Imidocarb Injection Formulation

Hospira UK Limited

Revision date : 2019-07-30

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GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

79-09-4

Name of the chemical

propionic acid

Concentration

>=1-<5

EC/CAS

7647-01-0

Name of the chemical

Hydrochloric acid

Concentration

N/A

General Information

Version

1.2

Revision date

2019-07-30

Product name

Imidocarb Injection Formulation

Product name

Imidocarb Injection Formulation

Identification on the label/Trade name

Naloxone Hydrochloride Injection

Product Synonyms

HYDROCHLORIC ACID

Chemical name

Mixture

CAS No.

7647-01-0

1.2.1 Relevant identified uses

Pharmaceutical product

Emergency telephone

1-800-424-9300, +1-703-527-3887, 1-800-879-3477, 1-908-423-6000

Icons in SDS

GHS08

Company Information

company name

Hospira UK Limited

e-mail address of the competent person responsible for the Safety Data Sheet

pfizer-MSDS@pfizer.com, EHSDATASTEWARD@merck.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H361d, H370, H372

Hazard statements

Code

Statements

H361d

Suspected of damaging the unborn child

Section 2

SECTION 2: Hazards identification

Signal word

Danger

Hazard statements

H361d Suspected of damaging the unborn child. H370 Causes damage to organs (Central nervous system) if swallowed. H372 Causes damage to organs (Liver, Kidney) through prolonged or repeated exposure if swallowed.

Prevention

P201 Obtain special instructions before use. 1 / 16 Imidocarb Injection Formulation Version revision date SDS Number Date of last issue 04/15/2018 3.0 08/30/2018 632255-00006 Date of first issue 05/02/2016 P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe mist or vapors. P264 Wash skin thoroughly after handling. P270 Do not eat drink or smoke when using this product. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.

Response

P307 + P311 IF exposed Call a POISON CENTER or doctor/ physician.

Storage

P405 Store locked up.

Disposal

P501 Dispose of contents/ container to an approved waste dis- posal plant

Other hazards

None known

2.1 Classification of the substance or mixture

Category 2 Specific target organ : Category 1 (Central nervous system) systemic toxicity - single exposure (Oral) Specific target organ : Category 1 (Liver, Kidney) systemic toxicity - repeated exposure (Oral) GHS label elements Hazard pictograms : Signal Word : Danger Hazard Statements : H361d Suspected of damaging the unborn child. H370 Causes damage to organs (Central nervous system) if swallowed. H372 Causes damage to organs (Liver, Kidney) through prolonged or repeated exposure if swallowed. Precautionary Statements : Prevention: P201 Obtain special instructions before use. 1 / 16 Imidocarb Injection Formulation Version Revision Date: SDS Number: Date of last issue: 04/15/2018 3.0 08/30/2018 632255-00006 Date of first issue: 05/02/2016 P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe mist or vapors. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection. Response: P307 + P311 IF exposed: Call a POISON CENTER or doctor/ physician. Storage: P405 Store locked up. Disposal: P501 Dispose of contents/ container to an approved waste dis- posal plant. Other hazards None known. SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS Substance / Mixture : Mixture Components Chemical name CAS-No. Concentration (% w/w) Imidocarb 27885-92-3 >= 10 - < 20 Propionic acid 79-09-4 >= 1 - < 5 Actual concentration is withheld as a trade secret SECTION 4. FIRST AID MEASURES General advice : In the case of accident or if you feel unwell, seek medical advice immediately. When symptoms persist or in all cases of doubt seek medical advice. If inhaled : If inhaled, remove to fresh air. Get medical attention. In case of skin contact : In case of contact, immediately flush skin with soap and plenty of water. Remove contaminated clothing and shoes. Get medical attention. Wash clothing before reuse. Thoroughly clean shoes before reuse. In case of eye contact : Flush eyes with water as a precaution. Get medical attention if irritation develops and persists. If swallowed : If swallowed, DO NOT induce vomiting. 2 / 16 Imidocarb Injection Formulation Version Revision Date: SDS Number: Date of last issue: 04/15/2018 3.0 08/30/2018 632255-00006 Date of first issue: 05/02/2016 Get medical attention. Rinse mouth thoroughly with water. Never give anything by mouth to an unconscious person. Most important symptoms : Suspected of damaging the unborn child. and effects, both acute and Causes damage to organs if swallowed. delayed Causes damage to organs through prolonged or repeated exposure if swallowed. Protection of first-aiders : First Aid responders should pay attention to self-protection, and use the recommended personal protective equipment when the potential for exposure exists. Notes to physician : Treat symptomatically and supportively. SECTION 5. FIRE-FIGHTING MEASURES Suitable extinguishing media : Water spray Alcohol-resistant foam Carbon dioxide (CO2) Dry chemical Unsuitable extinguishing : None known. media Specific hazards during fire : Exposure to combustion products may be a hazard to health. fighting Hazardous combustion prod- : Carbon oxides ucts Specific extinguishing meth- : Use extinguishing measures that are appropriate to local cir- ods cumstances and the surrounding environment. Use water spray to cool unopened containers. Remove undamaged containers from fire area if it is safe to do so. Evacuate area. Special protective equipment : In the event of fire, wear self-contained breathing apparatus. for fire-fighters Use personal protective equipment. SECTION 6. ACCIDENTAL RELEASE MEASURES Personal precautions, protec- : Use personal protective equipment. tive equipment and emer- Follow safe handling advice and personal protective gency procedures equipment recommendations. Environmental precautions : Discharge into the environment must be avoided. Prevent further leakage or spillage if safe to do so. Prevent spreading over a wide area (e.g., by containment or oil barriers). Retain and dispose of contaminated wash water. Local authorities should be advised if significant spillages 3 / 16 Imidocarb Injection Formulation Version Revision Date: SDS Number: Date of last issue: 04/15/2018 3.0 08/30/2018 632255-00006 Date of first issue: 05/02/2016 cannot be contained. Methods and materials for : Soak up with inert absorbent material. containment and cleaning up For large spills, provide diking or other appropriate containment to keep material from spreading. If diked material can be pumped, store recovered material in appropriate container. Clean up remaining materials from spill with suitable absorbent. Local or national regulations may apply to releases and disposal of this material, as well as those materials and items employed in the cleanup of releases. You will need to determine which regulations are applicable. Sections 13 and 15 of this SDS provide information regarding certain local or national requirements. SECTION 7. HANDLING AND STORAGE Technical measures : See Engineering measures under EXPOSURE CONTROLS/PERSONAL PROTECTION section. Local/Total ventilation : Use only with adequate ventilation. Advice on safe handling : Avoid inhalation of vapor or mist. Do not swallow. Avoid contact with eyes. Avoid prolonged or repeated contact with skin. Handle in accordance with good industrial hygiene and safety practice, based on the results of the workplace exposure assessment Take care to prevent spills, waste and minimize release to the environment. Conditions for safe storage : Keep in properly labeled containers. Store locked up. Store in accordance with the particular national regulations. Materials to avoid : Do not store with the following product types: Strong oxidizing agents Organic peroxides Explosives Gases SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Ingredients with workplace control parameters Components CAS-No. Value type Control parame- Basis (Form of ters / Permissible exposure) concentration Imidocarb 27885-92-3 TWA 50 µg/m3 (OEB 3) Internal Wipe limit 500 µg/100 cm² Internal Propionic acid 79-09-4 TWA 10 ppm ACGIH 4 / 16 Imidocarb Injection Formulation Version Revision Date: SDS Number: Date of last issue: 04/15/2018 3.0 08/30/2018 632255-00006 Date of first issue: 05/02/2016 TWA 10 ppm NIOSH REL 30 mg/m³ ST 15 ppm NIOSH REL 45 mg/m³ Engineering measures : Use appropriate engineering controls and manufacturing technologies to control airborne concentrations (e.g., drip- less quick connections). All engineering controls should be implemented by facility design and operated in accordance with GMP principles to protect products, workers, and the environment. Containment technologies suitable for controlling compounds are required to control at source and to prevent migration of the compound to uncontrolled areas (e.g., open-face containment devices). Minimize open handling. Personal protective equipment Respiratory protection : General and local exhaust ventilation is recommended to maintain vapor exposures below recommended limits. Where concentrations are above recommended limits or are unknown, appropriate respiratory protection should be worn. Follow OSHA respirator regulations (29 CFR 1910.134) and use NIOSH/MSHA approved respirators. Protection provided by air purifying respirators against exposure to any hazardous chemical is limited. Use a positive pressure air supplied respirator if there is any potential for uncontrolled release, exposure levels are unknown, or any other circumstance where air purifying respirators may not provide adequate protection. Hand protection Material : Chemical-resistant gloves Remarks : Consider double gloving. Eye protection : Wear safety glasses with side shields or goggles. If the work environment or activity involves dusty conditions, mists or aerosols, wear the appropriate goggles. Wear a faceshield or other full face protection if there is a potential for direct contact to the face with dusts, mists, or aerosols. Skin and body protection : Work uniform or laboratory coat. Additional body garments should be used based upon the task being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces. Use appropriate degowning techniques to remove potentially contaminated clothing. Hygiene measures : Ensure that eye flushing systems and safety showers are located close to the working place. 5 / 16 Imidocarb Injection Formulation Version Revision Date: SDS Number: Date of last issue: 04/15/2018 3.0 08/30/2018 632255-00006 Date of first issue: 05/02/2016 When using do not eat, drink or smoke. Wash contaminated clothing before re-use. The effective operation of a facility should include review of engineering controls, proper personal protective equipment, appropriate degowning and decontamination procedures, industrial hygiene monitoring, medical surveillance and the use of administrative controls. SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance : liquid Color : clear Odor : No information available. Odor Threshold : No data available pH

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