MATERIAL SAFETY DATA SHEET
Order No.:
ESR105G/M/A, ESR1051G/M, 1052G/M and B235 (Annex A)
Product Name:
SERION ELISA classic Herpes-Simplex Virus 1+2 IgG/IgM/IgA,
SERION ELISA classic Herpes-Simplex Virus 1, 2 IgG/IgM and stopping solution (Annex A)
Product name: SERION ELISA classic
Herpes-Simplex Virus 1+2 IgG/IgM/IgA
SERION ELISA classic Herpes-Simplex Virus 1, 2 IgG/IgM
Order-No.: ESR105G/M/A, ESR1051G/M, ESR1052G/M
Company: Institut Virion\Serion GmbH
Serion Immundiagnostica GmbH
Konradstr. 1
97072 W眉rzburg, Germany
Phone 0049 (0) 931 鈥? 30 98 60
Fax. 0049 (0) 931 鈥? 5 26 50
Emergency phone: 0049 (0) 931 - 30 98 60
0049 (0) 228 - 2 87 32 11
1. Biological Safety
Antigen: purified virus particles of HSV type 1 and/or 2 (strain F and/or strain G)
Infectivity: production procedures are sufficient to inactivate the antigenic material;
however, it should be handled as if potentially infectious
Control sera: (diluted) human serum samples;
all control and cut-off sera have been tested and found negative for HBs-
Ag-, HCV- and HIV-antibodies
Products derived
From bovine sera: for stabilisation of control sera bovine serum albumin (BSA) and fetal calf
sera (FCS) are used; these products are derived from animals from BSE-
free geographical areas.
2. Toxicity of single components/chemicals
Kit Components Chemicals EU R- and S-paragraphs
Control sera Sodium azide (<0.1 %) R:28-32; S:28-45
Dilution buffer Sodium azide (<0.1 %) R:28-32; S:28-45
Tween-20 (0.1 %) R&S1
Washing solution Tween-20 (1.65 %) R&S1
(conc.) Sodium azide (<0.1 %) R:28-32; S:28-45
Stopping solution Sodium hydroxide (4.8 %) R35; S:26-37; S: 39-45
* see Annex A according to 91/155/EEC
Date: 23.07.03 replaces version dated: 03.07.03 page 1 of 7
Institut Virion\Serion GmbH according to 91/155/EEC
Serion Immundiagnostica GmbH
W眉rzburg, Germany
Annex A
Material Safety Data Sheet
Order-No.: B235
Product Name: Stopping solution
1. Identification of substance / preparation
and company identification
Product name: Stopping solution
Order-No.: B235
Synonym: Sodium hydroxide solution
Application: Stopping solution in SERION ELISA classic
Herpes-Simplex Virus 1+2 IgG/IgM/IgA
SERION ELISA classic Herpes-Simplex Virus 1, 2 IgG/IgM
Company: Institut Virion\Serion GmbH
Serion Immundiagnostica GmbH
Konradstr. 1
97072 W眉rzburg
Tel. 0049 - 931 鈥? 30 98 60
Fax. 0049 - 931 鈥? 5 26 50
Emergency phone no.: 0049 - 228 - 2 87 32 11
2. Composition / information on ingredients
Aqueous solution
Hazardous ingredients:
Chemical name* CAS No. % EU-number Classification
Sodium hydroxide 1310-73-2 4 - 5 215-185-5 C; R35
Full text of R-phrases in section 16
* The maximum allowable concentration (if available) is listed in section 8
3. Hazards identification
Causes severe burns.
4. First aid measures
After inhalation: fresh air. Call in physician.
After swallowing: drink plenty of water (if necessary several liters), avoid
vomiting (danger of perforation!). Call in physician
immediately. Do not attempt to neutralize.
After skin contact: Wash of with plenty of water. Dab with polyethylene glycol
400. Remove contaminated clothing immediately.
After eye contact: rinse (eyelid wide open) with plenty of water (at least for
10 minutes). Call in ophtalmologist immediately.
Date: 23.07.03 replaces version dated: 03.07.03 page 2 of 7
Institut Virion\Serion GmbH according to 91/155/EEC
Serion Immundiagnostica GmbH
W眉rzburg, Germany
Annex A
Material Safety Data Sheet
Order-No.: B235
Product Name: Stopping solution
5. Fire fighting measures
Suitable extinguishing media: In adaptation to materials stored in the
immediate neighborhood.
Special risks: Non-combustible. Hydrogen may form upon
contact with light metals (danger of explosion).
Ambient fire may liberate hazardous vapors.
Special protective equipment for Do not stay in dangerous zone without suitable
fire fighting: chemical protection clothing and self-contained
breathing apparatus
Other information: Prevent fire-fighting water from entering surface
water or groundwater.
6. Accidental release measures
Person-related Do not inhale vapors/aerosols. Avoid
precaution measures: substance contact. Ensure supply of fresh air in
enclosed rooms
Environmental protection measures: Do not allow entering sewage system.
Procedure for cleaning/absorption: Take up with liquid absorbent material (e.g.
庐
Chemizorb ). Forward for disposal. Clean up
affected area.
7. Handling and storage
Handling: Can not be stored indefinitely. No further
requirements.
Storage: Tightly closed. Requirements or storage rooms
and containers: no aluminum, tin, or zinc
containers.
Date: 23.07.03 replaces version dated: 03.07.03 page 3 of 7
Institut Virion\Serion GmbH according to 91/155/EEC
Serion Immundiagnostica GmbH
W眉rzburg, Germany
Annex A
Material Safety Data Sheet
Order-No.: B235
Product Name: Stopping solution
8. Exposure control / personal protection
Borderline Values for safety at work:
TRGS 900
Name Values Maximum Values fetopathical
Sodium 2 mg/m鲁 =1= concentration Y substances without risk of
hydroxide inhalable exceeding of fetopathy when MAC and biological
amount of borderline values workplace tolerance values are not
dust not allowed exceeded
Exposure control:
Protective clothing should be selected specifically for the working place, depending
on concentration and quantity of the hazardous substances handled. The resistance
of the protective clothing to chemicals should be ascertained with the respective
supplier.
Respiratory protection: required when vapors/aerosols are generated.
Skin and body protection: Suitable protective clothing
Hand protection: required
Eye protection: required
Industrial hygiene: Change contaminated clothing immediately.
Wash hands, arms and face thoroughly after
working with the product, before eating,
smoking, going to the lavatory and after work.
9. Physical and chemical properties
Form: liquid
Color: colorless
Odour: odorless
pH-value: (20掳C) ~ 13.7
Melting point: not available
Boiling point: not available
Ignition temperature: not available
Flash point: not available
Explosion limits: not available
Oxidizing properties: not available
Steam pressure: not available
Density: (20掳C) 1,05 g/cm鲁
Solubility in water: (20掳C) soluble-
Date: 23.07.03 replaces version dated: 03.07.03 page 4 of 7
Institut Virion\Serion GmbH according to 91/155/EEC
Serion Immundiagnostica GmbH
W眉rzburg, Germany
Annex A
Material Safety Data Sheet
Order-No.: B235
Product Name: Stopping solution
10. Stability and Reactivity
Conditions to be avoided: no information available
Substances to be avoided: Metals, light metals: Hydrogen could be formed
(risk of explosion!)
Ammonium compounds: ammonia could be
formed;
Acids.
Hazardous decomposition products: no information available
11. Toxicological information
Acute Toxicity: Quantitative data on toxicity of this product are
not available.
Subacute to chronic toxicity: Applicable to partial components
Further toxicological information Property that must be anticipated on the basis
from the components of the preparation:
After inhalation: Irritation of mucuous membranes, coughing
and dyspnoea.
After skin contact: Burns.
After eye contact: Burns. Risk of blindness!
After swallowing: Burns in mouth, throat, oesophagus and
gastrointestinal tract.
Further data: Further hazardous properties cannot be
excluded. The product shoud be handled with
usual care when dealing with chemicals.
12. Ecological information
Ecotoxic effects: Toxic effect on fish and plankton. Harmful
effects due to pH-shift. Death of fish possible.
Does not cause biological oxygen deficit.
Neutralization possible in waste water
treatment plants.
Fish toxicity: LC50 :
189 mg/l (1,2 N solution = 48 g/l)
Futher ecologic data: Do not allow to enter water bodies, waste
water, or soil.
Date: 23.07.03 replaces version dated: 03.07.03 page 5 of 7
Institut Virion\Serion GmbH according to 91/155/EEC
Serion Immundiagnostica GmbH
W眉rzburg, Germany
Annex A
Material Safety Data Sheet
Order-No.: B235
Product Name: Stopping solution
13. Disposal considerations
Product / Packaging: Waste material hast to be disposed due to
federal environmental regulations
14. Transport information
Land Transport ADR/RID
Shipping name: Sodium hydroxide, 1,2 N
Packaging group: II
Hazard class: 8
UN/NA: UN1824
Maritime Transport IMDG/GGVSee
Shipping name: Sodium hydroxide, 1,2 N
Packaging group: II
Hazard class: 8
UN/NA: UN1824
EmS: 8-06
Air Transport ICAO/IATA
Shipping name: Sodium hydroxide, 1,2 N
Packaging group: II
Hazard class: 8
UN/NA: UN1824
15. Regulations
EU-directives:
Symbol(s): C Corrosive
R-phrases: R35 Causes severe burns.
S-phrases: 26-36/37/39-45
In case of contact with eyes, immediately rinse
with plenty of water and seek medical advice.
Wear suitable protective clothing, gloves and
eye/face protection. In case of accident or if
you feel unwell, seek medical advice
immediately (show the label if possible).
Includes:
Application of the product: classification and identification according to EU-
regulations 67/548/EEC and 1999/45/EG,
including changes, and intended use.
- application by end-user.
Date: 23.07.03 replaces version dated: 03.07.03 page 6 of 7
Institut Virion\Serion GmbH according to 91/155/EEC
Serion Immundiagnostica GmbH
W眉rzburg, Germany
Annex A
Material Safety Data Sheet
Order-No.: B235
Product Name: Stopping solution
National regulations:
Germany:
Restricted employment due to MuSchG / JarbSchG.: (Yes)
Failure regulations: (No)
Water hazard class: 1
16. Other information
Text of any R-phrases referred to under heading 2:
R35: causes severe burns
Classification from chapter 2:
C: corrosive
Reason for changes: general revision
Date: 23.07.2003
Replaces document dated: 03.07.2003
Note:
The information contained herein is based on the present state of our knowledge. It
characterizes the product with regard to the appropriate safety precautions. It does
not represent a guarantee of the properties of the product.
All material can cause unknown risks and has to be used carefully. Certain risks are
described in this document but we can not guarantee that these are the only possible
risks.
The data provided serves as a description of safety precautions that have to be
considered when working with the product. The data provided is no guarantee for the
properties of the product.
Date: 23.07.03 replaces version dated: 03.07.03 page 7 of 7
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