appropriate anaesthetic

circuit. Levels of anaesthesia may

altered rapidly and easily. I

Flo may be administered

oxygen

oxygen/nitrous oxide mixtures.

Premedication:

I so

used with other drugs commonly used in veterinary anaesthetic regimes. Drugs used

for premedication should

selected for the individual patient. See Contra-indications, warnings etc

for potential drug interactions.

The MAC (minimal alveolar concentration)

oxygen given below for the target species should

used as a guide only. The actual concentrations required

practice will depend

many variables

including the concomitant use of other drugs and the clinical status of the patient.

Induction, Maintenance and Recovery:

See table

below

Species

MAC(%)

Inductions

(o/o)"

Maintenance(%)

Horse

1.31

3.0-5.0 (foals)

1.5-2.5

1.28

to 5.0

1.5-2.5

1.63

up to 4.0

1.5-3.0

Ornamental birds

Ca 1.45

3.0-5.0

0.6-5.0

Reptiles

Not published

2 0-4 0

1.0-3.0

Small mammals

2.05 (rabbit)

1.34 (mouse)

2.0-3.0

0.25-2.0

1.38-2.40 (rat)

mduct1on

usually occurs

a face mask.

all species, recovery is normally smooth and rapid.

General Information

Metabolism

lsoflurane

minimal (about 0.2%) mainly to inorganic fluoride and almost

of the

administered lsoflurane

excreted unchanged by the lungs.

I so Flo produces unconsciousness

its action

the central nervous system

is a good muscle

relaxant for surgical procedures. It has negligible analgesic properties and consideration should

given

the analgesic requirements of the patient before recovery from anaesthesia takes place.

MEAT WITHHOLDING PERIOD: Treated animals MUST NOT

be

used or processed for human

consumption.

22 July 2013

50140_xxxxx_RLP

Page 6

TEXT

LABEL: lsoflo"" Inhalation anaesthetic

Leaflet Text appearing above the

Header

and below the Footer lines

is

not included

in

the label

SAFETY DIRECTIONS:

May irritate the eyes and skin. Avoid contact with eyes and skin and ensure

adequate ventilation during use.

Additional User Safety Information:

Eyes should be protected from splashes and plastic (not rubber) gloves should be worn.

Do not breathe the vapour. The recommended occupational exposure standard (OES) on an 8 hour

time weighted basis

50 ppm (UK standards).

Operating rooms should

provided with adequate ventilation and active extraction to prevent the

accumulation

lsoflurane vapours. Induction and recovery areas should

well ventilated.

Care should be taken when dispensing lsoFio into the vaporiser. Spillage should be contained or

removed immediately, using sawdust, sand

other inert absorbents, to a well ventilated place.

Repeated exposure

halogenated anaesthetics has been linked to increased miscarriages

personnel

operating theatres.

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

Australia 131126.

Additional User First Aid Information:

the event

severe acute accidental exposure remove the operator from the source

exposure,

seek urgent medical assistance and show the label. Wash any splashes from skin immediately with

soap and water. Contaminated eyes should be washed with water for

minutes.

Abbott

Australasia

ACN 000 180 389

32-34

Lord

Street

Botany

2019

Ph: (02)

9384

9700;

(02)

9384

9800

Disposal:

Dispose

empty

container

wrapping

with

paper

putting

garbage.

Store below 25°C (air conditioning)

Protect from direct sunlight and direct heat.

Store

tightly closed original container.

Batch No:

Expiry Date:

APVMA:

50140/60545

22 July 2013

50140_xxxxx_RLP

Page 7 of 7

Product Name:

Isoflurane

Issued:

Jan-02-2013

SAFETY DATA SHEET

Section 1. Identification of the substance/mixture and of the company/undertaking

1.1 Product Identifier

Product Name:

Isoflurane

Chemical Name:

1-Chloro-1-(difluoromethoxy)-2,2,2-trifluoroethane

Synonyms:

Forane; Forene; Isoflurane liquid; Isoflurane; Isoflurane USP; 1-Chloro-2,2,2-

trifluoroethyldifluoromethyl ether

List Number:

5260; B506

Drug Code Number:

38765

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

Recommended use:

General inhalation anaesthetic

1.3 Details of the supplier of the safety data sheet

Supplier:

AbbVie Inc.

North Chicago, IL 60064

U.S.A.

1-800-255-5162

+1-847-937-7433

Customer Service Telephone:

1-800-255-5162 (US and Canada only)

+1-847-937-7433

E-mail Address:

AbbVie.SDS@abbvie.com

1.4 Emergency telephone number

Emergency Telephone:

CHEMTREC: 1(800) 424-9300 (in USA and Canada)

or +1-703-527-3887 (international)

Section 2. Hazards identification

2.1 Classification of the substance or mixture

Regulation (EC) No 1272/2008

General Note

Specific target organ systemic

toxicity (single exposure)

Category 3

Classification according to EU Directives 67/548/EEC or 1999/45/EC

Indication of danger:

Risk Phrases:

R67 - Vapors may cause drowsiness and dizziness

2.2 Label elements

Page 1 of 9

Product Name:

Isoflurane

Issued:

Jan-02-2013

Section 2. Hazards identification

Signal Word:

Warning

Hazard Statements:

H336 - May cause drowsiness or dizziness

P261 - Avoid breathing dust/fume/gas/mist/vapors/spray

P271 - Use only outdoors or in a well-ventilated area

P304 + P340 - IF INHALED: Remove to fresh air and keep at rest in a position

comfortable for breathing

P312 - Call a POISON CENTER or doctor/physician if you feel unwell

P403 + P233 - Store in a well-ventilated place. Keep container tightly closed

2.3 Other hazards

Not determined

Section 3. Composition/information on ingredients

Chemical Name

Percent

EINECS/ELINCS

Number

EEC Classification

EU - GHS

Substance

Classification

REACH No.

Isoflurane

26675-46-7

98-100

247-897-7

STOT SE 3 (H336)

No data available

For the full text of the R-phrases mentioned in this Section, see Section 16

For the full text of the H-Statements mentioned in this Section, see Section 16

Section 4. First aid measures

4.1 Description of first aid measures

Eye Contact:

Remove from source of exposure. Flush with copious amounts of water. If irritation

persists or signs of toxicity occur, seek medical attention. Provide

symptomatic/supportive care as necessary.

Skin Contact:

Remove from source of exposure. Flush with copious amounts of water. If irritation

persists or signs of toxicity occur, seek medical attention. Provide

symptomatic/supportive care as necessary.

Inhalation:

Remove from source of exposure. If signs of toxicity occur, seek medical attention.

Provide symptomatic/supportive care as necessary.

Page 2 of 9

Product Name:

Isoflurane

Issued:

Jan-02-2013

Ingestion:

Remove from source of exposure. If signs of toxicity occur, seek medical attention.

Provide symptomatic/supportive care as necessary.

Protection of First-aiders:

Use personal protective equipment

4.2 Most important symptoms and effects, both acute and delayed

Signs and Symptoms:

None known from occupational exposure. Clinical data suggests the following:

headaches, incoordination, nausea, slow heart rate, sedation, sleep, drowsiness,

dizziness, hyperthermia, vomiting, breathing difficulty. Very rare instances of

allergic reactions.

Medical Conditions

Aggravated by Exposure:

Data suggest any pre-existing ailments in the following organs: central nervous

system, cardiovascular system, gastrointestinal system, respiratory system.

Hypersensitivity to the material and/or similar materials.

4.3 Indication of any immediate medical attention and special treatment needed

Notes To Physician:

Maintain ventilation, electrolyte balance and monitor cardiovascular function, as

necessary.

Section 5. Firefighting measures

5.1 Extinguishing Media

Suitable Extinguishing Media:

Use extinguishing agent suitable for type of surrounding fire

Unsuitable Extinguishing Media:

Not determined

5.2 Special hazards arising from the substance or mixture

Special Exposure Hazards:

Not determined

5.3 Advice for firefighters

Protective Equipment and

Precautions for Firefighters:

As in any fire, wear self-contained breathing apparatus and full protective gear

Section 6. Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures

Personal Precautions:

If spill response is required, supplied air respirators with impervious gloves and

clothing should be worn by response personnel..

6.2. Environmental precautions

Environmental Precautions:

Contain material and prevent release to waterways or soil.

6.3. Methods and material for containment and cleaning up

Methods for Cleaning Up:

Material evaporates very rapidly. Evacuate the area of the spill immediately and

provide ventilation until the applicable exposure levels are below those described in

Section 8.

Page 3 of 9

Product Name:

Isoflurane

Issued:

Jan-02-2013

6.4. Reference to other sections

Refer to Sections 8, 12, and 13 for further information.

Section 7. Handling and storage

7.1. Precautions for safe handling

Avoid contact with skin, eyes and clothing. Avoid breathing vapors or mists. Handle in accordance with good industrial

hygiene and safety practice.

7.2. Conditions for safe storage, including any incompatibilities

Store according to label instructions.

7.3. Specific end use(s)

Recommended use:

General inhalation anaesthetic

Section 8. Exposure controls/personal protection

8.1. Control parameters

Exposure limits:

Chemical Name

Employee Exposure Limit

Skin Notation

Isoflurane

26675-46-7

60 ppm (450 mg/m

) TWA

None

Chemical Name

ACGIH TLV

France

German MAK

Ireland

Italy

Isoflurane

26675-46-7

50 ppm (TWA)

380 mg/m

(TWA)

50 ppm (TWA)

Chemical Name

The Netherlands

Spain

Switzerland

UK OEL/MEL

Isoflurane

26675-46-7

383 mg/m

(TWA)

77 mg/m

(TWA)

616 mg/m

(STEL)

150 ppm (STEL)

1149 mg/m

(STEL)

150 ppm (STEL)

50 ppm (TWA)

383 mg/m

(TWA)

8.2. Exposure controls

Engineering Controls:

Anesthetic gas scavenging systems should be used during typical product application.

Handle inside a process enclosure or chemical fume hood during manufacturing or

laboratory use.

Respiratory Protection:

If engineering controls are in place, respirators are generally not required during

normal conditions of use.

Eyes:

Eye protection not required during typical product use conditions. Wear eye

protection appropriate to exposures during manufacturing/laboratory use.

Gloves:

Impervious gloves.

Page 4 of 9

Product Name:

Isoflurane

Issued:

Jan-02-2013

Other PPE Data:

Wear appropriate body coverings if contact may occur.

Environmental Exposure

Controls:

Not determined

Section 9. Physical and chemical properties

9.1. Information on basic physical and chemical properties

Appearance:

Clear Colorless Liquid

Odor:

Mild, pungent, musty, ethereal odor.

Odor Threshold:

Not determined

pH:

Not determined.

Boiling Pt. @ 760 mm Hg (°C):

48.5

Melting/Freezing Point (°C):

Not determined

Flash Point (°C):

Not determined.

Evaporation Rate at 20°C:

Not determined.

Flammability (Solid):

Not expected to be flammable in air.

Lower Explosive Limit:

14.5 (in 100% oxygen)

Upper Explosive Limit:

Not determined.

Vapor Pressure (mm Hg):

295 - 330 at 25 deg. C

Vapor Density (Air = 1):

Bulk Density at 20°C:

1.45

Specific Gravity:

1.496 @ 25 deg C

Solubility(ies):

Soluble in: organic solvents. Slightly soluble in: water.

Partition coefficient: n-

octanol/water

Not determined.

Autoignition Temp. (°C):

Not determined.

Decomposition temperature (°C):

Not determined.

Viscosity (centipoise):

Not determined.

Explosion Severity:

Not determined.

Oxidizer Properties:

Not determined.

9.2. Other information

Min. Ignition Energy-Cloud

(mJ):

> 5000 (no ignition)

Section 10. Stability and reactivity

10.1. Reactivity

Not determined

10.2. Chemical stability

Stable under normal conditions

10.3. Possibility of hazardous reactions

Hazardous reactions:

Not determined.

Self-Heating Tendency:

No exotherms seen below 300 deg C in ARC testing.

Page 5 of 9

Product Name:

Isoflurane

Issued:

Jan-02-2013

10.4. Conditions to avoid

Not determined.

10.5 Incompatible materials

Strong bases, Alkaline metals.

10.6 Hazardous decompostion products

When heated to decomposition it emits:, Hydrogen fluoride, Hydrogen chloride, Carbon oxides

Section 11. Toxicological information

11.1. Information on toxicological effects

Routes of Exposure:

Oral:

Not determined.

Dermal:

Not determined.

Inhalation:

Clinical Route

Acute Toxicity - Oral:

Data for component (s) given below.

Chemical Name

Acute Test

Value

Units

Species

Isoflurane

26675-46-7

LD50 =

4770

5080

mg/kg

Mice

Rats

Acute Toxicity - Dermal:

Not determined.

Acute Toxicity - Inhalation:

Data for component (s) given below.

Chemical Name

Test

Value

Units

Species

Isoflurane

26675-46-7

LC 50 =

15,300

16,800

Rats

Mice

Corrosivity:

Not determined.

Dermal Irritation:

Not determined.

Eye Irritation:

A similar material is an eye irritant.

Sensitization:

Not determined.

Toxicokinetics/Metabolism:

Not determined.

Target Organ Effects:

In clinical use target organ effects include: central nervous system.

Reproductive Effects:

Not determined.

Carcinogenicity:

Not determined.

Mutagenicity:

Data for component (s) given below.

Chemical Name

Micronucleus Assay

Ames Test:

Mouse Lymphoma

Assay

Chromosomal Abbr.

Assay

Isoflurane

26675-46-7

No Data.

Negative

No Data.

Negative

Page 6 of 9

Product Name:

Isoflurane

Issued:

Jan-02-2013

Aspiration hazard:

Not determined

Notes:

1. ALD: Approximate lethal dosage

2. LC50: Concentration in air that produces 50% mortality

3. LD50: Oral or dermal dosage that produces 50% mortality

Section 12. Ecological information

12.1. Toxicity

Not determined.

12.2. Persistence and degradability

Not determined.

12.3. Bioaccumulative potential

Not determined

12.4. Mobility in soil

Not determined.

12.5. Results of PBT or vPvB assessment

Chemical safety report is not required for this substance/product.

12.6. Other adverse effects

Do not allow undiluted material or large quantities to reach groundwater, bodies of water or sewer system.

Notes:

1. EC50: Concentration in water that produces 50% mortality in Daphnia sp.

2. LC50: Concentration in water that produces 50% mortality in fish.

3. EbC50/ErC50: Concentration in water that produces 50% inhibition of growth and in algae.

Section 13. Disposal considerations

13.1 Waste treatment methods

Waste Disposal Methods:

Disposal should be made in accordance with country, federal, state and local

regulations.

Section 14. Transport information

ICAO/IATA

Status:

Regulated

14.1. UN Number:

UN3334

14.2. Proper shipping name:

Aviation regulated liquid, n.o.s. (1-Chloro-1-(difluoromethoxy)-2,2,2-

trifluoroethane)

14.3. Hazard class:

14.4. Packing group:

Page 7 of 9

Product Name:

Isoflurane

Issued:

Jan-02-2013

14.5. Environmental hazard:

Not applicable

14.6. Special Provisions:

14.7. Transport in bulk according

to Annex II of MARPOL 73/78

and the IBC Code:

Not applicable

ADR, DOT, IMDG/IMO

Status:

Not regulated

14.1. UN Number:

Not applicable

14.2. Proper shipping name:

Not applicable

14.3. Hazard class:

Not applicable

14.4. Packing group:

Not applicable

14.5. Environmental hazard:

Not applicable

14.6. Special Provisions:

Not applicable

Section 15. Regulatory Information

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

International Inventories

Chemical Name

EINECS/ ELINCS

TSCA

DSL

NDSL

PICCS

Isoflurane

26675-46-7

247-897-7

Not listed.

Chemical Name

ENCS

ISHL

IECSC

AICS

KECL

New Zealand

Isoflurane

26675-46-7

HSR003785

Legend

EINECS/ELINCS - European Inventory of Existing Commercial Chemical Substances/EU List of Notified Chemical Substances

TSCA - United States Toxic Substances Control Act Section 8(b) Inventory

DSL/NDSL - Canadian Domestic Substances List/Non-Domestic Substances List

PICCS - Philippines Inventory of Chemicals and Chemical Substances

ENCS - Japan Existing and New Chemical Substances

ISHL - Japan Industrial Safety and Health Law

IECSC - China Inventory of Existing Chemical Substances

AICS - Australian Inventory of Chemical Substances

KECL - Korean Existing and Evaluated Chemical Substances

Carcinogenicity Rating:

Chemical Name

Percent

NTP:

IARC:

ACGIH:

Isoflurane

98-100

Not Listed

Not Listed

Not Listed

SARA 313 Information

Chemical Name

Percent

SARA 313 Chemical:

CERCLA RQ/SARA

EHS RQ (lbs):

SARA EHS TPQ (lbs):

Isoflurane

98-100

Not Applicable

Not applicable

Immediate Health:

Delayed Health:

Fire:

Page 8 of 9

Product Name:

Isoflurane

Issued:

Jan-02-2013

Sudden Pressure:

Reactivity:

RCRA Status:

Not determined.

Proposition 65 Status:

Does not contain chemicals known to the state of California to cause cancer or

reproductive harm.

WHMIS Hazard Class:

Not determined.

NFPA Rating:

Health: 2

Fire: 1

Reactivity: 0

Notes:

1. SARA = Superfund Amendments and the Reauthorization Act.

2. CERCLA = Comprehensive Environmental Response, Compensation and Liability Act.

3. FIFRA = Federal Insecticide, Fungicide and Rodenticide Act.

4. TSCA = Toxic Substances Control Act.

5. EC = European Community.

6. WHMIS = Canadian Workplace Hazardous Materials Information System.

7. UN GHS = United Nations Globally Harmonized System for Hazard Identification.

15.2. Chemical safety assessment

Chemical safety assessment has not been conducted on the substance/product.

Section 16. Other information

Risk Phrases:

R67 - Vapors may cause drowsiness and dizziness

Document Authored By:

Global Occupational Toxicology (D-03QC)

Issued:

Jan-02-2013

Supersedes the SDS dated:

Aug-09-2011

Disclaimer:

The information and recommendations contained herein are based upon tests believed to be reliable. However, AbbVie Inc. does not

guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A WARRANTY, WHETHER

EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE MERCHANTABILITY OF THE GOODS, OR THE

FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE. Adjustment to conform to actual conditions of usage may be required.

AbbVie Inc. assumes no responsibility for results obtained or for incidental or consequential damages, including lost profits, arising

from the use of these data. No warranty against infringement of any patent, copyright or trademark is made or implied.

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