Safety Data Sheet

Version 2.5 SDS Revision Date 8/31/2022
www.ichor.bio

1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING

   
   

   1. Product Identifiers

      
      

      Product Name: Dupilumab Biosimilar - Research Grade
      Catalogue Number: ICH5062

   2. Relevant identified uses of the substance or mixture and uses advised against

      
      

      Identified Uses:

      
      

   3. Details of the supplier of the safety data sheet

      
      

      Company: ichorbio Ltd, Boston House, Grove Business Park

      Downsview Road, Wantage, OX12 9FF, UK

      
      

      Internet: www.ichor.bio
      Email address: hello@ichor.bio

      
      

   4. Emergency Telephone Number

      
      

      Emergency Tel: UK: +44 7749 955031

      
      

2. HAZARDS IDENTIFICATION

   
   

   1. Classification of the substance or mixture

      
      

      This substance does not meet the classification criteria of the EC Directives 67/548/EEC, 1999/45/EC, 1272/2008 [CLP], GHS or 29 CFR 1910.1200 [OSHA].

   2. Label Elements

      
      

      The product does not need to be labelled in accordance with EC directives or respective national laws.

      
      

   3. Other Hazards

      
      

      None

      
      

3. COMPOSITION/INFORMATION ON INGREDIENTS

   
   

   1. Substances

      
      

      Not applicable

   2. Mixtures

      
      

      This product does not contain hazardous chemicals at concentrations of 1% or greater. This product is not known to contain carcinogens at concentrations of 0.1% or greater.

      
      

4. FIRST AID MEASURES

   
   

   1. Description of first aid measures General Advice

      
      

      Consult a doctor and show this safety data sheet.

      
      

      If Inhaled

      
      

      Remove to fresh air and monitor breathing. If breathing becomes difficult, give oxygen. If breathing stops, give artificial respiration. Consult a doctor.

      In Case of Skin Contact

      
      

      Immediately wash skin with copious amounts of soap and water for at least 15 minutes. Remove contaminated clothing and shoes and wash before reuse. Consult a doctor.

      In Case of Eye Contact

      
      

      Flush with copious amounts of water for at least 15 minutes. Consult a doctor.

      
      

      If Swallowed

      
      

      Rinse mouth with water. Do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Consult a doctor.

   2. Most important symptoms and effects, both acute and delayed

      
      

      To the best of our knowledge, the chemical, physical and toxicological properties have not been thoroughly investigated.

      
      

   3. Indication of immediate medical attention and special treatment needed

      
      

      Show this safety data sheet to the doctor in attendance. Immediate medical attention is required.

      
      

5. FIRE-FIGHTING MEASURES

   
   

   1. Extinguishing Media

      
      

      Suitable extinguishing media

      
      

      Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

      
      

   2. Special hazards arising from the substance or mixture

      
      

      In combustion, it may emit toxic fumes.

      
      

   3. Precautions for fire-fighters

      
      

      Wear suitable protective clothing to prevent contact with skin and eyes and self-contained breathing apparatus.

      
      

6. ACCIDENTAL RELEASE MEASURES

   
   

   1. Personal precautions, protective equipment and emergency procedures

      
      

      Do not take action without suitable protective clothing - see section 8 of SDS. Evacuate personnel to safe areas. Ensure adequate ventilation. Avoid breathing vapours, mist, dust or gas.

   2. Environmental precautions

      
      

      Do not let product enter drains.

      
      

   3. Methods and materials for containment and cleaning up

      
      

      Cover spillage with suitable absorbent material. Hold all material for appropriate disposal as described under section 13 of SDS.

   4. Reference to other sections

      
      

      For required PPE see section 8. For disposal see section 13.

      
      

7. HANDLING AND STORAGE

   
   

   1. Precautions for safe handling

      
      

      Avoid inhalation, contact with eyes, skin and clothing. Avoid the formation of dust and aerosols. Use in a well-ventilated area. Keep away from sources of ignition. Avoid prolonged or repeated exposure.

   2. Conditions for safe storage, including any incompatibilities

      
      

      Store in a cool, well-ventilated area. Keep away from direct sunlight. Keep the container tightly sealed until ready for use.

      
      

   3. Specific end uses

      
      

      Not applicable.

      
      

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

   
   

   1. Control parameters

      
      

      Components with workplace control parameters

      
      

      Contains no substances with occupational exposure limit values.

      
      

   2. Exposure controls Appropriate Engineering Controls

      Use in a fume hood where applicable. Ensure all engineering measures described under section 7 of SDS are in place. Ensure the laboratory is equipped with a safety shower and eyewash station.

      Personal Protective Equipment Eye / Face Protection

      
      

      Use appropriate safety glasses.

      
      

      Skin Protection

      
      

      Use appropriate chemical resistant gloves (minimum requirement use standard BS EN 374:2003). Gloves should be inspected before use. Wash and dry hands thoroughly after handling.

      Body Protection

      
      

      Wear appropriate protective clothing.

      
      

      Respiratory Protection

      
      

      If risk assessment indicates necessary, use a suitable respirator.

9. PHYSICAL AND CHEMICAL PROPERTIES

   
   

   1. Information on basic physical and chemical properties

      
      

      Appearance	Lyophilized white powder or clear liquid	Vapour Pressure	No data available.
      Odor	Little to none	Vapour Density	No data available.
      Odor Threshold	No data available.	Relative Density	No data available.
      pH	No data available.	Solubility(ies)	No data available.
      Melting / Freezing Point	No data available.	Partition Coefficient	No data available.
      Boiling Point / Range	No data available.	Autoignition Temperature	No data available.

      
      

      Flash Point No data available. Decomposition Temperature No data available. Evaporation Rate No data available. Viscosity No data available. Flammability (Solid, Gas) No data available. Explosive Properties No data available. Upper / Lower Flammability or Explosive Limits No data available Oxidising Properties No data available.

      
      

   2. Other safety information

      
      

      No data available.

      
      

10. STABILITY AND REACTIVITY

    
    

    1. Reactivity

       
       

       Stable under recommended transport or storage conditions.

       
       

    2. Chemical stability

       
       

       Stable under recommended storage conditions.

       
       

    3. Possibility of hazardous reactions

       
       

       Hazardous reactions will not occur under normal transport or storage conditions. Decomposition may occur on exposure to conditions or materials listed below.

    4. Conditions to avoid

       
       

       Heat, moisture.

       
       

    5. Incompatible materials

       
       

       Strong acids/alkalis, strong oxidising/reducing agents.

       
       

    6. Hazardous decomposition products

       
       

       Strong acids/alkalis, strong oxidising/reducing agents.

       
       

       
       

11. TOXICOLOGICAL INFORMATION

    
    

    1. Information on toxicological effects Acute Toxicity

       Classified based on available data Skin Corrosion / Irritation Classified based on available data Serious Eye Damage / Irritation Classified based on available data Respiratory or Skin Sensitization Classified based on available data Germ Cell Mutagenicity Classified based on available data Carcinogenicity

       Classified based on available data

       
       

       Reproductive Toxicity

       
       

       Classified based on available data

       
       

       Specific Target Organ Toxicity - Single Exposure

       
       

       Classified based on available data

       
       

       Specific Target Organ Toxicity - Repeated Exposure

       
       

       Classified based on available data

       
       

       Aspiration Hazard

       
       

       Classified based on available data

       
       

       Symptoms / Routes of Exposure

       
       

       Inhalation: There may be irritation of the throat with a feeling of tightness in the chest. Ingestion: There may be irritation of the throat.

       Skin: There may be mild irritation at the site of contact.

       
       

       Eyes: There may be irritation and redness. Delayed / Immediate Effects: No known symptoms.

       Additional Information

       
       

       Classified based on available data

       
       

12. ECOLOGICAL INFORMATION

    
    

    1. Toxicity

       
       

       No data available.

       
       

       
       

    2. Persistence and degradability

       
       

       No data available.

       
       

    3. Bioaccumulative potential

       
       

       No data available.

       
       

    4. Mobility in soil

       
       

       No data available.

       
       

    5. Results of PBT and vPvB assessment

       
       

       No data available.

       
       

    6. Other adverse effects

       
       

       No data available.

       
       

13. DISPOSAL CONSIDERATIONS

    
    

    1. Waste treatment methods Product

       
       

       Transfer to a suitable container and arrange for collection by a specialised disposal company in accordance with national, regional, or local legislation.

       Contaminated Packaging

       
       

       Dispose of in a regulated landfill site or other method for hazardous or toxic wastes in accordance with national, regional, or local legislation.

       
       

14. TRANSPORT INFORMATION

    
    

    Classified according to the criteria of the UN Model Regulations as reflected in the IMDG Code, ADR, RID, DOT and IATA.

    
    

    1. UN-Number

       
       

       Does not meet the criteria for classification as hazardous for transport.

       
       

    2. UN proper shipping name

       
       

       Does not meet the criteria for classification as hazardous for transport.

       
       

    3. Transport hazard class(es)

       
       

       Does not meet the criteria for classification as hazardous for transport.

       
       

    4. Packaging group

       
       

       Does not meet the criteria for classification as hazardous for transport.

       
       
       

    5. Environmental hazards

       Does not meet the criteria for classification as hazardous for transport.

       
       

    6. Special precautions for users

       
       

       Does not meet the criteria for classification as hazardous for transport.

       
       

       Additional Transport Information

       
       

       Does not meet the criteria for classification as hazardous for transport.

       
       

       
       

15. REGULATORY INFORMATION

    
    

    This safety datasheet complies with the requirements of Regulation (EC) No. 453/2010.

    
    

    1. Safety, health and environmental regulations/legislation specific for the substance or mixture

       
       

       TSCA (Toxic Substances Control Act) : Not applicable. SARA 313 : Not applicable.

       SARA 311/312 : Not applicable.

       
       

       CERCLA Reportable Quantity : California Proposition 65 : Not applicable.

       
       

    2. Chemical safety assessment

       
       

       A Chemical Safety Assessment has not been made for this product.

       
       

16. OTHER INFORMATION

Further Information

Copyright © 2022 ichorbio Ltd

This company shall not be held liable for any damage resulting from handling or from contact with the above product. This material must only be handled by suitably qualified experienced scientists in appropriately equipped and authorised facilities. The above information is believed to be correct but does not purport to be all inclusive and should be used as a guide only for experienced personnel. Always consult your safety advisor and follow appropriate local and national safety legislation. The absence of warning must not, under any circumstance, be taken to mean that no hazard exists.

End of safety data sheet