Safety Data Sheet

Trade name: Cidezyme XTRA

Product no.: SDS-101644
Current version : 2.2.1, issued: 29.01.2015 Replaced version: 2.2.0, issued: 05.03.2014 Region: USA

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

1.1 Product identifier
Trade name
Cidezyme XTRA
1.2 Relevant identified uses of the substance or mixture and uses advised against
Relevant identified uses of the substance or mixture
Detergent for cleaning medical equipment

1.3 Details of the supplier of the safety data sheet

Address
Advanced Sterilization Products
33 Technology Drive
Irvine, CA 92618
Telephone no. (800) 755-5900
.
Information provided by / telephone
Regulatory Affairs

1.4 Emergency telephone number

For medical advice
(703) 527-3887

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture
Classification in accordance with Regulation (EC) No 1272/2008
Skin corrosion (Category 1B) H314
Reproductive toxicity, Category 1B; H360FD
Classification information
This product does not meet the classification and labelling criteria given in the Dangerous Preparations Directive (1999/45/EC; DPD)
Classification and labelling on the basis of results obtained from toxicological examinations.
2.2 Label elements
Labelling according to Regulation (EC) No 1272/2008 (CLP Regulation):

Hazard pictograms

GHS08
Signal word
Danger
Hazard statements
H360FD May damage fertility or the unborn child.
Precautionary statements
P103 Read label before use.
P201 Obtain special instructions before use.
P280 Wear protective gloves/eye protection/face protection.
P301+P330+P331 IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P308+P313 IF exposed or concerned: Get medical advice/attention.
P405 Store locked up.

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 Safety Data Sheet
Trade name: Cidezyme XTRA
Product no.: SDS-101644
Current version : 2.2.1, issued: 29.01.2015 Replaced version: 2.2.0, issued: 05.03.2014 Region: USA

Supplemental label elements

Contains: ALPHA-AMYLASE; Cellulase; Subtilisin - May produce an allergic reaction.
2.3 Other hazards
No data available.

SECTION 3: Composition/information on ingredients

3.1 Substances
Not applicable. The product is not a substance.

3.2 Mixtures
Chemical characterization
enzymatic detergent
Hazardous ingredients
No Substance name
CAS / Classification 67/548/EEC Concentration %-b.w.
EC /
REACH no
1 sodium tetraborate decahydrate
1303-96-4 > 5 - < 10 %-b.w.
215-540-4
-
Reproductive toxicity, Category 1B; H360FD
Full text for all notes: pls. see section 16

SECTION 4: First aid measures

4.1 Description of first aid measures
General information
In case of persisting adverse effects, consult a physician. Remove soiled or soaked clothing immediately.
After inhalation
Remove affected person from the immediate area. Ensure supply of fresh air.
After skin contact
Wash off immediately with soap and water.
After eye contact
Separate eyelids, wash the eyes thoroughly with water (15 min.). In case of irritation consult an ophthalmologist.
After ingestion
Do not induce vomiting. Rinse out mouth and give plenty of water to drink. Summon a doctor immediately. Never give anything by
mouth to an unconscious person.
4.2 Most important symptoms and effects, both acute and delayed
No data available.

4.3 Indication of any immediate medical attention and special treatment needed
No data available.

SECTION 5: Firefighting measures

5.1 Extinguishing media
Suitable extinguishing media
Extinguishing measures to suit surroundings.
Unsuitable extinguishing media
Full water jet
5.2 Special hazards arising from the substance or mixture
In the event of fire, the following can be released: Carbon dioxide (CO2); Carbon monoxide (CO)

5.3 Advice for firefighters

Use self-contained breathing apparatus. Run-off water from fire fighting must not be discharged into drains or enter surface water.

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures
For non-emergency personnel
Refer to protective measures listed in sections 7 and 8.

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 Safety Data Sheet
Trade name: Cidezyme XTRA
Product no.: SDS-101644
Current version : 2.2.1, issued: 29.01.2015 Replaced version: 2.2.0, issued: 05.03.2014 Region: USA

For emergency responders

No data available. Personal protective equipment (PPE) - see Section 8.

6.2 Environmental precautions

Do not discharge into the drains/surface waters/groundwater. Do not discharge into the subsoil/soil.
6.3 Methods and material for containment and cleaning up
Take up with absorbent material (e.g., sand, kieselguhr, universal binder). When picked up, treat material as prescribed under
heading "Disposal considerations".
6.4 Reference to other sections
Observe protective measures in sections 7 and 8.

SECTION 7: Handling and storage

7.1 Precautions for safe handling
Advice on safe handling
Open and handle container with care. Avoid formation of aerosols. Avoid eye, skin and clothing contact.
General protective and hygiene measures
Do not eat, drink or smoke during work time. Keep away from foodstuffs and beverages. Avoid contact with eyes and skin. Remove
soiled or soaked clothing immediately. Wash hands before breaks and after work. Provide eye wash fountain in work area. Do not
inhale vapours.
Advice on protection against fire and explosion
No special measures necessary.
7.2 Conditions for safe storage, including any incompatibilities
Technical measures and storage conditions
Keep container tightly closed in a cool, well-ventilated place.
Recommended storage temperature
Value 15 - 30 °C
Requirements for storage rooms and vessels
Containers which are opened must be carefully resealed and kept upright to prevent leakage. Always keep in containers of same
material as the original one.
Advice on storage assembly
Do not store together with foodstuffs. Do not store together with animal feedstocks. Do not store together with oxidizing agents.
7.3 Specific end use(s)
No data available.

SECTION 8: Exposure controls/personal protection

8.1 Control parameters
Occupational exposure limit values
No Substance name CAS no. EC no.
2 disodium tetraborate decahydrate 1303-96-4 215-540-4
List of approved workplace exposure limits (WELs) / EH40
Disodium tetraborate, decahydrate
true
TWA 5 mg/m³
Other information
Please see your local regulations.

8.2 Exposure controls

Appropriate engineering controls
No data available.
Personal protective equipment
Respiratory protection
If workplace exposure limits are exceeded, a respiration protection approved for this particular job must be worn. In case of aerosol
and mist formation, take appropriate measures for breathing protection in the event workplace threshold values are not specified.
Eye / face protection
Safety glasses with side protection shield (EN 166)

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 Safety Data Sheet
Trade name: Cidezyme XTRA
Product no.: SDS-101644
Current version : 2.2.1, issued: 29.01.2015 Replaced version: 2.2.0, issued: 05.03.2014 Region: USA

Hand protection
In case of intensive contact, wear protective gloves (EN 374). Sufficient protection is given wearing suitable protective gloves
checked according to i.e. EN 374, in the event of risk of skin contact with the product . Before use, the protective gloves should be
tested in any case for its specific work-station suitability (i.e. mechanical resistance, product compatibility and antistatic properties).
Adhere to the manufacturer’s instructions and information relating to the use, storage, care and replacement of protective gloves.
Protective gloves shall be replaced immediately when physically damaged or worn. Design operations thus to avoid permanent use
of protective gloves.
Appropriate Material Polyethylene
Other
Normal chemical work clothing.
Environmental exposure controls
Ensure adequate ventilation.

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties
Form/Colour
liquid
270
blue; clear
190

Odour
30
characteristic
Odour threshold
No data available
pH value
Value 7,8
7,8 - 8,8 8,8

Boiling point / boiling range

No data available
Melting point / melting range
No data available
Decomposition point / decomposition range
No data available
Flash point
n.a.
Not applicable
Auto-ignition temperature
No data available
Oxidising properties
No data available
Explosive properties
No data available
Flammability (solid, gas)
No data available
Lower flammability or explosive limits
No data available
Upper flammability or explosive limits
No data available
Vapour pressure
No data available
Vapour density
No data available
Evaporation rate
No data available
Relative density
No data available
Density
No data available
Solubility in water
No data available

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 Safety Data Sheet
Trade name: Cidezyme XTRA
Product no.: SDS-101644
Current version : 2.2.1, issued: 29.01.2015 Replaced version: 2.2.0, issued: 05.03.2014 Region: USA

Solubility(ies)
No data available
Partition coefficient: n-octanol/water
No data available
Viscosity
No data available

SECTION 10: Stability and reactivity

10.1 Reactivity
No data available.

10.2 Chemical stability

No data available.
10.3 Possibility of hazardous reactions
No data available.
10.4 Conditions to avoid
Keep from freezing.
10.5 Incompatible materials
Oxidizing agents
10.6 Hazardous decomposition products
No hazardous decomposition products known.

SECTION 11: Toxicological information

11.1 Information on toxicological effects
Acute oral toxicity
No data available
Acute dermal toxicity
No data available
Acute inhalational toxicity
No data available
Skin corrosion/irritation
Corrosive, causes severe skin burns
Serious eye damage/irritation
Corrosive, causes severe eye damage
Respiratory or skin sensitisation
No data available
Germ cell mutagenicity
No data available
Reproduction toxicity
No data available
Carcinogenicity
No data available
STOT-single exposure
No data available
STOT-repeated exposure
No data available
Aspiration hazard
No data available
Delayed and immediate effects as well as chronic effects from short and long-term exposure
U_935
By appropiate use of the product no health damage is known.
Other information
Lk.7002639
Exercise customary precautions when handling chemicals.

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 Safety Data Sheet
Trade name: Cidezyme XTRA
Product no.: SDS-101644
Current version : 2.2.1, issued: 29.01.2015 Replaced version: 2.2.0, issued: 05.03.2014 Region: USA

SECTION 12: Ecological information

12.1 Toxicity
Fish toxicity
No data available
Daphnia toxicity
No data available
Algae toxicity
No data available
Bacteria toxicity
No data available
12.2 Persistence and degradability
Biodegradability
Evaluation biodegradable

12.3 Bioaccumulative potential

No data available.
12.4 Mobility in soil
No data available.
12.5 Results of PBT and vPvB assessment
No data available.
12.6 Other adverse effects
No data available.

12.7 Other information

Other information
Ecological data are not available.
700
Do not allow to enter soil, waterways or waste water canal.

SECTION 13: Disposal considerations

13.1 Waste treatment methods
Product
Allocation of a waste code number, according to the European Waste Catalogue, should be carried out in agreement with the
regional waste disposal company.
Packaging
Residuals must be removed from packaging and when emptied completely disposed of in accordance with the regulations for waste
removal. Incompletely emptied packaging must be disposed of in the form of disposal specified by the regional disposer.

SECTION 14: Transport information

14.1 Transport ADR/RID/ADN
The product is not subject to ADR/RID/ADN regulations.

14.2 Transport IMDG

The product is not subject to IMDG regulations.
14.3 Transport ICAO-TI / IATA
The product is not subject to ICAO-TI / IATA regulations.

14.4 Other information

No data available.
14.6 Special precautions for user
No data available.
14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not relevant

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 Safety Data Sheet
Trade name: Cidezyme XTRA
Product no.: SDS-101644
Current version : 2.2.1, issued: 29.01.2015 Replaced version: 2.2.0, issued: 05.03.2014 Region: USA

SECTION 15: Regulatory information

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
EU regulations

REACH candidate list of substances of very high concern (SVHC) for authorization
The product contains following substance(s) meeting the criteria in Article 57 in association with Article 59 of the REACH regulation
1907/2006 that are placed on the list of candidates considered for inclusion in annex XIV (substances subject to Authorization).
CAS no. 1303-96-4
EC no. 215-540-4
Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances
Remarks Annex I, part 1 + 2: not mentioned. With regard to possibly appropriate decomposition
products see Chapter 10.

15.2 Chemical safety assessment

No data available.

SECTION 16: Other information

Changes made since the last version
Sources of key data used to compile the data sheet:
EC Directive 67/548/EC resp. 99/45/EC as amended in each case.
Regulation (EC) No 1907/2006 (REACH), 1272/2008 (CLP) as amended in each case.
EC Directives 2000/39/EC, 2006/15/EC, 2009/161/EC
National Threshold Limit Values of the corresponding countries as amended in each case.
Transport regulations according to ADR, RID, IMDG, IATA as amended in each case.
The data sources used to determine physical, toxic and ecotoxic data, are indicated directly in the corresponding chapter.

Full text of the H- and EUH- phrases drawn up in sections 2 and 3 (provided not already drawn up in these
sections)
H360FD May damage fertility or the unborn child.
Department issuing safety data sheet
Ingenieur- und Sachverständigenbüro ROLAND BRAUN
Peter-Timm-Straße 21, D-22457 Hamburg
Tel.: +49 40 / 43 27 09 15 Fax: +49 40 / 43 27 09 16 e-mail: [email protected]
This information is based on our present state of knowledge. The security data sheet describes products with a view to
the security requirements. However, it should not constitute a guarantee for any specific product properties and shall
not establish a legally valid relationship.

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