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Safety Data Sheet EN

TAFIN HNC 50MG.001

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
TAFIN HNC 50MG.001
Chemical Name
DABRAFENIB MONOMESYLATE

Regulatory Identifiers

CAS Number
N/A

Identified Uses

Drug product (pharmaceutical bulk, primary packed, finished product, pharmaceutical intermediate)

Manufacturers & Suppliers

N

Novartis Pharma AG

manufacturer

4002 Basel, Switzerland

+41 61 324 11 11

Emergency Contacts

CHEMTEL

+1 813 676 1670

365/24/7

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified no signal word

GHS Pictograms

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type mixture

Remaining components are inert ingredients.

Chemical Name CAS Number Concentration Hazardous
DABRAFENIB MONOMESYLATE 1195768-06-9 35% No

For classification of declared components, see section 15, "Regulatory Information". For TLV values of declared components, see Section 8, Exposure controls / Personal

04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Remove the victim from danger zone, avoid further exposure.

Skin contact

Remove contaminated clothing. Rinse contaminated skin immediately with plenty of water and soap and seek medical advice.

Eye contact

Immediately rinse eyes thoroughly with running water as long as possible (approx. 15 min). Take injured quickly to factory medical center or call an ambulance (code word: eye accident).

Ingestion

If swallowed, seek medical advice immediately and show this container or label.

Immediate Medical Attention

Take injured quickly to factory medical center or call an ambulance (code word: eye accident).

Medical Treatment

General measures to eliminate the substance and to reduce absorption.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Water spray or fog, foam, dry chemical powder, CO2, dry sand

Unsuitable media

No restrictions

Specific hazards

carbon oxides, nitrogen oxides, sulfur oxides

Firefighter Protection

Wear self-contained breathing apparatus and fire protective suite.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Small spill

Clean up the rest with absorbent material and discharge properly.

Large spill

Transfer large quantities into a container.

Environmental

Must not be released into sewers, drains or wells.

Cleanup methods

Transfer large quantities into a container. Clean up the rest with absorbent material and discharge properly.

Materials: absorbent material

—

Related Products

Similar products with comparable safety profiles

N

NAFTOSAFE T HX 49055-1

---

N

NITROCET 50

CAS: 27247-96-7

N

NAFTOSAFE T HX 213 M

---

T

TOFAD 20

CAS: 61790-12-3

T

TOFAD 20

CAS: 61790-12-3

N

NAFTOSAFE CTT 80909/01

---

N

NAFTOSAFE HPT 77000

---

N

NAFTOSAFE HPT 77000

---

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

No special handling requirements for normal use of this material.

Storage

Store in a dry and cool place and observe special instructions from supplier.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Hands

Disposable gloves (EN374)

Eyes

Safety glasses (EN166)

Skin/Body

Lab coat

09

Physical and Chemical Properties

Appearance, physical state, melting point, boiling point, and material characteristics

Language Code
---
Physical State
Capsule
Physical State Data
solid
State Under Standard Conditions
---
Appearance
---
Colour
---
Colour Intensity
---
Form
Capsule
Odor
---
Odor Threshold
---
Ph
---
Melting Point
---
Boiling Point
---
Flash Point
not applicable
Freezing Point
---
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
---
Vapor Pressure
---
Vapor Density
---
Relative Density
---
Bulk Density
---
Density
---
Flammability
---
Upper Explosive Limit
---
Lower Explosive Limit
---
Explosive Limits
---
Auto Ignition Temperature
---
Decomposition Temperature
---
Solubility
---
Partition Coefficient
---
Solubility In Water
---
Solubility In Fat
---
Molecular Weight
---
Voc Content
---
Metal Corrosion
---
Dynamic Viscosity
---
Kinematic Viscosity
---
Properties Status
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

Under the normal conditions of use, the product is stable.

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

12.1 Toxicity

Biological Elimination: Degradation: 0 % (CO2) Not readily degradable Method: OECD Guidelines test 301B: CO2 Evolution. Fish chronic toxicity: LOEC: 3.09 mg/l, NOEC: 1.74 mg/l, Species: fathead minnow (pimephales promelas), Exp. time: 28 days, Method: OECD Guidelines 210. Aquatic invertebrate chronic toxicity: LOEC: 0.12 mg/l, NOEC: 0.07 mg/l, Species: daphnia magna (water flea), Exp. time: 21 days, Method: OECD Guidelines 211. Algae Toxicity: EC50: 0.33 mg/l, NOEC: 0.26 mg/l, Species: Green algae - fresh water (Pseudokirchneriella subcapitata), Exp. time: 72 hours. Bacterial Respiration Inhibition: IC50: > 370.3 mg/l, NOEC: 370.3 mg/l, Exp. time: 3 hours, Method: OECD Guidelines 209.

12.2 Persistence and degradability

Degradation: 0 % (CO2) Not readily degradable Method: OECD Guidelines test 301B: CO2 Evolution

12.3 Bioaccumulative potential

Bioaccumulation in water organisms is not likely based on the n-octanol/water partition coefficient (log Pow < 4.0).
13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Treatment

Incineration in an approved, controlled furnace with combustion gas scrubbing and emission gas control.

Disposal

Fill into suitable waste receptacles, seal and label them properly.

14

Transport Information

UN numbers, shipping names, transport classes, and regulatory requirements

UN Number
3077
Shipping Name
Environmentally hazardous substance, solid, n.o.s. ( DABRAFENIB CAPSULES)
Transport Class
9
Packing Group
III
15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

The data for this section has not been processed yet.

?

Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for TAFIN HNC 50MG.001?

The signal word is no signal word.

What is the physical form of TAFIN HNC 50MG.001?

TAFIN HNC 50MG.001 is a capsule .

What is TAFIN HNC 50MG.001 used for?

Drug product (pharmaceutical bulk, primary packed, finished product, pharmaceutical intermediate)