Material Safety Data Sheet
According to 93/112/EC, ISO 11014-1, and OSHA Standard 29 CFR 1910.1200
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
STREPTEX
Revision Date: 30 September 2003
Product Name Product Code Remel List Number Short Code
Streptex Kit (50 tests) WRZL5080U 30950501 ZL50
Streptex Latex Group A (50 tests) WRZL5180Q 30950601 ZL51
Streptex Latex Group B (50 tests) WRZL5280L 30950701 ZL52
Streptex Latex Group C (50 tests) WRZL5380G 30950801 ZL53
Streptex Latex Group D (50 tests) WRZL5480C 30950901 ZL54
Streptex Extraction Enzymes (11ml) WRZL5580X 30951001 ZL55
Streptex Latex Group F (50 tests) WRZL5680T 30951101 ZL56
Streptex Latex Group G (50 tests) WRZL5780P 30951201 ZL57
Streptex Positive Control (2 ml) WRZL5880K 30164601 ZL58
Streptex Acid Extraction Kit (50 tests) WRZL5980F 30951301 ZL59
Streptex Rapid Kit (50 tests) WRZL6080B 30950555 ZL60
Streptex Kit (200 test) WRZL6180A 30164701 ZL61
Contacts: -
Company Identification: REMEL EUROPE LTD.
REMEL HOUSE Martin C. Lacey
CLIPPER BOULEVARD WEST Tel: +44 1322 295600
CROSSWAYS Fax: +44 1322 225413
DARTFORD
KENT DA2 6PT
UK
2. CHEMICAL CHARACTERISATION
Test Latex ZL51-54 & ZL56-57 & Positive Control ZL59
Chemical(s) CAS No. EC Number Formula
Sodium Dihydrogen
13472-35-0 N/A H2NaO4P.2H2O
Orthophosphate dihydrate
Disodium hydrogen
7558-80-7 231-449-2 HNa2O4P
orthophosphate anhydrous
Sodium Azide (0.1%) 26628-22-8 247-852-1 N3Na
Extraction Enzyme ZL55 (diluted)
Chemical(s) CAS No. EC Number Formula
HOCH2CBr(NO2)C
Bronopol (0.112%) 52-51-7 200-143-0
H2OH
Calcium Chloride 7774-34-7 N/A CaCl2
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Acid Extraction Kit ZL59
Extraction Tube
Chemical(s) CAS No. EC Number Formula
Sodium Nitrite 7632-00-0 231-555-9 NaNO2
Extraction Reagent 1
Chemical(s) CAS No. EC Number Formula
Glacial Acetic Acid 64-19-7 200-580-7 CH3COOH
Bromocresol Purple 115-40-2 204-087-8 C21H16Br2O5S
Sodium Hydroxide 1310-73-2 215-185-5 NaOH
Extraction Reagent 2
Chemical(s) CAS No. EC Number Formula
Trizma Base 77-86-1 201-064-4 C4H11NO3
3. HAZARD IDENTIFICATION
Symbol R-phrase S-phrase
S35 This material and its container must be
R22 Harmful if swallowed disposed of in a safe way
R32 Contact with acids S36 Wear suitable protective clothing
liberates very toxic gas S46 If swallowed, seek medical advice
Harmful (Xn)
immediately and show this container or label
S22 Do not breathe dust
S26 In case of contact with eyes, rinse
immediately with plenty of water and seek
medical advice
S35 This material and its container must be
R36 Irritating to eyes
disposed of in a safe way
S37/39 Wear suitable gloves and eyes/face
Harmful (Xi)
protection if swallowed, seek medical
advice immediately and show this container
or label
Possible eyes, skin, respiratory and gastrointestinal tract irritant
Exposure effects
Ingestion of large amounts may cause gastrointestinal irritation, nausea, vomiting
Ingestion
and diarrhoea. Low hazard for usual industrial handling.
Repeated or prolonged inhalation of aerosols of this solution may cause mucous
Inhalation
membrane and respiratory tract irritation. Low hazard for usual industrial handling.
Prolonged contact may cause skin irritation. Low hazard for usual industrial
Skin
handling. May be absorbed through the skin.
May cause transient eye irritation. Symptoms include stinging, tearing, redness, and
Eyes
swelling of eyes.
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4. FIRST AID MEASURES
If victim is conscious and alert, give 2-4 cupfuls of milk or water. Never give anything by
Ingestion
mouth to an unconscious person. Get medical aid.
Remove from exposure to fresh air immediately. If not breathing, give artificial
Inhalation
respiration. If breathing is difficult, give oxygen. Get medical aid.
Flush skin with plenty of soap and water for at least 15 minutes while removing
Skin
contaminated clothing and shoes. Get medical aid if irritation develops or persists.
Flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and
Eyes
lower eyelids. Get medical aid.
5. FIRE FIGHTING MEASURE
Not considered to be a fire or explosion hazard.
Fire & Explosion Hazards
Use media suitable for extinguishing surrounding fire.
Extinguishing Media
None
Flash point
6. ACCIDENTAL RELEASE MEASURE
Eyes: Wear appropriate protective eyeglasses or chemical safety goggles as described by
Protection
OSHA's eye and face protection regulations in 29 CFR 1910.133 or European
Standard EN166.
Skin: Wear appropriate protective gloves to prevent skin exposure.
Clothing: Wear appropriate protective clothing to prevent skin exposure.
Dilute with large quantity of water, absorb the solution with inert materials (e.g.
Small spills or
vermiculite, sand or earth) and place into a suitable closed container for disposal. Dispose
leaks
of in a manner consistent with federal, state and local regulations.
7. HANDLING AND STORAGE
Store in a cool, dry place. Store in a tightly closed container, away from
Storage
sources of heat. The reagents should be stored at 2 to 8癈. Once
reconstituted, the Extraction Enzyme should be stored at 2 to 8癈 where
they will retain their activity for at least 6 months after reconstitution, or
until the date shown on the labelled bottle. DO NOT FREEZE AND
THAW MORE THAN ONCE.
Wash thoroughly after handling. Use only in a well ventilated area. Avoid
Handling
contact with eyes, skin, and clothing. Keep container tightly closed.
Avoid ingestion and inhalation. Use established Good Laboratory
Working Practices.
8. EXPOSURE CONTROL/PERSONAL PROTECTION
Eyes: Wear appropriate protective eyeglasses or chemical safety goggles as
Protection
described by OSHA's eye and face protection regulations in 29 CFR
1910.133 or European Standard EN166.
Skin: Wear appropriate protective gloves to prevent skin exposure.
Clothing: Wear appropriate protective clothing to prevent skin exposure.
Good general ventilation should be sufficient to control airborne contamination.
Ventilation
Use good laboratory techniques to avoid aerosol formation.
Respiratory protection should not be required under normal conditions of use. If
Respirator Use
respiratory protection is deemed necessary, follow OSHA respirator regulations in
29 CFR 1910.134, using a NOISH-approved organic vapour respirator.
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9. PHYSICAL AND CHEMICAL PROPERTIES
Strep. Group
Extraction Extraction Extraction Extraction
Pos. Control
A, B, C, D, F
Enzyme Reagent 1 Reagent 2 Tube
&G
Freeze-dried
Liquid Liquid Liquid Liquid Powder
Appearance
Pellet
White Colourless Brown Yellow Colourless Colourless
Colour
Characteristic Odourless Characteristic Characteristic Characteristic Characteristic
Odour
Water
Soluble Soluble Soluble Soluble Soluble Soluble
Solubility
Not Volatile Not Volatile Not Volatile Not Volatile Not Volatile Not Volatile
Volatility
Not Not Not Not Not Not
Flammability
Combustible Combustible Combustible Combustible Combustible Combustible
7.4 ?01 7.4 ?01 N/A 3 ?0.1 11 ?0.1 6.5 ?0.1
pH
10. STABILITY AND REACTIVITY
Stable
Chemical Stability
Will not generate hazardous polymerisation
Hazardous Polymerisation
Temperature above room temperature and incompatible substances.
Conditions to avoid
Stable under normal temperatures and pressures.
Stability
Strong oxidizing agents, strong reducing agents, strong bases, acid
Incompatibilities
chlorides, acid anhydrides, moisture.
Oxides of phosphorus, nitrogen oxides, carbon monoxide, carbon dioxide,
Hazardous Decomposition
sodium oxide, hydrogen bromide and nitrogen.
11. TOXICOLOGICAL INFORMATION
Carcinogenicity: IARC, NIOSH, NTP, or OSHA does not list Disodium hydrogen
orthophosphate, Sodium Dihydrogen Orthophosphate Dihydrate, Bronopol
and Calcium Chloride, Sodium nitrate, Acetic acid, Trizma Base,
Bromocresol purple and Sodium hydroxide as carcinogenic. ACGIH lists
sodium azide as: A4 ?Not Classifiable as a Human Carcinogen.
Acute Effects: Possible skin, eye, respiratory and gastrointestinal tract irritation.
Chronic Effects: None known.
Exposure Limits:
Ingredient OSHA PEL ACGIH TLV NIOSH REL
0.29 mg/m3
Sodium Azide None established None established
Disodium Hydrogen Orthophosphate None established None established None established
Sodium Dihydrogen Orthophosphate
None established None established None established
Dihydrate
Bronopol None established None established None established
Calcium Chloride None established None established None established
Sodium nitrate None established None established None established
Acetic acid 25 ppm 15 ppm 10 ppm
Bromocresol purple N/A N/A N/A
2 mg/m3 2 mg/m3 2 mg/m3
Sodium hydroxide
Trizma Base N/A N/A N/A
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Toxicological Data No toxicological data is available for these products as an entity. Selected
RTECS data for components:
Ingredient (RTECS Number) LD50, oral rate (Rodent)
Sodium Azide (VY8050000) 27 mg/kg
Disodium Hydrogen Orthophosphate
17mg/kg
(WC4500000)
Sodium Dihydrogen Orthophosphate >5008 mg/kg
Dihydrate (WA1900500)
Bronopol (TY3385000) 180 mg/kg
Calcium Chloride Dihydrate (EV9830000) Not available
Sodium nitrate (RA1225000) 180 mg/kg
Acetic acid (AF1225000) 3310 mg/kg
Bromocresol purple Not Available
Sodium hydroxide (WB4900000) 500 mg/kg (Rabbits)
Trizma Base (TY2900000) 5900 mg/kg
12. ECOLOGICAL INFORMATION
No data is available on the Ecotoxicity or Environmental Fate for these products.
13. DISPOSAL INFORMATION
Each product as an entity is not regulated as a hazardous waste by the US Environmental Protection Agency.
Wastes containing these products should be disposed of in a manner consistent with federal, state and local
regulations.
14. TRANSPORT INFORMATION
The United States Department of Transportation, or the International Air Transport Association/International
Civil Aviation Organisation does not currently regulate these products as hazardous material or dangerous
goods.
15. REGULATORY INFORMATION
European Labelling in accordance with EC Directive:
Symbol R-phrase S-phrase Directive
S35 This material and its container must be
R22 Harmful if swallowed disposed of in a safe way
R32 Contact with acids S36 Wear suitable protective clothing
liberates very toxic S46 If swallowed, seek medical advice
gas
Harmful (Xn) immediately and show this container or
label 2001/58/EC
98/79/EC
S22 Do not breathe dust
93/112/EC
S26 In case of contact with eyes, rinse
EN 375
immediately with plenty of water and
EN 980
seek medical advice
S35 This material and its container must
R36 Irritating to eyes
be disposed of in a safe way
Harmful (Xi) S37/39 Wear suitable gloves and eyes/face
protection if swallowed, seek medical
advice immediately and show this
container or label
Comply with the UK Chemicals (Hazard Information and Packaging for Supply) Regulations 2002
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USA:
All component solutions for each product are not listed on the Toxic Substances Control Act (TSCA)
Chemical Inventory, see regulations in 40 CFR 700 for details. Comply with 21 CFR 809 (In vitro
Diagnostic Products for Human Use), 21 CFR 809.10 (Labelling for In vitro Diagnostic Products) and 16
CFR 1500 (Hazardous Substance).
Canada:
These products have a WHMIS classification of Not Controlled.
Japan:
Sodium Azide is listed in the Poisonous and Deleterious Substance Control Act as a poisonous substance.
16. ADDITIONAL INFORMATION
The chemical, physical and toxicological properties of these products have not been thoroughly
investigated.
For in vitro diagnostic use only
For professional use only
These products contains bovine Serum Albumin
The above information is believed to be current and accurate; however, Remel makes no warranty with
respect to such information and assumes no liability for any loss or injury, which may result from the use of
this information. Users should conduct their own investigations to determine the suitability of the
information.
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