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Safety Data Sheet EN

ElisaRSR™ ZnT8 Ab™

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
ElisaRSR™ ZnT8 Ab™
Product Code
ZnT8/96

Regulatory Identifiers

CAS Number
N/A

Identified Uses

Quantitative determination of autoantibodies to ZnT8 in human serum

Manufacturers & Suppliers

R

RSR Limited

manufacturer

Parc Ty Glas, Llanishen, Cardiff, CF14 5DU, United Kingdom

+4429 2068 9299

Emergency Contacts

MHRA Medical Devices Adverse Incident Centre

+4420 3080 7080

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified danger

Hazard Classifications

Skin Sens. Cat. 1 H317
Repr. Cat. 1B H360D

GHS Pictograms

GHS07 - Health hazard

GHS07

Hazard Statements

H317 May cause an allergic skin reaction
H360D May damage the unborn child

Precautionary Statements

P202 Do not handle until all safety precautions have been read and understood
P233 Keep container tightly closed
P261 Avoid breathing mist, vapours
P270 Do not eat, drink or smoke when using this product
P272 Contaminated work clothing should not be allowed out of the workplace
P280 Wear protective gloves/protective clothing/eye protection/face protection
P281 Use personal protective equipment as required
P301 + P330 + P331 IF SWALLOWED: Rinse mouth. Do NOT induce vomiting
P302 + P352 IF ON SKIN: Wash with plenty of soap and 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
P308 + P313 IF exposed or concerned: Get medical advice/attention
P333 + P313 If skin irritation or rash occurs: Get medical advice/attention
P362 + P364 Take off contaminated clothing and wash it before reuse
P501 Dispose of contents/container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation

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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
K-Blue® Advanced TMB Substrate --- 100% Yes
2-pyrrolidone EC: 210-483-1 616-45-5 1 - 10% Yes
Urea Hydrogen Peroxide EC: 204-701-4 124-43-6 0.1% Yes
StabilZyme® HRP Conjugate Stabilizer --- 99% Yes
2-methyl-2H-isothiazol-3-one 2682-20-4 0.0126% Yes
CMIT/MIT 55965-84-9 0.0024% Yes
2-Chloroacetamide EC: 201-174-2 79-07-2 0.01 - 0.1% Yes
Sulphuric Acid EC: 231-639-5 7664-93-9 5% Yes
2-Methyl-4-isothiazolin-3-one hydrochloride (MIT) EC: 247-499-3 26172-54-3 0.1% Yes
Sodium Azide EC: 247-852-1 26628-22-8 0.1% Yes
04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Remove from exposure, rest and keep warm.

Skin contact

Wash off skin thoroughly with water for at least 15 minutes. Remove contaminated clothing.

Eye contact

Separate eyelids with fingers and flush eye with copious amounts of water for at least 15 minutes.

Ingestion

If patient is conscious, wash out mouth with water and give plenty of water to drink.

Immediate Medical Attention

In severe cases or if skin is broken, OBTAIN MEDICAL ATTENTION. OBTAIN MEDICAL ATTENTION (for eye contact). If breathing becomes difficult, OBTAIN MEDICAL ATTENTION. OBTAIN MEDICAL ATTENTION (for ingestion).

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Use water, dry powder or foam as appropriate to supporting fire.

Specific hazards

May evolve toxic fumes in fire.

Firefighter Protection

Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

Ventilate area and avoid breathing vapours, mist or gas.

Environmental

Prevent further leakage or spillage if safe to do so.

Cleanup methods

Wipe up liquid spills with absorbent paper. For solid spills, sweep up without raising dust. Once pick up is complete, wash site with detergent and water.

Materials: absorbent paper, detergent and water

—

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Material of human origin has been tested and found non-reactive for HIV 1 and 2 and HCV antibodies and HBsAg. All animal sourced material has been obtained from animals certified as healthy and free from disease. However all potentially biohazardous components should be considered as potentially infectious. Level 2 containment should be applied. Do not eat, drink or smoke in the laboratory. Do not pipette by mouth. Avoid skin and eye contact. Wear appropriate protective clothing as described in sub section 8.2. Avoid the use of needles or other sharp implements. Avoid prolonged or repeated exposure. Wash hands thoroughly after handling.

Storage

Keep containers tightly closed. Store in a dry place in the box supplied at a temperature between +2 and +8°C.

Hygiene

Do not eat, drink or smoke in the laboratory. Do not pipette by mouth. Wash hands thoroughly after handling.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

Good laboratory practice should be followed (see Section 7).

Hands

Chemical resistant gloves to be used in accordance with standard EN374 derived from Regulation (EU) 2016/425. Inspect gloves for damage prior to use and change if any sign of degradation. Proper glove removal technique must be used. Wash hands after use. The following are suitable as protective gloves: - Glove materials: Nitrile rubber - Glove Thickness: >= 0.4 mm thickness - Permeation Time: >= 480 min. This recommendation is advisory only and should be evaluated by the customer for suitability in their specific situation.

Eyes

Chemical safety glasses or goggles conforming to appropriate government standards such as EN166 (EU) or NIOSH (US).

Respiratory

Local exhaust.

Skin/Body

Chemical resistant gloves to be used in accordance with standard EN374 derived from Regulation (EU) 2016/425. Inspect gloves for damage prior to use and change if any sign of degradation. Proper glove removal technique must be used. Wash hands after use.

Environmental

Prevent further leakage or spillage if safe to do so. Prevent any reagents from entering drains.

09

Physical and Chemical Properties

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

Language Code
---
Physical State
---
Physical State Data
---
State Under Standard Conditions
---
Appearance
Colourless polystyrene microplate, White solid, Pink liquid, Pale brown/yellow liquid, Colourless liquid, Colourless to slight blue liquid, Pale yellow/brown liquid
Colour
---
Colour Intensity
---
Form
---
Odor
None, May be slightly sulphurous
Odor Threshold
---
Ph
~8.0, ~7.5, <1.0, ~7.6
Melting Point
---
Boiling Point
---
Flash Point
---
Freezing Point
---
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
---
Vapor Pressure
---
Vapor Density
---
Relative Density
---
Bulk Density
---
Density
---
Flammability
---
Upper Explosive Limit
---
Lower Explosive Limit
---
Explosive Limits
---
Auto Ignition Temperature
---
Decomposition Temperature
---
Solubility
In water
Partition Coefficient
---
Solubility In Water
In water
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

All components of the ElisaRSR™ ZnT8 Ab™ kit have been found stable for stated shelf life when stored under the recommended conditions.

Reactivity

Data is not available on the reactivity of individual kit components but is given, where available, on ingredients listed in sub section 3.2. Sulphuric acid is a strong oxidising agent and has a corrosive effect. There is no data available on the other ingredients.

Hazardous reactions

No hazardous reactions known for kit components although, hazardous reactions occur for the following ingredients listed in sub section 3.2: Sodium Azide: Risk of explosion and/or toxic gas formation exists with heavy metals, bromine, lead, chromyl chloride, dichloromethane, dimethylsulfate, halogenated hydrocarbon, acid, carbon disulphide, sulphuric acid, copper and nitric acid. Generates dangerous gases or fumes with acids and water, leading to the release of hydrazoic acid. Violent reactions possible with nitrates, benzoyl chloride and potassium nitrate. Sulphuric Acid: Violent reactions possible with: Water, alkali metals, alkali compounds, ammonia, aldehydes, acetonitrile, alkaline earth metals, alkalines, acids, alkaline earth compounds, metals, metal alloys, oxides of phosphorus, phosphorus, hydrides, halogen-halogen compounds, oxyhalogenic compounds, permanganates, nitrates, carbides, combustible substances, organic solvent, acetylcholine, nitriles, organic nitro compounds, anilines, peroxides, picrates, nitrides, lithium silicide, iron (III) compounds, bromates, chlorates, amines, perchlorates and hydrogen peroxide.

Avoid

Peroxidase substrate (TMB) is light sensitive and therefore the bottle should be kept tightly closed when not in use and stored in a dark place. Peroxidase substrate (TMB) must also be kept away from extreme temperatures. Proteins, sodium azide and sulphuric acid are heat sensitive and storage or use at the improper temperature may compromise the integrity of the kit.

Incompatible

2-Chloroacetamide: Strong oxidising agents, strong acids, strong bases and strong reducing agents; K-Blue® Advanced TMB Substrate: No data available; MIT: Strong oxidising agents; Sodium Azide: Aluminium and heavy metals; StabilZyme® HRP Conjugate Stabilizer: None known; Sulphuric Acid: Animal and vegetable tissues. Metals. Contact with metals liberates hydrogen gas.

Decomposition

No decomposition products are formed if kit is stored and used under the specified storage and handling conditions. May evolve toxic fumes in fire. Thermal decomposition products are not known for the kit components but hazardous combustion products of the ingredients listed in sub section 3.2 can be found in sub section 5.2.

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

12.1 Toxicity

*Definitions can be found in section 16 | Ingredient | Toxicity to | Measurement* | Value (inc. exposure time) | | --- | --- | --- | --- |

12.1 Toxicity

Ingredient | Toxicity to | Measurement* | Value (inc. exposure time) 2-Chloroacetamide | Fish (Carassius auratus (goldfish)) | LC50 | 19.8 mg/L (96h) 2-Chloroacetamide (continued) | Daphnia (Daphnia magna (water flea)) | EC50 | 14 mg/L (48h)

12.1 Toxicity

| Ingredient | Toxicity to | Measurement* | Value (inc. exposure time) | | MIT | Fish (Oncorhynchus mykiss (rainbow trout)) | LC_{50} | 4.77 mg/L (96h) (Flow through) | | | Daphnia (Daphnia magna (water flea)) | EC_{50} | 2.33 mg/L (48h) (Static) | | | Daphnia (Daphnia magna (water flea)) | EC_{50} | 0.998 mg/L (48h) (Flow through) | | | Algae (Pseudokirchneriella subcapitata (green algae)) | ErC_{50} | 0.289 mg/L (72h) (Static) |

12.1 Toxicity

12.1 Toxicity | Ingredient | Toxicity to | Measurement* | Value (inc. exposure time) | | Sodium Azide | Fish (Oncorhynchus mykiss (rainbow trout)) | LC_{50} | 2.75 mg/L (96h) (Flow through) | | | Algae (Psuedokirchneriella subcapita) | ErC_{50} | 0.35 mg/L (96h) (Static) |

12.1 Toxicity

| Ingredient | Toxicity to | Measurement* | Value (inc. exposure time) | | StabilZyme® HRP Conjugate Stabilizer | Fish (Oncorhynchus mykiss (rainbow trout)) | LC_{50} | 0.19 mg/L | | | Daphnia & other aquatic invertebrates (Crassostrea virginica (eastern oyster)) | EC_{50} | 0.028 mg/L | | | Algae (Raphidocelis subcapitata (green algae)) | EC_{50} | 0.018 mg/L (72h) |

12.1 Toxicity

| Ingredient | Toxicity to | Measurement* | Value (inc. exposure time) | | Sulphuric Acid | Daphnia & other aquatic invertebrates (Daphnia magna (water flea)) | EC_{50} | >100 mg/L (48h) | | | Algae (Desmodesmus subspicatus (green algae)) | ErC_{50} | >100 mg/L (72h) |

12.2 Persistence and degradability

Biodegradability: aerobic, exposure time 28 days Results: 94% - Readily biodegradable

12.2 Persistence and degradability

Biodegradability: aerobic, exposure time 28 days Results: 0% - Not readily biodegradable.

12.2 Persistence and degradability

| Ingredient | Test/Result | | StabilZyme® HRP Conjugate Stabilizer | Not rapidly degradable. |

12.3 Bioaccumulative potential

No data available for other ingredients listed in sub section 3.2. | Ingredient | Test/Result | | --- | --- |

12.3 Bioaccumulative potential

MIT | Partition coefficient: n-octanol/water – log Pow: -0.44 (Bioaccumulation is not expected)

12.3 Bioaccumulative potential

| Ingredient | Test/Result | | StabilZyme® HRP Conjugate Stabilizer | Log Kow: >5 (significant bioaccumulation) |

12.4 Mobility in soil

No data available for ingredients listed in sub section 3.2.

12.5 Results of PBT and vPvB assessment

| Ingredient | Test/Result | | --- | --- | | 2-Chloroacetamide | This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of ≥0.1%. | | MIT | | | Sodium Azide | | | Sulphuric Acid | |

2-Chloroacetamide is not considered to be persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of ≥0.1%.

12.6 Endocrine disrupting properties

The ingredients listed in sub section 3.2 do not have endocrine disrupting properties with respect to non-target organisms as it does not meet the criteria set out in section B of Regulation (EU) No 2017/2100.

The ingredients listed in sub section 3.2 do not have endocrine disrupting properties with respect to non-target organisms as it does not meet the criteria set out in section B of Regulation (EU) No 2017/2100.

12.7 Other adverse effects

The concentrations of ingredients listed in sub section 3.2 are below the acceptable limit for hazardous substances; the ecological risk is minimal. However, it is recommended that reagents do not enter drains in large quantities.

The ecological risk is considered minimal as ingredient concentrations are below hazardous limits, though large quantities should not be disposed of in drains.

13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Treatment

Chemical and biological residues are classified as special waste and as such, are covered by regulations which may vary according to location. Contact your local waste disposal authority for advice or pass to a licensed disposal company.

Disposal

Contact your local waste disposal authority for advice or pass to a licensed disposal company.

14

Transport Information

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

ADR

Transport of this product can be carried out at ambient temperature but in the event of delays store at 2 – 8°C with all reagents contained within the packaging provided.

IMDG

Transport of this product can be carried out at ambient temperature but in the event of delays store at 2 – 8°C with all reagents contained within the packaging provided.

IATA

Transport of this product can be carried out at ambient temperature but in the event of delays store at 2 – 8°C with all reagents contained within the packaging provided.

15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

Not applicable.

Chemical Safety Assessment Not performed
?

Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for ElisaRSR™ ZnT8 Ab™?

The signal word is danger.

What is the solubility of ElisaRSR™ ZnT8 Ab™?

In water

What is ElisaRSR™ ZnT8 Ab™ used for?

Quantitative determination of autoantibodies to ZnT8 in human serum

What are the hazard statements for ElisaRSR™ ZnT8 Ab™?

This substance has 2 hazard statements:

  • H317: May cause an allergic skin reaction
  • H360D: May damage the unborn child