OMEPRAZOLE MAGNESIUM

Dr.Reddy's Laboratories Limited Chemwatch Hazard Alert Code: 2

Chemwatch: 4132-10 Issue Date: 27/01/2020
Version No: 6.1.1.1 Print Date: 01/05/2020
Safety Data Sheet L.GHS.IND.EN

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

Product Identifier

Product name OMEPRAZOLE MAGNESIUM

Chemical Name omeprazole magnesium
C17-H19-N3-O3-S.Mg; 1H-benzimidazole, 5-methoxy-2-[((4-methoxy-3,5-dimethyl-2-pyridinyl)- methyl]sulfinyl-, magnesium; 5-methoxy-2-[((4-
Synonyms methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl]-benzimidazole magnesium; Losec MUPS Tablets; gastrointestinal agent/ gastric proton-pump
inhibitor; anti-ulcerative
Other means of identification Not Available
CAS number 95382-33-5

Relevant identified uses of the substance or mixture and uses advised against
Antiulcerative in the treatment of pathological hypersecretion (e.g. Zollinger-Ellison syndrome). A substituted benzimidazole which does not
exhibit anticholinergic or H2 histamine antagonist properties but suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase
enzyme system at the secretary surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the
gastric mucosa, omeprazole has been characterised as a gastric-pump inhibitor
Intermediate.
Relevant identified uses
Benzimidazole, a heterocyclic aromatic organic compound consisting of a fusion of benzene and imidazole, in an extension of the well-elaborated
imidazole system, has been used as a carbon skeleton for N-heterocyclic carbenes, usually used as ligand for transition metal complexes.
Pharmacological compounds of benzimidazole derivatives are potent inhibitors for a variety of enzymes. Benzimidazole is a privileged scaffold
(capable of binding to multiple receptors with high affinity), having a variety of therapeutic uses including antitumour, antifungal, antiparasitic,
analgesics, antiviral, antihistamine, as well as use in cardiovascular disease, neurology, endocrinology, and ophthalmology.

Details of the supplier of the safety data sheet

Registered company name Dr.Reddy's Laboratories Limited
Address 8-2-537, Road No 3, Banjara Hills, Hyderabad Telangana 500034 India
Telephone Not Available
Fax +91 40 4900 2999
Website www.drreddys.com
Email Not Available

Emergency telephone number

Association / Organisation Dr.Reddy's Laboratories Limited

Emergency telephone
+91 40 4900 2900
numbers
Other emergency telephone
Not Available
numbers

SECTION 2 HAZARDS IDENTIFICATION

Classification of the substance or mixture

CHEMWATCH HAZARD RATINGS

Min Max NFPA 704 diamond
Flammability 1
Toxicity 1
Body Contact 0
Reactivity 1 0 = Minimum
1 = Low Note: The hazard category numbers found in GHS classification in section 2
Chronic 2 2 = Moderate of this SDSs are NOT to be used to fill in the NFPA 704 diamond. Blue =
3 = High Health Red = Fire Yellow = Reactivity White = Special (Oxidizer or water
4 = Extreme reactive substances)

Classification Acute Toxicity (Oral) Category 5, Chronic Aquatic Hazard Category 3, Skin Sensitizer Category 1

Label elements

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OMEPRAZOLE MAGNESIUM

Hazard pictogram(s)

SIGNAL WORD WARNING

Hazard statement(s)
H303 May be harmful if swallowed.
H412 Harmful to aquatic life with long lasting effects.
H317 May cause an allergic skin reaction.

Precautionary statement(s) Prevention

P280 Wear protective gloves/protective clothing/eye protection/face protection.
P261 Avoid breathing dust/fumes.
P273 Avoid release to the environment.
P272 Contaminated work clothing should not be allowed out of the workplace.

Precautionary statement(s) Response

P312 Call a POISON CENTER/doctor/physician/first aider/if you feel unwell.
P321 Specific treatment (see advice on this label).
P302+P352 IF ON SKIN: Wash with plenty of water.
P333+P313 If skin irritation or rash occurs: Get medical advice/attention.

Precautionary statement(s) Storage

Not Applicable

Precautionary statement(s) Disposal

P501 Dispose of contents/container to authorised hazardous or special waste collection point in accordance with any local regulation.

SECTION 3 COMPOSITION / INFORMATION ON INGREDIENTS

Substances
CAS No %[weight] Name
95382-33-5 >98 omeprazole magnesium

Mixtures
See section above for composition of Substances

SECTION 4 FIRST AID MEASURES

Description of first aid measures

If this product comes in contact with the eyes:

Wash out immediately with fresh 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
Eye Contact
and lower lids.
Seek medical attention without delay; if pain persists or recurs seek medical attention.
Removal of contact lenses after an eye injury should only be undertaken by skilled personnel.
If skin contact occurs:
Immediately remove all contaminated clothing, including footwear.
Skin Contact
Flush skin and hair with running water (and soap if available).
Seek medical attention in event of irritation.
If dust is inhaled, remove from contaminated area.
Inhalation Encourage patient to blow nose to ensure clear passage of breathing.
If irritation or discomfort persists seek medical attention.
If swallowed do NOT induce vomiting.
If vomiting occurs, lean patient forward or place on left side (head-down position, if possible) to maintain open airway and prevent aspiration.
Observe the patient carefully.
Ingestion
Never give liquid to a person showing signs of being sleepy or with reduced awareness; i.e. becoming unconscious.
Give water to rinse out mouth, then provide liquid slowly and as much as casualty can comfortably drink.
Seek medical advice.

Indication of any immediate medical attention and special treatment needed

No antidote is known. Omeprazole is extensively protein-bound and is therefore not readily dialysable.
Treat symptomatically.

SECTION 5 FIREFIGHTING MEASURES

Extinguishing media
Water spray or fog.

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OMEPRAZOLE MAGNESIUM

Foam.
Dry chemical powder.
BCF (where regulations permit).

Special hazards arising from the substrate or mixture

Fire Incompatibility Avoid contamination with oxidising agents i.e. nitrates, oxidising acids, chlorine bleaches, pool chlorine etc. as ignition may result

Advice for firefighters

Alert Fire Brigade and tell them location and nature of hazard.
Wear breathing apparatus plus protective gloves.
Fire Fighting
Prevent, by any means available, spillage from entering drains or water courses.
Use water delivered as a fine spray to control fire and cool adjacent area.
Combustible solid which burns but propagates flame with difficulty; it is estimated that most organic dusts are combustible (circa 70%) -
according to the circumstances under which the combustion process occurs, such materials may cause fires and / or dust explosions.
Organic powders when finely divided over a range of concentrations regardless of particulate size or shape and suspended in air or some
other oxidizing medium may form explosive dust-air mixtures and result in a fire or dust explosion (including secondary explosions).
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 - particles exceeding this limit will generally not
form flammable dust clouds; once initiated, however, larger particles up to 1400 microns diameter will contribute to the propagation of an
Fire/Explosion Hazard explosion.
Combustion products include:
carbon monoxide (CO)
carbon dioxide (CO2)
nitrogen oxides (NOx)
sulfur oxides (SOx)
other pyrolysis products typical of burning organic material.
May emit poisonous fumes.
May emit corrosive fumes.

SECTION 6 ACCIDENTAL RELEASE MEASURES

Personal precautions, protective equipment and emergency procedures

See section 8

Environmental precautions
See section 12

Methods and material for containment and cleaning up

Clean up waste regularly and abnormal spills immediately.

Avoid breathing dust and contact with skin and eyes.
Minor Spills
Wear protective clothing, gloves, safety glasses and dust respirator.
Use dry clean up procedures and avoid generating dust.
Moderate hazard.
CAUTION: Advise personnel in area.
Major Spills
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 SDS.

SECTION 7 HANDLING AND STORAGE

Precautions for 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.
Safe handling Organic powders when finely divided over a range of concentrations regardless of particulate size or shape and suspended in air or some
other oxidizing medium may form explosive dust-air mixtures and result in a fire or dust explosion (including secondary explosions)
Minimise airborne dust and eliminate all ignition sources. Keep away from heat, hot surfaces, sparks, and flame.
Establish good housekeeping practices.
Remove dust accumulations on a regular basis by vacuuming or gentle sweeping to avoid creating dust clouds.
Store below 40 deg.
Store in original containers.
Other information 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

Glass container is suitable for laboratory quantities

Suitable container Polyethylene or polypropylene container.
Check all containers are clearly labelled and free from leaks.
Storage incompatibility Avoid reaction with oxidising agents

SECTION 8 EXPOSURE CONTROLS / PERSONAL PROTECTION

Control parameters

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OMEPRAZOLE MAGNESIUM

OCCUPATIONAL EXPOSURE LIMITS (OEL)

INGREDIENT DATA
Not Available
EMERGENCY LIMITS
Ingredient Material name TEEL-1 TEEL-2 TEEL-3
OMEPRAZOLE MAGNESIUM Not Available Not Available Not Available Not Available

Ingredient Original IDLH Revised IDLH

omeprazole magnesium Not Available Not Available

OCCUPATIONAL EXPOSURE BANDING

Ingredient Occupational Exposure Band Rating Occupational Exposure Band Limit
omeprazole magnesium D > 0.01 to ≤ 0.1 mg/m³
Occupational exposure banding is a process of assigning chemicals into specific categories or bands based on a chemical's potency and the
Notes: adverse health outcomes associated with exposure. The output of this process is an occupational exposure band (OEB), which corresponds to a
range of exposure concentrations that are expected to protect worker health.

MATERIAL DATA
CEL TWA: 0.5 mg/m3* *[AstraZeneca]
It is the goal of the ACGIH (and other Agencies) to recommend TLVs (or their equivalent) for all substances for which there is evidence of health effects at airborne concentrations
encountered in the workplace.
At this time no TLV has been established, even though this material may produce adverse health effects (as evidenced in animal experiments or clinical experience). Airborne
concentrations must be maintained as low as is practically possible and occupational exposure must be kept to a minimum.
NOTE: The ACGIH occupational exposure standard for Particles Not Otherwise Specified (P.N.O.S) does NOT apply.
Airborne particulate or vapour must be kept to levels as low as is practicably achievable given access to modern engineering controls and monitoring hardware. Biologically active
compounds may produce idiosyncratic effects which are entirely unpredictable on the basis of literature searches and prior clinical experience (both recent and past).

Exposure controls
Appropriate engineering
controls
Enclosed local exhaust ventilation is required at points of dust, fume or vapour generation.
HEPA terminated local exhaust ventilation should be considered at point of generation of dust, fumes or vapours.
Barrier protection or laminar flow cabinets should be considered for laboratory scale handling.
A fume hood or vented balance enclosure is recommended for weighing/ transferring quantities exceeding 500 mg.

Personal protection

When handling very small quantities of the material eye protection may not be required.
For laboratory, larger scale or bulk handling or where regular exposure in an occupational setting occurs:
Eye and face protection
Chemical goggles.
Face shield. Full face shield may be required for supplementary but never for primary protection of eyes.
Skin protection See Hand protection below
NOTE:
The material may produce skin sensitisation in predisposed individuals. Care must be taken, when removing gloves and other protective
equipment, to avoid all possible skin contact.
Contaminated leather items, such as shoes, belts and watch-bands should be removed and destroyed.
The selection of suitable gloves does not only depend on the material, but also on further marks of quality which vary from manufacturer to
manufacturer. Where the chemical is a preparation of several substances, the resistance of the glove material can not be calculated in advance
and has therefore to be checked prior to the application.
The exact break through time for substances has to be obtained from the manufacturer of the protective gloves and.has to be observed when
making a final choice.
Hands/feet protection Personal hygiene is a key element of effective hand care.
Rubber gloves (nitrile or low-protein, powder-free latex, latex/ nitrile). Employees allergic to latex gloves should use nitrile gloves in
preference.
Double gloving should be considered.
PVC gloves.
Experience indicates that the following polymers are suitable as glove materials for protection against undissolved, dry solids, where abrasive
particles are not present.
polychloroprene.
nitrile rubber.
butyl rubber.
Body protection See Other protection below
For quantities up to 500 grams a laboratory coat may be suitable.
For quantities up to 1 kilogram a disposable laboratory coat or coverall of low permeability is recommended. Coveralls should be buttoned at
Other protection
collar and cuffs.
For quantities over 1 kilogram and manufacturing operations, wear disposable coverall of low permeability and disposable shoe covers.

Respiratory protection
Particulate. (AS/NZS 1716 & 1715, EN 143:2000 & 149:001, ANSI Z88 or national equivalent)

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.

Required minimum protection factor Maximum gas/vapour concentration present in air p.p.m. (by volume) Half-face Respirator Full-Face Respirator
up to 10 1000 -AUS / Class1 P2 -
up to 50 1000 - -AUS / Class 1 P2
up to 50 5000 Airline * -

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OMEPRAZOLE MAGNESIUM

up to 100 5000 - -2 P2
up to 100 10000 - -3 P2
100+ Airline**

* - Continuous Flow ** - Continuous-flow or positive pressure demand

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)

Respirators may be necessary when engineering and administrative controls do not adequately prevent exposures.
The decision to use respiratory protection should be based on professional judgment that takes into account toxicity information, exposure measurement data, and frequency and
likelihood of the worker's exposure - ensure users are not subject to high thermal loads which may result in heat stress or distress due to personal protective equipment (powered,
positive flow, full face apparatus may be an option).
Published occupational exposure limits, where they exist, will assist in determining the adequacy of the selected respiratory protection. These may be government mandated or
vendor recommended.
Certified respirators will be useful for protecting workers from inhalation of particulates when properly selected and fit tested as part of a complete respiratory protection program.
Use approved positive flow mask if significant quantities of dust becomes airborne.
Try to avoid creating dust conditions.

SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES

Information on basic physical and chemical properties

Appearance White to off-white crystalline powder; mixes with water. A weak base, rapidly degraded in acid media.

Physical state Divided Solid Relative density (Water = 1) Not Available

Partition coefficient n-octanol
Odour Not Available Not Available
/ water
Odour threshold Not Available Auto-ignition temperature (°C) Not Available
pH (as supplied) Not Applicable Decomposition temperature Not available.
Melting point / freezing point
Not Available Viscosity (cSt) Not Available
(°C)
Initial boiling point and boiling
Not Available Molecular weight (g/mol) Not Available
range (°C)
Flash point (°C) Not Available Taste Not Available
Evaporation rate Not Applicable Explosive properties Not Available
Flammability Not Available Oxidising properties Not Available
Surface Tension (dyn/cm or
Upper Explosive Limit (%) Not available. Not Applicable
mN/m)
Lower Explosive Limit (%) Not Available Volatile Component (%vol) Negligible
Vapour pressure (kPa) Negligible Gas group Not Available
Solubility in water Miscible pH as a solution (1%) Not Available
Vapour density (Air = 1) >1 VOC g/L Not Available

SECTION 10 STABILITY AND REACTIVITY

Reactivity See section 7

Unstable in the presence of incompatible materials.
Chemical stability Product is considered stable.
Hazardous polymerisation will not occur.
Possibility of hazardous
See section 7
reactions
Conditions to avoid See section 7
Incompatible materials See section 7
Hazardous decomposition
See section 5
products

SECTION 11 TOXICOLOGICAL INFORMATION

Information on toxicological effects

The material is not thought to produce either adverse health effects or irritation of the respiratory tract following inhalation (as classified by EC
Directives using animal models). Nevertheless, adverse systemic effects have been produced following exposure of animals by at least one other
route and good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an occupational
setting.
Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, may incur further disability
Inhaled if excessive concentrations of particulate are inhaled.
If prior damage to the circulatory or nervous systems has occurred or if kidney damage has been sustained, proper screenings should be
conducted on individuals who may be exposed to further risk if handling and use of the material result
in excessive exposures.

Limited evidence exists that the substance may cause irreversible but non-lethal mutagenic effects following a single exposure.
Accidental ingestion of the material may be damaging to the health of the individual.
Ingestion Limited evidence exists that the substance may cause irreversible but non-lethal mutagenic effects following a single exposure.
Treatment with omeprazole is generally well tolerated. Side-effects may include headache, diarrhoea, abdominal pain, nausea, URI, dizziness,

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OMEPRAZOLE MAGNESIUM

vomiting, rash, constipation, cough, asthenia and back pain. Rare adverse events include fever, pain, fatigue, malaise, and abdominal swelling.
Other effects include;
Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, flatulence, faecal discolouration, oesophageal candidiasis, mucosal atrophy of
the tongue, dry mouth, fundic gland polyps (benign and reversible), gastroduodenal carcinoid (believed to be a manifestation of the underlying
condition associated with ZE syndrome);
Hepatic: Elevation of liver function tests (ALT(SGPT), AST(SGOT), gamma-glutamyl transpeptidase, alkaline phosphatase, and bilirubin
(jaundice), overt liver disease including hepatocellular, cholestatic or mixed hepatitis, liver necrosis (sometimes fatal), and hepatic
encephalopathy;
Metabolic: Hyponatraemia, hypoglycaemia, weight gain; Musculoskeletal: Muscle cramps, myalgia, muscle weakness, joint pain, leg pain;
Nervous System: Psychic disturbances including depression, aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy,
somnolence, anxiety, dream abnormalities, vertigo, paresthesia, hemifacial dysesthesia;
Respiratory: Epistaxis, pharyngeal pain;
Skin: Rash, and in very rare cases of severe generalised skin reactions, toxic epidermal necrosis (TEN), sometimes fatal, Stevens-Johnson
syndrome and erythema multiforme (sometimes severe), skin inflammation, urticaria, angioedema, pruritus, alopecia, dry skin, hyperhidrosis;
Special senses: Tinnitus, taste perversion; Urogenital: Interstitial nephritis (some with positive rechallenge), urinary tract infection, microscopic
pyuria, urinary frequency, elevated serum creatinine, proteinuria, haematuria, glycosuria, testicular pain, gynaecomastia;
Haematologic: Pancytopenia, agranulocytosis (sometimes fatal), thrombocytopenia, neutropenia, anaemia, leucocytosis, and haemolytic
anaemia.
Gastric proton pump inhibitors (GPPIs) are generally well tolerated, and the incidence of short-term adverse effects is relatively uncommon. The
range and occurrence of adverse effects are similar for all of the proton pump inhibitors, though they have been reported more frequently with
omeprazole. This may be due to its longer availability and hence clinical experience.
Common adverse effects include: headache, nausea, diarrhoea, abdominal pain, fatigue, dizziness.
The material is not thought to produce adverse health effects or skin irritation following contact (as classified by EC Directives using animal
models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational
setting.
Skin Contact
Open cuts, abraded or irritated skin should not be exposed to this material
Entry into the blood-stream through, for example, cuts, abrasions, puncture wounds 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.
Although the material is not thought to be an irritant (as classified by EC Directives), direct contact with the eye may cause transient discomfort
Eye characterised by tearing or conjunctival redness (as with windburn). Slight abrasive damage may also result. The material may produce foreign
body irritation in certain individuals.
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.
On the basis, primarily, of animal experiments, concern has been expressed by at least one classification body that the material may produce
carcinogenic or mutagenic effects; in respect of the available information, however, there presently exists inadequate data for making a
satisfactory assessment.
Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involving organs or
biochemical systems.
A number of benzimidazoles have been shown to also inhibit mammalian tubulin polymerisation and to be aneugenic in vivo. Aneugens affect cell
division and the mitotic spindle apparatus resulting in loss or gain of whole chromosomes, thereby inducing an "aneuploidy". Mitotic aneuploidy is
a characteristic of many types of tumorigenesis (in cancer). Several benzimidazoles have been shown to be genotoxic.
In a study of 135,000 people 50 or older, those taking high doses of GPPIs for longer than one year have been found to be 2.6 times more likely
Chronic to break a hip. Those taking smaller doses for 1 to 4 years were 1.2 to 1.6 times more likely to break a hip. The risk of a fracture increased with
the length of time taking GPPIs. Theories as to the cause of the increase are the possibility that the reduction of stomach acid reduces the
amount of calcium dissolved in the stomach or that GPPIs may interfere with the breakdown and rebuilding of bone by interfering with the acid
production of osteoclasts.
Omeprazole is a skin strong sensitiser in animal assays.
Repeated oral doses of omeprazole in animals have produced adverse effects on kidney and the gastrointestinal tract. Short term tests show that
the material is unlikely to be a carcinogenic hazard in man.
In two 24-month carcinogenicity studies in rats, omeprazole (given at 4-352 times the human dosage) produced gastric ECL cell carcinoids in a
dose-related manner in both male and female rats ECL cell hyperplasia was present in all treatment groups.

Long term exposure to high dust concentrations may cause changes in lung function (i.e. pneumoconiosis) caused by particles less than 0.5
micron penetrating and remaining in the lung. A prime symptom is breathlessness. Lung shadows show on X-ray.

TOXICITY IRRITATION
omeprazole magnesium
Oral (rat) LD50: 2210 mg/kg[2] Not Available

Legend: 1. Value obtained from Europe ECHA Registered Substances - Acute toxicity 2.* Value obtained from manufacturer's SDS. Unless otherwise
specified data extracted from RTECS - Register of Toxic Effect of chemical Substances

OMEPRAZOLE MAGNESIUM
for omeprazole: urine composition, changes in kidney tubules, normocytic anaemia, body temperature increase, pleural effusion, cough, urticaria,
allergic rhinitis, serum sickness, eosinophilia, interstitial nephritis, dermatitis after systemic exposure, joint abnormalities, effects on inflammation,
ptosis, changes in motor activity, respiratory depression, diarrhoea, dyspnea, convulsions, ataxia, body temperature decrease, maternal effects
recorded.
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. The significance of the contact allergen is not simply determined by its sensitisation potential: the
distribution of the substance and the opportunities for contact with it are equally important.
Exposure to the material may result in a possible risk of irreversible effects. The material may produce mutagenic effects in man. This concern is
raised, generally, on the basis of
appropriate studies with similar materials using mammalian somatic cells in vivo. Such findings are often supported by positive results from in
vitro mutagenicity studies.
NOTE: Substance has been shown to be mutagenic in at least one assay, or belongs to a family of chemicals producing damage or change to
cellular DNA.

Acute Toxicity Carcinogenicity

Skin Irritation/Corrosion Reproductivity
Serious Eye Damage/Irritation STOT - Single Exposure
Respiratory or Skin
STOT - Repeated Exposure
sensitisation

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Mutagenicity Aspiration Hazard

Legend: – Data either not available or does not fill the criteria for classification
– Data available to make classification

SECTION 12 ECOLOGICAL INFORMATION

Toxicity

ENDPOINT TEST DURATION (HR) SPECIES VALUE SOURCE

omeprazole magnesium Not Not Not
Not Available Not Available
Available Available Available

Legend: Extracted from 1. IUCLID Toxicity Data 2. Europe ECHA Registered Substances - Ecotoxicological Information - Aquatic Toxicity 3. EPIWIN Suite
V3.12 (QSAR) - Aquatic Toxicity Data (Estimated) 4. US EPA, Ecotox database - Aquatic Toxicity Data 5. ECETOC Aquatic Hazard Assessment
Data 6. NITE (Japan) - Bioconcentration Data 7. METI (Japan) - Bioconcentration Data 8. Vendor Data

Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
Do NOT allow product to come in contact with surface waters or to intertidal areas below the mean high water mark. Do not contaminate water when cleaning equipment or disposing
of equipment wash-waters.
Wastes resulting from use of the product must be disposed of on site or at approved waste sites.
For omeprazole:
Environmental fate:
Omeprazole hydrolyses readily in acid pH, and rapidly undergoes photodegradation (complete in 3 hours). Omeprazole is not readily biodegradable. The log Kow=2.38.
Ecotoxicity:
Daphnia magna LC50 (48 h): 0.088 ppb
Fish LC50 (96 h): Zebra fish 42 mg/l*
Daphnia magna EC50 (48 h): >100 mg/l/*
Green algae EC50 (72 h): 30 mg/l/*
There is evidence of inhibition of the aerobic treatment process at a concentration of >100 mg/l
*[AstraZeneca]
DO NOT discharge into sewer or waterways.

Persistence and degradability

Ingredient Persistence: Water/Soil Persistence: Air
No Data available for all ingredients No Data available for all ingredients

Bioaccumulative potential
Ingredient Bioaccumulation
No Data available for all ingredients

Mobility in soil
Ingredient Mobility
No Data available for all ingredients

SECTION 13 DISPOSAL CONSIDERATIONS

Waste treatment methods

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 SDS and observe all notices pertaining to the product.
Legislation addressing waste disposal requirements may differ by country, state and/ or territory. Each user must refer to laws operating in their
area. In some areas, certain wastes must be tracked.
A Hierarchy of Controls seems to be common - the user should investigate:
Product / Packaging disposal
Reduction
Reuse
Recycling
Disposal (if all else fails)
This material may be recycled if unused, or if it has not been contaminated so as to make it unsuitable for its intended use.
DO NOT allow wash water from cleaning or process equipment to enter drains.
It may be necessary to collect all wash water for treatment before disposal.
In all cases disposal to sewer may be subject to local laws and regulations and these should be considered first.
Where in doubt contact the responsible authority.

SECTION 14 TRANSPORT INFORMATION

Labels Required

Marine Pollutant NO

Land transport (UN): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS

Air transport (ICAO-IATA / DGR): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS

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Sea transport (IMDG-Code / GGVSee): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS

Transport in bulk according to Annex II of MARPOL and the IBC code

Not Applicable

SECTION 15 REGULATORY INFORMATION

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

OMEPRAZOLE MAGNESIUM IS FOUND ON THE FOLLOWING REGULATORY LISTS

Not Applicable

National Inventory Status

National Inventory Status
Australia - AICS No (omeprazole magnesium)
Canada - DSL No (omeprazole magnesium)
Canada - NDSL No (omeprazole magnesium)
China - IECSC No (omeprazole magnesium)
Europe - EINEC / ELINCS / NLP No (omeprazole magnesium)
Japan - ENCS No (omeprazole magnesium)
Korea - KECI No (omeprazole magnesium)
New Zealand - NZIoC No (omeprazole magnesium)
Philippines - PICCS No (omeprazole magnesium)
USA - TSCA No (omeprazole magnesium)
Taiwan - TCSI No (omeprazole magnesium)
Mexico - INSQ No (omeprazole magnesium)
Vietnam - NCI Yes
Russia - ARIPS No (omeprazole magnesium)
Yes = All CAS declared ingredients are on the inventory
Legend:
No = One or more of the CAS listed ingredients are not on the inventory and are not exempt from listing(see specific ingredients in brackets)

SECTION 16 OTHER INFORMATION

Revision Date 27/01/2020

Initial Date 18/10/2003

SDS Version Summary

Version Issue Date Sections Updated
6.1.1.1 27/01/2020 Chronic Health, Toxicity and Irritation (Other), Use

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.

The 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.

Definitions and abbreviations

PC－TWA: Permissible Concentration-Time Weighted Average
PC－STEL: Permissible Concentration-Short Term Exposure Limit
IARC: International Agency for Research on Cancer
ACGIH: American Conference of Governmental Industrial Hygienists
STEL: Short Term Exposure Limit
TEEL: Temporary Emergency Exposure Limit。
IDLH: Immediately Dangerous to Life or Health Concentrations
OSF: Odour Safety Factor
NOAEL :No Observed Adverse Effect Level
LOAEL: Lowest Observed Adverse Effect Level
TLV: Threshold Limit Value
LOD: Limit Of Detection
OTV: Odour Threshold Value
BCF: BioConcentration Factors
BEI: Biological Exposure Index

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.

end of SDS