Safety Data Sheet - Fast

Fast-track Diagnostics Luxembourg S.à.r.l.
Z.A.C. Laangwiss
L-6131 Junglinster, Luxembourg
Tel. +352 780290329
Fax: +352 780290514
Safety Data Sheet
Revision 10: 24/07/2014
According to 1907/2006/EC, Article 31
1. Identification of the
company/undertaking
substance/preparation
Product details:
Each FTD product contains:
A)
Primer and probe mix
B)
Internal control
C)
Positive control
D)
Negative control
Detailed information can be obtained from manual of the product.
Catalogue number:
FTD no
FTD 1
FTD 2
FTD 2+
FTD 2P
FTD 3
FTD 5
FTD 6
FTD 7
FTD 8
FTD 9
FTD 10
FTD 11
FTD 12
FTD 13
FTD 14
FTD 15
FTD 16
FTD 17
FTD 19
FTD 20
FTD 21
FTD 23
FTD 24
FTD 25
FTD 27
FTD 28
FTD 29
FTD 30
FTD 31
FTD 32
FTD 33
FTD 34
FTD 35
FTD 36
FTD 37
FTD 38
FTD 39
FTD name
FTD ACE
FTD Respiratory pathogens 21
FTD Respiratory pathogens 21 plus
FTD Respiratory pathogens 33
FTD Viral Gastroenteritis
FTD Hepatitis B DNA
FTD Hepatitis C RNA
FTD vesicular rash
FTD Cytomegalovirus
FTD Dermatophytes
FTD Fever and rash
FTD Urethritis
FTD Vaginal swabs
FTD Viral Meningitis
FTD Bacterial Gastroenteritis
FTD Eye
FTD Mumps
FTD GC confirmatory
FTD Genital ulcer
FTD Stool parasites
FTD FLU
FTD EPA
FTD c.difficile
FTD Noro-C.diff
FTD Pneumocystis jirovecii
FTD Bacterial meningitis
FTD Bacterial pneumonia_CAP
FTD Bacterial pneumonia_HAP
FTD Bordetella
FTD Neonatal sepsis
FTD Urethritis basic
FTD Neonatal meningitis
FTD Enteric fever
FTD Tropical fever core
FTD Tropical fever Africa
FTD Tropical fever Asia
FTD Malaria
Safety data sheet: FTD products
1/7
and
of
the
Fast-track Diagnostics Luxembourg S.à.r.l.
Z.A.C. Laangwiss
L-6131 Junglinster, Luxembourg
Tel. +352 780290329
Fax: +352 780290514
FTD no
FTD 40
FTD 41
FTD 42
FTD 43
FTD 44
FTD 45
FTD 46
FTD 48
FTD 50.1
FTD 52
FTD 53
FTD 54
FTD 55
FTD 56
FTD 57
FTD 60
FTD 62
FTD 63
FTD 66
FTD CC
FTD name
FTD Malaria differentiation
FTD GBS
FTD Urethritis plus
FTD Dengue / Chik
FTD Dengue differentiation
FTD Noro
FTD Measles
FTD FLU/HRSV
FTD hCoV-EMC
FTD STD9
FTD Atypical CAP
FTD BCE
FTD BKV
FTD HCoV
FTD Internal Control EAV
FTD Neuro9
FTD Flu differentiation
FTD HAdV/HMPV/HBoV
FTD SPn/Staph/MC/HI
FTD LC480 Color Compensation
Manufacturer/Supplier:
Fast-track Diagnostics Luxembourg S.à.r.l.
Z.A.C Laangwiss
L-6131 Junglinster, Luxembourg,
Tel. +352 780290329
Fax: +352 780290514
DR
2. Hazards identification
A)
B)
C)
Primer and probe mix
Internal control
Positive control
Per OSHA 29CFR1910.1200, Commonwealth of Australia [NOHSC:1005,1008(1999)] and the
latest amendments to the European Union Directives 67/548/EC and 1999/45/EC, the following
products do not require a Material Safety Data Sheet (MSDS). They do not contain more than 1%
of a component classified as hazardous and do not contain more than 0,1% of a component
classified as carcinogenic. Therefore a MSDS for the primer and probe mix, the internal control
and for the positive control is not necessary. When working with these or any chemical reagents,
we always recommend the use of gloves, lab coats, and eye protection.
D)
Negative control (lysis buffer: Qiagen, AL buffer)
Hazard description:
Xn Harmful
Information concerning particular hazards for human and environment:
R 22 Harmful if swallowed.
R 36/38 Irritating to eyes and skin.
Classification system:
The classification is according to the latest editions of the EU-lists, and extended by
company and literature data.
Safety data sheet: FTD products
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Fast-track Diagnostics Luxembourg S.à.r.l.
Z.A.C. Laangwiss
L-6131 Junglinster, Luxembourg
Tel. +352 780290329
Fax: +352 780290514
3. Composition/Information of ingredients
Chemical characterization
Description: Mixture of substances listed below with nonhazardous additions.
Dangerous components :
CAS: 50-01-1
guanidinium chloride
25-50%
EINECS: 200-002-3 Xn, Xi; R 22-36/38
4. First-aid measures
General information:
Fist aider: ensure self-protection
Remove contaminated clothing
The induction of vomiting by a layperson is generally not recommended
After inhalation: Supply fresh air; consult a doctor in case of complaint
After skin contact: Rinse immediately with water and soap and rinse thoroughly and
consult a doctor in case of complaints
After eye contact: Rinse opened eye for 10 minutes under running water and then consult
a doctor
After swallowing: Do not induce vomiting. Call immediately for a doctor and show the
packaging or label.
5. Fire-fighting measures
Suitable extinguishing agents:
CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.
For safety reasons unsuitable extinguishing agents: Water with full jet
Protective equipment:
Do not inhale explosion gases or combustion gases
Wear self-contained breathing apparatus
Wear full protection suit
6. Accidental release measures
Person-related safety precautions:
Avoid eye and skin contact
Ensure adequate ventilation
Environmental protection measures:
Do not allow to enter sewers/surface or ground water
Measures for cleaning and collecting:
Absorb with liquid-binding material
Dispose the absorbed material according to item 13
Reference to other paragraphs:
Information about a safe handling: item 7
Information about personal protection: item 8
Safety data sheet: FTD products
3/7
Fast-track Diagnostics Luxembourg S.à.r.l.
Z.A.C. Laangwiss
L-6131 Junglinster, Luxembourg
Tel. +352 780290329
Fax: +352 780290514
7. Handling and storage
Handling
Information for safe handling:
Handling according Good Laboratory Practice
Keep receptacles tightly sealed
Information about fire- and explosion protection:
No special measures required
Condition for storage including any incompatibilities
Storage:
Requirements to be met by storerooms and receptacles: no special requirements
Information about storage in one common storage facility: separate from food
Further information about storage conditions: keep receptacle tightly sealed
Specific end applications: any other relevant information available
8. Handling and storage
Additional information about design of technical facilities: No further data; see item
7.
Personal protective equipment:
General protective and hygienic measures:
When using do not eat, drink or smoke
Keep away from foodstuffs, beverage and feed
Immediately remove all soiled and contaminated clothing
Wash hands before breaks and at the end of work
Avoid contact with the eyes and skin
Protection of hands: Protective gloves
Material of gloves:
The selection of the suitable gloves does not only depend on the material, but also on further
marks of quality and varies from manufacturer to manufacturer
Penetration time of glove material:
The exact break through time has to be found out by the manufacturer of the protective
gloves and has to be observed
Eye protection: tightly sealed goggles
Body protection: protective work wear
Safety data sheet: FTD products
4/7
Fast-track Diagnostics Luxembourg S.à.r.l.
Z.A.C. Laangwiss
L-6131 Junglinster, Luxembourg
Tel. +352 780290329
Fax: +352 780290514
9. Physical and chemical properties
General information
Appearance : Fluid
Colour
: Colorless
Odour
: practically odourless
Change in condition:
Melting point/Melting range: Undetermined
Boiling point/Boiling range : Undetermined
Flash point: not applicable
Self-igniting: product is not self-igniting
Explosive properties: product does not present an explosion hazard
Vapour pressure: not applicable
Solubility at 20°C: 1.16 g/cm3
Solubility in / Miscibility with water: fully miscible
10.
Stability and reactivity
Thermal decomposition / conditions to be avoided: No decomposition if used
according to specifications
Dangerous reactions: Reacts with acids, alkalis and oxidizing agents
Dangerous decomposition products: Danger of forming toxic pyrolysis products
11.
Toxicological information
Acute toxicity:
LD/LC50 values that are relevant for classification:
Acute oral toxicity
: LD50 475/kg (rat)
Acute dermal toxicity : LD50 >2000mg/kg (rabbit)
Acute inhaling toxicity: LC50/4H 5.3mg/l (rat)
Primary irritant effect:
On the skin: irritant to skin and mucous membranes
On the eye:
irritant effect
Sensitization: no sensitizing effects known
Additional toxicological information:
The product shows the following dangers according to the calculation method of the General
EU Classification Guidelines for Preparations:
Harmful
Irritant
Safety data sheet: FTD products
5/7
Fast-track Diagnostics Luxembourg S.à.r.l.
Z.A.C. Laangwiss
L-6131 Junglinster, Luxembourg
Tel. +352 780290329
Fax: +352 780290514
12.
Ecological information
Information about the elimination (persistence and degradability): not readily
biodegradable
Ecotoxical effects:
Aquatic toxicity: toxicity based on guanidine hydrochloride solid
Toxicity to fish:
LC50 1759mg/l/48h (Leuciscus idus)
Comment: Do not allow to enter waters, waste water or soils.
Additional ecological information
General notes:
Water hazard class 1 (self-assessment): slightly hazardous for water.
Do not allow undiluted products or large quantities of it to reach ground water, water course
or sewage system.
13.
Ecological information
Product:
Recommendation:
The disposal is regulated differently in each region; therefore the disposal should be in
accordance with country, state or local regulations.
The product and its container have to be disposed of as hazardous waste.
Uncleaned packaging:
Recommendation: Disposal must be made according to official regulation
Recommended cleansing agents: water, if necessary together with cleansing agents.
14.
Transport information
Land transport ADR/RID (cross-border)
ADR/RID class: /
Maritime transport IMDG:
IMDG Class: /
Maritime pollutant: No
Air transport ICAO and IATA-DGR:
ICAO/IATA Class: /
Safety data sheet: FTD products
6/7
Fast-track Diagnostics Luxembourg S.à.r.l.
Z.A.C. Laangwiss
L-6131 Junglinster, Luxembourg
Tel. +352 780290329
Fax: +352 780290514
15.
Regulatory information
Labeling according to EU guidelines:
The product has been classified and marked in accordance with EU Directives
Code letter and hazard designation of the product:
Xn Harmful
Hazard-determining components of labeling:
Guanidinium chloride
Risk phrase:
22
Harmful if swallowed
36/38 Irritating to eyes and skin
Safety phrases:
13
Keep away from food, drink and animal feeding stuffs
26
In case of contact with eyes, rinse immediately with plenty of water and seek medical
advice
36
Wear suitable protective clothing
46
If swallowed, seek medical advice and show this container or label
Water hazard class: Water hazard class 1 (self-assessment): slightly for water
16.
Other information
This information is based on our present knowledge. However, this shall not constitute a
guarantee for any product specific features and shall not establish a legally valid contractual
relationship.
Safety data sheet: FTD products
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