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FIDE014& Aperlan Poka-Yoke - Agent A Version : I
According to 1907/2006/CE, Article 31

SECTION 1: Identification of the substance/mixture and of the company/

undertaking
1.1 Product identifier:
Trade name: APERLAN POKA-YOKE AGENT A

1.2 Relevant identified uses of the substance or mixture and uses advised against:
Professional and / or industrial use
Application of the substance / the preparation:
Disinfecting flexible endoscopes in washer disinfector.
1.3 Details of the supplier of the safety data sheet:
GETINGE LANCER
30 BD DE L'INDUSTRIE Z.I. DU PAHIN
31170 TOURNEFEUILLE FRANCE
Tel. +33 (0)5 61 15 11 11
Fax. +33 (0)5 61 15 16 16
Further information obtainable from: lancersite@lancer.fr

1.4 Emergency telephone number:

France (ORFILA 24h/24) - Tel : +33 (0)1 45 42 59 59
NHS Direct : 0845 46 47 / Fax : 0845 606 46 47

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture:

Classification according to Directive 67/548/EEC or Directive 1999/45/EC:

C: Corrosive
R34: Causes burns.

Xn; Harmful
R22: Harmful if swallowed.

O: Oxidising
R8: Contact with combustible material may cause fire.
Information concerning particular hazards for human and environment:
The product has to be labelled in the latest valid version according to the calculation procedure of
the "General Classification guideline for preparations of the EU".
Classification system:
The classification is according to the latest editions of the EU-lists, and extended by company and
literature data.
2.2 Label elements:
Labelling according to EU guidelines:
The product has been marked in accordance with EU Directives / respective national laws.
2008/58/CE (30th ATP) ; 2009/2/CE (31st ATP) ; 2006/8/CE

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Code letter and hazard designation of product:

C Corrosive
O Oxidising

Hazard-determining components of labelling:

hydrogen peroxide
acetic acid
peracetic acid
Risk phrases:
8 Contact with combustible material may cause fire.
22 Harmful if swallowed.
34 Causes burns.
Safety phrases:
3/7 Keep container tightly closed in a cool place.
14 Keep away from reducing agents, heavy metal compounds, acids and alkalis.
26 In case of contact with eyes, rinse immediately with plenty of water and seek medical
advice.
36/37/39 Wear suitable protective clothing, gloves and eye/face protection.
45 In case of accident or if you feel unwell, seek medical advice immediately (show the label
where possible).

2.3 Other hazards:

Results of PBT and VPVB assessment:
PBT: Not applicable.
VPVB: Not applicable.

SECTION 3: Composition/information on ingredients

3.2 Mixtures:
Description: Solution of the following substances with harmless additives.

· Dangerous components:
CAS: 64-19-7 acetic acid
EINECS: 200-580-7 C R35
10-25%
Index number:607-002- R10
00-6 Flam. Liq. 3, H226; Skin Corr. 1A, H314
RTECS : AF 1225000
CAS: 7722-84-1 hydrogen peroxide
EINECS: 231-765-0 C R35; Xn R20/22; O R8 >20%
Index number : 008- R5
003-00-9 Ox. Liq. 1, H271; Skin Corr. 1A, H314; Acute Tox. 4, H302; Acute
Tox. 4, H332
peracetic acid
CAS: 79-21-0 C R35; Xn R20/21/22; O R7; N R50 5%
EINECS: 201-186-8 R10
Index number: 607-094-
Flam. Liq. 3, H226; Org. Perox. CD, H242; Skin Corr. 1A, H314;
00-8 Aquatic Acute 1, H400; Acute Tox. 4, H302; Acute Tox. 4, H312;
RTECS: SD 8750000 Acute Tox. 4, H332
Additional information: For the wording of the listed risk phrases, refer to section 16.

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SECTION 4: First aid measures

4.1 Description of first aid measures:
General information:
Involve doctor immediately.
Immediately remove any clothing soiled by the product.
After excessive inhalation:
In case of unconsciousness place patient in a stable laying down side position for transportation.
Supply fresh air. If required, provide artificial respiration. Keep patient warm. Consult doctor if
symptoms persist. Seek medical treatment.
After skin contact:
Wash immediately with plenty of water and rinse thoroughly.
Seek immediate medical advice.
After eye contact:
Flush eyes for at least 15 minutes under running water in well disapplying eyelids and consult a
doctor.
After swallowing:
Do not induce vomiting. Rinse mouth with water. Ask a medical emergency. Give small amounts of
water.

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: Firefighting measures

5.1 Extinguishing media:
Fire-extinguishing powder.
Foam.
Water spray.
For safety reasons unsuitable extinguishing agents:
Water with full jet.
Carbon dioxide.

5.2 Special hazards arising from the substance or mixture:

Formation of toxic gases is possible during heating or in case of fire.

5.3 Advice for firefighters:

Protective equipment:
Wear self-contained respiratory protective device.
Wear fully protective suit.
Acid resistant protective clothing.
Additional information
Cool closed containers and close by spraying water.

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SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures:
Ensure adequate ventilation.
Handle in accordance with good industrial hygiene and safety practice.
Keep away from ignition sources, ignition.
Use respiratory protective device against the effects of fumes/dust/aerosol.

6.2 Environmental precautions:

Do not allow to enter drainage system, surface water and the groundwater.

6.3 Methods and material for containment and cleaning up:

Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Send for recovery or disposal in suitable receptacles.
Ensure adequate ventilation.
Clean the affected area carefully; suitable cleaners are: Water.

6.4 Reference to other sections:

See Section 8 for information on personal protective equipment.
See Section 13 for disposal information.

SECTION 7: Handling and storage

7.1 Precautions for safe handling:
Ensure good ventilation/exhaustion at the workplace. Prevent formation of aerosols.
Never return unused product in the container storage. Open and handle receptacle with care.
Information about fire - and explosion protection:
Keep away from flame or spark source. Do not smoke. Keep away from combustible materials.
May cause or intensify fire: oxidizer.
7.2 Conditions for safe storage, including any incompatibilities:
Storage:
Requirements to be met by storerooms and receptacles:
Use packaging HDPE, polyethylene, glass. Materials unsuitable for containers: metal. Keep only
in original container. Store in a container fitted with a vent.
Provide floor trough without outlet.
Information about storage in one common storage facility:
Do not store together with reducing agents, heavy-metal compounds, acids and alkalis.
Further information about storage conditions:
Keep container tightly sealed.
Protect from heat and direct sunlight.
Store in a cool place, heat will increase pressure and may lead to the receptacle bursting.
Store receptacle in a well ventilated area.
Do not seal receptacle gas tight.
Recommended storage temperature: 5-25°C

7.3 Specific end use(s):

No further relevant information available.

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SECTION 8: Exposure controls/personal protection

Additional information about design of technical facilities:
Ensure that the locations of eyewash and safety are close to the locations and workstations.
8.1 Control parameters:
· Ingredients with limit values that require monitoring at the workplace:
64-19-7 acetic acid
IOELV (EU) Long-term value: 25 mg/m³, 10 ppm
7722-84-1 hydrogen peroxide
WEL (Great Britain) Short-term value: 2.8 mg/m³, 2 ppm
Long-term value: 1.4 mg/m³, 1 ppm
Additional information:
As a basis for the production of this document, the most current valid lists were used.
8.2 Exposure controls:
Personal protective equipment:
General protective and hygienic measures:
Keep away from foodstuffs, beverages and food.
Immediately remove all soiled and contaminated clothing.
Wash hands before breaks and at the end of work.
Avoid contact with the eyes and skin.
Do not inhale gases / fumes / aerosols.
Do not eat, drink, smoke or sniff while working.
The usual precautionary measures are to be adhered to when handling chemicals.
Respiratory protection:

Suitable respiratory protective device recommended.

In case of low exposure or short-term, use a filter respirator (filter combined A2B2E2K1P2); in case
of intense or prolonged exposure, use breathing apparatus independent of the ambient air.
Protection of hands:

Protective gloves

Gloves material:
Rubber gloves nitrile or butyl rubber.
The selection of suitable gloves does not only depend on the material, but also on further marks of
quality which may vary from manufacturer to manufacturer. As the product is a preparation of
several substances, the resistance of the glove material can not be calculated in advance and has
therefore to be checked before use.
Penetration time of glove material
For the mixture of chemicals mentioned below the penetration time has to be at least >480 minutes
(Permeation according to EN 374 Part 3: Level >480).

Eye protection:

Tightly sealed goggles

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Body protection:

Acid resistant protective clothing

Boots

Use protective suit.

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties:

· General Information
· Appearance:
Form: Liquid
Colour: Colourless
Odour: Pungent
· pH-value (1000 g/l) at 20°C: <1
· Change in condition
Melting point/Melting range: <26°C
Boiling point/Boiling range: 100°C
· Flash point: Not applicable.
· Ignition temperature: 485°C
· Decomposition temperature: <100°C
· Self-igniting: Product is not self igniting.
· Danger of explosion: Product does not present an explosion hazard.
· Vapour pressure at 20°C: 21 hPa (50° 100 hPa)
· Density at 20°C: 1.12 g/cm³
· Solubility in / Miscibility with
water: Fully miscible.

9.2 Other information:

No further relevant information available.

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SECTION 10: Stability and reactivity

10.1 Reactivity:

10.2 Chemical stability:

Thermal decomposition / conditions to be avoided:
No decomposition if used according to specifications.
To avoid thermal decomposition do not overheat.
Decomposition starts at: 60°C (SADT/TDAA)
Stable until approx.: 30°C

10.3 Possibility of hazardous reactions:

Reactions to contact with strong bases and reducing agents.
With inorganic acid chlorides and aldehydes.
Reacts with strong acids and oxidizing agents.
Reacts with certain metals.

10.4 Conditions to avoid:

No further relevant information available.

10.5 Incompatible materials:

No further relevant information available.

10.6 Hazardous decomposition products:

Oxygen.

SECTION 11: Toxicological information

11.1 Information on toxicological effects:
Acute toxicity:
· LD/LC50 values relevant for classification:
64-19-7 acetic acid
Oral LD50 3310 mg/kg (rat)
Dermal LD50 1060 mg/kg (rabbit)
Inhalative CL50 >39.8 mg/l (4h) (rat)
79-21-0 peracetic acid
Oral LD 50 315 mg/kg (rat)
Inhalative CL 50 0.59 mg/l 1h (rat) (OCDE 403)
7722-84-1 hydrogen peroxide
Oral LD50 801-872 mg/kg (rat)
Dermal LD50 2000 mg/kg (rabbit)
Inhalative CL0 16.1 mg/l 4h (rat)
Primary irritant effect:
On the skin: Caustic effect on skin and mucous membranes.
On the eyes: Strong caustic effect.
Sensitization: No sensitizing effects known.
Additional toxicological information:
The product shows the following hazards according to the calculation method of the General EU
Classification Guidelines for Preparations as issued in the latest version:
Corrosive
Swallowing will lead to a strong caustic effect on mouth and throat and to the danger of perforation
of esophagus and stomach.

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SECTION 12: Ecological information

12.1 Toxicity:
· Aquatic toxicity:
79-21-0 peracetic acid
CE50 3.3 mg/l, 48 h (daphnia)
CL50 13 mg/l, 96 h (fish)
7722-84-1 hydrogen peroxide
CE50 2.5 mg/l, 72 h (algae)
2.4 mg/l, 48 h (daphnia)
CL50C 16.4-37.4 mg/l, 96 h (fish)
64-19-7 acetic acid
CE100 720 mg/l, 0.25 h (algae)
CE50 95 mg/l, 24 h (daphnia)
CL50 251 mg/l, 96 h (fish)
12.2 Persistence and degradability:
No further relevant information available.

12.3 Bioaccumulative potential:

No further relevant information available.

12.4 Mobility in soil:

No further relevant information available.
Additional ecological information:
General notes:
In the diluted product used, the pH-value is considerably reduced, so that after the use of the
product the aqueous waste, emptied into drains, is only slightly polluting for water.
This preparation contains no substance as persistent or bioaccumulative, and toxic (PBT).
Must not reach sewage water or drainage ditch undiluted or unneutralized.
At present there are no ecotoxicological assessments available.
Water hazard class 1 (Self-assessment): slightly hazardous for water.
Do not allow undiluted product or large quantities of it to reach ground water, water course or
sewage system.

12.5 Results of PBT and VPVB assessment:

PBT: Not applicable.
VPVB: Not applicable.

12.6 Other adverse effects:

No further relevant information available.

SECTION 13: Disposal considerations

13.1 Waste treatment methods
Recommendation :
Must not be disposed of together with household garbage. Do not allow product to reach sewage
system.
Waste disposal key: EWC 160903

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European waste Catalogue

16 00 00 Wastes not otherwise specified in the list
16 09 00 Oxidizing substances
16 09 03* Peroxides, for example, hydrogen peroxide
Uncleaned packaging:
Recommendation:
Disposal must be made according to official regulations.
Dispose of packaging according to regulations on the disposal of packagings.
Packagings that may not be cleansed are to be disposed of in the same manner as the product.
Recommended cleansing agents: Water, if necessary together with cleansing agents.

SECTION 14: Transport information

14.1 UN-Number
· ADR, IMDG, IATA UN3149
14.2 UN proper shipping name
· ADR 3149 HYDROGEN PEROXIDE AND
PEROXYACETIC ACID MIXTURE, STABILIZED
· IMDG, IATA HYDROGEN PEROXIDE AND PEROXYACETIC
ACID MIXTURE, STABILIZED
14.3 Transport hazard class(es)
· ADR

· Class 5.1 (OC1) Oxidising substances.

· Label 5.1+8
· IMDG, IATA

· Class 5.1 Oxidising substances.

· Label 5.1+8
14.4 Packing group
· ADR, IMDG, IATA II
14.5 Environmental hazards:
· Marine pollutant: No
14.6 Special precautions for user Warning: Oxidising substances.
· Danger code: 58
· EMS Number: F-H,S-Q
· Segregation groups Peroxides
14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not applicable.
· Transport/Additional information:
· ADR
· Limited quantities (LQ) 1L
· Transport category 2
· Tunnel restriction code E

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· UN "Model Regulation": UN3149, H YDROGEN PEROXIDE AND

PEROXYACETIC ACID MIXTURE, STABILIZED,
5.1 (8), II

SECTION 15: Regulatory information

15.1 Safety, health and environmental regulations/legislation specific for the substance or
mixture:
Regulation of major accident hazards involving dangerous substances.
The product is classified in at least one of the categories 1 to 11 of Annex 1 of Directive 1996/82/EC
on the control of major accident hazards.

15.2 Chemical safety assessment:

Exempt.

SECTION 16: Other information

This information is based on our present knowledge. However, this shall not constitute a guarantee
for any specific product features and shall not establish a legally valid contractual relationship.
Relevant phrases
H226 Flammable liquid and vapour.
H242 Heating may cause a fire.
H271 May cause fire or explosion; strong oxidiser.
H302 Harmful if swallowed.
H312 Harmful in contact with skin.
H314 Causes severe skin burns and eye damage.
H332 Harmful if inhaled.
H400 Very toxic to aquatic life.
R10 Flammable.
R20/21/22 Harmful by inhalation, in contact with skin and if swallowed.
R20/22 Harmful by inhalation and if swallowed.
R35 Causes severe burns.
R5 Heating may cause an explosion.
R50 Very toxic to aquatic organisms.
R7 May cause fire.
R8 Contact with combustible material may cause fire.

Training hints
- Germicide classification:
Aperlan Poka-Yoke Agent A, combined with Aperlan Poka-Yoke Agent B, is a high level
disinfectant for use with semi-critical devices.
A high level disinfectant is a germicide that inactivates all microbial pathogens, except large
numbers of bacterial endospores, when used according to labeling.

- Information on selection and use of germicides for endoscopes reprocessing:

Chose a germicide with the level of microbicidal activity that is appropriate for the endoscope. See
the labeling for the endoscope or contact its manufacturer for further instructions. As a
consequence if the Aperlan Poka-Yoke High Level Disinfectant microbicidal activity is not
appropriate, the flexible endoscope can not be reprocessed in the Getinge AER.

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- Mode of action of germicidal activity.

Mode of action of the peracetic acid formula :
G.R. Dychdala, from synthesis of the literature data (1988;1993), declares that the destruction of
the microbial cell by PAA can be explained by the three following mechanisms:
• Denaturation of cell proteins and interruption of cell transport
• Inactivation of enzymes essential to cell metabolism, and
• Disruption of cell membranes and their permeability.
The addition of a surface-active agent increases the phenomenons due to the wetting power of the
formula.
- References:
Dychdala, G.R. 1988 New hydrogen peroxide-peroxyacetic disinfectant. Proc.4th Conference of
Progresses in Chemical Disinfection, Binghampton, NY, pp. 315-342
Dychdala, G.R. 1993 SANITIZERS: HALOGENS, SURFACE-ACTIVE AGENTS and PEROXIDES
Source: Name of Journal not indicated, pp. 469-537

- Material and device compatibility:

The compatibility tests of Aperlan Poka-Yoke with endoscopes components have shown that the
use of this high level disinfectant with its directions for use was safe for the endoscope.
The compatibility tests have shown that the Aperlan Poka-Yoke is fully compatible with the Getinge
AER. As other washer/disinfectors have not been tested with Aperlan Poka-Yoke, do not use it on
an other machine that the Getinge AER.

- Pre-cleaning agent compatibility:

Use non- or low-foaming type of pre-cleaning agent to brush endoscope channels before it is
reprocessed in the Getinge AER.

- Toxicology and adverse reaction:

Refer to chapter 11 above for toxicology and possible adverse reaction.

Abbreviations and acronyms:

ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road.
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
LC50: Lethal concentration, 50 percent
LD50: Lethal dose, 50 percent

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