Promonitor-ANTI-RTX-1DV

Progenika Biopharma, S.A

Revision date : 2016-11-17

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GHS07 GHS05
Health risk rating 2
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

231-639-5/7664-93-9

Name of the chemical

sulphuric acid

Concentration

<5%

EC/CAS

247-852-1/26628-22-8

Name of the chemical

Sodium Azide

Concentration

<0.00001%

General Information

Revision date

2016-11-17

Product name

Promonitor-ANTI-RTX-1DV

Substance name

Sodium azide at concentrations greater than 0 1% is considered fatal if swallowed or in contact with skin and may

Product Synonyms

Sulfuric acid

CAS No.

7664-93-9

Manufacturer Name

Progenika Biopharma, S.A

Emergency telephone

915 620 420

Icons in SDS

GHS05 GHS07

Company Information

company name

Progenika Biopharma, S.A

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

support@progenika.grifols.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H315, H319

Hazard statements

Code

Statements

H315

Causes skin irritation

Section 2

SECTION 2: Hazards identification

2.2 Label elements

Sulfuric acid 5-15 %

Signal word

Danger H315 - Causes skin irritation.

Hazard statements

H319 - Causes serious eye irritation. P264 - Wash exposed parts of the body thoroughly after handling. P280 - Wear protective gloves/ protective clothing/ eye protection/ face protection. P302 + P352 - IF ON SKIN: Wash with plenty of soap and water.

Precautionary statements

P305 + P351 + P338 – IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P332 + P313 - If skin irritation occurs: Get medical advice/attention. P337 + P313 - If eye irritation persists: Get medical advice/attention. P362 - Take off contaminated clothing and wash before reuse.

2.3 Other hazards

None known Note: Progenika Biopharma S.A. decided to include the exclamation mark pictogram for advising customers about the hazards related to the substance TMB, which should be handled with care, with appropriate personal protective equipment and following good laboratory and safety practices, although very diluted. This exclamation mark appears in the external kit label and in the SUBSTRATE reagent label. Equally, the reagents containing sodium azide should be handled following good laboratory and safety practices. In this case, any label was considered as necessary due to its concentration (<0.00001%) is far from the 0.1% concentration cut-off for being considered hazardous. Always handling these substances, work in a well-ventilated area. Remove immediately all contaminated clothing. If in contact to skin or eyes, rinse immediately with plenty of water. If ingested, rinse mouth with water, do not induce vomiting. Get medical attention/advice if you feel unwell.

2.1 Classification of the substance or mixture

Skin Corrosion/irritation Category 2 Serious Eye Damage/Eye Irritation Category 2 GHS label elements: Sulfuric acid 5-15 % Hazard Pictograms Signal Word Danger H315 - Causes skin irritation. Hazard Statements H319 - Causes serious eye irritation. P264 - Wash exposed parts of the body thoroughly after handling. P280 - Wear protective gloves/ protective clothing/ eye protection/ face protection. P302 + P352 - IF ON SKIN: Wash with plenty of soap and water. Precautionary Statements P305 + P351 + P338 – IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P332 + P313 - If skin irritation occurs: Get medical advice/attention. P337 + P313 - If eye irritation persists: Get medical advice/attention. P362 - Take off contaminated clothing and wash before reuse. Other hazards: None known. Note: Progenika Biopharma S.A. decided to include the exclamation mark pictogram for advising customers about the hazards related to the substance TMB, which should be handled with care, with appropriate personal protective equipment and following good laboratory and safety practices, although very diluted. This exclamation mark appears in the external kit label and in the SUBSTRATE reagent label. Equally, the reagents containing sodium azide should be handled following good laboratory and safety practices. In this case, any label was considered as necessary due to its concentration (<0.00001%) is far from the 0.1% concentration cut-off for being considered hazardous. Always handling these substances, work in a well-ventilated area. Remove immediately all contaminated clothing. If in contact to skin or eyes, rinse immediately with plenty of water. If ingested, rinse mouth with water, do not induce vomiting. Get medical attention/advice if you feel unwell. SECTION 3. COMPOSITION / INFORMATION ON INGREDIENTS Below Promonitor- reportabl ANTI-RTX- Substance Weight % IUPAC CAS No. EC No. e cut-off 1DV reagent quantity STOP Sulfuric acid < 5% Sulfuric acid 7664-93-9 231-639-5 No 4-(4-amino-3,5- 3,3',5,5'- dimethylphenyl) SUBSTRATE Tetramethylbenzi < 0.05% 54827-17-7 259-364-6 Yes -2,6- dine (TMB) dimethylaniline Calibrators Sodium azide < 0.00001% Sodium azide 26628-22-8 247-852-1 Yes and PC SECTION 4. FIRST-AID MEASURES Description of necessary first-aid measures: Inhalation: Remove victim to fresh air and seek medical advice immediately. If breathing is difficult, give oxygen. Do not use mouth-to-mouth resuscitation if victim ingested or inhaled the substance; induce artificial respiration with a respiratory medical device. Skin contact: Remove all contaminated clothing and shoes. Wash skin with water and soap for at least 15 minutes. Seek medical advice immediately. Eye contact: Flush eyes with water for at least 15 minutes, also under the eyelids, and seek medical advice immediately. Remove contact lenses and continue rinsing. Ingestion: Rinse mouth with water. Never give anything by mouth to an unconscious person. Do not induce vomiting. Seek medical attention immediately. Protection of first-aiders: Ensure that medical personnel are aware of the material(s) involved, take precautions to protect themselves and prevent spread of contamination. Most important symptoms/effects, acute and delayed: The most important known symptoms and effects are described in Section 2: Hazard Identification and Section 11: Toxicological Information. Indication of immediate medical attention and special treatment needed: Symptomatic treatment by physician. Show this document to the doctor. SECTION 5. FIRE-FIGHTING MEASURES Suitable extinguishing media: No restrictions. Specific hazards arising from the chemical: Thermal decomposition of sulfuric acid can release Sulphur oxides. Special protective actions for fire-fighters: Fire-fighters should wear appropriate protective equipment and self- contained breathing apparatus. SECTION 6. ACCIDENTAL RELEASE MEASURES Personal precautions, protective equipment and emergency procedures Ensure adequate ventilation and use personal protective equipment (see Section 8: Exposure Controls/Personal Protection). Environmental precautions It should not be released into the environment (see Section 12: Ecological information). Do not allow to enter drain/sewers, surface or ground water. Methods and material for containment and cleaning up After spillage, collect the dry solid waste, avoiding the formation of dust. Carefully collect the liquid after diluting with water in suitable containers for disposal (see Section 13: Disposal Considerations). No restrictions on absorbent material. Reference to other sections Not applicable. SECTION 7. HANDLING AND STORAGE Precautions for safe handling Wear personal protective equipment. Non-inflammable liquid. Non-consumable liquid, avoid ingestion and inhalation. Handle with care, with appropriate personal protective equipment and following good laboratory and safety practices. Conditions for safe storage, including any incompatibilities Containers which are opened must be carefully resealed and kept upright to prevent leakage. Store according to manufacturer specifications and in a cool, dry and well-ventilated place. Avoid store sulfuric acid together with: Alkalis (caustic solutions). SECTION 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Control parameters: Occupational exposure limits / Biological limit values: The product does not contain any relevant quantities of hazardous materials with critical values that have to be monitored at the workplace. The lowest listed indicative occupational exposure limit value is TWA = 0.05 mg/m3 8 hr. Derived No Effect Level (DNEL) Exposure Route

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