SAFETY DATA SHEET

Product Name HbA1c Control Material

specification 1 set（2×0.1ml)

level 1
Components
level 2

Version: 1.3

Print date: January 8th, 2019

Revision date: January 8th, 2019

Reported By:

Company Name: Shenzhen Lifotronic Technology Co., Ltd.

Authorized Person: Weijie Tang Signature: Weijie Tang

 Material Safety Data Sheet
HbAlc Control Material level 1/level 2

1. Identification of the Substance/Mixture and of the Company/Undertaking

1.1 Product identifier:

Mixture name: HbAlc Control Material level 1/level 2

REACH
COMPONENT CAS No. EC No. Registration % by wt.
No.
Mixture of 5 - chloro -2- methyl -4-
isothiazolin-3-one [EC no. 247-500-7] 0.0006%-
55965-84-9 613-167-00-5 -
and 2-methyl-4-isothiazolin-3-one [EC no. 0.001%
220-239-6](3:1)

1.2 Relevant identified uses of the mixture and uses advised against
Mixture of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one: help extend the shelf
life of IVD reagents by effectively inhibiting a broad spectrum of microbes.

1.3 Details of the supplier of the Safety Data Sheet

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Add: Unit A, 4th Floor, Building 15, Yijing Estate, No.1008 Songbai Road, Nanshan District, Shenzhen
City, Guangdong Province, 518055, P.R.China
For information, call: +86-755-29060197
For emergencies, call: +86-755-29060026
Fax: +86-755-29060036
Mail: service@lifotronic.com
National Contact:
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Tel: +49-40-2513175 Fax: +49-40-255726

1.4 Emergency telephone number

186662216036
Only available during office hours.
Other comments: language should be English or Chinese.

2. Hazards Identification

2.1 Classification according to Regulation (EC) No 1272/2008 [CLP]

This mixture doesn’t result in classification on aspect of chemical, physical and environment according to
CLP.

2.2. Label elements

None. Not Applicable.

2.3 other hazards

Though this mixture doesn’t result in classification, the mixture is consist of several chemical materials, it
must be handled carefully to avoid discomfort.
3. Composition/information on ingredients of mixture
Description of the mixture:
Mixture of HbAlc Control Material level 1/level 2
Hazardous ingredients: None
4. First Aid Measures
General Information: In all cases of doubt, or when symptoms persist, seek medical attention.Never give
anything by mouth to unconscious person. Unconsciousness: Lateral position - call
a physician.

4.1 In case of inhalation:

Consult a doctor. Remove to fresh air immediately. If not breathing, give artificial respiration. If
breathing is difficult, give oxygen. Maintain an open airway.

4.2 In case of skin contact:

Consult a doctor. Immediately cleanse the affected skin areas with soap under running water. Remove
contaminated clothing and shoes.

4.3 In case of eyes contact:

Rinse the affected eye with widely spread lids for 10 minutes under running water whilst protecting
the unimpaired eye. Thereafter arrange for immediate transportation of the injured person to a
physician.

4.4 In case of ingestion:

Induce vomiting. If the casualty is still conscious, rinse the mouth and spit the fluids out and drink
copious amounts of milk or water. In the meantime call an emergency physician to the scene of the
accident.
5. Fire Fighting Measures

Suitable Extinguishing Media: CO2, powder or water spray. Fight larger fires with water sprayor
alcohol resistant foam.
Special Hazard During Fire oxycarbide，oxynitride，sulfur oxide，hydrochloric acid gas.
Advice for firefighters: Wear self-contained respirator. Wear fully protective impervious suit.

6. Accidental Release Measures

Personal precautions, protective equipment and emergency procedures:

Wear suitable protective equipment like protective clothing, gloves and respirator to avoid direct contact
with the leakage of fluid.

Environmental precautions:
Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Discharge into the
environment must be avoided.
Methods for containment and cleaning up:
Absorb with liquid-binding material, Dispose material as waste according to item 13.

Reference to other sections: Refer to item 8 of the SDS.

7. Handling and Storage

7.1 Precautions for safe handling

Protective measures:
Measures to prevent fire:
Keep away from sources of ignition and segregate from incompatible materials and flammables area.
Measures to prevent aerosol and dust generation:
No special requirements.
Measures to protect the environment:
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.
Advice on general occupational hygiene:
Do not eat, drink or smoke when using this product. Wash hands thoroughly after handling. Remove
contaminated clothing and protective equipment before entering eating areas.

7.2 Conditions for safe storage, including any incompatibilities

Keep out of the reach of children.Keep container closed and store at room temperature. Keep away from
strong oxidizers.

7.3 Specific end use(s):

Diagnostic agents.

8. Exposure Controls And Personal Protection

8.1 Control parameters:

8.1.1 Occupational exposure limits: No data.
8.1.2 Additional exposure limits under the conditions of use: No data.
8.1.3 DNEL/DMEL and PNEC-Values: No data.

8.2 Exposure controls:

8.2.1 Appropriate engineering controls:
Use adequate ventilation to keep airborne concentrations low.
8.2.2 Personal protective equipment：
8.2.2.1 Eye/face protection:
Protective eyeglasses or chemical safety goggles should be used when a risk assessment indicates this
is necessary to avoid exposure to liquid splashes, mists or dusts. 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.
8.2.2.2 Skin protection:
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.
 Body protection: Protective clothing with elasticized cuffs and closed neck. Boots made of PVC.
8.2.2.3 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.
8.2.3 Environmental exposure controls:
Avoid discharge into the environment. Emissions from ventilation or work process equipment should
be checked to ensure they comply with the requirements of environmental protection legislation.

9. Physical and Chemical Properties

General Information
Physical State: solid
Color: White or Transparent
Odor: brownness
pH: ---
Vapor Pressure: No data available
Vapor density: No data available
Viscosity: No data available
Boiling Point: No data available
Freezing: No data available
Melting Point: No data available
ignition Temperature: No data available
Self igniting: No data available
Flash Point: No data available
Explosion Limits, lower: No data available
Explosion Limits, upper: No data available
Danger of explosion: No data available
Solubility in water: No data available
Specific Gravity/Density: No data available
Molecular Weight: ---

10. Stability and Reactivity

10.1 Reactivity:
Stable under recommended transport or storage conditions.

10.2 Chemical stability:

Stable under normal temperatures and pressures.

10.3 Possibility of hazardous reactions:

No data available.

10.4 Conditions to avoid:

No data available.

10.5 Incompatible materials:

 strong oxidant, reducing agent

10.6 Hazardous decomposition products:

No data available.

11. Toxicological Information

Acute toxicity:
Product/ingredient name Result Species Dose
HbAlc Control Material LD50 Dermal rat 862kg/kg
level 1/level 2 (0.02% ) LD50 Skin rabbit 2800kg/kg
Skin corrosion/Irritation: No specific data.
Serious eye damage/irritation: No specific data.
Respiratory or skin sensitization: No specific data.
Carcinogenicity: No known significant effects or critical hazards.
Germ cell mutagenicity: No specific data.
Reproductive toxicity: No specific data.
STOT- single exposure: No specific data.
STOT-repeated exposure: No specific data.
Aspiration hazard: No specific data.

12. Ecological Information

12.1 Toxicity: No data available.

12.2 Persistence and degradability: No data available.

12.3 Bioaccumulative potential: No data available.

12.4 Mobility in soil: No data available.

12.5 Results of PBT&vPvB assessment: No data available.

12.6 Other adverse effects: No data available.

13. Disposal Considerations

Waste treatment methods
The generation of waste should be avoided or minimized wherever possible. Empty containers or liners
may retain some product residues. This material and its container must be disposed of in a safe way.
Dispose of surplus and non-recyclable products via a licensed waste disposal contractor. Disposal of this
product, solutions and any by-products should at all times comply with the requirements of environmental
protection and waste disposal legislation and any regional local authority requirements. Avoid dispersal of
spilt material and runoff and contact with soil, waterways, drains and sewers.
Uncleaned Packaging -Recommendation
Disposal must be made according to official regulations.

14. Transport Information

Not a hazardous material for transportation.
NOT restricted as IATA DRG 60th Edition.
DOT regulation:
Hazard class: None
Land transport ADR/RID(cross-boarder)ADR/RID class: None
Maritime transport IMDG:
IMDG Class: None
Air transport ICAO-TI and IATA-DGR:
ICAO/IATA Class: Product is Non-DG cargo under 2019 IATA Dangerous goods regulation 60th Edition
and all applicable carrier and governmental regulations.
Transport/Additional information: Not dangerous according to the above specifications.

15. Regulations

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture

REGULATION (EC) No 689/2008:

No components of this mixture are subject to the REGULATION (EC) No 689/2008.

DIRECTIVE 96/82/EC:
No components of this mixture are subject to the DIRECTIVE 96/82/EC.

DIRECTIVE 2008/105/EC:
No components of this mixture are subject to the DIRECTIVE 2008/105/EC.

REGULATION (EC) No 850/2004:

This mixture does not contain any persistent organic pollutants.

REGULATION (EC) No 2037/2000:

This mixture does not contain any components that deplete the ozone layer.

National regulations (Germany):

Water Hazard Classes:

No Water Hazard Classes.

Technical Instructions on Air Quality Control (TA-Luft):

This mixture does not contain any hazardous air pollutants.

15.2 Chemical Safety Assessment: N/A

16. Other Information

This information is based on our present knowledge. However, this shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.