SAFETY DATA SHEET

1. Identification
Product identifier Cidex® OPA Concentrate
Other means of identification
SDS number 11340-US
Product code 20398
Recommended use High level disinfection.
Recommended restrictions None known.
Manufacturer/Importer/Supplier/Distributor information
Company name Advanced Sterilization Products,Inc.
Address 33 TECHNOLOGY DRIVE
IRVINE, CA 92618

Country US
Telephone number 1-888-783-7723
E-mail [email protected]

24 Hour Emergency CHEMTREC US: 1-800-424-9300 CCN 795874

Telephone
CHEMTREC International: +1 703-741-5970

2. Hazard(s) identification
Physical hazards Flammable liquids Category 3
Health hazards Skin corrosion/irritation Category 2
Serious eye damage/eye irritation Category 1
Sensitization, skin Category 1
Environmental hazards Hazardous to the aquatic environment, acute Category 1
hazard
Hazardous to the aquatic environment, Category 1
long-term hazard
OSHA defined hazards Not classified.

Label elements

Signal word Danger

Hazard statement Flammable liquid and vapor. Causes skin irritation. Causes serious eye damage. May cause an
allergic skin reaction. Very toxic to aquatic life with long lasting effects.
Precautionary statement
Prevention Keep away from heat/sparks/open flames/hot surfaces. - No smoking. Keep container tightly
closed. Ground/bond container and receiving equipment. Use explosion-proof
electrical/ventilating/lighting equipment. Use only non-sparking tools. Take precautionary
measures against static discharge. Avoid breathing mist/vapors. Wash thoroughly after handling.
Contaminated work clothing must not be allowed out of the workplace. Avoid release to the
environment. Wear protective gloves/eye protection/face protection.
Response If on skin (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower.
If skin irritation or rash occurs: Get medical advice/attention. Wash contaminated clothing before
reuse. If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing. Immediately call a poison center/doctor. In case of fire:
Use water fog, alcohol resistant foam, dry chemical powder, carbon dioxide to extinguish. Collect
spillage.
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 Storage Store in a well-ventilated place. Keep cool.
Disposal Dispose of contents/container in accordance with local/regional/national/international regulations.
Hazard(s) not otherwise None known.
classified (HNOC)
Supplemental information The product has been reported to cause anaphylactic-like reactions.

3. Composition/information on ingredients
Mixtures
Chemical name CAS number %
Ethanol 64-17-5 20

Phthalaldehyde 643-79-8 5.8

Composition comments All concentrations are in percent by weight unless ingredient is a gas. Gas concentrations are in
percent by volume. Components not listed are either non-hazardous or are below reportable limits.

4. First-aid measures
Inhalation Move to fresh air. Call a physician if symptoms develop or persist.
Skin contact Remove contaminated clothing immediately and wash skin with soap and water. In case of
eczema or other skin disorders: Seek medical attention and take along these instructions.
Eye contact Immediately flush eyes with plenty of water for at least 15 minutes. Remove contact lenses, if
present and easy to do. Continue rinsing. Get medical attention immediately.
Ingestion Rinse mouth. Get medical attention if symptoms occur.
Most important Causes serious eye damage. Symptoms may include stinging, tearing, redness, swelling, and
symptoms/effects, acute and blurred vision. Permanent eye damage including blindness could result. Skin irritation. May cause
delayed redness and pain. Sensitization. May cause anaphylactic shock.
Indication of immediate Provide general supportive measures and treat symptomatically. Thermal burns: Flush with water
medical attention and special immediately. While flushing, remove clothes which do not adhere to affected area. Call an
treatment needed ambulance. Continue flushing during transport to hospital. Keep victim under observation.
Symptoms may be delayed.
General information Take off all contaminated clothing immediately. Ensure that medical personnel are aware of the
material(s) involved, and take precautions to protect themselves. Wash contaminated clothing
before reuse.

5. Fire-fighting measures
Suitable extinguishing media Water fog. Alcohol resistant foam. Dry chemical powder. Carbon dioxide (CO2).
Unsuitable extinguishing Do not use water jet as an extinguisher, as this will spread the fire.
media
Specific hazards arising from Vapors may form explosive mixtures with air. Vapors may travel considerable distance to a source
the chemical of ignition and flash back. During fire, gases hazardous to health may be formed.
Special protective equipment Self-contained breathing apparatus and full protective clothing must be worn in case of fire.
and precautions for firefighters
Fire fighting In case of fire and/or explosion do not breathe fumes. Move containers from fire area if you can do
equipment/instructions so without risk.
Specific methods Use standard firefighting procedures and consider the hazards of other involved materials.
General fire hazards Flammable liquid and vapor.

6. Accidental release measures

Personal precautions, Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Eliminate all
protective equipment and ignition sources (no smoking, flares, sparks, or flames in immediate area). Wear appropriate
emergency procedures protective equipment and clothing during clean-up. Avoid breathing mist/vapors. Do not touch
damaged containers or spilled material unless wearing appropriate protective clothing. Ventilate
closed spaces before entering them. Local authorities should be advised if significant spillages
cannot be contained. For personal protection, see section 8 of the SDS.

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Methods and materials for Eliminate all ignition sources (no smoking, flares, sparks, or flames in immediate area). Keep
containment and cleaning up combustibles (wood, paper, oil, etc.) away from spilled material. Take precautionary measures
against static discharge. Use only non-sparking tools. This product is miscible in water. Prevent
product from entering drains.

Large Spills: Stop the flow of material, if this is without risk. Dike the spilled material, where this is
possible. Use a non-combustible material like vermiculite, sand or earth to soak up the product
and place into a container for later disposal. Following product recovery, flush area with water.

Small Spills: Absorb with earth, sand or other non-combustible material and transfer to containers
for later disposal. Clean surface thoroughly to remove residual contamination.

Never return spills to original containers for re-use. For waste disposal, see section 13 of the SDS.
Environmental precautions Avoid release to the environment. Inform appropriate managerial or supervisory personnel of all
environmental releases. Prevent further leakage or spillage if safe to do so. Avoid discharge into
drains, water courses or onto the ground.

7. Handling and storage

Precautions for safe handling Do not handle, store or open near an open flame, sources of heat or sources of ignition. Protect
material from direct sunlight. When using do not smoke. Explosion-proof general and local exhaust
ventilation. Take precautionary measures against static discharges. All equipment used when
handling the product must be grounded. Use non-sparking tools and explosion-proof equipment.
Do not get this material in contact with eyes. Avoid contact with skin and clothing. Avoid breathing
mist/vapors. Avoid prolonged exposure. Wear appropriate personal protective equipment. Avoid
release to the environment. Observe good industrial hygiene practices.
Conditions for safe storage, Keep away from heat, sparks and open flame. Prevent electrostatic charge build-up by using
including any incompatibilities common bonding and grounding techniques. Store in a cool, dry place out of direct sunlight. Store
in tightly closed container. Store in a well-ventilated place. Keep in an area equipped with
sprinklers. Store away from incompatible materials (see Section 10 of the SDS). Recommended
storage temperature: 15 - 30 °C.

8. Exposure controls/personal protection

Occupational exposure limits
US. OSHA Table Z-1 Limits for Air Contaminants (29 CFR 1910.1000)
Components Type Value
Ethanol (CAS 64-17-5) PEL 1900 mg/m3
1000 ppm
US. ACGIH Threshold Limit Values
Components Type Value Form

Ethanol (CAS 64-17-5) STEL 1000 ppm

Phthalaldehyde (CAS Ceiling 0.0001 ppm Vapor fraction
643-79-8)
US. NIOSH: Pocket Guide to Chemical Hazards
Components Type Value
Ethanol (CAS 64-17-5) TWA 1900 mg/m3
1000 ppm
Biological limit values No biological exposure limits noted for the ingredient(s).
Exposure guidelines
US ACGIH Threshold Limit Values: Skin designation
Phthalaldehyde (CAS 643-79-8) Danger of cutaneous absorption
Appropriate engineering Explosion-proof general and local exhaust ventilation. Good general ventilation should be used.
controls Ventilation rates should be matched to conditions. If applicable, use process enclosures, local
exhaust ventilation, or other engineering controls to maintain airborne levels below recommended
exposure limits. If exposure limits have not been established, maintain airborne levels to an
acceptable level. Eye wash facilities and emergency shower must be available when handling this
product.
Individual protection measures, such as personal protective equipment
Eye/face protection Wear chemical goggles and face shield.

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 Skin protection
Hand protection Wear appropriate chemical resistant gloves. Nitrile or butyl rubber gloves are recommended. Be
aware that the liquid may penetrate the gloves. Frequent change is advisable. Suitable gloves can
be recommended by the glove supplier.
Skin protection
Other Wear appropriate chemical resistant clothing. Use of an impervious apron is recommended.
Respiratory protection If engineering controls do not maintain airborne concentrations below recommended exposure
limits (where applicable) or to an acceptable level (in countries where exposure limits have not
been established), an approved respirator must be worn.
Thermal hazards Wear appropriate thermal protective clothing, when necessary.

General hygiene When using do not smoke. Always observe good personal hygiene measures, such as washing
considerations after handling the material and before eating, drinking, and/or smoking. Routinely wash work
clothing and protective equipment to remove contaminants. Contaminated work clothing should not
be allowed out of the workplace.

9. Physical and chemical properties

Appearance
Physical state Liquid.
Form Liquid.
Color Dark blue. Clear.
Odor Alcohol-like.
Odor threshold Not available.
pH 7.5
Melting point/freezing point < 32 °F (< 0 °C)
Initial boiling point and boiling 190 °F (87.8 °C)
range
Flash point 90.0 °F (32.2 °C)
Evaporation rate Not available.
Flammability (solid, gas) Not applicable.
Upper/lower flammability or explosive limits
Flammability limit - lower Not available.
(%)
Flammability limit - upper Not available.
(%)
Explosive limit - lower (%) Not available.
Explosive limit - upper (%) Not available.
Vapor pressure Not available.
Vapor density Not available.
Relative density 0.99
Relative density temperature 68 °F (20 °C)
Solubility(ies)
Solubility (water) Soluble in water.
Partition coefficient 0.677
(n-octanol/water)
Auto-ignition temperature Not available.
Decomposition temperature Not available.
Viscosity Not available.
Other information
Explosive properties Not explosive.
Oxidizing properties Not oxidizing.

10. Stability and reactivity

Reactivity The product is stable and non-reactive under normal conditions of use, storage and transport.
Chemical stability Material is stable under normal conditions.
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Possibility of hazardous No dangerous reaction known under conditions of normal use.
reactions
Conditions to avoid Avoid heat, sparks, open flames and other ignition sources. Avoid temperatures exceeding the
flash point. Contact with incompatible materials.
Incompatible materials Acids. Alkali metals. Oxidizing agents. Reducing agents.
Hazardous decomposition No hazardous decomposition products are known.
products

11. Toxicological information

Information on likely routes of exposure
Inhalation May cause irritation to the respiratory system. Prolonged inhalation may be harmful.
Skin contact Causes skin irritation. May cause an allergic skin reaction.
Eye contact Causes serious eye damage.
Ingestion May cause discomfort if swallowed.
Symptoms related to the Causes serious eye damage. Symptoms may include stinging, tearing, redness, swelling, and
physical, chemical and blurred vision. Permanent eye damage including blindness could result. Skin irritation. May cause
toxicological characteristics redness and pain. Sensitization. May cause anaphylactic shock.
Information on toxicological effects
Acute toxicity Not expected to be acutely toxic.
Components Species Test Results
Ethanol (CAS 64-17-5)
Acute
Inhalation
LC50 Rat 20000 ppm, 10 Hours
Oral
LD50 Rat 6.2 g/kg
Phthalaldehyde (CAS 643-79-8)
Acute
Oral
LD50 Rat 178 mg/kg
Skin corrosion/irritation Causes skin irritation.
Corrosivity
Cidex® OPA Concentrate OECD 435
Result: Non-corrosive
Serious eye damage/eye Causes serious eye damage.
irritation
Respiratory or skin sensitization
ACGIH sensitization
O-PHTHALALDEHYDE, VAPOR FRACTION Dermal sensitization
(CAS 643-79-8)
Respiratory sensitization
Respiratory sensitization Not a respiratory sensitizer.
Skin sensitization May cause an allergic skin reaction.
Germ cell mutagenicity No data available to indicate product or any components present at greater than 0.1% are
mutagenic or genotoxic.
Carcinogenicity Not classifiable as to carcinogenicity to humans.
IARC Monographs. Overall Evaluation of Carcinogenicity
Not listed.
NTP Report on Carcinogens
Not listed.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1053)
Not listed.
Reproductive toxicity This product is not expected to cause reproductive or developmental effects.

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Specific target organ toxicity - Not classified.
single exposure
Specific target organ toxicity - Not classified.
repeated exposure
Aspiration hazard Not an aspiration hazard.
Chronic effects Prolonged inhalation may be harmful.
Further information None known.

12. Ecological information

Ecotoxicity Very toxic to aquatic life with long lasting effects.
Components Species Test Results
Ethanol (CAS 64-17-5)
Aquatic
Acute
Crustacea EC50 Water flea (Daphnia obtusa) 10100 - 11200 mg/l, 48 hours
Fish LC50 Fathead minnow (Pimephales promelas) 13480 mg/l, 96 hours
Phthalaldehyde (CAS 643-79-8)
Aquatic
Crustacea EC50 Daphnia magna 0.087 mg/l, 48 hours
Fish LC50 Oncorhynchus mykiss 0.072 mg/l, 96 hours
Persistence and degradability No data is available on the degradability of this product.
Bioaccumulative potential
Partition coefficient n-octanol / water (log Kow)
Cidex® OPA Concentrate 0.677
Ethanol (CAS 64-17-5) -0.31
Mobility in soil No data available for this product.
Other adverse effects No other adverse environmental effects (e.g. ozone depletion, photochemical ozone creation
potential, endocrine disruption, global warming potential) are expected from this component.

13. Disposal considerations

Disposal instructions Collect and reclaim or dispose in sealed containers at licensed waste disposal site. Incinerate the
material under controlled conditions in an approved incinerator. Do not allow this material to drain
into sewers/water supplies. Do not contaminate ponds, waterways or ditches with chemical or used
container. Dispose of contents/container in accordance with local/regional/national/international
regulations.
CIDEX OPA Concentrate IN USE solution can be discarded down hospital drains per hospital
policy. Check local disposal requirements. Undiluted CIDEX OPA Concentrate may be neutralized
with 334 grams of glycine per 5 liters. After a reaction time of 24 hours, the neutralized solution
can be discarded in accordance with local disposal requirements for non hazardous waste.
Container disposal: Discard empty container as hazardous waste per local regulations.
Local disposal regulations Dispose in accordance with all applicable regulations.
Hazardous waste code The waste code should be assigned in discussion between the user, the producer and the waste
disposal company.
Waste from residues / unused Dispose of in accordance with local regulations. Empty containers or liners may retain some
products product residues. This material and its container must be disposed of in a safe manner.
Contaminated packaging Since emptied containers may retain product residue, follow label warnings even after container is
emptied. Empty containers should be taken to an approved waste handling site for recycling or
disposal.

14. Transport information

DOT
UN number UN1170
UN proper shipping name Ethanol solutions
Transport hazard class(es)
Class 3
Subsidiary risk -
Label(s) 3

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 Packing group III
Special precautions for user Read safety instructions, SDS and emergency procedures before handling.
Special provisions 24, B1, IB3, T2, TP1
Packaging exceptions 4b, 150
Packaging non bulk 203
Packaging bulk 242
IATA
UN number UN1170
UN proper shipping name Ethanol solutions
Transport hazard class(es)
Class 3
Subsidiary risk -
Packing group III
Environmental hazards No.
ERG Code 3L
Special precautions for user Read safety instructions, SDS and emergency procedures before handling.
IMDG
UN number UN1170
UN proper shipping name ETHANOL SOLUTIONS
Transport hazard class(es)
Class 3
Subsidiary risk -
Packing group III
Environmental hazards
Marine pollutant No.
EmS F-E, S-D
Special precautions for user Read safety instructions, SDS and emergency procedures before handling.
Transport in bulk according to Not established.
Annex II of MARPOL 73/78 and
the IBC Code

15. Regulatory information

US federal regulations This product is a "Hazardous Chemical" as defined by the OSHA Hazard Communication
Standard, 29 CFR 1910.1200.
TSCA Section 12(b) Export Notification (40 CFR 707, Subpt. D)
Not regulated.
CERCLA Hazardous Substance List (40 CFR 302.4)
Not listed.
SARA 304 Emergency release notification
Not regulated.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1053)
Not listed.
Toxic Substances Control Act (TSCA) All components of the mixture on the TSCA 8(b) inventory are designated
“active”.
Superfund Amendments and Reauthorization Act of 1986 (SARA)
SARA 302 Extremely hazardous substance
Not listed.
SARA 311/312 Hazardous Yes
chemical
Classified hazard Flammable (gases, aerosols, liquids, or solids)
categories Skin corrosion or irritation
Serious eye damage or eye irritation
Respiratory or skin sensitization

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 SARA 313 (TRI reporting)
Not regulated.

Other federal regulations

Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List
Not regulated.
Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130)
Not regulated.
Safe Drinking Water Act Not regulated.
(SDWA)
FEMA Priority Substances Respiratory Health and Safety in the Flavor Manufacturing Workplace
Ethanol (CAS 64-17-5) Low priority
US state regulations
US. Massachusetts RTK - Substance List
Ethanol (CAS 64-17-5)
US. New Jersey Worker and Community Right-to-Know Act
Ethanol (CAS 64-17-5)
US. Pennsylvania Worker and Community Right-to-Know Law
Ethanol (CAS 64-17-5)
US. Rhode Island RTK
Ethanol (CAS 64-17-5)
California Proposition 65
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): This material
is not known to contain any chemicals currently listed as carcinogens or reproductive toxins. For
more information go to www.P65Warnings.ca.gov.
International Inventories
Country(s) or region Inventory name On inventory (yes/no)*
Australia Australian Inventory of Chemical Substances (AICS) Yes
Canada Domestic Substances List (DSL) Yes
Canada Non-Domestic Substances List (NDSL) No
China Inventory of Existing Chemical Substances in China (IECSC) Yes
Europe European Inventory of Existing Commercial Chemical Yes
Substances (EINECS)
Europe European List of Notified Chemical Substances (ELINCS) No
Japan Inventory of Existing and New Chemical Substances (ENCS) Yes
Korea Existing Chemicals List (ECL) No
New Zealand New Zealand Inventory Yes
Philippines Philippine Inventory of Chemicals and Chemical Substances Yes
(PICCS)
Taiwan Taiwan Chemical Substance Inventory (TCSI) Yes
United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory Yes
*A "Yes" indicates this product complies with the inventory requirements administered by the governing country(s).
A "No" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governing
country(s).

16. Other information, including date of preparation or last revision

Issue date 01-May-2020
Revision date 26-May-2021
Version # 7.1
HMIS® ratings Health: 3
Flammability: 3
Physical hazard: 0
Personal protection: D
List of abbreviations EC50: Effective Concentration 50%.
LC50: Lethal Concentration 50%.
LD50: Lethal Dose 50%.
STEL: Short-Term Exposure Limit.
TWA: Time Weighted Average Value.
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References HSDB® - Hazardous Substances Data Bank
IARC Monographs. Overall Evaluation of Carcinogenicity
Disclaimer Advanced Sterilization Products cannot anticipate all conditions under which this information and
its product, or the products of other manufacturers in combination with its product, may be used. It
is the user’s responsibility to ensure safe conditions for handling, storage and disposal of the
product, and to assume liability for loss, injury, damage or expense due to improper use. The
information in the sheet was written based on the best knowledge and experience currently
available.

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