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BioMedica Diagnostics 238L 說明書
SAFETY DATA SHEET
Trade name or designation of the mixture
Registration number Synonyms
Product code Issue date Version number
SPECTROZYME® TH 50 umole
-
None.
238L
01-December-2017
02
Revision date 11-July-2017
Supersedes date 14-July-2015
Identified uses
Uses advised against
Research use only.
Use in accordance with supplier's recommendations.
The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies.
Health hazards
Skin corrosion/irritation
Serious eye damage/eye irritation
Specific target organ toxicity - single exposure
Category 2
Category 2
Category 3 respiratory tract irritation
H315 - Causes skin irritation.
H319 - Causes serious eye irritation.
H335 - May cause respiratory irritation.
Hazard summary Irritating to eyes, respiratory system and skin.
Label according to Regulation (EC) 272/2008 as amended
Contains: H-D-cyclohexylalanyl-alanyl-arginine-para-nitroanilide diacetate saltt
Signal word Warning
H315 Causes skin irritation.
H319 Causes serious eye irritation.
H335 May cause respiratory irritation.
P261 Avoid breathing dust.
P264 Wash thoroughly after handling.
P271 Use only outdoors or in a well-ventilated area.
P280 Wear protective gloves.
P280 Wear eye/face protection.
P302 + P352 IF ON SKIN: Wash with plenty of water.
P304 + P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312 Call a POISON CENTER/doctor if you feel unwell. P332 + P313 If skin irritation occurs: Get medical advice/attention. P337 + P313 If eye irritation persists: Get medical advice/attention.
P362 + P364 Take off contaminated clothing and wash it before reuse.
P403 + P233 Store in a well-ventilated place. Keep container tightly closed. P405 Store locked up.
P501 Dispose of contents/container in accordance with local/regional/national/international regulations.
2.3. Other hazards Not a PBT or vPvB substance or mixture.
Chemical name
% CAS-No / EC
No
REACH Registration No
INDEX No
Notes
H-D-cyclohexylalanyl-alanyl-arginine- para-nitroanilide diacetate saltt
45 - 65
None - -
-
Classification: Skin Irrit. 2;H315, Eye Irrit. 2;H319, STOT SE 3;H335
Glycine
20 - 40
56-40-6 - -
200-272-2
All concentrations are in percent by weight unless ingredient is a gas. Gas concentrations are in percent by volume. The full text for all H-statements is displayed in section 16.
Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves. If you feel unwell, seek medical advice (show the label where possible).
Inhalation Skin contact Eye contact
Ingestion
4.2. Most important symptoms and effects, both acute and delayed
4.3. Indication of any immediate medical attention and special treatment needed
Remove victim to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or doctor/physician if you feel unwell.
Remove contaminated clothing. Wash with plenty of soap and water. If skin irritation occurs: Get medical advice/attention. Wash contaminated clothing before reuse.
Do not rub eyes. Immediay flush eyes with plenty of water for at least 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if irritation develops and persists.
Rinse mouth. Get medical attention if symptoms occur.
May cause redness and pain. Symptoms of overexposure may be headache, dizziness, tiredness, nausea and vomiting.
Provide general supportive measures and treat symptomatically.
5.1. Extinguishing media Suitable extinguishing media
Unsuitable extinguishing media
5.2. Special hazards arising from the substance or mixture
5.3. Advice for firefighters Special protective equipment for firefighters
Special fire fighting procedures
No unusual fire or explosion hazards noted. Will burn if involved in a fire.
Water fog. Foam. Dry chemical powder. Carbon dioxide (CO2). Do not use water jet as an extinguisher, as this will spread the fire. During fire, gases hazardous to health may be formed.
Self-contained breathing apparatus and full protective clothing must be worn in case of fire. Use standard firefighting procedures and consider the hazards of other involved materials.
For non-emergency personnel
For emergency responders
6.2. Environmental precautions
6.3. Methods and material for containment and cleaning up
6.4. Reference to other sections
Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Wear appropriate protective equipment and clothing during clean-up. Avoid inhalation of dust. Ensure adequate ventilation. Local authorities should be advised if significant spillages cannot be contained.
Keep unnecessary personnel away. Use personal protection recommended in section 8 of the SDS.
Avoid discharge into drains, water courses or onto the ground.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces with compressed air). Collect dust using a vacuum cleaner equipped with HEPA filter. Stop the flow of material, if this is without risk.
Large Spills: Wet down with water and dike for later disposal. Shovel the material into waste container. Following product recovery, flush area with water.
Small Spills: Sweep up or vacuum up spillage and collect in suitable container for disposal. Clean surface thoroughly to remove residual contamination.
For personal protection, see section 8. For waste disposal, see section 13 of the SDS.
7.2. Conditions for safe storage, including any incompatibilities
7.3. Specific end use(s)
Minimise dust generation and accumulation. Provide appropriate exhaust ventilation at places where dust is formed. Avoid breathing dust. Avoid contact with eyes, skin, and clothing. Avoid prolonged exposure. Wear appropriate personal protective equipment. Observe good industrial hygiene practices.
Store locked up. Store in original tightly closed container. Store in a well-ventilated place. Store away from incompatible materials (see section 10 of the SDS).
Research use only.
Occupational exposure limits Biological limit values
Recommended monitoring procedures
No exposure limits noted for ingredient(s).
No biological exposure limits noted for the ingredient(s). Follow standard monitoring procedures.
Derived no-effect level (DNEL) Not available.
8.2. Exposure controls
Not available.
Good general ventilation (typically 10 air changes per hour) should be used. Ventilation rates should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. If exposure limits have not been established, maintain airborne levels to an acceptable level. If engineering measures are not sufficient to maintain concentrations of dust particulates below the OEL (occupational exposure limit), suitable respiratory protection must be worn. If material is ground, cut, or used in any operation which may generate dusts, use appropriate local exhaust ventilation to keep exposures below the recommended exposure limits. Eye wash facilities and emergency shower must be available when handling this product.
General information
Eye/face protection Skin protection
- Hand protection
- Other
Respiratory protection
Thermal hazards Hygiene measures
Environmental exposure controls
Use personal protective equipment as required. Personal protection equipment should be chosen according to the CEN standards and in discussion with the supplier of the personal protective equipment.
Wear safety goggles and a face shield.
Wear appropriate chemical resistant gloves. Suitable gloves can be recommended by the glove supplier.
Wear appropriate chemical resistant clothing.
In case of inadequate ventilation or risk of inhalation of dust or fumes, use suitable respiratory equipment.
Wear appropriate thermal protective clothing, when necessary.
Always observe good personal hygiene measures, such as washing after handling the material and before eating, drinking, and/or smoking. Routinely wash work clothing and protective equipment to remove contaminants.
Environmental manager must be informed of all major releases.
Physical state Form
Colour Odour
Solid.
White powder.
White.
Not available.
Odour threshold Not available.
pH Not available.
Melting point/freezing point Not available.
Not available.
Flash point Not available.
Evaporation rate Not available.
Flammability (solid, gas) Not available.
Flammability limit - lower (%)
Flammability limit - upper (%)
Not available.
Not available.
Vapour pressure Not available.
Vapour density Not available.
Relative density Not available.
Solubility(ies) Soluble in water.
Not available.
Auto-ignition temperature Not available. Decomposition temperature Not available. Viscosity Not available.
9.2. Other information
Not available.
Not available.
No relevant additional information available.
10.2. Chemical stability
10.3. Possibility of hazardous reactions
10.4. Conditions to avoid
10.5. Incompatible materials
10.6. Hazardous decomposition products
The product is stable and non-reactive under normal conditions of use, storage and transport. Material is stable under normal conditions.
Hazardous polymerisation does not occur.
Contact with incompatible materials. Strong oxidising agents. Strong acids. Carbon monoxide. Carbon dioxide.
General information Occupational exposure to the substance or mixture may cause adverse effects.
Inhalation Dust may irritate respiratory system. Prolonged inhalation may be harmful.
Skin contact Causes skin irritation.
Eye contact Causes serious eye irritation.
Ingestion May cause discomfort if swallowed.
Symptoms Symptoms of overexposure may be headache, dizziness, tiredness, nausea and vomiting. May cause redness and pain.
Acute toxicity May cause discomfort if swallowed.
Serious eye damage/eye irritation
Causes skin irritation. Causes serious eye irritation.
Respiratory sensitisation Not a respiratory sensitiser.
Not a skin sensitiser.
No data available to indicate product or any components present at greater than 0.1% are mutagenic or genotoxic.
Carcinogenicity Not classifiable as to carcinogenicity to humans.
Specific target organ toxicity - single exposure
Specific target organ toxicity - repeated exposure
This product is not expected to cause reproductive or developmental effects. May cause respiratory irritation.
Not classified.
Aspiration hazard Not classified.
Not available.
Other information No other specific acute or chronic health impact noted.
12.1. Toxicity The product is not classified as environmentally hazardous. However, this does not exclude the possibility that large or frequent spills can have a harmful or damaging effect on the environment.
12.3. Bioaccumulative potential
Partition coefficient
n-octanol/water (log Kow)
No data is available on the degradability of this product.
Not available.
Bioconcentration factor (BCF) Not available.
12.5. Results of PBT and vPvB assessment
No data available.
Not a PBT or vPvB substance or mixture.
12.6. Other adverse effects No other adverse environmental effects (e.g. ozone depletion, photochemical ozone creation potential, endocrine disruption, global warming potential) are expected from this component.
Residual waste
Contaminated packaging
EU waste code
Disposal methods/information
Dispose of in accordance with local regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see: Disposal instructions).
Empty containers should be taken to an approved waste handling site for recycling or disposal. Since emptied containers may retain product residue, follow label warnings even after container is emptied.
The Waste code should be assigned in discussion between the user, the producer and the waste disposal company.
Collect and reclaim or dispose in sealed containers at licensed waste disposal site. Dispose of contents/container in accordance with local/regional/national/international regulations.
Not regulated as dangerous goods.
Not regulated as dangerous goods.
Not regulated as dangerous goods.
Not regulated as dangerous goods.
Not regulated as dangerous goods.
Not applicable.
Regulation (EC) 005/2009 on substances that deplete the ozone layer, Annex I and II, as amended
Not listed.
Not listed.
Not listed.
Not listed.
Not listed.
Not listed.
Not listed.
Not listed.
Regulation (EC) 907/2006, REACH Annex XIV Substances subject to authorization, as amended
Not listed.
Regulation (EC) No1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended
Not listed.
Not listed.
Not listed.
Directive 2012/18/EU on major accident hazards involving dangerous substances
Not listed.
Not listed.
Not listed.
National regulations
15.2. Chemical safety assessment
The product is classified and labelled in accordance with Regulation (EC) 1272/2008 (CLP Regulation) as amended and respective national laws implementing EC directives. This Safety Data Sheet complies with the requirements of Regulation (EC) 907/2006.
In the European Union this product is regulated under the In Vitro Diagnostic Medical Devices Directive (98/79/EC).
Follow national regulation for work with chemical agents. No Chemical Safety Assessment has been carried out.
References
Information on evaluation method leading to the classification of mixture
Full text of any H-statements not written out in full under Sections 2 to 15
Training information Disclaimer
DNEL: Derived No-Effect Level.
PNEC: Predicted No-Effect Concentration.
IARC Monographs. Overall Evaluation of Carcinogenicity
The classification for health and environmental hazards is derived by a combination of calculation methods and test data, if available.
H315 Causes skin irritation.
H319 Causes serious eye irritation. H335 May cause respiratory irritation.
Follow training instructions when handling this material.
The information above is provided in good faith. It is believed to be accurate and represents the best information currently available to us. HOWEVER, WE MAKE NO WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER TYPE, EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCTS DESCRIBED OR DATA OR INFORMATION PROVIDED, AND WE ASSUME NO LIABILITY RESULTING FROM THE USE OF
SUCH PRODUCTS, DATA OR INFORMATION. Users should make their own investigations to determine the suitability of the information for their particular purposes, and the user assumes all risk arising from their use of the material. The user is required to comply with all laws and regulations relating to the purchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted safe handling procedures. In no event shall BioMedica Diagnostics be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if BioMedica Diagnostics has been advised of the possibility of such damages.
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