SAFETY DATA SHEET MSDS-98

SAFETY DATA SHEET MSDS-98

PRODUCT: INGEZIM GLUTEN QUICK REF: 3.0.GL2.K.2

LAST REVISION: 24/6/15 PAGE: Page 1 of 23

1. IDENTIFICATION

MANUFACTURER: INMUNOLOGIA Y GENETICA APLICADA, SA

ADDRESS: Hnos. García Noblejas 41, 2ª planta.

28037 MADRID (SPAIN)

TELEPHONE NUMBER: 91 3680501

FAX: 91 4087598 e-mail: [email protected]

2. PRODUCT COMPOSITION

PRODUCT # DESCRIPTION WS01-25 Washing Solution DE12-05 Sample diluent SU01-01 Substrate SF01-01 Stop Solution 30GLUK2 Conjugate 30GLUK2 Gliadin European Standards 30GLUK2 Coated Plates 30GLUK3 Extraction Buffer




3. MATERIAL SAFETY DATA

PRODUCT #: WS01-25 Washing Solution

1. IDENTIFICATION: Product Name: Washing Solution 25x concentrated Product use: Laboratory reagent for diagnostic or research use

Chemical reagents are purchased from SIGMA, MERCK and PANREAC, and finally handled in INGENASA

2. HAZARDS IDENTIFICATION:

Statement of hazardous nature : Kathon CG is used in this composition.

Risk phrases KATHON CG: Irritating to eyes, respiratory system and skin.

Safety phrases KATHON CG: S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice; S45: In case of accident or if you feel unwell, seek medical advice

immediately (show label where possible); S28: After contact with skin, wash immediately with plenty

of ... (to be specified by the manufacturer) ; S56: Dispose of this material and its container to hazardous or special waste collection point

Hazardous Ingredients

Approximate concentration

Exposure Limits LD50/LC50 Species and route

TOXICITY

Kathon CG 0.2% vol/vol - - Not at use dilution

Statement of hazardous nature : Non hazardous reagents above 1% are used in this formulation or carcinogens above 0.1% so the solution is classified as not dangerous under EU Directives (67/548/ECC and 1999/45/EC) or hazardous under US OSHA Hazard Communication Regulations (29 CFR 1910-1200.

Safety phrases: S20: When using do not eat or drink. S36: Wear suitable protective clothing.

2.1. Emergency overview Physical state: Liquid Odour and appearance: Clear solution with no odour

2.2. Potential health effects Due to the composition and the concentration of the reagents used for the formulation of this solution, it can be considered as non hazardous.

Route of entry: Not known Toxicological properties: Not known Irritancy to product: Not known Sensitivity to product: Not known

3. COMPOSITION/INFORMATION ON INGREDIENTS:

Mixture of salts and detergent, in distilled water

4. FIRST AID MEASURES:

Although the reagent can be considered non hazardous, in case of: Skin contact: Flush with water. Obtain medical attention if irritation occurs. Eyes contact: Flush with copious amounts of water. Obtain medical attention if irritation occurs. Inhalation: Not applicable

Ingestion: Drink as much water as possible. Obtain medical attention if any gastric disorders appear.




5. FIRE AND EXPLOSION HAZARD DATA: Flammability: No Means of extinction: Not applicable Hazardous combustion products: Not known

6. ACCIDENTAL RELEASE MEASURES: Clean up the area with water.

7. HANDLING AND STORAGE: Personal protective equipment is not required. Any case, we recommend wearing adequate laboratory clothes. The reagent must be stored between 2º and 8ºC.

8. EXPOSURE AND CONTROL: Non special equipment is required.

9. PHISICAL AND CHEMICAL PROPERTIES Physical state: Liquid Boiling point: 100ºC Odour and appearance: Clear solution with no odour Solubility in water at 20ºC: 290 g/l Freezing point: 0ºC pH: 7,0 - 7,4

10. STABILITY AND REACTIVITY Stability: Stable at +4ºC Incompatible materials: Not known

11. TOXICOLOGICAL INFORMATION Toxicological properties: Not known

12. ECOLOGICAL INFORMATION WGK: 0 Substance slightly dangerous for water.

13. DISPOSAL CONSIDERATIONS Observe local, state and federal rules for proper disposal

14. TRANSPORT INFORTMATION

ADG Code: This product is not classified as a dangerous good. No special transport conditions are necessary.

15. REGULATORY INFORMATION The significant ingredients of this formulation are compliant with Spanish regulations.

16. OTHER INFORMATION

This MSDS contains only safety-related information. For other data, contact with INGENASA.

NOTE Although the information and recommendations contained in this INGENASA Material Health and Safety Data Sheet are compiled from sources believed to be reliable, we accept no responsibility its accuracy, sufficiency or reliability or for any loss or injury resulting from use of this information.




PRODUCT #: DE12-05 Diluent

1. IDENTIFICATION: Product Name: Diluent DE12-05 Product use: Laboratory reagent for diagnostic or research use

Chemical reagents are purchased from SIGMA, MERCK and PANREAC, and finally handled at INGENASA


Statement of hazardous nature : Kathon CG is used in this composition.

Risk phrases KATHON CG: Irritating to eyes, respiratory system and skin.

Safety phrases KATHON CG: S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice; S45: In case of accident or if you feel unwell, seek medical advice

immediately (show label where possible); S28: After contact with skin, wash immediately with plenty

of ... (to be specified by the manufacturer) ; S56: Dispose of this material and its container to hazardous or special waste collection point




TOXICITY

Kathon CG 0,1% vol/vol - - Not at use dilution


2.2. Potential health effects

Due to the concentration of the reagents used for the formulation of this solution, it can be considered as non hazardous.



Mixture of salts, detergent and preservative, in distilled water


Although the reagent can be considered non hazardous, in case of: Skin contact: Flush with water. Obtain medical attention if irritation occurs. Eyes contact: Flush with copious amount of water. Obtain medical attention if irritation occurs. Inhalation: Not applicable









9. PHYSICAL AND CHEMICAL PROPERTIES: Physical state: Liquid Boiling point: 100ºC Odour an appearance: Clear solution with no odour Solubility in water at 20ºC: 120 g/l Freezing point: 0ºC pH: 7,0 - 7,4

10. STABILITY AND REACTIVITY: Stability: Stable at +4ºC Incompatible materials: Not known







16. OTHER INFORMATION This MSDS contains only safety-related information. For other data, contact with INGENASA.





PRODUCT #: SU01-01 Substrate













PRODUCT #: SF02-01 Stop Solution

1. IDENTIFICATION: Product Name: Sulphuric acid in water solution Product use: Laboratory reagent for diagnostic or research use

Chemical reagent is are purchased from PANREAC, and finally handled in INGENASA


Pictogram

GHS05

Signal Word: Danger

Statement of hazardous nature : Sulphuric acid 93/98% is classified as: C, Corrosive (67/548/CEE, 1999/45/CE).

Hazard statements: H314, H290.

Precautionary statements: P280-P303+P361+P353-P304+P340+P310-P315+P351+P338.

1.1. Emergency overview Physical state: Liquid Odour and appearance: Clear solution with no odour Major Health Hazards: Causes burns, skin irritant.


Statement of hazardous nature : Sulphuric acid 93/98% is classified as: C, Corrosive. At concentration used in this

“stop solution” (<0,3%) it is irritant.

Risk phrases R36, 37, 38. Irritating to eyes, respiratory system and skin.

Safety phrases: S20, S23, S28, S36, S46, S24/25. When using, do not eat or drink. Do not breathe vapours or mist. After contact with skin, wash inmediatelly with plenty of soap and water. Wear suitable protective clothing. If swallowed, contact a doctor ot Poisons Information center inmediatelly and show this MSDS. Avoid contact with skin and eyes.





TOXICITY

H2SO4 <3% vol/vol - - Irritant at % used





4.1 General indications: The product stop solution is a 0.5M dilution of sulphuric acid and hence is not as toxic as the pure reagent. Nevertheless we recommend observing all recommendations for pure reagent. Never provide drink or induce vomiting in the event of loss of consciousness.

4.2 Inhaling: Take the person out into the fresh air. In the event sickness persists, seek medical assistance.

4.3 Contact with the skin: Wash with plenty of water. Remove contaminated clothing. Take the product out with cotton wool soaked in polyethylene-glycol 400.

4.4 Eyes: Wash with plenty of water (for at least 15 minutes), keeping eyelids open. Seek medical assistance.

4.5 Swallowing: Drink large amounts of water. Avoid vomiting (there is a risk of perforation). Seek immediate medical assistance. Do not neutralize.

4. FIRE AND EXPLOSION HAZARD DATA: The product stop solution is a 0.5M dilution of sulphuric acid and hence is not as toxic as the pure reagent. Nevertheless we recommend observing all recommendations for pure reagent.

5.1 Suitable fire-extinguishing means: As appropriate to the environment.

5.2 Fire-fighting means which must NOT be used: No specific data.

5.3 Special risks: Incombustible. In the event of fire, toxic fumes may form: SOx. Upon contact with metals, hydrogen gas may form (there is a risk of explosion).

5.4 Protective equipment: Suitable clothing and footwear. Self-contained breathing equipment.

5. ACCIDENTAL RELEASE MEASURES: The product stop solution is a 0.5M dilution of sulphhuric acid and hence is not as toxic as the pure reagent. Nevertheless we recommend observing all recommendations for pure reagent.

6.1 Individual precautions: Do not inhale the fumes. Avoid contact with the skin, eyes or clothing. Ensure adequate ventilation.

6.2 Precautions for care of the environment: Do not allow it to enter the drainage system. Avoid pollution of the soil, water supplies and drains.




6.3 Methods for collection/cleaning: Collect up with absorbent materials (Panreac General Absorbent, Kieselguhr, etc.) or, if none available, dry sand or earth, and deposit in waste containers for subsequent elimination in accordance with current legislation. Clean any remains with plenty of water. Neutralize with diluted sodium hydroxide.

6. HANDLING AND STORAGE:

7.1 Handling: No special indications.

7.2 Storage: Well sealed containers. In well ventilated premises. Room temperature. Do not store in metal containers.

7. EXPOSURE AND CONTROL: The product stop solution is a 0.5M dilution of sulphhuric acid and hence is not as toxic as the pure reagent. Nevertheless we recommend observing all recommendations for pure reagent.

8.1 Technical protective measures: Ensure good ventilation and renewal of the air in the premises.

8.2 Exposure limit control: VLA-EC: 3 mg/m3 VLA-ED(H2SO4): 1 mg/m3

8.3 Respiratory protection: In the event of fumes forming/aerosols, use suitable respiratory protection. Filter P.

8.4 Hand protection: Use suitable gloves neopren PVC

8.5 Eye protection: Use suitable goggles.

8.6 Individual hygiene measures: Remove contaminated clothing. Use suitable work clothing. Wash hands and face before breaks and when the job is done.

8.7 Environmental exposure controls: Fulfill the commitments under local environmental protection legislation.

8. PHYSICAL AND CHEMICAL PROPERTIES: Appearance: liquid Colour: Colourless Granulometry: N/A Odour: Characteristic. pH: N/A freezing point: 0°C

Initial boiling point and boiling range: 100 °C Flash point: N/A Flammability (solid, gas): N/A Upper/lower flammability or explosive limits: N/A




Vapour density: N/A Solubility: Miscible with water Auto-ignition temperature: N/A Decomposition temperature: N/A Viscosity: N/A

9. STABILITY AND REACTIVITY:

10.1 Conditions which should be avoided: The product is chemically stable under standar ambient conditions (room temperature).

10.2 Hazardous decomposition products: Toxic gases.

10.3 Complementary information: Hygroscopic. Corrosive.

10. TOXICOLOGICAL INFORMATION The product stop solution is a 0.5M dilution of sulphhuric acid and hence is not as toxic as the pure reagent. Nevertheless we recommend observing all recommendations for pure reagent.

11.1 Acute toxicity: LD50 oral rat : 2.150 mg/kg LC50 inh rat : 510 mg/m3 2h

11.2 Dangerous effects for health: If fumes inhaled: Irritations to the respiratory tracts. Very corrosive substance. Upon contact with the skin: Causes burns Through contact with the eyes: burns blindness (irreversible injury of the optic nerve) If swallowed: Burns in the digestive apparatus Severe pains, with risk of perforation. Can cause nausea vomiting diarrhoea After a period of latency: pylorostenosis.

11. ECOLOGICAL INFORMATION The product stop solution is a 0.5M dilution of sulphhuric acid and hence is not as toxic as the pure reagent. Nevertheless we recommend observing all recommendations for pure reagent.

12.1 Toxicity: 12.1.1 - EC50 test (mg/l): Water organisms 10 mg/l (96h) Classification: Extr. toxic Fish (For sulphuric ac.) 1,2 mg/l Classification: Extr. toxic Fish (For sodium sulphate) 7000 mg/l Classification: Toxic Bacteria (For sodium sulphate) 2500 mg/l Classification:




Very toxic 12.1.2. - Receptor medium: Risk for the water environment High Risk for the land environment Medium 12.1.3. - Observations: Extremely toxic for fish. The ecotoxicity is due to the pH deviation and the formation of sodium sulphate.

12.2 Persistence and Degradability : 12.2.1 - Test: 12.2.2. - Biotic degradation classification: BOD5/COD Biodegradability 12.2.3. - Abiotic degradation depending on pH: 12.2.4. - Observations:

12.3 Bioaccumulative potential: 12.3.1. - Test: 12.3.2. - Bioaccumulation: Risk 12.3.3. - Observations:

12.4 Mobility in soil : Data not available.

12.5 Assessment PBT and MPMB : Data not available.

12.6 Other possible effects on the environment: Neutralize with NaOH at pH 7. Highly corrosive product. There is danger in the event of uncontrolled dumping (in either rivers or water channels).

12. DISPOSAL CONSIDERATIONS

13.1Substance or preparation:

In the European Union, there are no homogeneous standards established for elimination of chemical waste, which is waste of a special nature, and treatment and elimination of same is subject to the domestic legislation in each country.

In view of this, in each case, you should contact the competent authority or those companies legally authorized for elimination of waste.

2001/573/EC: Council Decision of 23 July 2001 amending Commission Decision 2000/532/EC as regards the list of wastes.Council Directive 91/156/EEC of 18 March 1991 amending Directive 75/442/EEC on waste.

13.2Contaminated containers:

Contaminated containers and packaging of dangerous substances or preparations must be treated in the same manner as the actual products contained in them.




13. TRANSPORT INFORMATION No special transport conditions are necessary.

14. REGULATORY INFORMATION

The substance pure is subject to Regulation (EC) No 273/2004 of the European Parliament and of the Council, of 11 February 2004 on drug precursors, Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors, Commission Regulation (EC) No 1277/2005 of 27 July 2005 laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and for Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors.


All data described concerns to the Sulphuric acid 93-98% from MSDS of PANREAC. Bear in mind that the

product named as “stop solution” which is included in this kit, is a solution of Sulphuric acid 0.5M. INGENASA

has decided to describe the worst effects in worst conditions regarding health although the solution 0.5M has

lower hazardous effects. This MSDS contains only safety-related information. For other data, contact with INGENASA.





PRODUCT #: 30GLUK2 Extration Buffer

1. IDENTIFICATION: Product Name: Extration Buffer. Product use: Laboratory reagent for diagnostic or research use ORIGEN: Chemical reagents are purchased from SIGMA, MERCK and PANREAC, and finally handled at INGENASA.






Due to the concentration of the reagents used for the formulation of this solution, it can be considered as non hazardous.



Mixture of salts n distilled water


Although the reagent can be considered non hazardous, in case of: Skin contact: Flush with water. Obtain medical attention if irritation occurs. Eyes contact: Flush with copious amount of water. Obtain medical attention if irritation occurs. Inhalation: Not applicable









9. PHYSICAL AND CHEMICAL PROPERTIES: Physical state: Liquid Boiling point: 100ºC Odour an appearance: Clear solution with no odour Solubility in water at 20ºC: 120 g/l Freezing point: 0ºC pH: 7,0 - 7,4

10. STABILITY AND REACTIVITY: Stability: Stable at +4ºC Incompatible materials: Not known







16. OTHER INFORMATION This MSDS contains only safety-related information. For other data, contact with INGENASA.





PRODUCT #: 30GLUK2 Conjugate

1. IDENTIFICATION: Product Name: Conjugate Product use: Laboratory reagent for diagnostic or research use




CAS# EINECS# EU Classification TOXICITY

Bromonitrodioxane 0,02% 30007-47-7 250-001-7 Xn,R22,S36/37/39 Not at use dilution

Methylisothiazolone 0,02% 2682-20-4 220-239-6 N, C, r20/21-34-43-50/53, S24-26-

36/37/39-45-60-61

Not at use dilution




2.2. Potential health effects Route of entry: Not known Toxicological properties: Not known Irritancy to product: Not known Sensitivity to product: Not known


Dilution of HPLC Purified monoclonal antibody specific for secalin, in a stabilizing solution (SurModics, Stabilizime Select solution)


Although the reagent can be considered non hazardous, in case of: Skin contact: Flush with water. Obtain medical attention if irritation occurs. Eyes contact: Flush with copious amounts of water. Obtain medical attention if irritation occurs. Inhalation: Not applicable








Personal protective equipment is not required. Any case, we recommend wearing adequate laboratory clothes. The reagent must be stored between 2º and 8ºC.


9. PHISICAL AND CHEMICAL PROPERTIES

Physical state: Liquid Boiling point: 100ºC Odour and appearance: Clear solution with no odour Solubility in water at 20ºC: 290 g/l Freezing point: 0ºC pH: 7,0 - 7,4


11. TOXICOLOGICAL INFORMATION

Toxicological properties: Not known

12. ECOLOGICAL INFORMATION

WGK: 0 Substance slightly dangerous for water.


Observe local, state and federal rules for proper disposal


This product is not classified as a dangerous good. No special transport conditions are necessary.








PRODUCT #: 30GLUK2 Gliadin Standards

1. IDENTIFICATION: Product Name: Gliadin Standars Product use: Laboratory reagent for diagnostic or research use.

Chemical reagent is are purchased from SIGMA, and finally handled at INGENASA

2. HAZARDS IDENTIFICATION



CAS# EINECS# EU Classification TOXICITY

Bromonitrodioxane 0,02% 30007-47-7 250-001-7 Xn,R22,S36/37/39 Not at use dilution

Methylisothiazolone 0,02% 2682-20-4 220-239-6 N, C, r20/21-34-43-50/53, S24-26-

36/37/39-45-60-61

Not at use dilution

2.1 Classification of the substance or mixture Non hazardous reagents above 1% are used in this formulation or carcinogens above 0.1% so the solution is classified as not dangerous under EU Directives No 1272/2008. This substance is not classified as dangerous according to Directive 67/548/EEC.

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

3. COMPOSITION/INFORMATION ON INGREDIENTS

Gliadin from wheat diluted in a stabilizing solution (SurModics, Stabilizime Select solution).

4. FIRST AID MEASURES No special measures are needed. Use laboratory appropriate clothes.

5. FIREFIGHTING MEASURES Flammability: No Means of extinction: Not applicable Hazardous combustion products: Not known

6. ACCIDENTAL RELEASE MEASURES Clean the pace with water.

7. HANDLING AND STORAGE

7.1 Precautions for safe handling Avoid contact with skin and eyes.

7.2 Conditions for safe storage, including any incompatibilities Store in cool place.




8. EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1 Control parameters Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.

Personal protective equipment The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.

9. PHYSICAL AND CHEMICAL PROPERTIES Physical state: Liquid Boiling point: 100ºC Odour and appearance: Clear solution with characteristic odour Solubility in water at 20ºC: yes Freezing point: 0ºC pH: 7,0 - 7,4

















PRODUCT #: 30GLUK2 Coated Plates

1. IDENTIFICATION: Product Name: Coated plates Product use: Laboratory reagent for diagnostic or research use


Statement of hazardous nature : Non hazardous reagents are used in it composition.


2.1. Emergency overview Physical state: Solid Odour and appearance: Not applicable

2.2. Potential health effects Due to the composition and the concentration of the reagents used for the formulation of this solution, it can be considered as non hazardous.



Polystyrene 96-wells plates coated with gliadin, secalin and hordein-specific Monoclonal Antibody.


Skin contact: Not applicable Eyes contact: Not applicable Inhalation: Not applicable

Ingestion: Not applicable


6. ACCIDENTAL RELEASE MEASURES:

Not applicable


Personal protective equipment is not required. Any case, we recommend wearing adequate laboratory clothes. The reagent must be stored between 2º and 8ºC.





9. PHISICAL AND CHEMICAL PROPERTIES

Physical state: Solid Boiling point: Not applicable Odour and appearance: Not applicable Solubility in water at 20ºC: Not applicable Freezing point: Not applicable pH: Not applicable










15. REGULATORY INFORMATION

The significant ingredients of this formulation are compliant with Spanish regulations.




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SAFETY DATA SHEET MSDS-98