MSDS: 6053
ChemTrol Plus, Level 2
Page 1 of 5
EC-Material Safety Data Sheet (according 91/155/EWG)
1. Chemical identification of the preparation and company
ChemTrol Plus, Level 2
Product trading name:
Designation: Control material
Article number: 15140-02
Field of application: Clinical chemistry
Date of issue: 02.08.2006
Date of revision:
Supplier: DiaServe Laboratories GmbH
Seeshaupter Str. 27
82393 Iffeldorf, Germany
Phone: +49 (0) 8856 80 36 05
Fax: +49 (0) 8856 80 36 07
e-mail diaserve@t-online.de
Information in case of emergency: +49 (0) 8856 80 36 05
2. Composition/information on ingredients
The product described is a pure substance: no
Chemical characterization: see below
Dangerous components: with the used amounts: none
ChemTrol Plus, Level 2
CAS-No. designation content [%] Kb 1 Kb 2 Kb 3 Risk regulations
component
79-33-4 L(+)-Lactic Acid < 20 Xi n/a n/a 41
7782-63-0 Iron Sulfate < 25 Xn n/a n/a 22
Hydrate
7758-99-8 Copper Sulfate < 25; < 0,25 Xn N n/a 22
Pentahydrate
7446-20-0 Zinc Sulfate < 25; < 0,25 Xn N n/a 22-41
Heptahydrate
10035-04-8 Calcium Chloride < 20 Xi n/a n/a 36
Dihydrate
103-90-2 Acetaminophen < 25 Xn n/a n/a 22-36/37/38
298-46-4 Carbamacepine < 25 Xn n/a n/a 22-42/43
50-23-7 Hydrocortisone < 25 Xn n/a n/a 63
20803-75-5 Digoxin <3 T n/a n/a 25
1405-41-0 Gentamycin < 20 Xn n/a n/a 42/43
57-30-7 Phenobarbital <3 T n/a n/a 20-40-43
57-41-0 Phenytoin <3 T n/a n/a 45-61-22
125-33-7 Primidone < 25 Xn n/a n/a 22-40
69-72-7 Salycilic Acid < 25 Xn n/a n/a 22-41
58-55-9 Theophylline < 25 Xn n/a n/a 22
26628-22-8 CRP <3 T n/a n/a 25-32-52/53
6893-02-3 T3 < 20 Xi n/a n/a 36/37/38
MSDS: 6053
ChemTrol Plus, Level 2
Page 2 of 5
CAS-No. designation content [%] Kb 1 Kb 2 Kb 3 Risk regulations
component
Buffering and < 20; < 25 Xi Xn n/a 22-36
conserving
components
Microbiozide <1 C n/a n/a 34-43
Enzymes in defined n/a n/a n/a -
amounts
Anorganic ions n/a n/a n/a -
Proteins n/a n/a n/a -
Cholesterol n/a n/a n/a -
n/a: not applicable
3. Hazard identification
Basing on the concentrations in the composition it is not a hazardous product in terms of directive 1999/45/EG.
4. First aid measures
If inhaled: Remove to fresh air.
In case of skin contact: Flush with copious amount of water.
In case of contact with eyes: Flush with copious amount of water while separating the eyelids with fingers.
If irritations appear and persist call a physician.
If swallowed: Flush with copious amount of water. Call a physician.
5. Fire fighting
Extinguishing media:
Water, CO2, foam, powder
6. Spillage, accidental release
Personal precautions:
Avoid swallowing; do not store together with food.
Environment precautions:
Avoid release into sewerage.
Procedures for clean-up/absorption:
Sweep up with cellulose and hold for waste disposal.
7. Handling and storage
Handling:
No special requirements
Storage:
Dry. At +2掳C to +8掳C.
8. Exposure controls/personal protection
Threshold value for maintenance of industrial health and safety standards:
Application of minimum protective standards are mandatory.
MSDS: 6053
ChemTrol Plus, Level 2
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Personal protection:
Protection wear according to national laboratory regulations are sufficient for personal safety (coat, safety goggles,
shoes, disposable gloves (latex)).
After finishing work, wash hands and use preventing skin care.
9. Physical and chemical properties
Appearance: solid
Color: white/slightly yellow
Odour: no data available
value/range
pH: 7,2 +/- 0,2
boiling point/-range: not determined
flammability: not flammable
explosive properties: not explosive
vapor pressure: not determined
relative density: not determined
solubility in water: water soluble
10. Stability and reactivity
Avoidable conditions:
nothing known
Avoidable substances:
nothing known
Dangerous decomposition products:
nothing determined
Further declarations:
none
11. Toxicological information
Toxicity data: (toxicological determinating components)
Digoxin
LD50 (intravenous, men): 200 碌g/kg
LD50 (oral, rat): 28,27 mg/kg
Phenobarbital
LD50 (oral, rat) 150 mg/kg
LD50 (intraperitoneal, rat) 152 mg/kg
LD50 (subcutane, rat) 195 mg/kg
LD50 (intravenous, rat) 83 mg/kg
Phenytoin
LDLo (oral, child) 100 mg/kg
LD50 (oral, rat) 1635 mg/kg
LD50 (intraperitoneal, rat) 352 mg/kg
LD50 (subcutane, rat) >1500 mg/kg
LD50 (intravenous, rat) 101 mg/kg
MSDS: 6053
ChemTrol Plus, Level 2
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Further statements regarding the toxicological effects:
The components in the preparation are used in such low concentrations that with proper handling and use no
toxicological effects are expected.
Further declarations:
Handle the product with for chemicals usual care.
The product is manufactured with donator blood, which is checked for the absence of HIV 1&2, HCV antibodies and
HBs-antigen with a CE licensed test. Since the danger of infection could not be excluded completely, the product
should be handled with same care as patient materials.
12. Ecological information
Ecotoxicological effects:
Quantitative data of the ecological impact of this composition are not yet known.
Biological degradability:
not known
Biological effects:
Copper Sulfate and Zinc Sulfate are toxic for water organisms. They harm the water environment during longer
exposure times. Referring to the presence of these components, the product should not get into environmental
waters, sewage or soil. In case of accidental release flush or dilute with copious amounts of water.
13. Disposal considerations
Product:
There are no uniform regulations for disposal of chemical within the member states of the EC.
Contact a licensed professional waste disposal service for dispose of this material. Observe all federal, state and
local environmental regulations.
Due to human sera components, used solutions should be inactivated appropriately before disposal.
Packaging:
Dispose according the regulations of the public authorities. Contaminated packaging has to be treated like the
composition. If not otherwise regulated by public authorities, not contaminated packaging can be treated like
household waste or brought to recycling procedures.
14. Transport information
Land transport: GGVS, GGVE, ADR, RID
class: ---
designation: ---
Inland ship transport: ADN, ADNR
class: ---
Ocean shipping transport: IMDG, GGVSee
class: ---
EmS: ---
MFAG: ---
designation: ---
Air transport: ICAO, IATA
class: ---
designation: ---
This product is no matter of the shipping regulations.
MSDS: 6053
ChemTrol Plus, Level 2
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15. Regulatory information
Indication following the EC directives:
Symbols: ---
Risk regulations: ---
Safety Regulations: ---
German regulations:
Class of water hazard: WGK 1 (Low water hazard potential according VwVwS)
Note:
The Product is not under duty for indication according the EC directive 67/548 and 1999/45 EG.
16. Other information
The specifications basing on the up to date knowledge and serve to describe the product with regard to the
necessary safety precautions. It is no assurance for properties of the specified product.
Exclusive distribution by:
Scil Diagnostics GmbH
DiaServe Laboratories GmbH
Dina-Wei脽mann-Allee 6
Seeshaupter Str. 27
D-68519 Viernheim / Germany
D-82393 Iffeldorf - Germany
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