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BioMedica Diagnostics 238L 說明書

SAFETY DATA SHEET

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1. Product identifier

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

1.2. Relevant identified uses of the substance or mixture and uses advised against

Identified uses

Uses advised against

Research use only.

Use in accordance with supplier's recommendations.

SECTION 2: Hazards identification

2.1. Classification of the substance or mixture

The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies.

Classification according to Regulation (EC) 272/2008 as amended

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.

2.2. Label elements

Label according to Regulation (EC) 272/2008 as amended

Contains: H-D-cyclohexylalanyl-alanyl-arginine-para-nitroanilide diacetate saltt

Hazard pictograms

Signal word Warning

Hazard statements

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.

Response

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.

Storage

P403 + P233 Store in a well-ventilated place. Keep container tightly closed. P405 Store locked up.

Disposal

P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

Supplemental label information None.

2.3. Other hazards Not a PBT or vPvB substance or mixture.

SECTION 3: Composition/information on ingredients

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

Classification: -

20 - 40

56-40-6 - -

200-272-2

Composition comments

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.

SECTION 4: First aid measures

General information

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).

4.1. Description of first aid measures

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.

SECTION 5: Firefighting measures

General fire hazards

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.

SECTION 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures

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.

SECTION 7: Handling and storage

7.1. Precautions for safe handling

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.

SECTION 8: Exposure controls/personal protection

8.1. Control parameters

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.

Predicted no effect concentrations (PNECs)

8.2. Exposure controls

Not available.

Appropriate engineering controls

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.

Individual protection measures, such as personal protective equipment

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.

SECTION 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties Appearance

Physical state Form

Colour Odour

Solid.

White powder.

White.

Not available.

Odour threshold Not available.

pH Not available.

Melting point/freezing point Not available.

Initial boiling point and boiling range

Not available.

Flash point Not available.

Evaporation rate Not available.

Flammability (solid, gas) Not available.

Upper/lower flammability or explosive limits

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.

Partition coefficient (n-octanol/water)

Not available.

Auto-ignition temperature Not available. Decomposition temperature Not available. Viscosity Not available.

Explosive properties Oxidizing properties

9.2. Other information

Not available.

Not available.

No relevant additional information available.

SECTION 10: Stability and reactivity

10.1. Reactivity

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.

SECTION 11: Toxicological information

General information Occupational exposure to the substance or mixture may cause adverse effects.

Information on likely routes of exposure

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.

11.1. Information on toxicological effects

Acute toxicity May cause discomfort if swallowed.

Skin corrosion/irritation

Serious eye damage/eye irritation

Causes skin irritation. Causes serious eye irritation.

Respiratory sensitisation Not a respiratory sensitiser.

Skin sensitisation Germ cell mutagenicity

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.

Reproductive toxicity

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.

Mixture versus substance information

Not available.

Other information No other specific acute or chronic health impact noted.

SECTION 12: Ecological information

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.

12.2. Persistence and degradability

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.

12.4. Mobility in soil

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.

SECTION 13: Disposal considerations

13.1. Waste treatment methods

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.

SECTION 14: Transport information

ADR

Not regulated as dangerous goods.

RID

Not regulated as dangerous goods.

ADN

Not regulated as dangerous goods.

IATA

Not regulated as dangerous goods.

IMDG

Not regulated as dangerous goods.

14.7. Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code

Not applicable.

SECTION 15: Regulatory information

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

Regulation (EC) 005/2009 on substances that deplete the ozone layer, Annex I and II, as amended

Not listed.

Regulation (EC) No 850/2004 On persistent organic pollutants, Annex I as amended

Not listed.

Regulation (EC) No 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 1 as amended

Not listed.

Regulation (EC) No 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 2 as amended

Not listed.

Regulation (EC) No 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 3 as amended

Not listed.

Regulation (EC) No 689/2008 concerning the export and import of dangerous chemicals, Annex V as amended

Not listed.

Regulation (EC) No 166/2006 Annex II Pollutant Release and Transfer Registry, as amended

Not listed.

Regulation (EC) 907/2006, REACH Article 59(10) Candidate List as currently published by ECHA

Not listed.

Authorisations

Regulation (EC) 907/2006, REACH Annex XIV Substances subject to authorization, as amended

Not listed.

Restrictions on use

Regulation (EC) No1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended

Not listed.

Directive 2004/37/EC: on the protection of workers from the risks related to exposure to carcinogens and mutagens at work, as amended

Not listed.

Directive 92/85/EEC: on the safety and health of pregnant workers and workers who have recently given birth or are breastfeeding, as amended

Not listed.

Other EU regulations

Directive 2012/18/EU on major accident hazards involving dangerous substances

Not listed.

Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work

Not listed.

Directive 94/33/EC on the protection of young people at work

Not listed.

Other regulations

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.

SECTION 16: Other information

List of abbreviations

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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