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Safety Data Sheet EN

Level 1

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
Level 1

Regulatory Identifiers

CAS Number
N/A

Identified Uses

Laboratory chemicals, Refer to product literature for further details.

Manufacturers & Suppliers

R

Roche Diagnostics Deutschland GmbH

national supplier

Sandhoferstrasse 116 68305 Mannheim Deutschland

+496217590

Emergency Contacts

Central Works Security, Roche Diagnostics GmbH

+49(0)621-759-2203

Centre for detoxification

+49(0)6131-19240

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified warning

Hazard Classifications

Eye Irrit. Cat. 2 H319
Aquatic Acute Cat. 1 H400
Aquatic Chronic Cat. 3 H412

GHS Pictograms

GHS07 - Health hazard

GHS07

GHS09 - Environmental hazard

GHS09

Hazard Statements

H319 Causes serious eye irritation.
H410 Very toxic to aquatic life with long lasting effects.

Precautionary Statements

P264 Wash skin thoroughly after handling.
P273 Avoid release to the environment.
P280 Wear eye protection/ face protection.
P337 + P313 If eye irritation persists: Get medical advice/ attention.
P391 Collect spillage.
P501 Dispose of contents/ container to an approved waste disposal plant.

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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
Ethylenediaminetetraacetic acid disodium salt dihydrate 6381-92-6 1 - 10% Yes
tetradonium bromide EC: 214-291-9 1119-97-7 1 - 2.5% Yes
disodium dihydrogen ethylenediaminetetraacetate EC: 205-358-3 139-33-3 0.1 - 1% Yes
04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

If unconscious, place in recovery position and seek medical advice. If symptoms persist, call a physician.

Skin contact

If skin irritation persists, call a physician. If on skin, rinse well with water. If on clothes, remove clothes.

Eye contact

Immediately flush eye(s) with plenty of water. Remove contact lenses. Protect unharmed eye. Keep eye wide open while rinsing. If eye irritation persists, consult a specialist.

Symptoms: Causes serious eye irritation.

Ingestion

Clean mouth with water and drink afterwards plenty of water. Keep respiratory tract clear. Do not give milk or alcoholic beverages. Never give anything by mouth to an unconscious person. If symptoms persist, call a physician.

Medical Treatment

Treat symptomatically.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.

Unsuitable media

High volume water jet

Specific hazards

Do not allow run-off from fire fighting to enter drains or water courses.

Firefighter Protection

Wear self-contained breathing apparatus for firefighting if necessary.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

Use personal protective equipment. Avoid dust formation. Avoid breathing dust. Refer to protective measures listed in sections 7 and 8.

Environmental

Prevent product from entering drains. Prevent further leakage or spillage if safe to do so. If the product contaminates rivers and lakes or drains inform respective authorities.

Cleanup methods

Keep in suitable, closed containers for disposal.

—

Related Products

Similar products with comparable safety profiles

C

Ctr Level 1

---

L

L1

---

C

Control 1

---

M

Maternal Screening Control, Level 1

---

C

Cal 1

---

C

Cal 1

---

C

Cal 1

---

C

Cal 1

---

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Avoid formation of respirable particles. Do not breathe vapours/dust. Avoid contact with skin and eyes. For personal protection see section 8. Smoking, eating and drinking should be prohibited in the application area.

Storage

Keep container tightly closed in a dry and well-ventilated place. Containers which are opened must be carefully resealed and kept upright to prevent leakage.

Hygiene

When using do not eat or drink. When using do not smoke. Wash hands before breaks and at the end of workday.

Fire prevention

Avoid dust formation.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Hands

Material: Protective gloves. Remarks: Please observe the instructions regarding permeability and breakthrough time which are provided by the supplier of the gloves. Also take into consideration the specific local conditions under which the product is used, such as the danger of cuts, abrasion, and the contact time. This recommendation is only valid for the product mentioned in the safety data sheet and provided by us and for the application specified by us. The suitability for a specific workplace should be discussed with the producers of the protective gloves. The selected protective gloves have to satisfy the specifications of Regulation (EU) 2016/425 and the standard EN 374 derived from it.

Eyes

Eye wash bottle with pure water. Tightly fitting safety goggles. Wear face-shield and protective suit for abnormal processing problems.

Skin/Body

Choose body protection according to the amount and concentration of the dangerous substance at the work place.

09

Physical and Chemical Properties

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

Language Code
---
Physical State
solid
Physical State Data
solid
State Under Standard Conditions
---
Appearance
---
Colour
white, light yellow
Colour Intensity
---
Form
(lyophilised)
Odor
---
Odor Threshold
Not applicable
Ph
6,9 - 7,1 (25 °C) (as aqueous solution)
Melting Point
No data available
Boiling Point
No data available
Flash Point
does not flash
Freezing Point
---
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
No data available
Vapor Pressure
No data available
Vapor Density
---
Relative Density
---
Bulk Density
---
Density
---
Flammability
Sustains combustion
Upper Explosive Limit
No data available
Lower Explosive Limit
No data available
Explosive Limits
---
Auto Ignition Temperature
No data available
Decomposition Temperature
No data available
Solubility
---
Partition Coefficient
No data available
Solubility In Water
completely soluble
Solubility In Fat
---
Molecular Weight
---
Voc Content
---
Metal Corrosion
---
Dynamic Viscosity
Not applicable
Kinematic Viscosity
Not applicable
Properties Status
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

Stable under normal conditions.

Reactivity

No dangerous reaction known under conditions of normal use.

Hazardous reactions

No decomposition if stored and applied as directed.

Avoid

No data available

Incompatible

Strong oxidizing agents

Decomposition

No hazardous decomposition products are known.

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

12.7 Other adverse effects

Product: Additional ecological information : An environmental hazard cannot be excluded in the event of unprofessional handling or disposal. Very toxic to aquatic life. Very toxic to aquatic life with long lasting effects. Harmful to aquatic life with long lasting effects.

An environmental hazard cannot be excluded in the event of unprofessional handling or disposal. The product is classified as very toxic to aquatic life with long lasting effects.

12.1 Toxicity

Components: Ethylenediaminetetraacetic acid disodium salt dihydrate: Level 1

12.1 Toxicity

Toxicity to fish : LC50 (Lepomis macrochirus (Bluegill sunfish)): 41 mg/l Exposure time: 96 h Toxicity to daphnia and other aquatic invertebrates : EC50 (Daphnia magna (Water flea)): 140 mg/l Exposure time: 48 h Test Type: static test Method: DIN 38412 Toxicity to microorganisms : EC20 (activated sludge): > 500 mg/l Exposure time: 0,5 h Test Type: Respiration inhibition Method: OECD Test Guideline 209 Ecotoxicology Assessment Acute aquatic toxicity : This product has no known ecotoxicological effects. Chronic aquatic toxicity : This product has no known ecotoxicological effects. Toxicity Data on Soil : Not expected to adsorb on soil. Other organisms relevant to the environment : No data available

12.1 Toxicity

Toxicity to fish : LC50 (Danio rerio (zebra fish)): 1,81 mg/l Exposure time: 96 h Toxicity to daphnia and other aquatic invertebrates : EC50 (Daphnia magna (Water flea)): 0,022 mg/l Exposure time: 48 h Toxicity to algae/aquatic plants : EC50 (Pseudokirchneriella subcapitata (green algae)): 0,00538 mg/l Exposure time: 72 h NOEC (Pseudokirchneriella subcapitata (green algae)): 0,0013 mg/l Exposure time: 72 h M-Factor (Acute aquatic toxicity) : 100 Toxicity to microorganisms : EC50 (Natural microorganism): 19 mg/l Toxicity to daphnia and other aquatic invertebrates (Chronic toxicity) : NOEC: 0,023 mg/l Exposure time: 21 d Species: Daphnia magna (Water flea) M-Factor (Chronic aquatic toxicity) : 1

12.1 Toxicity

Toxicity to fish : LC50 (Lepomis macrochirus (Bluegill sunfish)): > 100 mg/l Exposure time: 96 h Test Type: static test Remarks: nominal concentration Based on data from similar materials Toxicity to daphnia and other aquatic invertebrates: - EC50 (Daphnia magna (Water flea)): > 100 mg/l - Exposure time: 48 h - Test Type: static test - Method: DIN 38412 - Remarks: nominal concentration Toxicity to algae/aquatic plants: - ErC50 (Pseudokirchneriella subcapitata (green algae)): > 100 mg/l - Exposure time: 72 h - Test Type: static test - Remarks: Based on data from similar materials Toxicity to microorganisms: - EC20 (activated sludge): > 500 mg/l - Exposure time: 30 min - Method: OECD Test Guideline 209 Toxicity to fish (Chronic toxicity): - NOEC: >= 36,9 mg/l - Exposure time: 35 d - Species: Danio rerio (zebra fish) - Test Type: flow-through test - Method: OECD Test Guideline 210 - Remarks: Based on data from similar materials

12.2 Persistence and degradability

- Biodegradability: Result: Not readily biodegradable.

12.2 Persistence and degradability

- Biodegradability: Result: Readily biodegradable.

12.2 Persistence and degradability

- Biodegradability: Test Type: aerobic - Result: Not readily biodegradable. - Method: OECD Test Guideline 301D - Remarks: Based on data from similar materials

12.3 Bioaccumulative potential

- Partition coefficient: n-octanol/water - Remarks: No data available

No data available regarding the partition coefficient.

12.3 Bioaccumulative potential

Bioaccumulation : Bioconcentration factor (BCF): 750 Remarks: Does not bioaccumulate. Partition coefficient: n-octanol/water : log Pow: 2,2 (20 °C)

12.3 Bioaccumulative potential

Bioaccumulation : Species: Lepomis macrochirus (Bluegill sunfish) Exposure time: 28 d Bioconcentration factor (BCF): 1,8 Remarks: Bioaccumulation is unlikely. Partition coefficient: n-octanol/water : log Pow: -4,3 (25 °C) pH: 4,5

12.4 Mobility in soil

No data available

12.5 Results of PBT and vPvB assessment

Product: Assessment: 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% or higher.

The 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% or higher.

12.6 Endocrine disrupting properties

The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.

The substance/mixture does not contain components considered to have endocrine disrupting properties at levels of 0.1% or higher.

13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Disposal

Send to a licensed waste management company.

14

Transport Information

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

UN Number
3077
Shipping Name
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (Tetradonium bromide)
Transport Class
9
Packing Group
III
15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

?

Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for Level 1?

The signal word is warning.

What is the physical form of Level 1?

Level 1 is a solid with white, light yellow color.

What is Level 1 used for?

Laboratory chemicals, Refer to product literature for further details.

What are the hazard statements for Level 1?

This substance has 2 hazard statements:

  • H319: Causes serious eye irritation.
  • H410: Very toxic to aquatic life with long lasting effects.

What is the melting point of Level 1?

The melting point is No data available and the boiling point is No data available.