088030 Adv Sterilization 500-20390 SDS.pdf

SAFETY DATA SHEET

Version 1.24

Revision Date:

2018/06/21

SDS Number:

100000011327

Date of last issue: 2018/06/08 Date of first issue: 2015/03/27

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SECTION 1. IDENTIFICATION

Substance name : CIDEX OPA Solution

Manufacturer or supplier's details

Company name of supplier : Advanced Sterilization Products

Address : 33 Technology Drive Irvine, CA 92618

US

Telephone : (800) 755-5900 E-mail address Responsi-ble/issuing person

: SDSJanssen@its.jnj.com

Emergency telephone number

: CHEMTREC US: 1-800-424-9300

CHEMTREC International: +1 703-527-3887

Recommended use of the chemical and restrictions on use

Recommended use : High level disinfection

SECTION 2. HAZARDS IDENTIFICATION

GHS Classification

Skin sensitisation

: Category 1

GHS label elements

Medicinal devices are not subject to GHS labeling.

Hazard pictograms

Signal word

: Warning

Hazard statements

: H317 May cause an allergic skin reaction.

Precautionary statements

: Prevention:

P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.

P272 Contaminated work clothing should not be allowed out of the workplace.

P280 Wear protective gloves.

Response:

ITEM# 088030

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2018/06/21

SDS Number:

100000011327

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P302 + P352 IF ON SKIN: Wash with plenty of soap and water.

P333 + P313 If skin irritation or rash occurs: Get medical advice/ attention.

P363 Wash contaminated clothing before reuse.

Disposal:

P501 Dispose of contents/ container to an approved waste dis-posal plant.

Other hazards

None known.

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS

Substance / Mixture

: Mixture

Chemical nature

: Liquid

Hazardous components

Chemical name CAS-No. Concentration (%) phthalaldehyde 643-79-8 >= 0.1 - < 1

SECTION 4. FIRST AID MEASURES

If inhaled

: If breathed in, move person into fresh air.

If symptoms persist, call a physician.

In case of skin contact

: Take off contaminated clothing and shoes immediately.

Wash off with plenty of water.

If symptoms persist, call a physician.

In case of eye contact

: Rinse immediately with plenty of water, also under the eyelids, for at least 5 minutes.

Remove contact lenses.

If eye irritation persists, consult a specialist.

If swallowed

: If swallowed, rinse mouth with water (only if the person is con-scious).

Call a physician immediately.

Most important symptoms and effects, both acute and delayed

: Allergic reactions

Notes to physician

: Treat symptomatically.

SECTION 5. FIREFIGHTING MEASURES

Suitable extinguishing media

: Use extinguishing measures that are appropriate to local cir-cumstances and the surrounding environment.

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2018/06/21

SDS Number:

100000011327

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Hazardous combustion prod-ucts

: No hazardous combustion products are known

Further information : No information available.

Special protective equipment for firefighters

: In the event of fire, wear self-contained breathing apparatus.

SECTION 6. ACCIDENTAL RELEASE MEASURES

Personal precautions, protec-tive equipment and emer-gency procedures

: In the event of an accidental release the emergency response team must respond based on a risk assessment and use per-sonal protective equipment as appropriate.

Do not breathe vapours or spray mist.

Evacuate personnel to safe areas.

Environmental precautions

: Should not be released into the environment.

Do not flush into surface water or sanitary sewer system.

Methods and materials for containment and cleaning up

: Large spills: Dam up. Soak up with inert absorbent material.

Keep in properly labelled containers.

Small spills: Gently cover the spill with an absorbent towel or pad.

Large spills + Small spills: Keep in suitable, closed containers for disposal. Treat recovered material as described in the sec-tion "Disposal considerations".

SECTION 7. HANDLING AND STORAGE

Advice on protection against fire and explosion

: No data available

Advice on safe handling

: To avoid thermal decomposition, do not overheat.

Avoid inhalation, ingestion and contact with skin and eyes.

Use personal protective equipment as required.

Conditions for safe storage

: To maintain product quality, do not store in heat or direct sun-light.

Store in original container.

Keep containers tightly closed in a dry, cool and well-ventilated place.

Keep away from heat and sources of ignition.

Recommended storage tem-perature

: 15 - 30 °C

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Components with workplace control parameters

Contains no substances with occupational exposure limit values.

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2018/06/21

SDS Number:

100000011327

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Hazardous components without workplace control parameters

Components CAS-No.

phthalaldehyde 643-79-8

Engineering measures : All personal protective equipment should be based on a risk assessment. Consult a Environment Health Safety expert if necessary.

Personal protective equipment

Respiratory protection

: Engineering controls should always be the primary method of controlling exposures.

If respiratory protective equipment is needed for certain activ-ities, the type as well as the corresponding protection factor will depend upon the risk assessment and air concentrations, hazards, physical and warning properties of substances pre-sent.

No personal respiratory protective equipment normally re-quired.

In case of mist, spray or aerosol exposure wear suitable per-sonal respiratory protection and protective suit.

Hand protection

Remarks

: Take note of the information given by the producer concern-ing permeability and break through times, and of special workplace conditions (mechanical strain, duration of contact).

Impervious gloves

Eye protection

: Safety glasses with side-shields

Skin and body protection

: No special precautions required.

Protective measures

: The type of protective equipment must be selected based on the Environmental Health and Safety risk assessment. Con-sult a Environmental Health and Safety expert if necessary.

Hygiene measures

: Handle in accordance with good industrial hygiene and safety practice.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES

Appearance

: liquid

Colour

: light blue, clear

Odour

Odour Threshold pH

: 7.2 - 7.8

Melting point/range

: 0 °C

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2018/06/21

SDS Number:

100000011327

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Boiling point/boiling range

: 100 °C

Flash point

Evaporation rate

Lower explosion limit

Vapour pressure

Relative vapour density

Density

: 1.0 g/cm3 (20 °C)

Solubility(ies) Water solubility

: soluble

Auto-ignition temperature

Decomposition temperature

Viscosity Viscosity, dynamic

Viscosity, kinematic

Explosive properties

Oxidizing properties

SECTION 10. STABILITY AND REACTIVITY

Reactivity

: None reasonably foreseeable.

Chemical stability

: Stable under normal conditions.

Possibility of hazardous reac-tions

: No dangerous reaction known under conditions of normal use.

Conditions to avoid

: To avoid thermal decomposition, do not overheat.

Heat, flames and sparks.

Incompatible materials

: Acids Alkali metals Reducing agents Oxidizing agents Water

Hazardous decomposition products

: None known.

Revision Date:

2018/06/21

SDS Number:

100000011327

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SECTION 11. TOXICOLOGICAL INFORMATION

Acute toxicity

Product:

Acute oral toxicity : Acute toxicity estimate: > 5,000 mg/kg Method: Calculation method

Components:

phthalaldehyde Acute oral toxicity : LD50 Oral (Rat): 178 mg/kg

Skin corrosion/irritation

Product:

Remarks: slight irritation

Result: Corrosive after 3 minutes to 1 hour of exposure

Serious eye damage/eye irritation

Remarks: slight irritation

Respiratory or skin sensitisation

Remarks: Repeated or prolonged skin contact may cause allergic reactions with susceptible persons.

Result: May cause sensitisation by skin contact.

Germ cell mutagenicity

No data available

Carcinogenicity

No data available

Reproductive toxicity

Components:

phthalaldehyde Effects on foetal development

: Species: Rat, female Application Route: Oral Dose: <10 milligram per kilogram

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2018/06/21

SDS Number:

100000011327

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Result: No teratogenic effects

STOT - single exposure

STOT - repeated exposure

No data available

Repeated dose toxicity

Components:

phthalaldehyde Species: Rat NOAEL: 5 mg/kg Application Route: Oral Exposure time: 90 days

Aspiration toxicity

SECTION 12. ECOLOGICAL INFORMATION

Ecotoxicity

Product:

Toxicity to algae : Remarks: The active ingredient o-phthalaldehyde is considered toxic to algae. However upon dilution the activity is reduced.

Toxicity to fish : (Oncorhynchus mykiss (rainbow trout)): 0.072 mg/l

Exposure time: 96 h Test Type: LC50

Toxicity to daphnia and other aquatic invertebrates

: EC50 (Daphnia magna (Water flea)): 0.087 mg/l Exposure time: 48 h

Persistence and degradability

Bioaccumulative potential

Components:

phthalaldehyde Partition coefficient: n-octanol/water

: Remarks: No data available

Mobility in soil

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2018/06/21

SDS Number:

100000011327

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Other adverse effects

Product:

Ozone-Depletion Potential : Regulation: 40 CFR Protection of Environment; Part 82 Protection of Stratospheric Ozone - CAA Section 602 Class I Substances Remarks: This product neither contains, nor was manufactured with a Class I or Class II ODS as defined by the U.S. Clean Air Act Section 602 (40 CFR 82, Subpt. A, App.A + B).

Additional ecological information

: An environmental hazard cannot be excluded in the event of unprofessional handling or disposal.

This product has no known ecotoxicological effects.

SECTION 13. DISPOSAL CONSIDERATIONS

Disposal methods

Waste from residues : In accordance with National, Federal, State and Local regula-tions.

Contaminated packaging : Empty containers should be taken to an approved waste han-dling site for recycling or disposal.

SECTION 14. TRANSPORT INFORMATION

International Regulations

UNRTDG

Not regulated as a dangerous good

IATA-DGR

Not regulated as a dangerous good

IMDG-Code Not regulated as a dangerous good

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code

Not applicable for product as supplied.

National Regulations

49 CFR

Not regulated as a dangerous good

SECTION 15. REGULATORY INFORMATION

EPCRA - Emergency Planning and Community Right-to-Know Act

Revision Date:

2018/06/21

SDS Number:

100000011327

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SARA 302

: This material does not contain any components with a section

302 EHS TPQ.

SARA 313

: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.

Clean Air Act

This product neither contains, nor was manufactured with a Class I or Class II ODS as defined by the U.S. Clean Air Act Section 602 (40 CFR 82, Subpt. A, App.A + B).

This product does not contain any hazardous air pollutants (HAP), as defined by the U.S. Clean Air Act Section 112 (40 CFR 61).

This product does not contain any chemicals listed under the U.S. Clean Air Act Section 112(r) for Accidental Release Prevention (40 CFR 68.130, Subpart F).

This product does not contain any chemicals listed under the U.S. Clean Air Act Section 111 SOCMI Intermediate or Final VOC's (40 CFR 60.489).

Clean Water Act

This product does not contain any Hazardous Substances listed under the U.S. CleanWater Act, Section 311, Table 116.4A.

This product does not contain any Hazardous Chemicals listed under the U.S. CleanWater Act, Section 311, Table 117.3.

This product does not contain any toxic pollutants listed under the U.S. Clean Water Act Section

US State Regulations

Massachusetts Right To Know

No components are subject to the Massachusetts Right to Know Act.

California Prop 65 : This product does not contain any chemicals known to State of California to cause cancer, birth defects, or any other re-productive harm.

Other regulations

: Restricted to professional users.

This product is not subject to TSCA and TSCA 12(b) Export notification because Food, Drugs and cosmetic products are exempt.

Revision Date:

2018/06/21

SDS Number:

100000011327

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SECTION 16. OTHER INFORMATION

Further information

NFPA: HMIS III:

Revision Date

: 2018/06/21

Date and Number Formats

This document uses the following notation for printing dates and numbers:

Date: Dec 31th, 2012 as 2012/12/31

Numbers: 123456,78 as 123,456.78

The information provided in this Safety Data Sheet is correct to the best of our knowledge, in-formation and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text.

US / EN

Flammability

H e a lt h

In s ta b ility

FLAMMABILITY

PHYSICAL HAZARD

HEALTH

Special hazard.

0 = not significant, 1 =Slight, 2 = Moderate, 3 = High

4 = Extreme, * = Chronic