🛡️ Hazard Overview
- GHS Class: GHS07; GHS08
- Signal Word: Danger
- Hazard Statements: H302; H312; H317; H332; H361; H372
🧤 PPE Guidelines
- Gloves: Chemical‑resistant gloves suggested
- Eye Protection: Safety goggles suggested
- Respirator: Dust respirator if dust occurs
❄️ Storage
- Storage Temp: -20°C (-4°F) Keep dry
🚑 Emergency First Aid
- For inhalation, skin, eye or ingestion exposure, please refer to full SDS Section 4.
Product identifier
- Product Name: Apremilast
- Catalog Number: S8034
- CAS Number: 608141-41-9
- IUPAC Name: Acetamide, N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]-
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
2.1 GHS classification in accordance with 29 CFR 1910 (OSHA HCS):
Acute toxicity (oral): Category 4. H302
Acute toxicity (dermal): Category 4. H312
Skin sensitization: Category 1. H317
Acute toxicity (inhalation): Category 4. H332
Reproductive toxicity: Category 2. H361
Specific target organ toxicity (repeated exposure): Category 1. H372
2.2 GHS Label elements, including precautionary statements
Hazard Pictogram(s):
Signal Word:
Danger
Hazard statement(s):
H302: Harmful if swallowed
H312: Harmful in contact with skin
H317: May cause an allergic skin reaction
H332: Harmful if inhaled
H361: Suspected of damaging fertility or the unborn child
H372: Causes damage to organs through prolonged or repeated exposure
Precautionary statement(s):
Prevention:
P203: Obtain, read and follow all safety instructions before use.
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P264: Wash hands thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection.
Response:
P301+P317: IF SWALLOWED: Get medical help.
P302+P352: IF ON SKIN: wash with plenty of water.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P317: Get emergency medical help.
P318: if exposed or concerned, get medical advice.
P319: Get medical help if you feel unwell.
P321: Specific treatment (see information on this label and safety datasheet)).
P330: Rinse mouth.
P333+P317: If skin irritation or rash occurs: Get medical help.
P362+P364: Take off contaminated clothing and wash it before reuse.
Storage:
P405: Store locked up.
Disposal:
P501: P501 Dispose of contents/ container to an approved waste disposal plant.
2.3 Other hazards
None.
3.1 Substances
Product name: Apremilast
CAS Number: 608141-41-9
PubChem CID: 11561674
3.2 Mixtures
Not applicable (pure substance).
4.1 Description of first aid measures
Inhalation: Move to fresh air. Keep at rest in a position comfortable for breathing. Seek medical attention if symptoms persist.
Skin contact: Wash with plenty of soap and water. Remove contaminated clothing. Seek medical attention if irritation develops.
Eye contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. Seek medical attention.
Ingestion: Rinse mouth. Do NOT induce vomiting unless directed by medical personnel. Seek medical attention.
4.2 Most important symptoms and effects, both acute and delayed
See Section 11 (Toxicological Information).
4.3 Indication of any immediate medical attention and special treatment needed
Treat symptomatically. Contact a poison control center or physician for severe exposure.
5.1 Extinguishing media
Suitable: Water spray, dry chemical, carbon dioxide (CO2), alcohol-resistant foam.
Unsuitable: None known.
5.2 Specific hazards arising from the substance or mixture
Combustible. Heating may produce toxic fumes.
5.3 Advice for firefighters
Wear self-contained breathing apparatus (SCBA) and full protective clothing.
Fight fire from upwind. Cool containers with water spray until fire is extinguished.
6.1 Personal precautions, protective equipment and emergency procedures
Wear appropriate personal protective equipment (see Section 8).
Avoid breathing dust/vapor. Ensure adequate ventilation.
Evacuate personnel to safe areas. Keep people away from and upwind of spill.
6.2 Environmental precautions
Prevent product from entering drains, waterways, or soil.
Contain spill with inert absorbent material.
6.3 Methods and materials for containment and cleaning up
SRP: At the time of review, regulatory criteria for small quantity disposal are subject to significant revision, however, household quantities of waste pharmaceuticals may be managed as follows: Mix with wet cat litter or coffee grounds, double bag in plastic, discard in trash.
SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.
7.1 Precautions for safe handling
Store tablets below 30 °C (86 deg F).
7.2 Conditions for safe storage, including any incompatibilities
Store tablets below 30 °C (86 deg F).
Store away from incompatible materials (see Section 10).
[Note: Specific storage temperature not available in public databases. Refer to supplier Certificate of Analysis (COA) for exact storage conditions.]
8.1 Exposure controls
8.1.1 Occupational exposure limits (OEL)
OSHA PEL: Not established.
ACGIH TLV: Not established.
NIOSH REL: Not established.
No occupational exposure limit values are established for this substance.
Use the lowest feasible exposure level (ALARA principle).
8.1.2 Appropriate engineering controls
Use in a well-ventilated area. Chemical fume hood recommended for powder handling.
8.2 Individual protection measures
8.2.1 Eye/face protection
Wear safety glasses with side shields.
8.2.2 Skin protection
Wear protective gloves. Recommended material: Nitrile rubber.
Wear suitable protective clothing (lab coat).
8.2.3 Respiratory protection
Use NIOSH-approved dust/mist respirator (N95 or higher) if ventilation is inadequate.
8.2.4 Thermal hazards
Not applicable.
9.1 Information on basic physical and chemical properties
a) Appearance: Solid powder (typical for research compounds)
b) Odor: No data available
c) Odor threshold: No data available
d) pH: No data available
e) Melting point/freezing point: No data available
f) Initial boiling point and boiling range: 741.3±60.0
g) Flash point: No data available
h) Evaporation rate: No data available
i) Flammability (solid, gas): No data available
j) Upper/lower flammability or explosive limits: No data available
k) Vapor pressure: No data available
l) Vapor density: No data available
m) Relative density: No data available
n) Water solubility: Soluble in DMSO; slightly soluble in water
o) Partition coefficient: n-octanol/water: Log P: No data available
p) Auto-ignition temperature: No data available
q) Decomposition temperature: No data available
r) Viscosity: No data available
s) Explosive properties: No data available
t) Oxidizing properties: No data available
9.2 Other information
10.1 Reactivity
No specific reactivity hazards identified under normal handling conditions.
10.2 Chemical stability
Stable under recommended storage conditions.
10.3 Possibility of hazardous reactions
No hazardous reactions under normal conditions.
10.4 Conditions to avoid
Avoid heat, sparks, open flames, direct sunlight, and moisture.
10.5 Incompatible materials
Strong oxidizing agents, strong acids, strong bases.
10.6 Hazardous decomposition products
No data available.
See also Section 5 (Fire-fighting measures) for combustion products.
11.1 Information on toxicological effects
Acute toxicity:
No acute toxicity data available.
Skin corrosion/irritation:
No data available.
Serious eye damage/eye irritation:
No data available.
Respiratory or skin sensitization:
May cause an allergic skin reaction (H317).
Germ cell mutagenicity:
No data available.
Carcinogenicity:
No data available.
Reproductive toxicity:
Suspected of damaging fertility or the unborn child (H361).
Specific target organ toxicity (single exposure):
H372
Specific target organ toxicity (repeated exposure):
No data available.
Aspiration hazard:
No data available.
11.2 Additional information
No additional toxicological information available.
12.1 Toxicity
EXPERIMENTAL: The lacteal excretion of apremilast was evaluated following oral administration of apremilast to lactating CD-1 mice. In this study, female mice approximately 13 days postpartum received a single oral dose of apremilast at 10 mg/kg, administered by oral gavage in a volume of 10 mL/kg. Milk and blood samples from 5 animals per time point were obtained at 1, 6, and 24 hr postdose and apremilast concentrations determined in plasma and milk using LC-MS/MS analysis. The mean apremilast plasma concentrations at 1 and 6 hr post-dose were 984 and 138 ng/mL, while concentrations in milk were 1441 and 186 ng/mL, respectively. The resulting mean milk-to-plasma ratios ranged from 1.46 to 1.62, indicating transfer of apremilast into milk in mice. Plasma and milk concentrations were below the detection limit of 3 ng/mL in the 24-hr samples.
EXPERIMENTAL: It is not known whether Otezla or its metabolites are present in human milk; however apremilast was detected in milk of lactating mice.
12.2 Persistence and degradability
No data available.
12.3 Bioaccumulative potential
No data available.
12.4 Mobility in soil
No data available.
12.5 Results of PBT and vPvB assessment
PBT/vPvB assessment not available.
12.6 Other adverse effects
No other adverse ecological effects identified.
13.1 Waste treatment methods
Waste Treatment Methods: Waste material must be disposed of in accordance with national and local regulations. Leave chemicals in original containers and do not mix with other waste. Handle uncleaned containers in the same manner as the product itself.
14.1 UN number
Not regulated as dangerous goods (research quantities typically exempt).
14.2 UN proper shipping name
Not subject to transport regulations (small quantities for research use).
14.3 Transport hazard class(es)
Not classified as dangerous goods for transport (research quantities).
14.4 Packing group
Not applicable (not regulated as dangerous goods in typical research quantities).
14.5 Environmental hazards
Marine pollutant: No (not classified as environmentally hazardous per GHS).
14.6 Special precautions for user
Transport in original packaging. Ensure containers are tightly sealed.
For bulk or commercial quantities, consult applicable transport regulations (DOT, IATA, IMDG).
14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not applicable.
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
US EPA / TSCA: Not available in public databases.
EU ECHA / REACH: Not available in public databases.
SARA 302 Components:
No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313 Components:
This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards:
Acute (short-term) health hazard
Chronic (long-term) health hazard
Massachusetts Right To Know Components:
This material contains components subject to the Massachusetts Right to Know Act. See Section 2 for hazard classification.
Pennsylvania Right To Know Components:
This material contains components subject to the Pennsylvania Right to Know Act. See Section 2 for hazard classification.
New Jersey Right To Know Components:
This material contains components subject to the New Jersey Right to Know Act. See Section 2 for hazard classification.
California Prop. 65 Components:
This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm.
Other regulatory listings:
- FDA Requirements: The Approved Drug Products with Therapeutic Equivalence Evaluations identifies currently marketed prescription drug products, including apremilast, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.
15.2 Chemical safety assessment
A chemical safety assessment has not been carried out for this substance.
For research-use-only compounds, no CSA is required under REACH Annex I.
Revision Date: 2026/09/10
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.