Levonorgestrel SDS/MSDS (Safety Data Sheet)

3.1 Substances
Product name: Levonorgestrel
CAS Number: 797-63-7
PubChem CID: 13109
Molecular formula: C21H28O2
Molecular weight: 312.4 g/mol
IUPAC name: (8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one

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
Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire and materials. ... As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.

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
Wear approved respiratory protection, chemically compatible gloves, and protective clothing. Wipe up spillage or collect spillage using a high-efficiency vacuum cleaner. Avoid breathing dust. Wash spill site. Place spillage and all contaminated cleanup materials in a thick plastic hazardous waste disposal bag or leakproof container and label it CAUTION: HAZARDOUS CHEMICAL WASTE.
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.
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.
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.
As a general rule, when handling USP Reference Standards, avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Wash thoroughly after handling.
This material is assumed to be combustible. As with all dry powders, it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity.
Engineering controls such as exhaust ventilation are recommended.
SRP: Contaminated protective clothing should be segregated in such a manner so that there is no direct personal contact by personnel who handle, dispose, or clean the clothing. The completeness of the cleaning procedures should be considered before the decontaminated protective clothing is returned for reuse by the workers. Contaminated clothing should not be taken home at the end of shift, but should remain at employee's place of work for cleaning.
For more Preventive Measures (Complete) data for NORGESTREL (6 total), please visit the HSDB record page.

7.1 Precautions for safe handling
Store at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F).
Store in tight, light-resistant container as defined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity.
Store levonorgestrel tablets at 20 to 25 °C (68 to 77 °F)
The levonorgestrel-releasing intrauterine system should be stored at a temperature of 25 °C but may be exposed to temperatures ranging from 15-30 °C. The system is supplied as a sterile device and should not be resterilized. The device should not be used if the inner package is damaged or has been opened.
Estrogen-progestin combinations generally should be stored at room temperature in a well-closed container, unless otherwise specified by the manufacturer. Commercially available oral contraceptives are provided in mnemonic (memory-aid) dispensing packages which are exempted from the child-safety packaging requirements of the US Poison Prevention Packaging Act of 1970.

7.2 Conditions for safe storage, including any incompatibilities
Store at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F).
Store in tight, light-resistant container as defined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity.
Store levonorgestrel tablets at 20 to 25 °C (68 to 77 °F)
The levonorgestrel-releasing intrauterine system should be stored at a temperature of 25 °C but may be exposed to temperatures ranging from 15-30 °C. The system is supplied as a sterile device and should not be resterilized. The device should not be used if the inner package is damaged or has been opened.
Estrogen-progestin combinations generally should be stored at room temperature in a well-closed container, unless otherwise specified by the manufacturer. Commercially available oral contraceptives are provided in mnemonic (memory-aid) dispensing packages which are exempted from the child-safety packaging requirements of the US Poison Prevention Packaging Act of 1970.
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.]

9.1 Information on basic physical and chemical properties
a) Appearance: Solid
b) Odor: Odorless
c) Odor threshold: No data available
d) pH: No data available
e) Melting point/freezing point: 232-239
f) Initial boiling point and boiling range: No data available
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: In water, 1.73 mg/L, temp not stated.
o) Partition coefficient: n-octanol/water: Log P (n-octanol/water): 3.3
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
Topological Polar Surface Area (TPSA): 37.3 Ų
Complexity: 609

11.1 Information on toxicological effects
Acute toxicity:
No acute toxicity data available.
Skin corrosion/irritation:
Causes skin irritation (H315).
Serious eye damage/eye irritation:
Causes serious eye irritation (H319).
Respiratory or skin sensitization:
No data available.
Germ cell mutagenicity:
No data available.
Carcinogenicity:
Suspected of causing cancer (H351).
Reproductive toxicity:
May damage fertility or the unborn child (H360).
Specific target organ toxicity (single exposure):
No data available.
Specific target organ toxicity (repeated exposure):
No data available.
Aspiration hazard:
No data available.

11.2 Additional information
Carcinogen classification:
Norgestrel: Group 2B, possibly carcinogenic to humans. (L135)
Exposure routes:
Levonorgestrel is not subjected to a "first-pass" effect and is virtually 100% bioavailable.
Data source: Hazardous Substances Data Bank (HSDB) via PubChem.

12.1 Toxicity
/AQUATIC SPECIES/ ...The effects of two progestins currently marketed in contraceptive formulations, levonorgestrel (LNG) and drospirenone (DRSP), were investigated in adult fathead minnows (Pimephales promelas) following an OECD 21-day fish reproduction screening assay draft protocol with additional end points. Levonorgestrel was tested at measured concentrations of 0.8, 3.3, and 29.6 ng/L, and DRSP at concentrations of 0.66, 6.5, and 70 uL. Both tested progestins caused an inhibition of reproduction. For LNG, this occurred at concentrations of 2:0.8 ng/L, no no-observed-effect concentration (NOEC) could be defined. Higher concentrations resulted in masculinization of females with de novo synthesis of nuptial tubercles. Drospirenone treatment, however, affected the reproductive success of fathead minnow at concentrations of 6.5 uL and higher with a clear dose-response relationship and a NOEC of 0.66 uL, which is above environmentally relevant concentrations.
Norgestrel's production and use as in oral contraceptive formulations may result in its release to the environment through various waste streams. If released to air, an estimated vapor pressure of 1.0X10-9 mm Hg at 25 °C indicates norgestrel will exist solely in the particulate phase in the atmosphere. Particulate-phase norgestrel will be removed from the atmosphere by wet or dry deposition. Norgestrel contains chromophores that absorb at wavelengths >290 nm, and therefore may be susceptible to direct photolysis by sunli

12.2 Persistence and degradability
No data available.

12.3 Bioaccumulative potential
Log P (n-octanol/water): 3.3
Potential for bioaccumulation exists (Log P > 3).

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
This substance is classified as hazardous to the aquatic environment.

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: Yes (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
Environmental 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:
- California Safe Cosmetics Program (CSCP) Reportable Ingredient: Hazard Traits - Reproductive Toxicity Authoritative List - Prop 65 Report - regardless of intended function of ingredient in the product
- California Safe Cosmetics Program (CSCP) Reportable Ingredient: Hazard Traits - Developmental Toxicity Authoritative List - Prop 65 Report - regardless of intended function of ingredient in the product
- FDA Requirements: The Approved Drug Products with Therapeutic Equivalence Evaluations identifies currently marketed prescription drug products, including norgestrel, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. /In combination with Ethinyle

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: 2026/09/08
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.