RESEARCH USE ONLY · FORMULATION Safety Data Sheet

Supplier details

Identifier note: CAS 34580-14-8 corresponds to ketotifen fumarate (the salt, C23H23NO5S, 425.50 g/mol; PubChem CID 5282408). The free base (ketotifen, C19H19NOS, 309.43 g/mol, PubChem CID 3827) is listed for reference only; salt-form values are used throughout this SDS.

Mixture hazard determination, measured data applied. The client-supplied Mix 1 carrier has an ASTM D93 Method A closed-cup flash point of 61 °C (141.8 °F) with stated uncertainty of ±1 °C. OSHA Appendix B places Category 3 at ≤60 °C and Category 4 above 60 °C through 93 °C. Because the uncertainty interval reaches 60 °C, the conservative final determination is Flammable liquid, Category 3 (H226). The laboratory’s Class IIIA designation is a workplace fire-code label, not a GHS or transport class.

Precautionary statements

P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P233 Keep container tightly closed.

P240 Ground and bond container and receiving equipment.

P241 Use explosion-proof electrical, ventilating and lighting equipment.

P242 Use non-sparking tools.

P243 Take action to prevent static discharges.

P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

P370+P378 In case of fire: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide to extinguish.

P403+P235 Store in a well-ventilated place. Keep cool.

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.

These statements are the label elements corresponding to the classification in this section.

Health hazard of the active ingredient (Section 2, independent of flammability): the active is present at 1 mg/mL, equivalent to approximately 0.081% w/w using the measured mixture density of 1.233 g/mL. No health-hazard class is triggered by the active at this concentration (below the 0.1% GHS cut-off for CMR endpoints). The active is a pharmacologically active antihistamine / mast-cell stabilizer and is addressed under hazards not otherwise classified. Health-hazard classification of the mixture was determined against the GHS generic concentration cut-off values in 29 CFR 1910.1200 Appendix A (0.1% for carcinogenicity, germ cell mutagenicity and reproductive toxicity; 1% for acute toxicity, irritation and specific target organ toxicity).

Acute-toxicity mixture assessment: applying the Appendix A mixture ATE method to the active concentration and the reviewed ingredient toxicity estimate gives a mixture ATE above 2,000 mg/kg; no acute oral toxicity category is assigned.

Liquid research formulation containing Ketotifen fumarate at 1 mg/mL in a carrier base of 70% vegetable glycerine / 20% distilled water / 10% ethyl alcohol. The stated carrier percentages describe the carrier base supplied by Loti Labs; active concentration is stated separately. The active corresponds to approximately 0.081% w/w of the mixture using the measured density of 1.233 g/mL.

Prime Process Safety Center tested the client-supplied sample identified as Mix 1 as received (report PPSCQ2686-TR-092026). Loti’s controlled formulation record assigns Mix 1 (70% vegetable glycerine / 20% distilled water / 10% ethyl alcohol) to this product. The measured density is recorded as laboratory data; it differs from an idealized component-density estimate and is not used as proof of composition.

The mixture has a measured closed-cup flash point of 61 °C (141.8 °F) and is classified as a flammable liquid. Keep away from heat, hot surfaces, sparks, open flames, and other ignition sources. Use water spray to cool containers exposed to fire.

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

Absorb with inert compatible material, collect into a sealed labeled container, and clean the affected area.

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 heat, ignition sources, light, moisture, 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

Liquid research formulation containing Ketotifen fumarate at 1 mg/mL in a carrier base of 70% vegetable glycerine / 20% distilled water / 10% ethyl alcohol. The active corresponds to approximately 0.081% w/w of the mixture using the measured density of 1.233 g/mL.

Occupational exposure limits

No OSHA PEL, NIOSH REL, or ACGIH TLV identified for Ketotifen fumarate. Ethanol is present in the carrier; OSHA PEL 1,000 ppm (1,900 mg/m³) TWA, NIOSH REL 1,000 ppm TWA, and ACGIH TLV 1,000 ppm STEL apply to the ethanol component. Glycerin (mist): OSHA PEL 15 mg/m³ total particulate and 5 mg/m³ respirable fraction (8-h TWA, 29 CFR 1910.1000 Table Z-1). Maintain exposure as low as reasonably achievable.

Engineering controls

Use local exhaust ventilation or effective containment for open transfer, dilution, or any task with potential for airborne dust, mist, or vapor. Provide accessible eyewash and safety shower. Use appropriate local exhaust ventilation.

Personal protective equipment

PPE must be selected by the employer based on task-specific risk assessment, quantity, physical form, and exposure potential.

Measured physicochemical data (Section 9): closed-cup flash point 61 °C (141.8 °F) by ASTM D93 Method A; pH 6.39 at 30 °C; density 1.233 g/mL; kinematic viscosity 1.897 mm²/s and dynamic viscosity 2.339 mPa·s at 25 °C. Determined on the Mix 1 carrier under ISO/IEC 17025 accreditation (Prime Process Safety Center report PPSCQ2686-TR-092026, dated 2026-09-15) and applied to this product by GHS bridging, the active being a non-volatile solid at approximately 0.081% w/w. The laboratory did not perform the sustained-combustibility test (reported as not applicable), so no exception for liquids that do not sustain combustion is claimed in Section 14. Melting point, boiling point, vapor pressure, and partition coefficient remain undetermined for the formulation.

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.

11. Toxicological information · continued

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.

Transport classification basis: see the transport assessment below. Limited-quantity, small-quantity and excepted-quantity provisions depend on the packaging and transport mode of each consignment.

Transport assessment (Section 14): 49 CFR 173.120(a), the UN Model Regulations, the IATA Dangerous Goods Regulations and the IMDG Code all define a Class 3 flammable liquid by a closed-cup flash point of not more than 60 °C. The Mix 1 carrier measured 61 °C by ASTM D93 Method A with a stated uncertainty of ±1 °C (Prime Process Safety Center report PPSCQ2686-TR-092026), so the result does not demonstrate a flash point above 60 °C. The combustible-liquid definition of 49 CFR 173.120(b) is therefore not relied upon; the exceptions in 173.120(a)(3) and (a)(4) are not relied upon because no sustained-combustibility or fire-point test was performed, and the exception in (a)(5) does not apply (water content 20%, not more than 90%). The mixture is assigned to Class 3. Packing Group III applies under 49 CFR 173.121(a) because the flash point is at least 23 °C and the initial boiling point is above 35 °C (no component boils below ethanol’s 78 °C). Ethanol is the only flammable constituent and the other constituents (glycerine, water and the active ingredient at not more than about 4% w/w) are not dangerous goods, so the applicable entry is UN 1170, Ethanol solutions (49 CFR 172.101; UN/IATA/IMDG: ETHANOL SOLUTION), Class 3, Packing Group III. The aqueous-alcohol exception of 49 CFR 173.150(e)(2) does not apply because the carrier contains 20% water (at least 50% is required), and the optional reclassifications as a combustible liquid under 49 CFR 173.150(e)(1) and (f)(1) are not applied. This uses the same 60 °C boundary and the same conservative determination as the OSHA classification in Section 2 (Flammable liquid, Category 3). The laboratory’s Class IIIA designation is an NFPA 30 workplace fire-code label, not a transport classification.

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: 34580-14-8. U.S. TSCA: no exact CAS match on that public inventory (34580-14-8); confidential identities are not visible in the public file. Carrier components ethanol (64-17-5), glycerol (56-81-5) and water (7732-18-5) are listed as active on the TSCA Inventory. California Proposition 65 (ethyl alcohol is listed only as “ethyl alcohol in alcoholic beverages”, which does not apply to this product): 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.

Principal sources consulted

PubChem. Ketotifen fumarate, Compound Summary, CID 5282408. National Center for Biotechnology Information. https://pubchem.ncbi.nlm.nih.gov/compound/5282408. Accessed 2026-07-15.

PubChem. Glycerol (CID 753), Ethanol (CID 702), and Water (CID 962). National Center for Biotechnology Information. 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.

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.

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.