BioVendor - Laboratorn铆 medic铆na a.s.
CTPark Mod艡ice, Evropsk谩 873
664 42 Mod艡ice, Czech Republic
Phone: +420 549 124 185
Fax: +420 549 211 460
E-mail: info@biovendor.com
Web: www.biovendor.com
____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
. MATERIAL SAFETY DATA SHEET .
. According to the decree No. 231/2004 Coll. .
Human Intact Proinsulin ELISA
Product name:
Catalog number: RD193094100
1st May 2006
Date of issue:
31st August 2007
Date of review:
1. Substance/preparation and manufacturer/importer identification
Characteristics: Human Intact Proinsulin ELISA kit
Use of substance/preparation: Determination of human intact proinsulin concentration in serum
Manufacturer/importer: Manufacturer
Name or commercial name: BioVendor - Laboratorn铆 medic铆na a.s.
Registered office: CTPark Modrice, Evropska 873, 664 42 Modrice, Czech Republic
Identification number: 63471507
Emergency telephone number:
Toxicology Information Centre, Na Bojisti 1, 128 21 Prague, Czech Republic
Telephone (round-the-clock service) +420-2-24 81 92 93 and +420-2-24 91 54 02
2. Information on product/preparation composition
The product contains the following hazardous substances and those with the following highest permissible concentrations in the
working environment:
2.1 Microtiter strips (96 wells, coated with monoclonal anti- proinsulin specific antibody, vacuum sealed)
Identification numbers Chemical name of substance Concentrations Risk and safety statements
CAS: None None
EC (EINECS): None
Merck Index: None
2.2 Human Proinsulin Calibrators (purified native protein, lyophilized)
Identification numbers Chemical name of substance Concentrations Risk and safety statements
CAS: 54-64-8 Merthiolate 0.01 % T+, R26/27/28-33,50/53
EC (EINECS): 200-210-4 S13-28.1-36-45-60-61
Merck Index: 13,9389
2.3 Quality control (Quality control low and Quality control high) (conserved pooled human serum or plasma with determined
Intact Proinsulin concentrations, lyophilized)
Identification numbers Chemical name of substance Concentrations Risk and safety statements
CAS: 54-64-8 Merthiolate 0.01 % T+, R26/27/28-33,50/53
EC (EINECS): 200-210-4 S13-28.1-36-45-60-61
Merck Index: 13,9389
_________________________________________________________________________________________________________________________________________________________________
BioVendor - Laboratorn铆 medic铆na a.s. Phone: +420 549 124 185 E-mail: info@biovendor.com
CZECH REPUBLIC Fax: +420 549 211 460 Web: www.biovendor.com
EN ISO 9001, EN ISO 13485 T脺V CERTIFIED Update 08 310807 page: 1 of 5
2.4 HRP Conjugate (anti-proinsulin monoclonal antibody, horseradish peroxidase conjugate)
Identification numbers Chemical name of substance Concentrations Risk and safety statements
CAS: 54-64-8 Merthiolate 0.01 % T+, R26/27/28-33,50/53
EC (EINECS): 200-210-4 S13-28.1-36-45-60-61
Merck Index: 13,9389
2.5 Wash solution concentrate
Identification numbers Chemical name of substance Concentrations Risk and safety statements
CAS: None None
EC (EINECS): None
Merck Index: None
2.6 Substrate buffer
Identification numbers Chemical name of substance Concentrations Risk and safety statements
CAS: 7722-84-1 Hydrogen peroxide < 0.1 % R34,
EC (EINECS): 231-765-0 S28.1-36/39-45
Merck Index: 13,4819
2.7 Chromogen (TMB)
Identification numbers Chemical name of substance Concentrations Risk and safety statements
CAS: 67-68-5 dimethyl sulfoxide 4% R36/37/38,
EC (EINECS): 200-664-3
Merck Index: 13,3285
CAS: 54827-17-7 3,3鈥?,5,5鈥?-Tetramethylbenzidine 0.03 % R36/37/38,
EC (EINECS): 259-364-6 S26-36/37
Merck Index: None
2.8 Stop solution
Identification numbers Chemical name of substance Concentrations Risk and safety statements
CAS: 7664-93-9 Sulphuric acid 4.9 % (w/w) C, R35
EC (EINECS): 231-639-5 S26-30-45
Merck Index: 13,9064
Risk symbols
T+ Very toxic
Xi Irritating
C Corrosive
Risk phrases
R20/21/22 Harmful by inhalation, in contact with skin and if swallowed
R21/22 Harmful in contact with skin and if swallowed
R22 Harmful if swallowed
R26/27/28 Very Toxic by inhalation, in contact with skin and if swallowed
R28 Very Toxic if swallowed
R32 Releases very toxic gas in contact with acids
R33 Danger of cumulative effects
R34 Causes burns
Causes severe burns
R35
R36/37/38 Irritating to eyes, respiratory system and skin
R40 Possible risk of irreversible effects
R43 May cause sensitization by skin contact
_________________________________________________________________________________________________________________________________________________________________
BioVendor - Laboratorn铆 medic铆na a.s. Phone: +420 549 124 185 E-mail: info@biovendor.com
CZECH REPUBLIC Fax: +420 549 211 460 Web: www.biovendor.com
EN ISO 9001, EN ISO 13485 T脺V CERTIFIED Update 08 310807 page: 2 of 5
Safety phrases
S13 Keep away from food, drink and animal feeding stuffs
S23 Do not breath spray
S24/25 Avoid contact with skin and eyes
S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
S28.1 After contact with skin, wash immediately with plenty of water
S30 Never add water to this product.
S36 Wear suitable protective clothing
S36/37 Wear suitable protective clothing and gloves
S45 In case of accident or if you feel unwell, seek medical advice immediately (show label where possible)
S60 This material and its container must be disposed of as hazardous waste
S61 Avoid release to the environment. Refer to special instructions / safety data sheets
3. Substance/preparation hazards data
The amount of dangerous substances is under the limit on which the kit is considered dangerous as a whole.
When used, the most adverse impacts of the substance/preparation on human health include:
The followed components can damage health if ingested and/or can irritate eyes and skin: Stop solution, Substrate buffer and
Chromogen (TMB) solution, HRP conjugate, Human Intact Proinsulin Calibrators and Quality control (Quality control low and Quality
control high). The Stop solution contains sulphuric acid in total concentration < 5% and is not classified as 鈥淐orrosive鈥? or 鈥淚rritating鈥?.
The Quality controls (Quality control low and Quality control high) contain HIV-1, HIV-2, HCV and HBsAg negative human sera or
components isolated from human sera or plasma and must be handled as potentially infectious material.
The Quality controls (Quality control low and Quality control high), HRP conjugate, Substrate buffer, Chromogen and Stop Solution
contain a dangerous substances in such a low amount, that they are not regarded for classification.
4. First aid instructions
General instructions: Immediately rinse with soap and plenty of water. Use personal protective working aids.
If inhaled: Transport the affected person into the open air. When there are respiratory complaints, oxygen must be administered.
When irritation persists, seek medical advice.
In case of skin contact: The contaminated clothing and footwear must be taken off, the affected skin must be rinsed with plenty of
water. Use soap to completely remove the substance. When irritation persists, seek medical advice.
In case of contact with eyes: Remove contact lenses. Rinse with a stream of water for at least 15 minutes. Thorough rinsing must
be ensured by opening the eyelids using sterile (clean) fingers. When irritation persists, seek medical advice.
If ingested: Rinse the mouth, administer a big amount of water to dilute the substance. In the case of unconsciousness, never
administer anything orally. Seek medical advice.
5. Extinguishing measures:
Suitable fire-extinguishing media: Carbon dioxide, dry powder, foam, water.
Thermal decomposition: No thermal decomposition degradation products are expected.
Special hazards: None.
Special protective means for firemen: None.
6. Incidental leakage measures:
Safety measures to protect humans: Avoid contact with skin and eyes. Wear suitable protective clothing and gloves.
Environmental safety measures: Avoid penetration into sewerage systems, surface and ground water. Avoid soil pollution.
Recommended cleaning and disposal methods: Cover with suitable absorbing material. After removing the substance, rinse the
spot of spilling thoroughly with water and soap.
7. Handling and storage instructions:
Handling instructions: Avoid contact with skin, eyes and clothing. Use suitable protective means to work with the substance.
Storage instructions: Store at temperatures between + 2 and + 8掳C in a dry and dark place.
8. Exposition checking and protection of persons:
Technical measures: Do not eat, drink and smoke when working with the kit. Use the kit only in rooms enabling good ventilation.
Local exhaustion is necessary, general (forced) exhaustion is recommended.
Personal protective means 鈥? protection of respiratory organs: None
Personal protective means 鈥? eye protection: None
Personal protective means 鈥? hand protection: Protective gloves (wash your hands before and after work)
Personal protective means 鈥? body protection: Protective clothing
9. Physical/chemical properties
State (at 20掳C):
_________________________________________________________________________________________________________________________________________________________________
BioVendor - Laboratorn铆 medic铆na a.s. Phone: +420 549 124 185 E-mail: info@biovendor.com
CZECH REPUBLIC Fax: +420 549 211 460 Web: www.biovendor.com
EN ISO 9001, EN ISO 13485 T脺V CERTIFIED Update 08 310807 page: 3 of 5
Solid: Microtiter strips
Liquids: HRP conjugate, Wash solution concentrate, Substrate buffer, Chromogen, Stop solution
Powders: Proinsulin Calibrators, Quality controls
Colour:
Lightly bluish: Chromogen
Colourless: HRP conjugate, Substrate buffer, Stop solution, Wash solution concentrate
Creamy to white: Proinsulin Calibrators, Quality controls
Smell (odour): Odourless
pH value (at 25掳C): Stop solution: < 1
Others: 6.8 - 7.4
Melting temperature (temperature range) (掳C): No data available.
Boiling temperature (temperature range) (掳C): No data available.
Flash point (掳C): No data available.
Inflammability: No data available.
Vapour tension (掳C): No data available.
Water solubility: Soluble.
Partition coefficient n-octanol/water: No data available.
10. Stability and reactivity
Conditions to be avoided: Heat
Substances and materials with which the product is not allowed to get in touch: Acids
Hazardous decomposition products: Not known
Other data: No hazardous polymerisation
11. Toxicological information:
Toxicological information
The product contains thimerosal in total concentration 0.01%.
Acute toxicity-LD50 orally, rat (mg/kg): Not known
Acute toxicity-LD50 dermally, rat or rabbit (mg/kg): Not known
Acute gingivostomatitis LD50: Not known
Acute toxicity-LD50 inspiration: Not known
Irritability: No data available
Mutagenicity: No data available
Reproduction toxicity: No data available
Tests on animals: No data available
Other data: Not known chronic effect.
12. Environmental information
Water hazard class: 2 (water-damaging substances)
Biological effect:
Fish: toxicity L. macrochirus organismus: cca 5 mg/ml
Acute toxicity for cold-blooded animals: 10 mg/ml of total concentration sodium azide
13. Disposal Information
The manner of disposing the substance/preparation:
Mix or dissolve the material in a combustible solvent and burn up in a facility whose equipment matches all regulations in effect.
Every waste disposal must be carried out in coincidence with national and local legislation or administrative regulations, respectively.
Packages:
In coincidence with local legislation or administrative regulations, respectively.
14. Transportation information
Overland transportation (ADR/RID): As a mixture, the substance is subject to no limitations.
Transatlantic transportation (IMDG): As a mixture, the substance is subject to no limitations.
Air transportation (ICAO/IATA): As a mixture, the substance is subject to no limitations.
15. Information on legal regulations
According to the Act No. 356/2003 Coll. on chemical substances and chemical preparations and on amendments in some other laws
and acts, components contained in the Human Intact Proinsulin ELISA are non-hazardous substances in said concentrations.
Human Intact Pronsulin ELISA is subject to special marking regulations according to the EC regulations (28/10/1999).
Human Intact Proinsulin ELISA:
R20/21/22-21/22-22-26/27/28-28-32-33-34-35-36/37/38-40-43
_________________________________________________________________________________________________________________________________________________________________
BioVendor - Laboratorn铆 medic铆na a.s. Phone: +420 549 124 185 E-mail: info@biovendor.com
CZECH REPUBLIC Fax: +420 549 211 460 Web: www.biovendor.com
EN ISO 9001, EN ISO 13485 T脺V CERTIFIED Update 08 310807 page: 4 of 5
S13-24/25-26-28.1-30-36-36/37-45-60-61.
16. Additional information
The material safety data sheet contains data necessary to ensure safety and health and environmental protection in working with
chemical substances. The above-stated data match the contemporary state of knowledge and experience and are in coincidence
with legal regulations currently in effect. This product is a chemical substance and can be solely used by persons with chemical
education at their own risk.
Human Intact Proinsulin ELISA is designed for biomedical research. The manufacturer has no responsibility for damage caused by
unsuitable use and by disrespecting the enclosed working instructions.
The above-stated information cannot be considered as complete and must be understood to be only a methodical instruction.
_________________________________________________________________________________________________________________________________________________________________
BioVendor - Laboratorn铆 medic铆na a.s. Phone: +420 549 124 185 E-mail: info@biovendor.com
CZECH REPUBLIC Fax: +420 549 211 460 Web: www.biovendor.com
EN ISO 9001, EN ISO 13485 T脺V CERTIFIED Update 08 310807 page: 5 of 5
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