SAFETY DATA SHEET

Version Revision Date: SDS Number: Date of last issue: 04.12.2018

4.0 11.07.2019 20993 Date of first issue: 10.08.2017

SECTION 1. PRODUCT AND COMPANY IDENTIFICATION

1.1 Product identifier

TAGRISSO TABLETS
Details of the supplier of the : ASTRAZENECA PTY LTD Emergency Telephone
safety data sheet PO Box 131 +44 (0) 1235 239 670
66 Talavera Rd, North Ryde
NSW 2113
AUSTRALIA
+61 2 9978 3500

SafetyDataSheets.AlderleyPark@astrazeneca.com

Alternative Names
AZD9291 Tablets
AZD9291 Mesylate tablets
Osimertinib tablets
Osimertinib mesylate tablets
CAS No. : Not applicable

1.2 Relevant identified uses of the substance or mixture and uses a dvised against
Use of the Substance/Mixture : Potential anti-cancer agent

SECTION 2. HAZARDS IDENTIFICATION

GHS Classification
Skin sensitisation : Category 1

Reproductive toxicity : Category 2

Specific target organ toxicity - : Category 1 (Reproductive organs, Eyes, Gastrointestinal tract,
repeated exposure (Oral) Bone marrow, Skin, thymus, lymph node)

Short-term (acute) aquatic : Category 2

hazard

Long-term (chronic) aquatic : Category 1

hazard

GHS label elements

Hazard pictograms :

Signal word : Danger

Hazard statements : H317 May cause an allergic skin reaction.

H361 Suspected of damaging fertility or the unborn child.
H372 Causes damage to organs (Reproductive organs, Eyes,
Gastrointestinal tract, Bone marrow, Skin, thymus, lymph node)
through prolonged or repeated exposure if swallowed.
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Version Revision Date: SDS Number: Date of last issue: 04.12.2018

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H401 Toxic to aquatic life.

H410 Very toxic to aquatic life with long lasting effects.

Precautionary statements :
Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been read
and understood.
P260 Do not breathe dust/ fume/ gas/ mist/ vapours/ spray.
P264 Wash skin thoroughly after handling.
P272 Contaminated work clothing should not be allowed out of
the workplace.
P273 Avoid release to the environment.
P280 Wear protective gloves.
P281 Use personal protective equipment as required.
Response:
P302 + P352 IF ON SKIN: Wash with plenty of soap and water.
P308 + P313 IF exposed or concerned: Get medical advice/
attention.
P333 + P313 If skin irritation or rash occurs: Get medical
advice/ attention.
P391 Collect spillage.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Other hazards which do not result in classification

Potentially irritant to the eye.
See Section 11.
The product may form flammable dust clouds in air, if dust from crushed tablets is allowed to
accumulate.

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS

Substance / Mixture : Mixture

Components
Chemical name CAS-No. Concentration (% w/w)
Celluloses 9004-34-6 19.2
Osimertinib 1421373-66-1 18.3

SECTION 4. FIRST AID MEASURES

If inhaled : Remove patient from exposure.

Obtain medical attention if ill effects occur.

In case of skin contact : Wash skin with soap and water.

In case of eye contact : Irrigate with eyewash solution or clean water, holding the
eyelids apart, for at least 10 minutes.
Obtain medical attention if ill effects remain.

If swallowed : Wash out mouth with water and give 200-300ml of water to
drink.

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Obtain medical attention if ill effects occur.

Do NOT induce vomiting as a First-Aid measure.

Most important symptoms : Refer to sections 2 and 11

and effects, both acute and May cause an allergic skin reaction.
delayed Suspected of damaging fertility or the unborn child.
Causes damage to organs through prolonged or repeated
exposure if swallowed.

Notes to physician : Symptomatic treatment and supportive therapy as indicated.

Emergency medical treatment advice varies within different
countries.
For further information consult the Local National Poisons
Information Services.

SECTION 5. FIREFIGHTING MEASURES

Suitable extinguishing media : water spray, foam, dry powder or CO2.

Unsuitable extinguishing : Avoid high pressure media which could cause the formation of
media a potentially explosible dust-air mixture.

Specific hazards during : If involved in a fire, it may emit noxious and toxic fumes.
firefighting

Special protective equipment : A self contained breathing apparatus and suitable protective
for firefighters clothing should be worn in fire conditions.
Prevent fire extinguishing water from contaminating surface
water or the ground water system.

SECTION 6. ACCIDENTAL RELEASE MEASURES

Personal precautions, : Ensure suitable personal protection during removal of

protective equipment and spillages.
emergency procedures Ensure adequate ventilation.
Avoid dispersal of dust in the air.
See Section 8.

Environmental precautions : Prevent entry into drains, sewers or watercourses.

Use appropriate containment to avoid environmental
contamination.
Collect spillage.

Methods and materials for : Avoid release to the environment.

containment and cleaning up Moisten spillages with water.
Transfer spilled tablets to a suitable container for disposal.
Wash the spillage area with water.

See section 13.

SECTION 7. HANDLING AND STORAGE

Advice on safe handling : Minimize dust generation and accumulation.

Do not breathe dust.
Avoid contact with skin and eyes.
Avoid release to the environment.

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SAFETY DATA SHEET

Version Revision Date: SDS Number: Date of last issue: 04.12.2018

4.0 11.07.2019 20993 Date of first issue: 10.08.2017

Wash hands after use.

The product may form flammable dust clouds in air, if dust
from crushed tablets is allowed to accumulate.

Conditions for safe storage : Use appropriate containment to avoid environmental

contamination.
Protect from light.

Recommended storage : < 30 °C

temperature

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Components with workplace control parameters

Components CAS-No. Value type Control Basis
(Form of parameters /
exposure) Permissible
concentration
Celluloses 9004-34-6 TWA 10 mg/m3 AU OEL
Further information: This value is for inhalable dust containing no
asbestos and < 1% crystalline silica
TWA 10 mg/m3 ACGIH
Osimertinib 1421373-66- TWA 0.02 mg/m3 COM
1
Engineering measures : The specific controls will depend on local circumstances and
should be based on the risk assessment. Appropriate
controls to reduce exposure may include engineering
controls, for example ventilation, procedural controls and the
use of personal protection equipment.

Prevent entry into drains, sewers or watercourses.

See Section 6 for environmental precautions.

Personal protective equipment

Respiratory protection : Use a self-contained breathing apparatus if the risk
assessment does not support the selection of other
protection.

Eye protection : Use safety glasses to protect against direct contact with the
product if the risk assessment does not support the s election
of other protection.

Skin and body protection : Use full chemical protective suit to protect against direct
contact with the product if the risk assessment does not
support the selection of other protection. If the product is
dissolved or wetted use a glove material that is resistant to
the solvent/liquid. Take note of the information given by the
PPE producer/supplier concerning permeability and
breakthrough times and special workplace conditions.

Protective measures : Decisions about whether the use of personal protective

equipment (PPE) is appropriate as part of the control strategy
should be based on the workplace risk assessment and

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SAFETY DATA SHEET

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should take account of local legislative requirements for

selection and use. There are multiple factors that will affect
the specific requirements such as amount and concentration
of the material, duration of exposure, frequency of exposure,
external environmental conditions, the task, the user etc.
All the information above should not be used in isolation and
should be considered in the context of the workplace risk
assessment on a case by case basis.

The recommended personal protective equipment (PPE) is

based on preventing the potential adverse health effects from
exposure to the active pharmaceutical ingredient (API). The
risk of exposure to the API in the formulation/product needs
to be taken into consideration.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES

Appearance : film-coated tablets

Colour : beige

Odour : No data available

Odour Threshold : No data available

pH : No data available

Melting point/range : No data available

Initial boiling point and boiling : No data available

range

Flash point : No data available

Evaporation rate : No data available

Flammability (solid, gas) : No data available

Upper explosion limit / Upper : No data available

flammability limit

Lower explosion limit / Lower : No data available

flammability limit

Vapour pressure : No data available

Relative vapour density : No data available

Relative density : No data available

Solubility(ies)
Water solubility : No data available

Solubility in other solvents : No data available

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SAFETY DATA SHEET

Version Revision Date: SDS Number: Date of last issue: 04.12.2018

4.0 11.07.2019 20993 Date of first issue: 10.08.2017

Partition coefficient: n- : No data available

octanol/water

Auto-ignition temperature : No data available

Decomposition temperature : No data available

Viscosity
Viscosity, dynamic : No data available

Viscosity, kinematic : No data available

Explosive properties : No data available

Oxidizing properties : No data available

SECTION 10. STABILITY AND REACTIVITY

Reactivity : No known reactivity hazard under normal conditions.

Chemical stability : Stable under normal conditions.

Possibility of hazardous : None known.

reactions

Conditions to avoid : Protect from light.

Stable at room temperature.

Incompatible materials : None known.

Hazardous decomposition : No hazardous decomposition products are known.

products

SECTION 11. TOXICOLOGICAL INFORMATION

11.1 Acute toxicity

Not classified based on available information.
Product:
Acute oral toxicity : Acute toxicity estimate: > 2,000 mg/kg
Method: Calculation method

Components:

Osimertinib:
Acute oral toxicity : Evident toxicity in rats at a dose of: 1,000 mg/kg

Oral maximum tolerated dose: 300 mg/kg

Assessment: The component/mixture is moderately toxic after

single ingestion.

Acute inhalation toxicity : Remarks: May cause effects as described under repeated
exposure.(STOT)

Acute dermal toxicity : Remarks: No information available.

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SAFETY DATA SHEET

Version Revision Date: SDS Number: Date of last issue: 04.12.2018

4.0 11.07.2019 20993 Date of first issue: 10.08.2017

11.2 Skin corrosion/irritation

Not classified based on available information.
Components:

Osimertinib:
Remarks : Unlikely to be corrosive to the skin.

11.3 Serious eye damage/eye irritation

Not classified based on available information.
Components:

Osimertinib:
Remarks : Potentially irritant to the eye.

11.4 Respiratory or skin sensitisation

Skin sensitisation
May cause an allergic skin reaction.
Respiratory sensitisation
Not classified based on available information.
Components:

Osimertinib:
Result : The product is a skin sensitiser, sub-category 1B.
Remarks : It is a moderate skin sensitiser in animal tests.

Chronic toxicity

11.5 Germ cell mutagenicity

Not classified based on available information.
Components:

Osimertinib:
Germ cell mutagenicity - : There is no evidence of genotoxic potential in in vitro and in
Assessment vivo tests.

11.6 Carcinogenicity
Not classified based on available information.
Components:

Osimertinib:
Carcinogenicity - : No information available.
Assessment

11.7 Reproductive toxicity

Suspected of damaging fertility or the unborn child.

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SAFETY DATA SHEET

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4.0 11.07.2019 20993 Date of first issue: 10.08.2017

Components:

Osimertinib:
Reproductive toxicity - : Some evidence of adverse effects on sexual function and
Assessment fertility, based on animal experiments., Adverse effects on
male and female reproduction in animals., (including
embryolethality).

11.8 STOT - single exposure

Not classified based on available information.
Components:

Osimertinib:
Remarks : May cause effects as described under repeated
exposure.(STOT)

11.9 STOT - repeated exposure

Causes damage to organs (Reproductive organs, Eyes, Gastrointestinal tract, Bone marrow,
Skin, thymus, lymph node) through prolonged or repeated exposure if swallowed.
Components:

Osimertinib:
Exposure routes : Oral
Target Organs : Reproductive organs, Eyes, Gastrointestinal tract, Bone
marrow, Skin, thymus, lymph node
Assessment : Causes damage to organs through prolonged or repeated
exposure.
Remarks : These effects are derived from studies in animals.

Remarks : May cause rash and diarrhea.

Based on human experience.

Repeated dose toxicity

Components:

Osimertinib:
Species : Rat
NOAEL : 1 mg/kg
Application Route : Oral
Exposure time : 90 d

Species : Dog
NOAEL : 3 mg/kg
Application Route : Oral
Exposure time : 90 d

11.10 Aspiration toxicity

Not classified based on available information.
Components:

Osimertinib:
No information available.

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SAFETY DATA SHEET

Version Revision Date: SDS Number: Date of last issue: 04.12.2018

4.0 11.07.2019 20993 Date of first issue: 10.08.2017

Further information

Product:
Remarks : This health hazard assessment is based on a consideration of
the composition of this product.

SECTION 12. ECOLOGICAL INFORMATION

Ecotoxicity

Product:

Ecotoxicology Assessment
Chronic aquatic toxicity : Very toxic to aquatic life with long lasting effects.
Remarks: This environmental hazard assessment is based on
information available on the components of the formulation.

Components:

Osimertinib:
Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 1.5 mg/l
aquatic invertebrates Exposure time: 48 h
Test Type: Immobilization
Method: OECD Test Guideline 202

Toxicity to algae : EC50 (Pseudokirchneriella subcapitata (green algae)): 0.23

mg/l
Exposure time: 72 h
Test Type: growth rate
Method: OECD Test Guideline 201

NOEC (Selenastrum capricornutum (green algae)): 0.014 mg/l

Exposure time: 72 h
Test Type: growth rate
Method: OECD Test Guideline 201

M-Factor (Acute aquatic : 1

toxicity)

Toxicity to fish (Chronic : NOEC (Pimephales promelas (fathead minnow)): 0.00075

toxicity) mg/l
Exposure time: 32 d
Test Type: Early-life Stage
Method: OECD Test Guideline 210

Toxicity to daphnia and other : NOEC (Daphnia magna (Water flea)): 0.026 mg/l
aquatic invertebrates Exposure time: 21 d
(Chronic toxicity) Method: OECD Test Guideline 211

NOEC (Chironomus riparius (harlequin fly)): 79

Exposure time: 28 d
Method: OECD Test Guideline 218

M-Factor (Chronic aquatic : 100

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SAFETY DATA SHEET

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toxicity)

Toxicity to microorganisms : EC50 (activated sludge): >= 320 mg/l

Exposure time: 3 h
Test Type: Respiration inhibition
Method: OECD Test Guideline 209

Persistence and degradability

Components:

Osimertinib:
Biodegradability : Result: Not readily biodegradable.
Remarks: The substance is substantially removed in biological
treatment processes.

Bioaccumulative potential

Components:

Osimertinib:
Bioaccumulation : Remarks: Due to the distribution coefficient n-octanol/water,
accumulation in organisms is not expected.
The substance has low potential for bioaccumulation.

Mobility in soil

Components:

Osimertinib:
Mobility : Remarks: The substance has low mobility in soil.

Distribution among : Remarks: No information available.

environmental compartments

Other adverse effects

No data available

SECTION 13. DISPOSAL CONSIDERATIONS

Disposal methods
Waste from residues : Disposal should be in accordance with local, state or national
legislation.
Waste, even small quantities, should never be poured down
drains, sewers or water courses.
Dispose of contents/ container to an approved incineration
plant.

Contaminated packaging : Empty container will retain product residue. Observe all
hazard precautions.

SECTION 14. TRANSPORT INFORMATION

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SAFETY DATA SHEET

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4.0 11.07.2019 20993 Date of first issue: 10.08.2017

ICAO/IATA

UN No. 3077
Proper Shipping Name : Environmentally hazardous substance, solid, n.o.s. (OSIMERTINIB )
Class : 9
Packing Group : III
Environmental hazards : Environmentally hazardous

IMO/IMDG

UN No. 3077
Proper Shipping Name : ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.
(OSIMERTINIB )
Class : 9
Packing Group : III
Marine pollutant : Marine pollutant

ADR

UN No. 3077
Proper Shipping Name : ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.
(OSIMERTINIB )
Class : 9
Label(s) : 9
Packing Group : III
Environmental hazards : Environmentally hazardous

SECTION 15. REGULATORY INFORMATION

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

mixture
In order to comply with legal duties it is necessary to consult local and national legislation.

Standard for the Uniform : No poison schedule number allocated

Scheduling of Medicines and
Poisons

Prohibition/Licensing Requirements : There is no applicable prohibition or

notification/licensing requirements,
including for carcinogens under
Commonwealth, State or Territory
legislation.

The components of this product are reported in the following inventories:

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SAFETY DATA SHEET

Version Revision Date: SDS Number: Date of last issue: 04.12.2018

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REACH : Not in compliance with the inventory

DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.

Osimertinib

AICS : Not in compliance with the inventory

ENCS : Not in compliance with the inventory

ISHL : Not in compliance with the inventory

IECSC : Not in compliance with the inventory

TCSI : Not in compliance with the inventory

TSCA : Not On TSCA Inventory

SECTION 16. OTHER INFORMATION

Further information
Revision Date : 11.07.2019

Other information : New significant SHE information:

8. New Occupational Exposure Limit Value
Minor changes:
2
11
15

Date format : dd.mm.yyyy

Full text of other abbreviations

ACGIH : USA. ACGIH Threshold Limit Values (TLV)
AU OEL : Australia. Workplace Exposure Standards for Airborne
Contaminants.

ACGIH / TWA : 8-hour, time-weighted average

AU OEL / TWA : Exposure standard - time weighted average

AICS - Australian Inventory of Chemical Substances; ANTT - National Agency for Transport by
Land of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR -
Carcinogen, Mutagen or Reproductive Toxicant; COM – In-house occupational exposure limit;
CPR - Controlled Products Regulations; DSL - Domestic Substances List (Canada); ECx -
Conc entration associated with x% response; ELx - Loading rate associated with x% response;
EmS - Emergency Schedule; ENCS - Existing and New Chemical Substanc es (Japan); ErCx -
Conc entration associated with x% growth rate response; ERG - Emergency Response Guide;
GHS - Globally Harmonized System; GLP - Good Laborat ory Practice; HYG – Analytical method
for occupational exposure monitoring; IARC - Int ernational Agency for Research on Cancer; IA TA
- International Air Transport Association; IC50 - Half maximal inhibitory concentration; ICAO -
International Civil A viation Organization; IE CSC - Inventory of Existing Chemical Substances in
China; IMDG - International Maritime Dangerous Goods; IMO - International Maritime
Organization; IS HL - Industrial Safety and Health Law (Japan); ISO - International Organisation
for Standardization; LC50 - Lethal Conc entration to 50 % of a test population; LD50 - Lethal Dose

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to 50% of a test population (Median Lethal Dose); n. o.s. - Not Otherwise Specified; Nch - Chilean
Norm; NO(A )EC - No Observed (Adverse) Effect Concentration; NO(A )EL - No Observed
(Adverse) Effect Level; NOELR - No Observable E ffect Loading Rate; NOM - Official Mexican
Norm; NTP - National Toxicology Program; OE CD - Organization for Economic Co-operation and
Development; OPP TS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent,
Bioaccumulative and Toxic substance; (Q)SAR - (Quantitative) Structure Activity Relationship;
REACH - Regulation (EC) No 1907/2006 of the European Parliament and of t he Council
concerning the Registration, E valuation, Authorisation and Restriction of Chemicals; SADT - S elf-
Accelerating Dec omposition Temperature; SDS - Safety Data Sheet; Sen – Capable of causing
respiratory sensitization; Sk – Can be absorbed through skin, thus contributing to systemic
effects; STEL – Short-term exposure limit 15-minutes time-weighted average; TLV – Threshold
Limit Value (A CGIH); TLV-C – Threshold Limit Value Ceiling limit (A CGIH); TS CA - Toxic
Substances Control Act (United States); TWA – Long-term exposure limit 8h time-weighted
average; UN - Unit ed Nations; UNRTDG - United Nations Recommendations on the Transport of
Dangerous Goods; vP vB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace
Hazardous Materials Information System

The information provided in this Safety Data Sheet is correct to the best of our knowledge,
information and belief at the date of its publication. The information given is designed only as a
guidance for safe handling, use, processing, storage, transportat ion, disposal and release and is
not to be c onsidered a warranty or quality specification. The information relates only to the
specific material designated and may not be valid for such material used in combination with any
other materials or in any process, unless specified in the text.

AU / EN

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