MIXTURE

SECTION 2: Hazards identification

According to Regulation (EC) No 1272/2008 [CLP Classification of the substance or mixture Collect and place in container for disposal according to local regulations

Hazard statements

- No special measures required.

Additional information

99% of the mixture consists of components of unknown toxicity. Contains 99% of components with unknown hazards to the aquatic 7.2 Conditions for safe storage, including any incompatibilities No special measures required. 7.3 Specific end use(s) environment. No further relevant information available Other hazards None known EXPOSURE CONTROLS/PERSONAL PROTECTION Control parameters The product does not contain any relevant quantities of

2.1 Classification of the substance or mixture

regulations. The substance is not classified according to Regulation (EC) No 6.4 Reference to other sections 1272/2008 [CLP]. See Sections 7, 8 and 13 as appropriate. 2.2 Label elements Labelling according to Regulation (EC) No 1272/2008 [CLP]: SECTION 7 HANDLING AND STORAGE non-regulated material. 7.1 Precautions for safe handling Hazard statement(s): - No special measures required. Precautionary statements: - 7.2 Conditions for safe storage, including any Additional information: 99% of the mixture consists of incompatibilities components of unknown toxicity. Contains 99% of No special measures required. components with unknown hazards to the aquatic 7.3 Specific end use(s) environment. No further relevant information available. 2.3 Other hazards None known. SECTION 8 EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parameters SECTION 3 COMPOSITION/INFORMATION ON INGREDIENTS The product does not contain any relevant quantities of 3.2 Mixtures materials with critical values that have to be monitored at the Hazardous ingredients according to Regulation (EC) No workplace, based on valid lists available during the making. 1272/2008 8.2 Exposure controls Non-regulated material. 8.2.1 Appropriate engineering controls Handle in accordance with good industrial hygiene and safety SECTION 4 FIRST AID MEASURES practice. Wash hands before breaks and at the end of 4.1 Description of first aid measures workday. Specimen collection and preparation: all the If inhaled: supply fresh air; if concerned, consult a physician. specimens should be considered potentially hazardous and In case of skin contact: generally, the product does not cause handled in the same manner as an infectious agent. skin irritation. 8.2.2 Personal protective equipment In case of eye contact: rinse opened eye for several minutes (a) Eye/face protection: Not required. under running water. If swallowed: if symptoms occur, consult a physician. (b) Skin protection: Not required. 4.2 Most important symptoms and effects, both acute and (c) Body Protection: No special measures are required. delayed (d) Respiratory protection: No required. No further relevant information available. 4.3 Indication of any immediate medical attention and special treatment needed No further relevant information available. SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES Respiratory or skin sensitisation: Based on available data, the 9.1 Information on basic physical and chemical properties classification criteria are not met. a) Appearance Form: solid Colour: white Germ cell mutagenicity: Based on available data, the b) Odour Odourless classification criteria are not met. c) Odour threshold Not applicable Carcinogenicity: Based on available data, the classification d) pH Not applicable criteria are not met. Reproductive toxicity: Based on available data, the e) Melting point / freezing point Not determined classification criteria are not met. f) Initial boiling point and boiling range Not determined Specific target organ toxicity - single exposure: Based on g) Flash point Not applicable available data, the classification criteria are not met. h) Evaporation rate Not applicable Specific target organ toxicity - repeated exposure: Based on i) Flammability (solid, gas) Product is not flammable available data, the classification criteria are not met. j) Upper/lower flammability or explosive limits Not Aspiration hazard: Based on available data, the classification determined criteria are not met. k) Vapour pressure Not applicable l) Vapour density Not applicable SECTION 12 ECOLOGICAL INFORMATION m) Relative density Not determined 12.1 Toxicity n) Solubility (ies) Insoluble No further relevant information available. o) Partition coefficient: n-octanol/water Not determined 12.2 Persistence and degradability p) Auto-ignition temperature Not determined No further relevant information available. q) Decomposition temperature Not determined 12.3 Bioaccumulative potential r) Viscosity Not applicable No further relevant information available. s) Explosive properties Product does not present an explosion 12.4 Mobility in soil hazard No further relevant information available. t) Oxidising properties Not applicable Additional ecological information – general notes: Generally 9.2 Other information not hazardous for water. Solvent content (organic solvents): 0.0% 12.5 Results of PBT and vPvB assessment Solids content: 100.0% Not applicable. No further relevant information available. 12.6 Other adverse effects No further relevant information available. SECTION 10 STABILITY AND REACTIVITY 10.1 Reactivity SECTION 13 DISPOSAL CONSIDERATIONS No further relevant information available. 13.1 Waste treatment methods 10.2 Chemical stability This material is not regarded as hazardous waste. Under storage at normal ambient temperatures the product is Product: Dispose of in accordance with all federal, state, and stable. local regulations. Thermal decomposition/conditions to be avoided: No Contaminated packaging: Dispose of as unused product. decomposition is used according to specifications. 10.3 Possibility of hazardous reactions No known dangerous reactions. SECTION 14 TRANSPORT INFORMATION ADR, ADN, IMDG, IATA: non-regulated material 10.4 Conditions to avoid No further relevant information available. 14.1 UN number: - 14.2 UN proper shipping name: - 10.5 Incompatible materials 14.3 Transport hazard class(es): - No further relevant information available. 14.4 Packing group: - 10.6 Hazardous decomposition products 14.5 Environmental hazards: Not applicable. No known dangerous decomposition products. 14.6 Special precautions for user: Not applicable. SECTION 11 TOXICOLOGICAL INFORMATION SECTION 15 REGULATORY INFORMATION 11.1 Information of toxicological effects 15.1 Safety, health and environmental regulations/ Acute toxicity: Based on available data, the classification legislation specific for the substance or mixture criteria are not met. Directive 2012/18/EU – Annex I – none of the ingredients are Skin corrosion/irritation: Based on available data, the listed. classification criteria are not met. National regulations: The product is subject to be labelled Serious eye damage/eye irritation: Based on available data, according with the prevailing version of the regulations on the classification criteria are not met. hazardous substances. 15.2 Chemical Safety Assessment No chemical safety assessment has been carried out for this product. SECTION 16 OTHER INFORMATION For professional in vitro diagnostic use only. Consult instructions for use. Amended sections are indicated by a line in the border. The information supplied in this SDS is correct to the best of our knowledge. We do not accept any liability for loss, injury or damage, which may result from its use. MDSS GmbH Schiffaraben 41 30175 Hanover Germany SECTION 1 IDENTIFICATION OF THE SUBSTANCE/ MIXTURE AND THE COMPANY/UNDERTAKING 1.1 Product Identifier: 1601 Leishmania Dipstick Rapydtest® Chase Buffer 1.2 Relevant identified uses of the substance or mixture and uses advised against: Medical device for professional in vitro diagnostic use only. Used with Leishmania Dipstick Rapydtest® in the qualitative detection of antibody to visceral leishmaniasis in serum. 1.3 Details of the supplier of the Safety Data Sheet: Apacor Limited, Unit 5 Sapphire Centre, Fishponds Road, Wokingham, Berkshire, RG41 2QL, United Kingdom +44 (0) 118 979 5566 technical@apacor.com 1.4 Emergency telephone number: +44 (0)118 979 5566 (Monday-Friday 0900-1700 excluding UK Public Holidays) SECTION 2 HAZARDS IDENTIFICATION 2.1 Classification of the substance or mixture The substance is not classified according to Regulation (EC) No 1272/2008 [CLP]. 2.2 Label elements Labelling according to Regulation (EC) No 1272/2008 [CLP]: non-regulated material. Hazard statement(s): - Precautionary statements: - 2.3 Other hazards None known. SECTION 3 COMPOSITION/INFORMATION ON INGREDIENTS 3.2 Mixtures Hazardous ingredients according to Regulation (EC) No 1272/2008 Component: Hydrochloric Acid CAS No: 7647-01-0 EINECS No: 231-595-7 Index No: 017-002-01-X Registration No: 01-2119484862-27-XXXX Classification: Skin Corr. 1B H314; Acute Tox. 4 H332; STOT SE 3 H335 Concentration: < 2.5% See Section 16 for the full text of H-Statements mentioned in this Section. SECTION 4 FIRST AID MEASURES 4.1 Description of first aid measures General Information: Symptoms of poisoning may even occur after several hours; medical observation should be carried out for at least 48 hours. If inhaled: supply fresh air. If required, give artificial respiration. Keep patient warm. Consult a physician if symptoms persist. If unconscious, place patient in a stable side position for transportation. In case of skin contact: generally, the product does not cause skin irritation. SDS078 v3 08/02/2021 In case of eye contact: rinse opened eye thoroughly for several minutes under running water. If swallowed: if symptoms occur, consult a physician. 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available. 4.3 Indication of any immediate medical attention and special treatment needed No further relevant information available. SECTION 5 FIRE FIGHTING MEASURES 5.1 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 No further relevant information available 5.3 Advice for firefighters Mouth respiratory protective device. Wear approved self- contained breathing apparatus (NIOSH approved or equivalent) for firefighting and full protective gear to prevent contact with eyes. SECTION 6 ACCIDENTAL RELEASE MEASURES 6.1 Personal precautions, protective equipment and emergency procedures Not required. 6.2 Environmental precautions No special measures required. 6.3 Methods and material for containment and cleaning up Contain spillage, soak up with inert absorbent material then collect and place in container for disposal according to local regulations. Ensure adequate ventilation. 6.4 Reference to other sections See Sections 7, 8 and 13 as appropriate. SECTION 7 HANDLING AND STORAGE 7.1 Precautions for safe handling No special measures are required. Ensure good ventilation at the workplace. Prevent formation of aerosols. Information about fire and explosion protection: No special measures required. 7.2 Conditions for safe storage, including any incompatibilities Store at room temperature. Keep container tightly sealed. No other special requirements. 7.3 Specific end use(s) SECTION 8 EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parameters Hydrochloric Acid Sodium Azide (NaN3), Sk 7647-01-0 26628-22-8 WEL STEL: 5 ppm STEL: 0.3 mg/m3 STEL: 8 mg/m3 TWA: 0.1 mg/m3 TWA: 1 ppm TWA: 2 mg/m3 Additional information: Based on valid lists available during the making. 8.2 Exposure controls 8.2.1 Appropriate engineering controls Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday. Specimen collection and preparation: all the specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. 8.2.2 Personal protective equipment (a) Eye/face protection: Safety goggles recommended. Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). (b) Skin protection: Not required. (c) Body Protection: Not required. (d) Respiratory protection: Not required. SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on basic physical and chemical properties a) Appearance form: liquid Colour: colourless b) Odour Odourless c) Odour threshold Not determined d) pH @ 20°C 7 e) Melting point / freezing point Not determined f) Initial boiling point and boiling range Not determined g) Flash point Not applicable h) Evaporation rate Not determined i) Flammability (solid, gas) Not applicable j) Upper/lower flammability or explosive limits 0 Vol % k) Vapour pressure Not determined l) Vapour density Not determined m) Relative density Not determined n) Solubility (ies) Fully miscible o) Partition coefficient: n-octanol/water Not determined p) Auto-ignition temperature Product is not self-igniting q) Decomposition temperature Not determined r) Viscosity Not determined s) Explosive properties Product does not present an explosion hazard t) Oxidising properties No data available 9.2 Other information Solvent content (organic solvents): 0.0% No further relevant information available. SECTION 10 STABILITY AND REACTIVITY 10.1 Reactivity No further relevant information available. SDS078 v3 08/02/2021 10.2 Chemical stability Under storage at normal ambient temperatures the product is stable. Thermal decomposition/conditions to be avoided: No decomposition is used according to specifications. 10.3 Possibility of hazardous reactions No known dangerous reactions. 10.4 Conditions to avoid No further relevant information available. 10.5 Incompatible materials No further relevant information available. 10.6 Hazardous decomposition products No known dangerous decomposition products. SECTION 11 TOXICOLOGICAL INFORMATION 11.1 Information of toxicological effects Acute toxicity: Based on available data, the classification criteria are not met. Skin corrosion/irritation: Based on available data, the classification criteria are not met. Serious eye damage/eye irritation: Based on available data, the classification criteria are not met. Respiratory or skin sensitisation: Based on available data, the classification criteria are not met. Germ cell mutagenicity: Based on available data, the classification criteria are not met. Carcinogenicity: Based on available data, the classification criteria are not met. Reproductive toxicity: Based on available data, the classification criteria are not met. Specific target organ toxicity - single exposure: Based on available data, the classification criteria are not met. Specific target organ toxicity - repeated exposure: Based on available data, the classification criteria are not met. Aspiration hazard: Based on available data, the classification criteria are not met. Additional Information Chemical Name Hydrochloric Acid LD50 oral 700mg/kg (Rat), 900mg/kg (Rabbit) 7647-01-0 LD50 dermal 5010mg/kg (Rabbit) LC50 inhalation 6.41mg/l (Rat) 4 h Skin corrosion/irritation: skin irritation (Rabbit) Serious eye damage/irritation: eye irritation (Rabbit) Sodium Azide LD50 oral 27mg/kg (Rat) 26628-22-8 LD50 dermal 20mg/kg (Rabbit) SECTION 12 ECOLOGICAL INFORMATION 12.1 Toxicity Toxicity to Fish Hydrochloric Acid EC50 3.6mg/l (Bluegill/Sunfish), >56mg/l (Daphnia) 7647-01-0 12.2 Persistence and degradability No further relevant information available. 12.3 Bioaccumulative potential No further relevant information available. 12.4 Mobility in soil Additional ecological information – general notes: Generally not hazardous for water. 12.5 Results of PBT and vPvB assessment Not applicable. 12.6 Other adverse effects No further relevant information available. SECTION 13 DISPOSAL CONSIDERATIONS 13.1 Waste treatment methods Product: Dispose of in accordance with all federal, state, and local regulations. Contaminated packaging: Dispose of as unused product. SECTION 14 TRANSPORT INFORMATION ADR, ADN, IMDG, IATA non-regulated material 14.1 UN number: - 14.2 UN proper shipping name: - 14.3 Transport hazard class(es): - 14.4 Packing group: - 14.5 Environmental hazards: - 14.6 Special precautions for user: - SECTION 15 REGULATORY INFORMATION 15.1 Safety, health and environmental regulations/ legislation specific for the substance or mixture Directive 2012/18/EU – Annex I – Hydrochloric acid National regulations: The product is subject to be labelled according with the prevailing version of the regulations on hazardous substances. 15.2 Chemical Safety Assessment No chemical safety assessment has been carried out for this product. SECTION 16 OTHER INFORMATION For professional in vitro diagnostic use only. Consult instructions for use. Amended sections are indicated by a line in the border. Full text of H-Statements referred to in Section 3 H314 Causes severe skin burns and eye damage. H332 Harmful if inhaled. H335 May cause respiratory irritation. Acute Tox. Acute toxicity Skin Corr. Skin corrosion STOT SE Specific target organ toxicity - single exposure The information supplied in this SDS is correct to the best of our knowledge. We do not accept any liability for loss, injury or damage, which may result from its use. MDSS GmbH Schiffaraben 41 30175 Hanover Germany