Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II - United Kingdom (UK)
SAFETY DATA SHEET
Calibrators
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Identification of the substance or preparation
Product name : Calibrators
: APTIMA HPV Assay 302610, 302611
Used in
APTIMA HPV Assay Calibrators Kit 302554
MSDS no. : 0096
Product type : Liquid.
Use of the : In vitro diagnostic.
substance/preparation
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
e-mail address of person : technicalsupport@gen-probe.com
responsible for this SDS
Emergency telephone number : CHEMTREC International: (703) 527-3887
(with hours of operation)
2. HAZARDS IDENTIFICATION
The product is not classified as dangerous according to Directive 1999/45/EC and its amendments.
Classification : Not classified.
See section 11 for more detailed information on health effects and symptoms.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance/preparation : Preparation
Due to differing non-hazardous components, the products listed in each part number in 鈥淯sed In鈥? section are
not interchangeable. See package insert for product use.
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations
applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
4. FIRST AID MEASURES
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Obtain medical attention if symptoms occur.
Skin contact : Wash with soap and water. Obtain medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : No specific treatment. Treat symptomatically. Contact poison treatment specialist
immediately if large quantities have been ingested or inhaled.
See section 11 for more detailed information on health effects and symptoms.
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5. FIRE-FIGHTING MEASURES
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : Decomposition products may include the following materials:
decomposition products carbon dioxide
carbon monoxide
sulfur oxides
metal oxide/oxides
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained
equipment for fire-fighters breathing apparatus (SCBA) with a full face-piece operated in positive pressure
mode.
6. ACCIDENTAL RELEASE MEASURES
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilt material. Avoid breathing vapour or mist.
Provide adequate ventilation. Wear appropriate respirator when ventilation is
inadequate. Put on appropriate personal protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilt material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop
up if water-soluble or absorb with an inert dry material and place in an appropriate
waste disposal container. Dispose of via a licensed waste disposal contractor.
Large spill : Stop leak if without risk. Move containers from spill area. Approach the release from
upwind. Prevent entry into sewers, water courses, basements or confined areas.
Wash spillages into an effluent treatment plant or proceed as follows. Contain and
collect spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite
or diatomaceous earth and place in container for disposal according to local
regulations (see section 13). Dispose of via a licensed waste disposal contractor.
Contaminated absorbent material may pose the same hazard as the spilt product.
Note: see section 1 for emergency contact information and section 13 for waste
disposal.
7. HANDLING AND STORAGE
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking
and smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and
smoking. Do not ingest. Avoid contact with eyes, skin and clothing. Avoid breathing
vapour or mist. Keep in the original container or an approved alternative made from a
compatible material, kept tightly closed when not in use. Empty containers retain
product residue and can be hazardous. Do not reuse container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible
materials (see section 10) and food and drink. Keep container tightly closed and
sealed until ready for use. Containers that have been opened must be carefully
resealed and kept upright to prevent leakage. Do not store in unlabelled containers.
Use appropriate containment to avoid environmental contamination.
Packaging materials
Recommended : Use original container.
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8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure limit values
Ingredient name Occupational exposure limits
No exposure limit value known.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace
procedures atmosphere or biological monitoring may be required to determine the effectiveness
of the ventilation or other control measures and/or the necessity to use respiratory
protective equipment. Reference should be made to European Standard EN 689 for
methods for the assessment of exposure by inhalation to chemical agents and
national guidance documents for methods for the determination of hazardous
substances.
Exposure controls
Occupational exposure : No special ventilation requirements. Good general ventilation should be sufficient to
controls control worker exposure to airborne contaminants. If this product contains ingredients
with exposure limits, use process enclosures, local exhaust ventilation or other
engineering controls to keep worker exposure below any recommended or statutory
limits.
Respiratory protection : Use a properly fitted, air-purifying or air-fed respirator complying with an approved
standard if a risk assessment indicates this is necessary. Respirator selection must
be based on known or anticipated exposure levels, the hazards of the product and the
safe working limits of the selected respirator.
Hand protection : Chemical-resistant, impervious gloves complying with an approved standard should
be worn at all times when handling chemical products if a risk assessment indicates
this is necessary.
Eye protection : Safety eyewear complying with an approved standard should be used when a risk
assessment indicates this is necessary to avoid exposure to liquid splashes, mists,
gases or dusts.
Skin protection : Personal protective equipment for the body should be selected based on the task
being performed and the risks involved and should be approved by a specialist before
handling this product.
Hygiene measures : Wash hands, forearms and face thoroughly after handling compounds and before
eating, smoking and using the lavatory and at the end of the day. During formulation,
follow good industrial hygiene practice.
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure
controls they comply with the requirements of environmental protection legislation. In some
cases, fume scrubbers, filters or engineering modifications to the process equipment
will be necessary to reduce emissions to acceptable levels.
9. PHYSICAL AND CHEMICAL PROPERTIES
General information
Appearance
Physical state : Liquid.
Colour : Colourless.
: Not available.
Odour threshold
Important health, safety and environmental information
pH : ~ 6.7.
Relative density : ~ 1.
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10. STABILITY AND REACTIVITY
Stability : The product is stable. Under normal conditions of storage and use, hazardous
polymerisation will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products
products should not be produced.
11. TOXICOLOGICAL INFORMATION
Potential acute health effects
Inhalation : No known significant effects or critical hazards.
Ingestion : No known significant effects or critical hazards.
Skin contact : No known significant effects or critical hazards.
Eye contact : No known significant effects or critical hazards.
Potential chronic health effects
Reproductive toxicity
Chronic effects : No known significant effects or critical hazards.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
Eyes : No specific data.
12. ECOLOGICAL INFORMATION
Environmental effects : No known significant effects or critical hazards.
Other adverse effects : No known significant effects or critical hazards.
13. DISPOSAL CONSIDERATIONS
Methods of disposal : Disposal should be in accordance with applicable regional, national and local laws
and regulations.
Hazardous waste : Within the present knowledge of the supplier, this product is not regarded as
hazardous waste, as defined by EU Directive 91/689/EEC.
14. TRANSPORT INFORMATION
International transport regulations
ADR/RID / IMDG / IATA Classes : Not regulated by any transport mode.
15. REGULATORY INFORMATION
EU regulations
Classification and labeling have been determined according to EU Directives 67/548/EEC and 1999/45/EC
(including amendments) and take into account the intended product use.
Risk phrases : This product is not classified according to EU legislation.
Product use : Industrial applications.
Europe inventory : Europe inventory: All components are listed or exempted.
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16. OTHER INFORMATION
History
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Version :1 0
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above-named
supplier, nor any of its subsidiaries, assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
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