RESEARCH USE ONLY · FORMULATION Safety Data Sheet
16-section GHS safety data sheet for RESEARCH USE ONLY · FORMULATION covering hazard identification, safe handling, storage, exposure controls, transport and disposal. Research use only. Specifications and current certificates of analysis are in the GW501516 Capsules compound library page.
01Identification
| Product identifier | GW501516 Capsules (10mg/capsule, 30 capsules) |
|---|---|
| Other means of identification | Loti Labs catalog listing “GW501516 Capsules (10mg/capsule, 30 capsules)” (lotilabs.com product ID 35834); SDS document ID LL-SDS-35834-001. |
| Formulation type | Capsule contents |
| Active ingredient | GW501516 |
| Active ingredient CAS number | 317318-70-0 |
| Active ingredient molecular formula | C21H18F3NO3S2 |
| Active ingredient PubChem CID | 9803963 |
| Active ingredient IUPAC name | 2-[2-methyl-4-[[4-methyl-2-[4-(trifluoromethyl)phenyl]-1,3-thiazol-5-yl]methylsulfanyl]phenoxy]acetic acid |
| Recommended use | Research laboratory chemical for in-vitro scientific research and development. |
| Restrictions on use | Not for human or veterinary use. Not for food, drug, cosmetic, household, agricultural, clinical, therapeutic, or diagnostic applications. |
Supplier details
| Company | Loti Labs |
|---|---|
| Address | 1204 S Broad St, Brooksville, FL 34601, United States |
| Telephone | 877-LOTI-LAB (877-568-4522) |
| Website | https://lotilabs.com/ |
| Emergency contact | CHEMTREC |
| Emergency phone | 800-424-9300 CHEMTREC (USA) +1-703-527-3887 CHEMTREC (International) 24 hours/day; 7 days/week |
Product form note (Section 1): the product is supplied in capsule form, each capsule containing the stated active amount in a 500 mg pharmaceutical-grade corn starch base, packaged 30 capsules per container. The capsule is provided as a physical barrier between the researcher and the chemical, minimizing direct handling and exposure during laboratory work. This product is sold for laboratory research use only; it is not approved, intended, or labeled for human or veterinary use, and no administration or consumption instructions are provided or implied.
02Hazard(s) identification
| OSHA/GHS classification | Carcinogenicity, Category 2 (H351). The active ingredient is present at 1.961% w/w of the capsule fill. The health classification is based on active-ingredient evidence and the supplied-form concentration. Open handling of the corn-starch-rich capsule contents can generate combustible dust. |
|---|---|
| Signal word | Warning |
| Hazard pictograms | GHS08 (health hazard) |
| Hazard statements | H351 Suspected of causing cancer. May form combustible dust concentrations in air. |
| Hazards not otherwise classified | Fine powder may cause mechanical irritation. Treat as a potentially bioactive research material with limited toxicological data. |
| Unknown acute toxicity | Approximately 1.96% of the mixture consists of an ingredient of unknown acute toxicity (the active ingredient; no acute toxicity estimate for it was used in classification). The mixture was not classified on the basis of testing of the mixture as a whole. |
Precautionary statements
P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P240 Ground and bond equipment used for open handling of capsule contents.
P241 Use dust-ignition-protected equipment where dispersed dust could occur.
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been read and understood.
P308+P313 IF exposed or concerned: Get medical advice/attention.
P405 Store locked up.
P264 Wash hands and exposed skin thoroughly after handling.
P280 Wear protective gloves, protective clothing, and eye protection.
P501 Dispose of contents/container in accordance with applicable regulations.
Avoid dust generation; fine organic powders may present a combustible dust hazard if dispersed in air near ignition sources.
These precautionary statements are label elements corresponding to the combustible-dust and health-hazard determinations in this section.
03Composition / information on ingredients
| Component | CAS | Formula | MW | Concentration |
|---|---|---|---|---|
| GW501516 | 317318-70-0 | C21H18F3NO3S2 | 453.5 g/mol | 10 mg/capsule |
| Pharmaceutical-grade corn starch | 9005-25-8 | (C6H10O5)n | polymer | 500 mg/capsule |
Capsule contents containing GW501516 at 10 mg/capsule. The capsule shell is outside the stated SDS scope; pharmaceutical-grade corn starch is the declared filler. The declared corn-starch content is 500 mg per capsule (see composition disclosure note below).
Composition disclosure note: each capsule contains 500 mg of pharmaceutical-grade corn starch as the carrier/filler plus the stated active amount. On a fill-contents basis this is approximately 1.96% w/w active and 98.04% w/w corn starch (capsule shell excluded). The capsule format is used for containment and handling of the research material; the product is sold for laboratory research use only and is not approved, intended, or labeled for human or veterinary use.
04First-aid measures
| Inhalation | Move person to fresh air. Keep at rest. Obtain medical advice if symptoms develop or persist. |
|---|---|
| Skin contact | Remove contaminated clothing. Wash thoroughly with soap and water. Seek medical advice if irritation develops. |
| Eye contact | Rinse cautiously with water for at least 15 minutes. Remove contact lenses if easy to do. Continue rinsing. Obtain medical attention if irritation persists. |
| Ingestion | Rinse mouth. Do not induce vomiting unless directed by medical personnel. Contact a poison center or physician if swallowed or symptoms occur. |
| Most important symptoms/effects | No formulation-specific clinical data available. Exposure may cause irritation. Delayed effects: suspected of causing cancer (Section 11). |
| Immediate medical attention | Treat symptomatically. No specific antidote known. |
Potential systemic effects have been reported in the GW501516 nonclinical literature (PPAR-delta agonist activity), even though data are limited.
05Fire-fighting measures
| Suitable extinguishing media | Water spray, dry chemical, carbon dioxide, or foam appropriate to the surrounding fire. |
|---|---|
| Unsuitable extinguishing media | Do not use a solid (high-pressure) water jet; it can disperse the powder and create a combustible dust cloud. |
| Specific hazards | Combustible organic powder. The product is not classified as a flammable solid, but fine organic dust dispersed in air may present a combustible dust hazard. Thermal decomposition may produce carbon oxides, nitrogen oxides, and other organic decomposition products; sulfur oxides may also form under fire or thermal decomposition conditions. Thermal decomposition may also release hydrogen fluoride. |
| Protective equipment | Firefighters should wear full protective equipment and positive-pressure self-contained breathing apparatus. |
06Accidental release measures
Personal precautions
Restrict access. Avoid contact and aerosol generation. Ensure adequate ventilation. Remove ignition sources where applicable. Wear PPE described in Section 8.
Environmental precautions
Prevent release to drains, sewers, surface water, and soil.
Containment and cleanup
Collect intact capsules. For released powder, avoid dust generation; gently collect using suitable tools or HEPA-filtered vacuum.
Small spills: collect powder using damp absorbent materials or a HEPA-filtered vacuum. Large spills: restrict access, avoid dust generation, and collect mechanically into sealed labeled containers. Treat the fine powder as potentially combustible dust.
07Handling and storage
Precautions for safe handling
Handle as a potentially bioactive research formulation of unknown or incompletely characterized toxicity. Avoid contact with eyes, skin, and clothing. Avoid generating dust, mist, or aerosols. Keep away from heat and ignition sources. Do not eat, drink, smoke, or apply cosmetics in work areas. Wash thoroughly after handling.
Storage conditions
Keep tightly closed in the original labeled container. Protect from moisture, heat, light, and physical damage. Follow product-label and lot-specific storage conditions.
Incompatibilities
Strong oxidizing agents, strong acids, strong bases, excessive heat, direct sunlight, and ignition sources.
Other information
Capsule contents containing GW501516 at 10 mg/capsule. The capsule shell is outside the stated SDS scope; pharmaceutical-grade corn starch is the declared filler.
The active ingredient is a PPAR-delta agonist; endocrine-mediated biological activity cannot be excluded on accidental exposure.
08Exposure controls / personal protection
Occupational exposure limits
Corn starch (CAS 9005-25-8): OSHA PEL 15 mg/m³ total dust and 5 mg/m³ respirable fraction; NIOSH REL 10 mg/m³ total and 5 mg/m³ respirable; ACGIH TLV 10 mg/m³ TWA (A4, not classifiable as a human carcinogen). No product-specific OEL is established for the active ingredient.
No OSHA PEL, NIOSH REL, or ACGIH TLV identified for GW501516. Maintain exposure as low as reasonably achievable.
Engineering controls
Use local exhaust ventilation or effective containment for open transfer or any task with potential for airborne dust. Provide accessible eyewash and safety shower.
Personal protective equipment
| Eye / face protection | Safety glasses with side shields as a minimum; sealed safety goggles for dust-generating or open-transfer tasks. |
|---|---|
| Hand protection | Disposable nitrile gloves suitable for the mixture. Inspect before use and replace if contaminated, damaged, or degraded. |
| Skin protection | Laboratory coat, long trousers, and closed-toe footwear. Add a disposable coverall for higher-exposure powder handling. |
| Respiratory protection | Normally unnecessary inside effective containment. Where controls cannot prevent exposure, use a NIOSH-approved respirator under a compliant respiratory-protection program (29 CFR 1910.134). |
| Hygiene | Wash hands after handling and before breaks. Remove contaminated clothing. Decontaminate work surfaces and equipment. |
PPE must be selected by the employer based on task-specific risk assessment, quantity, physical form, and exposure potential.
09Physical and chemical properties
| Physical state | Solid capsule contents / powder |
|---|---|
| Appearance | Encapsulated powder; active-content appearance is lot-specific |
| Color | Not determined for the capsule contents (the corn starch base is a white powder). |
| Odor / odor threshold | No reliable formulation-specific data available |
| Melting point / freezing point | Not determined for formulation |
| Boiling point / range | Not determined for formulation |
| Flammability | May form combustible dust concentrations in air when capsule contents are released and dispersed; no Kst or MEC test data available. |
| Lower / upper flammability or explosion limits | Not determined; no minimum explosible concentration (MEC) data are available for the dispersed dust. |
| Flash point | Not applicable (solid) |
| Auto-ignition / decomposition temperature | Not determined for formulation |
| pH | Not applicable (dry solid) |
| Kinematic viscosity | Not applicable to solid capsule contents |
| Particle characteristics | Fine powder (capsule contents); no lot-specific particle-size data available. |
| Solubility | No product-specific measured solubility data available |
| Partition coefficient | No formulation-specific data available |
| Vapor pressure / relative vapor density | Vapor pressure: negligible (non-volatile solid). Relative vapor density: not applicable (solid). |
| Evaporation rate | Not applicable (non-volatile solid). |
| Relative density | Not determined for formulation |
| Active ingredient molecular weight | 453.5 g/mol |
| Active ingredient molecular formula | C21H18F3NO3S2 |
Physicochemical summary: non-volatile solid with negligible vapor pressure; a sharp melting point is typically not observed because the material chars or decomposes on heating. Flash point and pH are not applicable to the dry solid.
10Stability and reactivity
| Reactivity | No dangerous reaction known under recommended handling and storage conditions. |
|---|---|
| Chemical stability | Expected to be stable when stored as directed; active compounds may degrade with heat, light, moisture, oxidation, or pH extremes. |
| Possibility of hazardous reactions | Hazardous polymerization is not expected. Fine dust from opened capsules, if dispersed in air at sufficient concentration, can form a combustible dust cloud that may deflagrate on contact with an ignition source (see Section 2). |
| Conditions to avoid | Heat, ignition sources, moisture, direct sunlight, ultraviolet exposure, and prolonged exposure to air. |
| Incompatible materials | Strong oxidizers, strong acids, and strong bases. |
| Hazardous decomposition products | Carbon monoxide, carbon dioxide, nitrogen oxides, and other irritating or toxic fumes under fire or thermal decomposition conditions; sulfur oxides may also form under fire or thermal decomposition conditions; hydrogen fluoride may also form. |
11Toxicological information
Toxicological assessment: The classification in Section 2 reflects the available component and formulation information. No additional GHS health-hazard classification is assigned beyond the hazards stated in Section 2.
| Likely routes of exposure | Inhalation, eye contact, skin contact, and ingestion. |
|---|---|
| Acute toxicity | No reliable quantitative formulation-specific oral, dermal, or inhalation toxicity data identified. |
| Skin corrosion / irritation | No reliable standardized formulation-specific test data identified. Irritation cannot be excluded. |
| Serious eye damage / irritation | No reliable standardized formulation-specific test data identified. Irritation cannot be excluded. |
| Respiratory / skin sensitization | No reliable formulation-specific data identified. Sensitization cannot be excluded. |
| Carcinogenicity | Category 2 (H351). Long-term rodent studies reported multi-organ tumors (GSK rat and mouse carcinogenicity studies reported as conference abstracts and referenced in the WADA alert, Section 16); the full study reports are not publicly available, so the evidence could not be evaluated against the Category 1B criterion and Category 2 is assigned. GW501516 is not listed in the NTP Report on Carcinogens or the IARC Monographs and is not regulated as a carcinogen by OSHA. The finished formulation has not been tested; the determination is derived from active-ingredient evidence and the concentration stated in Section 3. |
11. Toxicological information · continued
| Germ cell mutagenicity | No reliable formulation-specific data identified. |
|---|---|
| Reproductive toxicity | No reliable formulation-specific data identified. |
| STOT, single / repeated exposure | No reliable formulation-specific data identified. |
| Aspiration hazard | Not applicable to solid capsule contents. |
| Symptoms / delayed effects | No formulation-specific symptoms established. Delayed effects: suspected of causing cancer (see the rows above). Other effects of accidental exposure may be immediate or delayed; data are insufficient. |
| Numerical measures of toxicity | No reliable formulation-specific numerical toxicity values available. |
| Interactive effects | No information on interactive effects was identified. |
| Alternative information / method | Health-hazard classifications in Section 2 are derived from data on the active ingredient (published studies, regulatory product information and, where applicable, authoritative carcinogen and reproductive-toxicant listings, as cited in Sections 11 and 16), applied at the concentration in Section 3 using the generic cut-off values of 29 CFR 1910.1200 Appendix A. The finished product has not been tested. |
| Derived no-effect level (DNEL) | No formulation-specific DNEL has been derived. |
| Predicted no-effect concentration (PNEC) | No formulation-specific PNEC has been derived. |
GW501516 produced multi-organ tumors in long-term rodent carcinogenicity studies; the relevance to humans is not established.
12Ecological information
| Ecotoxicity | No reliable formulation-specific fish, aquatic invertebrate, or algae data identified. Avoid environmental release. |
|---|---|
| Persistence / degradability | No reliable formulation-specific biodegradation data identified. |
| Bioaccumulative potential | No reliable formulation-specific BCF or log Kow data identified. |
| Mobility in soil / other adverse effects | No reliable formulation-specific data available. |
13Disposal considerations
Waste treatment
Dispose of material, contaminated PPE, absorbents, and containers through a licensed waste contractor in accordance with federal, state, and local requirements. Do not discharge to drains, sewers, or waterways. The waste generator is responsible for determining whether the waste meets hazardous-waste criteria at the time of disposal.
14Transport information
| Framework | UN number | Proper shipping name | Class | Packing group |
|---|---|---|---|---|
| U.S. DOT | Not applicable | Not regulated as dangerous goods | Not applicable | |
| IATA | Not applicable | Not regulated as dangerous goods | Not applicable | |
| IMDG | Not applicable | Not regulated as dangerous goods | Not applicable | |
| Environmental hazards | Not listed as a marine pollutant (49 CFR 172.101 Appendix B; IMDG Code). No aquatic-toxicity data meeting the UN environmentally hazardous substance criteria were identified for the product. | |||
| Transport in bulk | Not applicable. The product is supplied in non-bulk packagings and is not transported in bulk under IMO instruments (MARPOL Annex II / IBC Code). | |||
| Special precautions | No special transport precautions beyond keeping containers closed and protected from heat, moisture, light and physical damage. |
Transport determination: this solid capsule product does not meet the criteria of a U.S. DOT, IATA or IMDG dangerous-goods class and is not regulated as dangerous goods in the supplied form.
15Regulatory information
Jurisdiction: this SDS is prepared for supply and use in the United States under the OSHA Hazard Communication Standard (29 CFR 1910.1200). Active ingredient CAS number(s) assessed: 317318-70-0. U.S. TSCA: no exact CAS match on that public inventory (317318-70-0); confidential identities are not visible in the public file. The corn starch base (starch, 9005-25-8) is listed as active on the TSCA Inventory. California Proposition 65: no exact active-ingredient CAS match on the official list dated July 31, 2026. CERCLA/SARA: no listed component was identified under 40 CFR 302.4 or 40 CFR 372.65 in the reviewed public records; threshold and release-reporting duties remain quantity- and use-dependent. Sources checked: EPA TSCA non-confidential Inventory (July 2026), OEHHA Proposition 65 list (July 31, 2026), 40 CFR 302.4 and 40 CFR 372.65. Public-inventory status is not product approval or authorization.
16Other information
| Document ID | LL-SDS-35834-001 |
|---|---|
| REVISION DATE | 2026-10-22 |
| VERSION | 1.8 |
| Prepared for | Loti Labs |
| Basis | OSHA Hazard Communication Standard, 29 CFR 1910.1200, including Appendix D; OSHA HCS 2024 alignment (primarily GHS Revision 7). Jurisdiction: United States; Section 14 covers U.S.-origin shipments under 49 CFR, the IATA Dangerous Goods Regulations and the IMDG Code. |
| Revision history | Revision 1.8 (2026-10-22): final line-by-line consistency review of all sections; Section 5 unsuitable extinguishing media stated (Appendix D 5(a)); Section 8 corn-starch ACGIH TLV added; Section 10 combustible-dust reaction stated; Section 16 carcinogenicity sources identified (WADA alert of 21 March 2013; Geiger et al. and Newsholme et al. 2009); wording, spelling (U.S.), units and batch-method text standardized. Revision 1.7 (2026-10-18): checked against the batch Certificate(s) of Analysis listed below; Section 1 other means of identification completed; Section 2 unknown-acute-toxicity statement added (Appendix D 2(e)); Section 9 completed for all Appendix D properties (color, flammability limits, vapor density, evaporation rate, particle characteristics); Section 11 interactive-effects and data-basis statements added (Appendix D 11(e), 11(g)); Section 14 environmental-hazard, bulk-transport and special-precaution entries completed; Section 15 limited to U.S. federal and state requirements (non-U.S. inventory statements removed); carcinogenicity basis stated consistently in Sections 2, 11 and 16 with the IARC/NTP/OSHA listing status (Appendix D 11(f)); Sections 5 and 10 hazardous decomposition products aligned with the elemental composition of the ingredients. Revision 1.6 (2026-10-03): completed manual formulation and identity review; finalized combustible-dust and health-hazard label elements; removed liquid-template residue; reconciled Sections 2, 3, 8, 9, 11, 14 and 15. |
| Batch documentation reviewed | SR Bio Labs COA, lot LOT-GW50-00002, dated 2025-08-05: identity by mass spectrometry (mass 453.1 Da); purity 96.51% (HPLC). This SDS is product-level; lot-specific identity, purity and content are governed by the batch Certificate of Analysis. |
Principal sources consulted
PubChem. GW501516, Compound Summary, CID 9803963. National Center for Biotechnology Information. https://pubchem.ncbi.nlm.nih.gov/compound/9803963. Accessed 2026-07-15.
OSHA. Hazard Communication Standard, 29 CFR 1910.1200, including Appendix D, Safety Data Sheets. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200. Accessed 2026-07-15.
ACGIH. Starch, CAS 9005-25-8: TLV-TWA 10 mg/m³, A4. https://www.acgih.org/starch/. Accessed 2026-10-22.
OSHA. Hazard Communication Standard Final Rule (2024). https://www.osha.gov/hazcom/rulemaking. Accessed 2026-07-15.
United Nations. Globally Harmonized System of Classification and Labelling of Chemicals, Revision 7 (2017). https://unece.org/transport/dangerous-goods/ghs-rev7-2017. Accessed 2026-07-15.
NTP / IARC. Report on Carcinogens and IARC Monographs classifications. https://ntp.niehs.nih.gov/whatwestudy/assessments/cancer/roc; https://monographs.iarc.who.int/agents-classified-by-the-iarc/. Accessed 2026-07-15.
World Anti-Doping Agency. WADA issues alert on GW501516 (news release, 21 March 2013): development terminated after serious toxicities were found in preclinical studies. https://www.wada-ama.org/en/news/wada-issues-alert-gw501516. Accessed 2026-10-22.
Geiger LE, Dunsford WS, Lewis DJ, et al. Rat carcinogenicity study with GW501516, a PPAR delta agonist. The Toxicologist (Toxicol Sci suppl.) 2009;108(1):185, abstract 895; Newsholme SJ, Dunsford WS, Brodie T, et al. Mouse carcinogenicity study with GW501516, a PPAR delta agonist. The Toxicologist 2009;108(1):185, abstract 896. Conference abstracts; full study reports not publicly available. Accessed 2026-10-22.
EPA. TSCA Chemical Substance Inventory, non-confidential portion (July 2026 release). https://www.epa.gov/tsca-inventory. Accessed 2026-10-18.
OEHHA. Proposition 65 List of chemicals known to the State of California to cause cancer or reproductive toxicity (list dated July 31, 2026). https://oehha.ca.gov/proposition-65/proposition-65-list. Accessed 2026-10-18.
Key abbreviations
CAS, Chemical Abstracts Service · GHS, Globally Harmonized System · IATA, International Air Transport Association · IMDG, International Maritime Dangerous Goods · NIOSH, National Institute for Occupational Safety and Health · OSHA, Occupational Safety and Health Administration · PPE, Personal protective equipment · STOT, Specific target organ toxicity.
Document review and approval
The reviewer confirmed that the supplied form, composition, hazard classification, transport classification and regulatory content of this safety data sheet were reviewed and approved for release.
| Checked by | Dr Afroza Begum |
|---|---|
| Credentials | PhD in Biosciences |
| Date | |
| Signature | Afroza Begum |
Scope of review: Reviewed for content, classification, labelling and transport under 29 CFR 1910.1200 (Appendices A to D) and 49 CFR. Compound identity was checked against public references (PubChem, CAS) and the supplier’s product specification. Batch composition, purity and certificates of analysis were not verified as part of this review. Transport classification reviewed for consistency with 49 CFR; classification for shipment remains the shipper’s responsibility. Applies to version 1.8 dated 2026-10-22 only.
RESEARCH USE ONLY. Loti Labs products are supplied for laboratory, analytical and research use. They are not drugs, foods or cosmetics and are not for human or veterinary use.