Safety data sheet. GHS / OSHA HCS 2012 format, 16 sections. Issued by Epic Peptides Lab for the catalogue items listed in Section 1.

Epic Peptides Lab

Safety data sheet · solution, preloaded autoinjector pen

Epic Peptides Lab · USA

Document number
PL-SDS-163
Revision
1.0 · 2026-10-03

Tesamorelin

solution, preloaded autoinjector pen

WARNING

1Identification

Product Identifier
Tesamorelin
Document Number
PL-SDS-163
Catalogue Items Covered
  • Id
    20633
    Name
    Preloaded Autoinjector | Tesamorelin | 3ml Pen | 10mg
    Sku
    PL-TESA-3ML-PEN
Recommended Use
Laboratory research use by trained personnel.
Restrictions On Use
Not for human or veterinary use.
Supplier / Distributor
Epic Peptides Lab, USA
Telephone
+1 (787) 468-5291
Email
info@epicpeptideslab.com

2Hazard(s) identification

Classification
  • Reproductive toxicity — Category 2 — H361
Label Elements
Pictograms
  • GHS08
Signal
Warning
Hazard statements
  • H361 Suspected of damaging fertility or the unborn child.
Precautionary statements
  • P201 Obtain special instructions before use.
  • P202 Do not handle until all safety precautions have been read and understood.
  • P280 Wear protective gloves, protective clothing and eye protection.
  • P308+P313 IF exposed or concerned: Get medical advice/attention.
  • P405 Store locked up.
  • P501 Dispose of contents and container to an approved waste disposal plant in accordance with local, state and federal regulations.
Signal Word
Warning
Other Hazards
No data available.

3Composition / information on ingredients

Description
Sterile aqueous solution in bacteriostatic water (0.9% benzyl alcohol), supplied in a 3 mL glass cartridge inside a preloaded autoinjector pen fitted with a needle.
Composition
  • Name
    Tesamorelin
    Full
    Tesamorelin (trans-3-hexenoyl-GHRH(1-44)-NH2)
    Cas
    218949-48-5
    Formula
    C221H366N72O67S
    Conc
    0.33% w/v
    Qty
    10 mg per 3 mL pen
    Hazards
    • Reproductive toxicity — Category 2 — H361
  • Name
    Benzyl alcohol (preservative)
    Full
    Benzyl alcohol, antimicrobial preservative (0.9% w/v in bacteriostatic water)
    Cas
    100-51-6
    Formula
    C7H8O
    Conc
    0.9% w/v
    Hazards
    • Acute toxicity, oral — Category 4 — H302
    • Acute toxicity, inhalation — Category 4 — H332
    • Serious eye damage/eye irritation — Category 2A — H319
    • Skin sensitisation — Category 1B — H317
  • Name
    Water for injection
    Full
    Water for injection
    Cas
    7732-18-5
    Formula
    H2O
    Conc
    balance to 100%

4First-aid measures

First Aid Measures
Inhalation
Move the person to fresh air and keep comfortable for breathing. If breathing is difficult or symptoms persist, call a POISON CENTER or doctor.
Skin
Take off contaminated clothing. Wash the skin with plenty of soap and water. If irritation or a rash develops, get medical advice.
Eyes
Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do; continue rinsing. If eye irritation persists, get medical advice.
Ingestion
Rinse mouth. Do not induce vomiting. Call a POISON CENTER or doctor if you feel unwell.
Injection
For an accidental needle-stick: wash the site with soap and water, do not squeeze, cover with a dressing and seek medical advice; report the incident according to your laboratory's sharps procedure.
General
If exposed or concerned, get medical advice. Show this safety data sheet to the doctor. Pregnant or nursing laboratory staff should avoid exposure.
Most Important Symptoms And Effects
No specific symptoms are known. Pharmacologically active material: systemic effects consistent with its mechanism of action are possible after accidental injection, ingestion or absorption.
Likely Routes Of Exposure
Accidental needle-stick injection; skin and eye contact from splashes; ingestion is unlikely.

5Fire-fighting measures

Fire Fighting Information
Aqueous solution containing 0.9% benzyl alcohol; not flammable and does not support combustion.

6Accidental release measures

Spill And Clean Up Procedures
Absorb small spills with paper towel or an inert absorbent, place in a sealed container for disposal and clean the area with water and detergent. Pick up broken glass with tongs or forceps, never by hand.

7Handling and storage

Safe Handling
Handle the device as a sharp: never recap or reuse needles, keep fingers away from the needle, and discard used devices into a rigid sharps container. Avoid splashes to eyes and skin. Wash hands after handling.
Safe Storage
Store at 2–8 °C in the original carton, protected from light. Do not freeze; discard if the solution has frozen or is discoloured or cloudy. Once in use, keep the device capped between uses.
Storage Temperature
2–8 °C, protected from light; do not freeze
Incompatible Materials
No further relevant information available (Cayman); generic: strong oxidizing agents, strong acids/bases

8Exposure controls / personal protection

Occupational Exposure Limits
  • Benzyl alcohol: no OSHA PEL, ACGIH TLV or NIOSH REL; AIHA WEEL 10 ppm (44 mg/m³) 8-h TWA. Present at 0.9%.
  • No occupational exposure limits have been established for the active ingredient(s).
Exposure Controls And PPE
No data available.

9Physical and chemical properties

Physical State
Liquid
Appearance
Clear, colourless to faintly yellow aqueous solution
Properties
Odor
Odourless to faint aromatic odour (benzyl alcohol)
Ph
Approximately 4.5–7.0 (bacteriostatic water, USP) unless adjusted
Melting
About 0 °C (aqueous solution)
Boiling
About 100 °C (aqueous solution)
Flash
Not flammable; aqueous solution (benzyl alcohol flash point 93–101 °C, present at 0.9%)
Vapour
As water (about 2.3 kPa at 20 °C)
Density
About 1.00–1.02 g/mL at 20 °C
Solubility
Aqueous solution; miscible with water
Logp
No data available
Decomp
Not applicable (aqueous solution); dissolved peptide degrades on heating

10Stability and reactivity

Stability And Reactivity
Reactivity
No dangerous reactions known; no decomposition if used according to specifications (Cayman)
Incompatible
No further relevant information available (Cayman); generic: strong oxidizing agents, strong acids/bases
Decomposition
No dangerous decomposition products known (Cayman); combustion yields carbon oxides, nitrogen oxides, sulfur oxides
Conditions To Avoid
No further relevant information available; store -20 °C desiccated and dark (lyophilized); reconstituted drug product must be used immediately per label
Conditions To Avoid
No data available.
Incompatible Materials
No data available.

11Toxicological information

Toxicological Information
  • Acute toxicity, oral

    No data available

  • Acute toxicity, dermal

    No data available

  • Acute toxicity, inhalation

    No data available

  • Skin corrosion/irritation

    No irritant effect (Cayman)

  • Serious eye damage/irritation

    No irritating effect (Cayman)

  • Respiratory or skin sensitisation

    No sensitizing effects known (Cayman). Clinical: hypersensitivity reactions and injection-site reactions reported with Egrifta

  • Germ cell mutagenicity

    No data available

  • Carcinogenicity

    Not listed by IARC, NTP or OSHA (Cayman)

  • Reproductive toxicity

    No data available in SDS. Egrifta prescribing information: contraindicated in pregnancy (formerly Pregnancy Category X) and developmental toxicity was observed in animal studies - reproductive-toxicity concern for a GHRH-analogue hormone (see notes)

  • STOT, single exposure

    No data available

  • STOT, repeated exposure

    No data available

  • Aspiration hazard

    No data available

Routes Of Exposure
Accidental needle-stick injection; skin and eye contact from splashes; ingestion is unlikely.
Symptoms
No specific symptoms are known. Pharmacologically active material: systemic effects consistent with its mechanism of action are possible after accidental injection, ingestion or absorption.

12Ecological information

Ecological Information
Cayman: Water hazard class 1 (self-assessment), slightly hazardous for water; no aquatic toxicity, persistence or bioaccumulation data.

13Disposal considerations

Disposal Guidance
No data available.

14Transport information

Transport Classification
Note
Not regulated as a dangerous good for transport by road (DOT 49 CFR), air (IATA/ICAO) or sea (IMDG). Not a marine pollutant. Ship refrigerated or frozen as required by Section 7; the coolant (dry ice, UN 1845) is regulated when used.

15Regulatory information

Regulatory Information
Tsca
Substance is not listed (Cayman)
Carcinogen Listings
Not listed by IARC, NTP, OSHA or EPA
Dea
Not a controlled substance
Other
FDA-approved prescription drug (Egrifta / Egrifta SV / Egrifta WR, Theratechnologies). WADA remark: tesamorelin is explicitly named on the WADA Prohibited List (S2 Peptide hormones, growth factors - GHRH and its analogues).
Carcinogen Listings
No data available.

16Other information

Revision
October 3, 2026
Sources Consulted
  • Cayman Chemical
  • Cayman Chemical product page
  • Sigma-Aldrich
  • Sigma-Aldrich / Supelco
  • MilliporeSigma
  • Sigma-Aldrich BVBA
  • Aldrich
  • American Regent - Sterile Water for Injection, USP
  • Hospira/Pfizer - Bacteriostatic Water for Injection
Confidence
medium
Additional Information
  • GHRH analogue. WADA Prohibited List class S2.
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