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Safety Data Sheet EN

S40™ Sterilant Concentrate

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
S40™ Sterilant Concentrate
Product Form
Mixture
Product Code
S4000, S4001, S4002, S4003

Regulatory Identifiers

CAS Number
N/A

Identified Uses

Sterilant. For professional use only. This product is intended to be used by professional nursing or technical staff trained in the reprocessing of medical devices for sterility. The packaged SYSTEM 1E Sterilant Concentrate consists of two parts: a liquid component (aka: PAA Concentrate Solution, Compartment A) and an ABC Builders powder (Compartment B), when mixed together, they form a SYSTEM 1E Sterilant Use Dilution which is a sterilant solution intended to be used in a SYSTEM 1E Processor for reprocessing endoscopes and other surgical instruments. The components of the sterilant are provided in a single sealed cup. Thus the operator is not in contact with the sterilant or its pre-mixed concentrates under normal use conditions.

Manufacturers & Suppliers

STERIS Corporation logo

STERIS Corporation

manufacturer

5960 Hensley, Mentor, OH 44060-1834; Chancery House, 190 Waterside Road, Hamilton Industrial Park, Leichester, LE5 1QZ, UK

1-800-548-4873

http://www.steris.com

Emergency Contacts

Emergency Contact

+44 (0) 1895 622639

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified danger

Hazard Classifications

Flam. Liq. Cat. 3 H226
Org. Perox. Cat. F H242
Acute Tox. Cat. 4 H302
Acute Tox. Cat. 4 H312
Acute Tox. Cat. 4 H332
Skin Corr. Cat. 1A H314
Eye Dam. Cat. 1 H318
STOT SE Cat. 3 H335
Aquatic Acute Cat. 1 H400
Skin Corr. Cat. 1B H314

GHS Pictograms

GHS02 - Flammable

GHS02

GHS05 - Corrosive

GHS05

GHS07 - Health hazard

GHS07

GHS09 - Environmental hazard

GHS09

Hazard Statements

H226 Flammable liquid and vapour
H242 Heating may cause a fire
H302 + H312 + H332 Harmful if swallowed, in contact with skin or inhaled.
H314 Causes severe skin burns and eye damage
H335 May cause respiratory irritation
H400 Very toxic to aquatic life

Precautionary Statements

P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P260 Do not breathe dust, fume, vapours, mist, spray.
P273 Avoid release to the environment.
P280 Wear protective clothing, protective gloves, eye and face protection.
P284 In case of inadequate ventilation, wear respiratory protection.
P301 + P330 + P331 + P310 IF SWALLOWED: Rinse mouth. Do NOT induce vomiting
P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with 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.
P312 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
Acetic acid EC: 200-580-7 64-19-7 40% Yes
Peroxyacetic acid EC: 201-186-8 79-21-0 35% Yes
Hydrogen peroxide EC: 231-765-0 7722-84-1 6.5% Yes
Sulfuric acid EC: 231-639-5 7664-93-9 1% Yes
Tetrasodium EDTA EC: 200-573-9 64-02-8 5 - 10% Yes
1H-Benzotriazole, sodium salt EC: 239-269-6 15217-42-2 5 - 10% Yes
04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

When symptoms occur: go into open air and ventilate suspected area. Remove to fresh air and keep at rest in a position comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.

Symptoms: Inhalation may cause immediate severe irritation progressing quickly to chemical burns.

Skin contact

Remove contaminated clothing. Immediately flush skin with plenty of water for at least 60 minutes. Immediately call a POISON CENTER or doctor/physician. Wash contaminated clothing before reuse.

Symptoms: Corrosive. Causes burns.

Eye contact

Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 60 minutes. Immediately call a POISON CENTER or doctor/physician.

Symptoms: Causes serious eye damage.

Ingestion

Rinse mouth. Do not induce vomiting. Immediately call a POISON CENTER or doctor/physician.

Symptoms: Swallowing a small quantity of this material will result in serious health hazard.

Immediate Medical Attention

Immediately call a POISON CENTER or doctor/physician.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Use extinguishing media appropriate for surrounding fire. Water spray, fog (flooding amounts).

Unsuitable media

Use of heavy stream of water may spread fire.

Specific hazards

Flammable liquid and vapour. Heating may cause a fire. May cause fire or explosion; strong oxidizer. May form flammable/explosive vapour-air mixture. Heat may build pressure, rupturing closed containers, spreading fire and increasing risk of burns and injuries. Heating may cause an explosion. May cause or intensify fire; oxidizer. Contains an organic peroxide; keep away from incompatible materials.

Instructions

Use water spray or fog for cooling exposed containers. In case of major fire and large quantities: Evacuate area. Fight fire remotely due to the risk of explosion.

Firefighter Protection

Do not enter fire area without proper protective equipment, including respiratory protection.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

Evacuate unnecessary personnel. Upon arrival at the scene, a first responder is expected to recognize the presence of dangerous goods, protect oneself and the public, secure the area, and call for the assistance of trained personnel as soon as conditions permit.

Environmental

Do not allow product to spread into the environment.

Cleanup methods

Clean up spills immediately and dispose of waste safely. Dilute with water. Soak up diluted material with inert solids or flush with large amount of water.

Materials: inert solids

—

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Avoid contact with eyes, skin and clothing.

Storage

Store in a dry, cool and well-ventilated place. Keep container closed when not in use. Keep in fireproof place. Store in original container. Store the bottle in upright position in a dark and cool place. Keep away from heat and direct sunlight. Store at temperatures not exceeding 27 °C (81 °F).

Hygiene

Handle in accordance with good industrial hygiene and safety procedures. Wash hands and other exposed areas with mild soap and water before eating, drinking, or smoking and again when leaving work. Do not eat, drink or smoke when using this product.

Fire prevention

Keep in fireproof place. Keep away from heat and direct sunlight. Avoid ignition sources.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapor or mists below the applicable workplace exposure limits indicated above. Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.

Hands

Wear chemically resistant protective gloves.

Eyes

Chemical safety goggles. A full face shield is recommended.

Respiratory

If exposure limits are exceeded or irritation is experienced, NIOSH approved respiratory protection should be worn.

Skin/Body

Wear suitable protective clothing. Wash contaminated clothing before reuse. Materials for protective clothing: Chemically resistant materials and fabrics.

09

Physical and Chemical Properties

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

Language Code
---
Physical State
Compartment A - Liquid Compartment B - Solid
Physical State Data
liquid
State Under Standard Conditions
---
Appearance
---
Colour
Compartment A - Colorless Compartment B - White to yellow granular powder
Colour Intensity
---
Form
---
Odor
Compartment A - Pungent vinegar like Compartment B - Odorless
Odor Threshold
No data available
Ph
2 - 3 (1% solution) Compartment A / ~9.3 (1% solution) Compartment B
Melting Point
-47 °C (-52,6 °F)
Boiling Point
107 °C (224,6 °F)
Flash Point
46 °C (114,8 °F) Closed cup (modified) Compartment A
Freezing Point
-47 °C (-52,6 °F)
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
No data available
Vapor Pressure
20 mm Hg @ 25 °C (77°F)
Vapor Density
---
Relative Density
---
Bulk Density
---
Density
1.13 g/ml Compartment A
Flammability
No data available
Upper Explosive Limit
Not applicable
Lower Explosive Limit
Not applicable
Explosive Limits
---
Auto Ignition Temperature
No data available
Decomposition Temperature
No data available
Solubility
Complete in water
Partition Coefficient
No data available
Solubility In Water
---
Solubility In Fat
---
Molecular Weight
---
Voc Content
75 % (PAA Concentrate Solution, Component A)
Metal Corrosion
---
Dynamic Viscosity
---
Kinematic Viscosity
---
Properties Status
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

Stable under recommended handling and storage conditions (see section 7). Heating may cause a fire.

Reactivity

Thermal decomposition generates corrosive vapours.

Hazardous reactions

Hazardous polymerization will not occur.

Avoid

Heating

Incompatible

Reducing agents. Alcohols. Heavy metals. Strong acids. Strong bases. Oxidizers. Combustible materials. Organic materials. Rust.

Decomposition

Oxygen. Acetic acid.

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

12.1. Toxicity

Ecology - general : Very toxic to aquatic life. | S40™ Sterilant Concentrate | | | --- | --- | | LC50 fishes 1 | < 1,1 mg/l (Compartment A), > 92 mg/L (Compartment B) | | EC50 Daphnia 1 | 0,8 mg/l (Compartment A), > 113 mg/L (Compartment B) |

12.1. Toxicity

12.1. Toxicity | Acetic acid (64-19-7) | | | --- | --- | | LC50 fishes 1 | 79 mg/l (Exposure time: 96 h - Species: Pimephales promelas [static]) | | EC50 Daphnia 1 | 65 mg/l (Exposure time: 48 h - Species: Daphnia magna [Static]) | | LC50 fish 2 | 75 mg/l (Exposure time: 96 h - Species: Lepomis macrochirus [static]) |

12.1. Toxicity

| Hydrogen peroxide (7722-84-1) | | | --- | --- | | LC50 fishes 1 | 16,4 mg/l (Exposure time: 96 h - Species: Pimephales promelas) | | EC50 Daphnia 1 | 18 - 32 mg/l (Exposure time: 48 h - Species: Daphnia magna [Static]) | | LC50 fish 2 | 18 - 56 mg/l (Exposure time: 96 h - Species: Lepomis macrochirus [static]) |

12.1. Toxicity

| Sulfuric acid (7664-93-9) | | | --- | --- | | LC50 fishes 1 | 500 mg/l (Exposure time: 96 h - Species: Brachydanio rerio [static]) | | LC50 fish 2 | 42 mg/l (Exposure time: 96 h - Species: Gambusia affinis [static]) |

12.1. Toxicity

| Tetrasodium EDTA (64-02-8) | | | --- | --- | | LC50 fishes 1 | 41 mg/l (Exposure time: 96 h - Species: Lepomis macrochirus [static]) | | LC50 fish 2 | 59,8 mg/l (Exposure time: 96 h - Species: Pimephales promelas [static]) |

12.2. Persistence and degradability

S40™ Sterilant Concentrate: Not established. May cause long-term adverse effects in the environment.

12.3. Bioaccumulative potential

S40™ Sterilant Concentrate: Not established.

12.3. Bioaccumulative potential

| Peroxyacetic acid (79-21-0) | | | --- | --- | | BCF fish 1 | (not bioaccumulative, rapid degradation) |

12.3. Bioaccumulative potential

| Acetic acid (64-19-7) | | | --- | --- | | Log Pow | -0,31 (at 20 °C) |

12.3. Bioaccumulative potential

| Hydrogen peroxide (7722-84-1) | | | --- | --- | | BCF fish 1 | (no bioaccumulation) |

12.3. Bioaccumulative potential

12.3. Bioaccumulative potential | Sulfuric acid (7664-93-9) | | | --- | --- | | BCF fish 1 | (no bioaccumulation) |

12.4. Mobility in soil

No additional information available

12.5. Results of PBT and vPvB assessment

No additional information available

12.6. Other adverse effects

Other information : Avoid release to the environment.
13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Disposal

Dispose of waste material in accordance with all local, regional, national, provincial, territorial and international regulations.

14

Transport Information

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

UN Number
3107 or 3109
Shipping Name
ORGANIC PEROXIDE TYPE E, LIQUID or ORGANIC PEROXIDE TYPE F, LIQUID
Transport Class
5.2
Packing Group
Not applicable
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 S40™ Sterilant Concentrate?

The signal word is danger.

What is the physical form of S40™ Sterilant Concentrate?

S40™ Sterilant Concentrate is a compartment a - liquid compartment b - solid with compartment a - colorless compartment b - white to yellow granular powder color. It has compartment a - pungent vinegar like compartment b - odorless odor.

What is the solubility of S40™ Sterilant Concentrate?

Complete in water

What is S40™ Sterilant Concentrate used for?

Sterilant. For professional use only. This product is intended to be used by professional nursing or technical staff trained in the reprocessing of medical devices for sterility. The packaged SYSTEM 1E Sterilant Concentrate consists of two parts: a liquid component (aka: PAA Concentrate Solution, Compartment A) and an ABC Builders powder (Compartment B), when mixed together, they form a SYSTEM 1E Sterilant Use Dilution which is a sterilant solution intended to be used in a SYSTEM 1E Processor for reprocessing endoscopes and other surgical instruments. The components of the sterilant are provided in a single sealed cup. Thus the operator is not in contact with the sterilant or its pre-mixed concentrates under normal use conditions.

What are the hazard statements for S40™ Sterilant Concentrate?

This substance has 6 hazard statements:

  • H226: Flammable liquid and vapour
  • H242: Heating may cause a fire
  • H302 + H312 + H332: Harmful if swallowed, in contact with skin or inhaled.
  • H314: Causes severe skin burns and eye damage
  • H335: May cause respiratory irritation
  • H400: Very toxic to aquatic life

What is the melting point of S40™ Sterilant Concentrate?

The melting point is -47 °C (-52,6 °F) and the boiling point is 107 °C (224,6 °F).