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Safety Data Sheet EN

IMMULITE® 2000 CMV IgM

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
IMMULITE® 2000 CMV IgM
Product Code
L2KCM2/6, 10381310, 10381320, 10370302

Regulatory Identifiers

CAS Number
N/A

Identified Uses

CMV IgM Reagent Wedge A Diagnostic agents. CMV IgM Reagent Wedge B Diagnostic agents. CMV IgM Reagent Wedge C Diagnostic agents. CMV IgM Adjustor (L2CMJ3) Diagnostic agents. CMV IgM Controls Diagnostic agents.

Uses advised against

For professional users only.

Manufacturers & Suppliers

S

Siemens Healthcare Diagnostics Limited

manufacturer

Sir William Siemens Square, Newton House, Camberley, Frimley, Surrey, GU16 8QD, UK

+44 (0) 1276 696000

Emergency Contacts

NHS Direct

0845 4647

NHS Direct

111

NHS 24

08454 24 24 24

Emergency Contact

01 809 2166

CHEMTREC

0870-8200418

CHEMTREC

+(353)-19014670

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified warning

Hazard Classifications

Eye Irrit. Cat. 2 H319
Aquatic Chronic Cat. 3 H412
Acute Tox. Cat. 4 H302
Acute Tox. Cat. 4 H312

GHS Pictograms

GHS07 - Health hazard

GHS07

Hazard Statements

H302 + H312 Harmful if swallowed or in contact with skin.
H319 Causes serious eye irritation.
H412 Harmful to aquatic life with long lasting effects.

Precautionary Statements

P264 Wash hands thoroughly after handling.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/eye protection/face protection.
P301 + P312 IF SWALLOWED: Call a POISON CENTER or physician if you feel unwell.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P501 Dispose of contents and container in accordance with all local, regional, and national regulations.
IF ON SKIN: Call a POISON CENTER or physician if you feel unwell.

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type mixture
Chemical Name CAS Number Concentration Hazardous
tetrasodium ethylene diamine tetraacetate EC: 200-573-9 64-02-8 3% Yes
aminocaproic acid EC: 200-469-3 60-32-2 3% Yes
2-methyl-2H-isothiazol-3-one EC: 220-239-6 2682-20-4 0.025% Yes
sodium azide EC: 247-852-1 26628-22-8 2% Yes

There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment, are PBTs, vPvBs or Substances of equivalent concern, or have been assigned a workplace exposure limit and hence require reporting in this section.

04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Remove victim to fresh air and keep at rest in a position comfortable for breathing. If not breathing, if breathing is irregular or if respiratory arrest occurs, provide artificial respiration or oxygen by trained personnel. If unconscious, place in recovery position and get medical attention immediately. Maintain an open airway. Loosen tight clothing such as a collar, tie, belt or waistband.

Skin contact

Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur. Wash clothing before reuse. Clean shoes thoroughly before reuse. For controls: Wash with plenty of soap and water. Wash contaminated clothing thoroughly with water before removing it, or wear gloves. Continue to rinse for at least 10 minutes. If necessary, call a poison center or physician.

Eye contact

Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Continue to rinse for at least 10 minutes. Get medical attention if irritation occurs.

Symptoms: pain or irritation, watering redness

Ingestion

Wash out mouth with water. Remove dentures if any. Remove victim to fresh air and keep at rest in a position comfortable for breathing. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Stop if the exposed person feels sick as vomiting may be dangerous. Do not induce vomiting unless directed to do so by medical personnel. If vomiting occurs, the head should be kept low so that vomit does not enter the lungs. Get medical attention if adverse health effects persist or are severe. Never give anything by mouth to an unconscious person. If unconscious, place in recovery position and get medical attention immediately. Maintain an open airway. Loosen tight clothing such as a collar, tie, belt or waistband.

Immediate Medical Attention

Get medical attention if adverse health effects persist or are severe. If unconscious, place in recovery position and get medical attention immediately.

Medical Treatment

Treat symptomatically.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Use an extinguishing agent suitable for the surrounding fire.

Unsuitable media

None known.

Specific hazards

In a fire or if heated, a pressure increase will occur and the container may burst. This material is harmful to aquatic life with long lasting effects.

Instructions

Promptly isolate the scene by removing all persons from the vicinity of the incident if there is a fire. No action shall be taken involving any personal risk or without suitable training.

Firefighter Protection

Fire-fighters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA) with a full face-piece operated in positive pressure mode. Clothing for fire-fighters (including helmets, protective boots and gloves) conforming to European standard EN 469 will provide a basic level of protection for chemical incidents.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

No action shall be taken involving any personal risk or without suitable training. Evacuate surrounding areas. Keep unnecessary and unprotected personnel from entering. Do not touch or walk through spilt material. Avoid breathing vapour or mist. Provide adequate ventilation. Wear appropriate respirator when ventilation is inadequate. Put on appropriate personal protective equipment.

Small spill

Stop leak if without risk. Move containers from spill area. Dilute with water and mop up if water-soluble. Alternatively, or if water-insoluble, absorb with an inert dry material and place in an appropriate waste disposal container. Dispose of via a licensed waste disposal contractor.

Large spill

Stop leak if without risk. Move containers from spill area. Approach the release from upwind. Prevent entry into sewers, water courses, basements or confined areas. Wash spillages into an effluent treatment plant or proceed as follows. Contain and collect spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth and place in container for disposal according to local regulations. Dispose of via a licensed waste disposal contractor. Contaminated absorbent material may pose the same hazard as the spilt product.

Environmental

Avoid dispersal of spilt material and runoff and contact with soil, waterways, drains and sewers.

Cleanup methods

Dilute with water and mop up if water-soluble. Alternatively, or if water-insoluble, absorb with an inert dry material. Wash spillages into an effluent treatment plant.

Materials: inert dry material, non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth

—

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Put on appropriate personal protective equipment (see Section 8). Do not ingest. Avoid contact with eyes, skin and clothing. Avoid breathing vapour or mist. Avoid release to the environment. Keep in the original container or an approved alternative made from a compatible material, kept tightly closed when not in use. Empty containers retain product residue and can be hazardous. Do not reuse container.

Storage

Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials (see Section 10) and food and drink. 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. Do not store in unlabelled containers.

Hygiene

Eating, drinking and smoking should be prohibited in areas where this material is handled, stored and processed. Workers should wash hands and face before eating, drinking and smoking. Remove contaminated clothing and protective equipment before entering eating areas.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

Good general ventilation should be sufficient to control worker exposure to airborne contaminants.

Hands

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. Considering the parameters specified by the glove manufacturer, check during use that the gloves are still retaining their protective properties. It should be noted that the time to breakthrough for any glove material may be different for different glove manufacturers. In the case of mixtures, consisting of several substances, the protection time of the gloves cannot be accurately estimated. Impervious gloves (e.g. butyl, nitrile, etc.) are recommended if skin contact is possible and for processing operations. Protective gloves must meet the standards in accordance with CEN EN374, ASTM F1001 or international equivalent.

Eyes

Safety eyewear complying with an approved standard should be used when a risk assessment indicates this is necessary to avoid exposure to liquid splashes, mists, gases or dusts. If contact is possible, the following protection should be worn, unless the assessment indicates a higher degree of protection: safety glasses with side-shields.

Respiratory

Based on the hazard and potential for exposure, select a respirator that meets the appropriate standard or certification. Respirators must be used according to a respiratory protection program to ensure proper fitting, training, and other important aspects of use.

Skin/Body

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. Appropriate footwear and any additional skin protection measures should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.

Environmental

Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation. In some cases, fume scrubbers, filters or engineering modifications to the process equipment will be necessary to reduce emissions to acceptable levels.

09

Physical and Chemical Properties

Appearance, physical state, melting point, boiling point, and material characteristics

Language Code
---
Physical State
Liquid (Reagent Wedge A, B, C); Solid (Adjustor, Controls)
Physical State Data
liquid
State Under Standard Conditions
---
Appearance
Liquid (Reagent Wedge A, B, C); Solid (Adjustor, Controls)
Colour
Colourless (Reagent Wedge A, B, C); Off-white (Adjustor, Controls)
Colour Intensity
---
Form
---
Odor
Odourless
Odor Threshold
Not relevant/applicable due to nature of the product.
Ph
7.95 to 8.05 (Reagent Wedge A, B, C); Not available (Adjustor); Not applicable (Controls)
Melting Point
Not available.
Boiling Point
Not available.
Flash Point
Not available.
Freezing Point
---
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
Not relevant/applicable due to nature of the product.
Vapor Pressure
Not relevant/applicable due to nature of the product.
Vapor Density
Not relevant/applicable due to nature of the product.
Relative Density
Not relevant/applicable due to nature of the product (Reagent Wedge A, B, C, Adjustor); 1 (Controls)
Bulk Density
---
Density
---
Flammability
Not relevant/applicable due to nature of the product.
Upper Explosive Limit
Not relevant/applicable due to nature of the product.
Lower Explosive Limit
Not relevant/applicable due to nature of the product.
Explosive Limits
---
Auto Ignition Temperature
Not relevant/applicable due to nature of the product.
Decomposition Temperature
Not relevant/applicable due to nature of the product.
Solubility
Not relevant/applicable due to nature of the product.
Partition Coefficient
Not relevant/applicable due to nature of the product.
Solubility In Water
Not relevant/applicable due to nature of the product.
Solubility In Fat
---
Molecular Weight
---
Voc Content
---
Metal Corrosion
---
Dynamic Viscosity
---
Kinematic Viscosity
---
Properties Status
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

The product is stable.

Reactivity

No specific test data related to reactivity available for this product or its ingredients.

Hazardous reactions

Under normal conditions of storage and use, hazardous reactions will not occur.

Avoid

No specific data.

Incompatible

No specific data.

Decomposition

Under normal conditions of storage and use, hazardous decomposition products should not be produced.

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

12.1 Toxicity

12.1 Toxicity | Product/ingredient name | Result | Species | Exposure | | --- | --- | --- | --- | | CMV IgM Reagent Wedge A | | | |

12.1 Toxicity

| Product/ingredient name | Result | Species | Exposure | | 2-methyl-2H-isothiazol-3-one | Acute EC50 0.18 ppm Fresh water | Daphnia - Daphnia magna | 48 hours | | | Acute LC50 0.07 ppm Fresh water | Fish - Oncorhynchus mykiss | 96 hours |

12.1 Toxicity

| Product/ingredient name | Result | Species | Exposure | | tetrasodium ethylene diamine tetraacetate | Acute LC50 486000 μg/l Fresh water | Fish - Lepomis macrochirus | 96 hours |

12.1 Toxicity

| Product/ingredient name | Result | Species | Exposure | | 2-methyl-2H-isothiazol-3-one | Acute EC50 0.18 ppm Fresh water | Daphnia - Daphnia magna | 48 hours | | | Acute LC50 0.07 ppm Fresh water | Fish - Oncorhynchus mykiss | 96 hours |

12.1 Toxicity

| Product/ingredient name | Result | Species | Exposure | | sodium azide | Acute EC50 0.348 mg/l Fresh water | Algae - Pseudokirchneriella subcapitata | 96 hours | | | Acute EC50 6.4 mg/l Fresh water | Crustaceans - Simocephalus serrulatus - Larvae | 48 hours | | | Acute EC50 4.2 mg/l Fresh water | Daphnia - Daphnia pulex - Larvae | 48 hours | | | Acute LC50 0.68 mg/l Fresh water | Fish - Lepomis macrochirus | 96 hours |

12.1 Toxicity

CMV IgM Controls | Chronic NOEC 5600 μg/l Marine water | Algae - Macrocystis pyrifera | 96 hours

12.1 Toxicity

| Product/ingredient name | Result | Species | Exposure | | | Acute EC50 0.348 mg/l Fresh water | Algae - Pseudokirchneriella subcapitata | 96 hours | | | Acute EC50 6.4 mg/l Fresh water | Crustaceans - Simocephalus serrulatus - Larvae | 48 hours | | | Acute EC50 4.2 mg/l Fresh water | Daphnia - Daphnia pulex - Larvae | 48 hours | | | Acute LC50 0.68 mg/l Fresh water | Fish - Lepomis macrochirus | 96 hours | | | Chronic NOEC 5600 μg/l Marine water | Algae - Macrocystis pyrifera | 96 hours |

12.3 Bioaccumulative potential

| Product/ingredient name | LogPow | BCF | Potential | | tetrasodium ethylene diamine tetraacetate | 5.01 | 1.8 | low |

12.3 Bioaccumulative potential

| Product/ingredient name | LogPow | BCF | Potential | | aminocaproic acid | -2.95 | - | low |

12.3 Bioaccumulative potential

| Product/ingredient name | LogPow | BCF | Potential | | tetrasodium ethylene diamine tetraacetate | 5.01 | 1.8 | low |

12.3 Bioaccumulative potential

| Product/ingredient name | LogPow | BCF | Potential | | aminocaproic acid | -2.95 | - | low |

12.3 Bioaccumulative potential

| Product/ingredient name | LogPow | BCF | Potential | | aminocaproic acid | -2.95 | - | low |

12.4 Mobility in soil

Soil/water partition coefficient (Koc) : CMV IgM Reagent Wedge A: Not available. CMV IgM Reagent Wedge B: Not available. CMV IgM Reagent Wedge C: Not available. CMV IgM Adjuster (L2CMJ3): Not available. CMV IgM Controls: Not available. Mobility : CMV IgM Reagent Wedge A: Not available. CMV IgM Reagent Wedge B: Not available. CMV IgM Reagent Wedge C: Not available. CMV IgM Adjuster (L2CMJ3): Not available. CMV IgM Controls: Not available.

12.5 Results of PBT and vPvB assessment

PBT : CMV IgM Reagent Wedge A: Not applicable. CMV IgM Reagent Wedge B: Not applicable. CMV IgM Reagent Wedge C: Not applicable. CMV IgM Adjuster (L2CMJ3): Not applicable. CMV IgM Controls: Not applicable. P: Not available. B: Not available. T: Not available. vPvB : CMV IgM Reagent Wedge A: Not applicable. CMV IgM Reagent Wedge B: Not applicable. CMV IgM Reagent Wedge C: Not applicable. CMV IgM Adjuster (L2CMJ3): Not applicable. CMV IgM Controls: Not applicable. vP: Not available. vB: Not available.

12.6 Other adverse effects

12.6 Other adverse effects : CMV IgM Reagent Wedge A: No known significant effects or critical hazards. CMV IgM Reagent Wedge B: No known significant effects or critical hazards. CMV IgM Reagent Wedge C: No known significant effects or critical hazards. CMV IgM Adjuster (L2CMJ3): No known significant effects or critical hazards. CMV IgM Controls: No known significant effects or critical hazards.
13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Treatment

The generation of waste should be avoided or minimised wherever possible. 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. Dispose of surplus and non-recyclable products via a licensed waste disposal contractor. Waste should not be disposed of untreated to the sewer unless fully compliant with the requirements of all authorities with jurisdiction.

Disposal

Dispose of surplus and non-recyclable products via a licensed waste disposal contractor.

14

Transport Information

UN numbers, shipping names, transport classes, and regulatory requirements

ADR

Transport within user's premises: always transport in closed containers that are upright and secure. Ensure that persons transporting the product know what to do in the event of an accident or spillage.

IMDG

Transport within user's premises: always transport in closed containers that are upright and secure. Ensure that persons transporting the product know what to do in the event of an accident or spillage.

IATA

Transport within user's premises: always transport in closed containers that are upright and secure. Ensure that persons transporting the product know what to do in the event of an accident or spillage.

15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

None of the components are listed in REACH Annex XIV or as SVHC. Not controlled under Seveso Directive. Europe inventory status not determined.

Chemical Safety Assessment Not performed
?

Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for IMMULITE® 2000 CMV IgM?

The signal word is warning.

What is the physical form of IMMULITE® 2000 CMV IgM?

IMMULITE® 2000 CMV IgM is a liquid (reagent wedge a, b, c); solid (adjustor, controls) appearing as liquid (reagent wedge a, b, c); solid (adjustor, controls) with colourless (reagent wedge a, b, c); off-white (adjustor, controls) color. It has odourless odor.

What is the solubility of IMMULITE® 2000 CMV IgM?

Not relevant/applicable due to nature of the product.

What is IMMULITE® 2000 CMV IgM used for?

CMV IgM Reagent Wedge A Diagnostic agents. CMV IgM Reagent Wedge B Diagnostic agents. CMV IgM Reagent Wedge C Diagnostic agents. CMV IgM Adjustor (L2CMJ3) Diagnostic agents. CMV IgM Controls Diagnostic agents.

What are the hazard statements for IMMULITE® 2000 CMV IgM?

This substance has 3 hazard statements:

  • H302 + H312: Harmful if swallowed or in contact with skin.
  • H319: Causes serious eye irritation.
  • H412: Harmful to aquatic life with long lasting effects.

What is the melting point of IMMULITE® 2000 CMV IgM?

The melting point is Not available. and the boiling point is Not available..