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Safety Data Sheet EN

CICLOSPORIN

CAS 59865-13-3

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
CICLOSPORIN
Chemical Name
CICLOSPORIN
Synonyms
CYCLO[[E)-(2 S,3 R,4 R)-3-HYDROXY-4-METHYL-2-(METHYLAMINO)-6-OCTEONYL]- L-2-AMINOBUTYRYL-N-METHYLGLYCYL-N-METHYL-L-LEUCYL-L-VALYL-N-METHYL-L-LEUCYL- L-ALANYL-D-ALANYL-N-METHYL-L-LEUCYL-N-METHYL-L-LEUCYL-N-METHYL-L-VALYL] * Cyclosporine

Regulatory Identifiers

CAS Number
59865-13-3 Check regulations →

Identified Uses

Active Pharmaceutical Ingredient. Pharmacological action: Immunosuppressant, Transplantation of organs.

Uses advised against

None known.

Manufacturers & Suppliers

N

Novartis Pharma AG

manufacturer

Novartis Campus, CH-4056, Basel, Switzerland

N

Novartis Ireland Limited

importer

Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, Ireland

Emergency Contacts

3E Global Incident

+1 760 476 3962

24 hours a day, 7 days a week, 365 days a year.

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified warning

Hazard Classifications

Acute Tox. Cat. 4 H302
Carc. Cat. 2 H351
Repr. Cat. 2 H361
STOT RE Cat. 2 H373

GHS Pictograms

GHS07 - Health hazard

GHS07

GHS08 - Serious health hazard

GHS08

Hazard Statements

H302 Harmful if swallowed.
H351 Suspected of causing cancer.
H361 Suspected of damaging fertility or the unborn child.
H373 May cause damage to organs through prolonged or repeated exposure.

Precautionary Statements

P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been read and understood.
P260 Do not breathe dust/fume/gas/mist/vapours/spray.
P264 Wash thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P273 Avoid release to the environment.
P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection.
P301 + P312 IF SWALLOWED: Call a POISON CENTRE/doctor if you feel unwell.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P330 Rinse mouth.
P405 Store locked up.
P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type substance
Chemical Name CAS Number Concentration Hazardous
Cyclosporin 59865-13-3 100% Yes

Notes

The full text for all H-statements is displayed in section 16.

04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Move to fresh air. Call a physician if symptoms develop or persist.

Symptoms: Dusts may irritate the respiratory tract.

Skin contact

Wash off with soap and water. Get medical attention if irritation develops and persists.

Symptoms: Dusts may irritate the skin.

Eye contact

Do not rub eyes. Rinse with water. Get medical attention if irritation develops and persists.

Symptoms: Dusts may irritate the eyes.

Ingestion

Rinse mouth. If vomiting occurs, keep head low so that stomach content doesn't get into the lungs. Get medical advice/attention if you feel unwell.

Medical Treatment

Provide general supportive measures and treat symptomatically.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Avoid high pressure media which could cause the formation of a potentially explosive dust-air mixture. Water fog. Foam. Dry chemical powder. Carbon dioxide (CO2). Apply extinguishing media carefully to avoid creating airborne dust.

Unsuitable media

Do not use water jet as an extinguisher, as this will spread the fire.

Specific hazards

Avoid generating dust; fine dust dispersed in air in sufficient concentrations and in the presence of an ignition source is a potential dust explosion hazard. During fire, gases hazardous to health may be formed.

Instructions

In case of fire and/or explosion do not breathe fumes. Move containers from fire area if you can do so without risk. Use standard firefighting procedures and consider the hazards of other involved materials.

Firefighter Protection

Self-contained breathing apparatus and full protective clothing must be worn in case of fire.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

For non-emergency personnel: Dust deposits should not be allowed to accumulate on surfaces, as these may form an explosive mixture if they are released into the atmosphere in sufficient concentration. For emergency responders: Keep unnecessary personnel away. Use only non-sparking tools. Ensure adequate ventilation.

Small spill

Sweep up or vacuum up spillage and collect in suitable container for disposal. Clean surface thoroughly to remove residual contamination.

Large spill

Wet down with water and dike for later disposal. Shovel the material into waste container. Following product recovery, flush area with water.

Environmental

Avoid release to the environment. Inform appropriate managerial or supervisory personnel of all environmental releases. Prevent further leakage or spillage if safe to do so.

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Do not taste or swallow. Avoid prolonged exposure. When using, do not eat, drink or smoke. Pregnant or breastfeeding women must not handle this product. Wear appropriate personal protective equipment. Wash hands thoroughly after handling.

Storage

Store locked up. Keep containers tightly closed in a dry, cool and well-ventilated place.

Hygiene

When using, do not eat, drink or smoke. Wash hands thoroughly after handling. Observe good industrial hygiene practices.

Fire prevention

Keep away from heat/sparks/open flames/hot surfaces. - No smoking.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

Explosion-proof general and local exhaust ventilation. Good general ventilation should be used. Ventilation rates should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. If exposure limits have not been established, maintain airborne levels to an acceptable level. It is recommended that all dust control equipment such as local exhaust ventilation and material transport systems involved in handling of this product contain explosion relief vents or an explosion suppression system or an oxygen-deficient environment. Ensure that dust-handling systems (such as exhaust ducts, dust collectors, vessels, and processing equipment) are designed in a manner to prevent the escape of dust into the work area (i.e., there is no leakage from the equipment). Use only appropriately classified electrical equipment and powered industrial trucks.

Hands

Wear appropriate chemical resistant gloves. Select suitable chemical resistant protective gloves (EN 374) with a protective index 6 (>480min permeation time). Nitrile gloves are recommended.

Eyes

Wear safety glasses with side shields (or goggles).

Respiratory

If engineering controls do not maintain airborne concentrations below recommended exposure limits (where applicable) or to an acceptable level (in countries where exposure limits have not been established), an approved respirator must be worn. Use filtering half-face mask according to EN 140 with filter type 3 (EN143) or disposable fine dust protection mask (EN374).

Skin/Body

Wear suitable protective clothing. Use of an impervious apron is recommended.

Environmental

Inform appropriate managerial or supervisory personnel of all environmental releases. Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation. Fume scrubbers, filters or engineering modifications to the process equipment may be necessary to reduce emissions to acceptable levels.

09

Physical and Chemical Properties

Appearance, physical state, melting point, boiling point, and material characteristics

Physical State
Solid.
Physical State Data
solid
State Under Standard Conditions
---
Appearance
---
Colour
White
Colour Intensity
---
Form
Solid.
Odor
odourless.
Odor Threshold
---
Ph
6.5 - 7 Concentration: 0.2 g/L; Temperature: 20.0 °C
Melting Point
148 - 151 °C (298.4 - 303.8 °F)
Boiling Point
Not available.
Flash Point
Not available.
Freezing Point
---
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
---
Vapor Pressure
<0.0000001 kPa (25 °C (77 °F))
Vapor Density
---
Relative Density
---
Bulk Density
200 - 450 kg/m3
Density
---
Flammability
---
Upper Explosive Limit
Not available.
Lower Explosive Limit
Not available.
Explosive Limits
---
Auto Ignition Temperature
380 °C (716 °F) BAM MINIMUM IGNITION TEMPERATURE (DUST CLOUD)
Decomposition Temperature
>350 °C (>662 °F) Heating Protocol: Tonset (airstream) (Grewer) >150 °C (>302 °F) Method: 8h long-term-stability temperature (LZT) 150 °C (302 °F) Heating Protocol: Tonset (open tube) (Lütolf)
Solubility
---
Partition Coefficient
5.5 OECD 107 * 1981 (flask-shaking method) Temperature: ~22.0 °C
Solubility In Water
0.2 g/l Solvent: Water; Temperature: 20.0 °C
Solubility In Fat
---
Molecular Weight
---
Voc Content
---
Metal Corrosion
---
Dynamic Viscosity
---
Kinematic Viscosity
Not available.
Properties Status
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

The product is stable and non-reactive under normal conditions of use, storage and transport.

Reactivity

The product is stable and non-reactive under normal conditions of use, storage and transport.

Hazardous reactions

No dangerous reaction known under conditions of normal use.

Avoid

Keep away from heat, sparks and open flame. Avoid temperatures exceeding the decomposition temperature. Contact with incompatible materials. Minimise dust generation and accumulation.

Incompatible

Reaction with Water: no violent reaction.

Decomposition

Carbon oxides. Nitrogen oxides (NOx).

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

The data for this section has not been processed yet.

13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

The data for this section has not been processed yet.

14

Transport Information

UN numbers, shipping names, transport classes, and regulatory requirements

15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

The data for this section has not been processed yet.

?

Frequently Asked Questions

Common questions about safety, handling, and properties

What other names is CICLOSPORIN known by?

CICLOSPORIN is also known as: CYCLO[[E)-(2 S,3 R,4 R)-3-HYDROXY-4-METHYL-2-(METHYLAMINO)-6-OCTEONYL]- L-2-AMINOBUTYRYL-N-METHYLGLYCYL-N-METHYL-L-LEUCYL-L-VALYL-N-METHYL-L-LEUCYL- L-ALANYL-D-ALANYL-N-METHYL-L-LEUCYL-N-METHYL-L-LEUCYL-N-METHYL-L-VALYL] * Cyclosporine

What is the hazard signal word for CICLOSPORIN?

The signal word is warning.

What is the physical form of CICLOSPORIN?

CICLOSPORIN is a solid. with white color. It has odourless. odor.

What is CICLOSPORIN used for?

Active Pharmaceutical Ingredient. Pharmacological action: Immunosuppressant, Transplantation of organs.

What are the hazard statements for CICLOSPORIN?

This substance has 4 hazard statements:

  • H302: Harmful if swallowed.
  • H351: Suspected of causing cancer.
  • H361: Suspected of damaging fertility or the unborn child.
  • H373: May cause damage to organs through prolonged or repeated exposure.

What is the melting point of CICLOSPORIN?

The melting point is 148 - 151 °C (298.4 - 303.8 °F) and the boiling point is Not available..