1.PRODUCT AND COMPANY IDENTIFICATION
Product identifier
- Product Name: Alpelisib (BYL719)
- Catalog Number: S2814
- CAS Number: 1217486-61-7
- IUPAC Name: 1,2-Pyrrolidinedicarboxamide, N1-[4-methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-, (2S)-
Relevant identified uses and uses advised against
- Identified uses: For research and development use only; laboratory chemicals; manufacture of substances.
- Uses advised against: Not for pharmaceutical, household, or other unapproved uses.
Details of the supplier
- Company : Selleck Chemicals
- TollFree : +1 877 796-6397
- Tel : +1 832 582-8158
- Fax : +1 832 582-8590
Emergency telephone number
- Emergency phone #: +1 832 582-8158
2. Hazard(s) identification
Classification of the substance or mixture:
- Reproductive toxicity 1B (H360): May damage fertility or the unborn child.
- Specific target organ toxicity (repeated exposure) 1 (H372): Causes damage to organs through prolonged or repeated exposure.
- Aquatic Chronic 2 (H411): Toxic to aquatic life with long lasting effects.
- Skin irritation 2 (H315): Causes skin irritation.
Pictogram:
,
, 
Signal word: Danger
Hazard statements:
- H315: Causes skin irritation.
- H360: May damage fertility or the unborn child.
- H372: Causes damage to organs through prolonged or repeated exposure.
- H411: Toxic to aquatic life with long lasting effects.
Precautionary statements:
- 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/vapors/spray.
- P264: Wash thoroughly after handling.
- P270: Do not eat, drink or smoke when using this product.
- P273: Avoid release to the environment.
- P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection.
- P302+P352: If on skin: Wash with plenty of water.
- P308+P313: IF exposed or concerned: Get medical advice/attention.
- P321: Specific treatment (see on this label).
- P314: Get medical advice/attention if you feel unwell.
- P362+P364: Take off contaminated clothing and wash it before reuse.
- P332+P313: If skin irritation occurs: Get medical advice/attention.
- P391: Collect spillage.
- P405: Store locked up.
- P501: Dispose of contents/container in accordance with local/regional/national/international regulations.
Other hazards:
- NFPA ratings (scale 0-4): Health = 1, Fire = 0, Reactivity = 0.
- HMIS-ratings (scale 0-4): Health = *1, Fire = 0, Reactivity = 0.
- PBT and vPvB assessment: Not applicable.
3. Composition/information on ingredients
Chemical characterization: Substances
CAS No. Description: 1217486-61-7 BYL719
Structural Formula: 1,2-Pyrrolidinedicarboxamide, N1-[4-methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-, (2S)-
4. First-aid measures
- General information: Symptoms of poisoning may occur after several hours; medical observation is recommended for at least 48 hours following the accident.
- After inhalation: In case of unconsciousness, place the patient stably in a side position for transportation.
- After skin contact: Immediately wash with water and soap and rinse thoroughly.
- After eye contact: Rinse the opened eye for several minutes under running water.
- After swallowing: If symptoms persist, consult a doctor.
- Most important symptoms and effects: No further relevant information available.
- Indication of any immediate medical attention and special treatment needed: No further relevant information available.
5. Fire-fighting measures
- Extinguishing media: Use fire-fighting measures that suit the environment. A solid water stream may be inefficient.
- Special hazards arising from the substance or mixture: No further relevant information available.
- Advice for firefighters: No special protective equipment measures required.
6. Accidental release measures
- Personal precautions, protective equipment and emergency procedures: Not required.
- Environmental precautions: Inform respective authorities in case of seepage into water courses or sewage systems. Do not allow to enter sewers, surface, or ground water.
- Methods and material for containment and cleaning up: Dispose of contaminated material as waste according to section 13.
- Reference to other sections: See Section 7 for safe handling, Section 8 for personal protection equipment, and Section 13 for disposal information.
7. Handling and storage
- Precautions for safe handling: No special precautions are necessary if used correctly. Avoid breathing dust/fume/gas/mist/vapors/spray. Avoid prolonged or repeated exposure. Keep away from sources of ignition. Take precautionary measures against static discharge.
- Conditions for safe storage: Store in accordance with information listed on the product insert. No special requirements for storerooms and receptacles.
- Specific end use(s): No further relevant information available.
8. Exposure controls/personal protection
- Control parameters: Components with limit values that require monitoring at the workplace are not required.
- Appropriate engineering controls: No further data; see section 7.
- General protective and hygienic measures: Keep away from foodstuffs, beverages, and feed. Immediately remove all soiled and contaminated clothing. Wash hands before breaks and at the end of work. Store protective clothing separately. Avoid contact with the eyes and skin.
- Breathing equipment: In case of brief exposure or low pollution, use a respiratory filter device. In case of intensive or longer exposure, use a respiratory protective device that is independent of circulating air.
- Protection of hands: Use protective gloves. The glove material must be impermeable and resistant to the product.
- Eye protection: Tightly sealed goggles.
9. Physical and chemical properties
- Physical state: powder
- Color: Not determined.
- Odor: Characteristic.
- Structural Formula: C19H22F3N5O2S
- Molecular Weight: 441.5 g/mol
- Melting point/Melting range: Undetermined.
- Boiling point/Boiling range: Undetermined.
- Flammability: Product is not flammable.
- Flash point: Not applicable.
- Decomposition temperature: Not determined.
- pH-value: Not applicable.
- Viscosity (Kinematic/Dynamic): Not applicable.
- Solubility: DMF: 30 mg/ml; DMSO: 30 mg/ml; DMSO: PBS(pH 7.2) (1:1): 0.5 mg/ml; Ethanol: 1 mg/ml.
- Water Solubility: Not determined.
- Partition coefficient (n-octanol/water): Not determined.
- Vapor pressure: Not applicable.
- Density/Relative density: Not determined.
- Appearance (Form): powder
- Danger of explosion: Product does not present an explosion hazard.
10. Stability and reactivity
- Reactivity: No further relevant information available.
- Chemical stability: Stable under recommended storage conditions; no decomposition if used according to specifications.
- Possibility of hazardous reactions: No dangerous reactions known.
- Conditions to avoid: No further relevant information available.
- Incompatible materials: Strong oxidizing agents.
- Hazardous decomposition products: Carbon dioxide, carbon monoxide, hydrogen fluoride, nitrogen oxides, sulfur oxides.
11. Toxicological information
- Acute toxicity: No specific data provided.
- Primary irritant effect (Skin): Irritant to skin and mucous membranes.
- Primary irritant effect (Eye): No irritating effect.
- Sensitization: No sensitizing effects known.
- Carcinogenic categories: Substance is not listed by IARC, NTP, or OSHA-Ca.
- Interactive effects: No interactive effects between components are known.
12. Ecological information
- Toxicity (Aquatic): No further relevant information available.
- Persistence and degradability: No further relevant information available.
- Bioaccumulative potential: No further relevant information available.
- Mobility in soil: No further relevant information available.
- PBT and vPvB assessment: Not applicable.
- Other adverse effects: Toxic for fish.
- General notes: Water hazard class 3 (Self-assessment): extremely hazardous for water. Do not allow product to reach ground water, water course, or sewage system. Poisonous for fish and plankton in water bodies.
13. Disposal considerations
- Waste treatment methods: Must not be disposed of together with household garbage. Do not allow product to reach sewage systems.
- Uncleaned packagings: Disposal must be made according to official regulations.
14. Transport information
- UN-Number (DOT, IMDG, IATA): UN3077
- UN proper shipping name:
- DOT, IATA: Environmentally hazardous substance, powder, n.o.s. (BYL719)
- IMDG: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, powder, N.O.S. (BYL719)
- Transport hazard class(es): Class 9 Miscellaneous dangerous substances and articles.
- Packing group: III
- Environmental hazards: Marine pollutant (Symbol: fish and tree).
- Special marking (IATA): Symbol (fish and tree).
- Transport in bulk: Not applicable.
- IATA Remarks: When sold in quantities of less than or equal to 1 mL or 1 g, with an Excepted Quantity Code of E1, E2, E4, or E5, this item meets the De Minimis Quantities exemption, per IATA 2.6.10.
- UN "Model Regulation": UN 3077 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, powder, N.O.S. (BYL719), 9, III
15. Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
No further relevant information available.
· Sara
· Section 355 (extremely hazardous substances):Substance is not listed.
· Section 313 (Specific toxic chemical listings):Substance is not listed.
· TSCA (Toxic Substances Control Act):Substance is not listed.
· Hazardous Air PollutantsSubstance is not listed.
· Chemicals known to cause cancer:Substance is not listed.
· Chemicals known to cause reproductive toxicity for females:Substance is not listed.
· Chemicals known to cause reproductive toxicity for males:Substance is not listed.
· Chemicals known to cause developmental toxicity:Substance is not listed.
· Carcinogenic categories
· EPA (Environmental Protection Agency)Substance is not listed.
· TLV (Threshold Limit Value)Substance is not listed.
· NIOSH-Ca (National Institute for Occupational Safety and Health)Substance is not listed.
· Chemical safety assessment:A Chemical Safety Assessment has not been carried out.
16. OTHER INFORMATION
Revision Date: 2026/07/07
Further Information: The information provided is believed to be correct but is not exhaustive and should be used only as a guideline based on current knowledge. It does not represent a guarantee of the properties of the product. Selleck Chemicals Corporation and its Affiliates shall not be held liable for any damage resulting from handling or contact with the product.