I-SRS-C-01_Home COVID Test Processing Fluid_Safety Data Sheet.pdf

D1013783 B.7 I-SRS-C-01 Home COVID Test Processing Fluid Safety Data Sheet Released

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I-SRS-C-01 Home COVID Test Processing Fluid Safety Data Sheet

SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE

COMPANY/UNDERTAKING

1.1 Product identifier

Trade name Ellume COVID-19 Home Test Processing Fluid

1.2 Relevant identified uses of the substance or

mixture and uses advised against

Identified use(s) In vitro diagnostic reagent.

1.3 Details of the supplier of the safety data sheet

Company Identification Ellume Limited

57 Didsbury Street East Brisbane, QLD 4169

Australia

Telephone +61 7 33931448 E-Mail (competent person) info@ellumehealth.com

1.4 Emergency telephone number

Emergency Phone No. (Office hours) +61 7 33931448

SECTION 2: HAZARDS IDENTIFICATION

2.1 Classification of the substance or mixture

OSHA Hazard Communication Standard 29

CFR 1910.1200 (HazCom 2012) / GHS

Not classified as hazardous.

2.2 Label elements No measures required.

2.3 Other hazards None anticipated.

SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS

3.2 Mixtures

Description: Aqueous solution.

Hazardous Ingredient(s) CAS No. Classification code:

Hazard Statement(s)

%W/W mixture of 5-Chloro-2-methyl-4-isothiazolin-3-one 2-Methyl-4-isothiazolin-3-one (3:1)

55965-84-9 Acute Tox. 3; H301, H311, H331 Skin Corr. 1B; H314 Skin Sens. 1; H317 Aquatic Acute 1; H400 Aquatic Chronic 1;

H410

0.002 – 0.005

3.3 Additional Information For full text of H Statements see section 16.

SECTION 4: FIRST AID MEASURES

4.1 Description of first aid measures

Inhalation Supply fresh air; consult doctor in case of complaint.

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Skin Contact Wash skin with soap and water. Remove contaminated clothing and wash clothing before reuse. If skin irritation or rash occurs: Get medical advice/attention.

Eye Contact Rinse cautiously with water for several minutes. Consult a doctor in case of complaint.

Ingestion Wash out mouth with water. Consult a doctor in case of complaint.

4.2 Most important symptoms and effects, both

acute and delayed

None

4.3 Indication of the immediate medical attention

and special treatment needed

None.

SECTION 5: FIRE-FIGHTING MEASURES

5.1 Extinguishing media

Suitable Extinguishing Media CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.

5.2 Special hazards arising from the substance or

mixture In case of fire, the following can be released: Carbon oxides (COx) nitrogen oxides (NOx), phosphorous oxides (PxOy).

5.3 Advice for fire-fighters Use fire-extinguishing methods suitable to surrounding conditions.

Wear full protective suit and self-contained breathing aparatus (SCBA) when extinguishing fires.

SECTION 6: ACCIDENTAL RELEASE MEASURES

6.1 Personal precautions, protective equipment

and emergency procedures

Refer to Section 8 for protective measures when handling the spillage.

6.2 Environmental precautions No special requirements.

6.3 Methods and material for containment and

cleaning up Absorb with liquid-binding material (paper towelling, sand, diatomite, acid binders, universal binders, sawdust).

Dispose of contaminated material as waste according to Section 13.

6.4 Reference to other sections 8, 13

SECTION 7: HANDLING AND STORAGE

7.1 Precautions for safe handling Avoid contact with the eyes, skin and mucous membranes.

Keep out of reach of children.

Wash hands before breaks and after work.

7.2 Conditions for safe storage, including any

incompatibilities

Store in the original container at 2 to 30°C.

7.3 Specific end use(s) In vitro diagnostic reagent.

SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1 Control parameters

8.1.1 Occupational Exposure Limits The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace.

8.2 Exposure controls

8.2.1 Appropriate engineering controls Not relevant for this material.

8.2.2 Personal protection equipment

Eye/face protection (Industrial/professional)

Not normally required.

Hand protection

Not normally required.

Body protection (Industrial/professional) Not normally required.

Respiratory protection Not normally required.

8.2.3 Environmental Exposure Controls No special measures are required.

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SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES

9.1 Information on basic physical and chemical

properties

Appearance Clear Liquid.

Colour Colourless.

Odour No odour.

Odour Threshold (ppm) Not applicable.

pH (Value) 7.2.

Melting Point (°C) / Freezing Point (°C) Similar to water, approximately 0°C.

Boiling point/boiling range (°C): 100 ± 1°C.

Flash Point (°C) Not relevant for this material*.

Evaporation rate (BA = 1) Not determined.

Flammability (solid, gas) Not applicable.

Explosive limit ranges Not applicable.

Vapour Pressure (Pascal) Similar to water, approximately 23 hPa.

Vapour Density (Air=1) Not determined.

Density (g/ml) ~ 1.0 Solubility (Water) Soluble.

Solubility (Other) Not determined.

Partition Coefficient (n-Octanol/water) Not determined.

Auto Ignition Temperature (°C) Not determined.

Decomposition Temperature (°C) Not determined.

Viscosity (mPa.s) Not determined.

Explosive properties Not explosive.

Oxidising properties Not oxidising.

9.2 Other information * The Processing Fluid contains one ingredient which in its stock form has a flash point of 118⁰C – closed cup. This stock solution is significantly diluted by adding it to the Processing Fluid in sufficient volume to produce a 0.09% v/v final concentration of that stock solution.

SECTION 10: STABILITY AND REACTIVITY

10.1 Reactivity None known.

10.2 Chemical stability The product is stable in accordance with the recommended storage conditions.

10.3 Possibility of hazardous reactions Hazardous polymerisation will not occur.

10.4 Conditions to avoid None.

10.5 Incompatible materials None known.

10.6 Hazardous Decomposition Product(s) None known.

SECTION 11: TOXICOLOGICAL INFORMATION

11.1 Information on toxicological effects

11.1.2 Mixtures

Acute toxicity Based upon the available data, the classification criteria are not met.

Skin corrosion/irritation Based upon the available data, the classification criteria are not met.

Serious eye damage/irritation Based upon the available data, the classification criteria are not met.

Respiratory/skin sensitization Based upon the available data, the classification criteria are not met.

Germ cell mutagenicity Based upon the available data, the classification criteria are not met.

Carcinogenicity Based upon the available data, the classification criteria are not met.

Reproductive toxicity Based upon the available data, the classification criteria are not met.

STOT-single exposure

Based upon the available data, the classification criteria are

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STOT-repeated exposure Based upon the available data, the classification criteria are

Aspiration hazard Based upon the available data, the classification criteria are

Health Effects and Symptoms Skin Contact Possibility of allergic reaction in individuals already sensitized to isithiazolines.

Eye Contact No significant harmful effects anticipated.

Ingestion No significant harmful effects anticipated.

11.2 Other information Not applicable.

SECTION 12: ECOLOGICAL INFORMATION

12.1 Toxicity The product does not contain significant quantities of ingredients that are environmentally toxic.

12.2 Persistence and degradability The product is not biodegradable. Inorganic salts.

12.3 Bioaccumulative potential None anticipated.

12.4 Mobility in soil The product is predicted to have high mobility in soil.

12.5 Results of PBT and vPvB assessment Not applicable.

12.6 Other adverse effects Not applicable.

SECTION 13: DISPOSAL CONSIDERATIONS

13.1 Waste treatment methods

Product: Disposal should be in accordance with local, state or national legislation. May be disposed of in a non-recyclable waste stream.

Packaging: Disposal should be in accordance with local, state or national legislation.

Contaminated packaging must be disposed of in the same manner as the product.

Non-contaminated packaging materials may be recycled.

Contact your local service providers for further information.

SECTION 14: TRANSPORT INFORMATION

14.1 UN number Not applicable

14.2 UN Proper Shipping Name Not applicable

14.3 Transport hazard class(es) Not classified as dangerous for transport.

14.4 Packing Group Not applicable

14.5 Environmental hazards Not applicable

14.6 Special precautions for user Not applicable

14.7 Transport in bulk according to Annex II of

MARPOL73/78 and the IBC Code Not applicable

SECTION 15: REGULATORY INFORMATION

15.1 Safety, health and environmental

regulations/legislation specific for the substance or mixture

OSHA Hazard Communication Standard 29 CFR 1910.1200 Consumer Product Safety Regulations 16 CFR 1500 IVD Product Labelling 21 CFR 809

Carcinogen listings IARC: None of the ingredients is listed.

NTP: None of the ingredients is listed.

ACGIH: None of the ingredients is listed.

OSHA: None of the ingredients is listed.

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EPA: None of the ingredients is listed.

Californian Proposition 65 Chemicals known to cause cancer: None of the ingredients is listed.

Chemicals known to cause reproductive toxicity: None of the ingredients is listed.

SARA

Section 355 (extremely hazardous substances): None of the ingredients is listed.

Section 313 (specific toxic chemical listings): None of the ingredients is listed.

15.2 Chemical Safety Assessment Not applicable.

SECTION 16: OTHER INFORMATION

LEGEND

STOT Specific Target Organ Toxicity

Classification code:

Acute Tox.

Acute toxicity; Category 3

Skin Sens. 1 Skin sensitization, Category 1 Skin Corr. 1B Skin corrosion/irritation; Category 1B Aquatic Acute 1 Hazardous to the aquatic environment, Acute, Category 1 Aquatic Chronic 1 Hazardous to the aquatic environment, Chronic, Category 1

Hazard statement(s)

H301: Toxic if swallowed.

H311: Toxic in contact with skin.

H314: Causes severe skin burns and eye damage.

H317: May cause an allergic skin reaction.

H331: Toxic if inhaled.

H400: Very toxic to aquatic life.

H410: Very toxic to aquatic life with long lasting effects.

References:

Raw material safety data sheets.

Additional Information

Prepared by: Ellume Limited, Email: info@ellumehealth.com

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.