SAFETY DATA SHEET

Revision date: 2023/09/30

Compliant with 29 CFR §1910.1200 HCS 2012
Compliant with HPR WHMIS 2015

Medley® Plus 300 L

1. PRODUCT AND COMPANY IDENTIFICATION

Product Name Medley® Plus 300 L

Chemical Name Enzyme preparation
Declared activity Protease, Alpha-amylase, Cellulase, Mannanase, Lipase

Use of the substance/preparation Novozymes' enzyme preparations are biocatalysts used in a variety of industrial processes and in
certain consumer products

Supplier's details
Novozymes North America, Inc.
77 Perry Chapel Church Rd., Box 576
Franklinton, NC 27525
E-mail: [email protected]
www.novozymes.com

Information Telephone Number

1-919-494-3000, 8 am - 4:30 pm EST M-F

Emergency Telephone Number

1-800-424-9300 (Chemtrec) 24 hours every day

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2. HAZARD IDENTIFICATION

Classification
Classification of the chemical in accordance with 29CFR §1910.1200
WHMIS Classification

Serious eye damage/eye irritation Category 2A

Respiratory sensitization Category 1
The classification of eye effects is based on testing of a similar mixture.

Label elements

Danger

Hazard statements
H319 - Causes serious eye irritation
H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled

Precautionary Statements - Prevention

P261 - Avoid breathing dust/fume/gas/mist/vapors/spray
P280 - Wear protective gloves/protective clothing/eye protection/face protection
P284 - In case of inadequate ventilation wear respiratory protection
Precautionary Statements - Response
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
P342 + P311 - If experiencing respiratory symptoms: Call a POISON CENTRE or doctor/physician

Hazards not otherwise classified (HNOC)

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3. COMPOSITION/INFORMATION ON INGREDIENTS

Chemical name CAS No IUB No. Weight-%

Protease (Subtilisin) (aep.) 9014-01-1 3.4.21.62 1 – <2.5
Cellulase (aep.) 9012-54-8 3.2.1.4 0.1 – <1
Lipase (aep) 9001-62-1 3.1.1.3 0.1 – <1
Alpha-amylase (aep.) 9000-90-2 3.2.1.1 0.1 – <1
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aep (active enzyme protein) contributes to the GHS classification.

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4. FIRST AID MEASURES

In case of unintended overexposure, the following measures apply

Inhalation
Effects May cause allergic respiratory reaction.
Symptoms Shortness of breath, wheezing and coughing.
The effect of inhalation may be delayed.
First Aid Remove person to fresh air. If signs/symptoms continue, get medical attention.
Show this safety data sheet to the doctor in attendance.

Skin Contact
Effects May cause slight irritation.
Symptoms Slight irritation.
First Aid Remove and wash contaminated clothing before re-use. Wash off immediately with plenty of water. If
symptoms persist, call a doctor. Show this safety data sheet to the doctor in attendance.

Eye Contact
Effects Irritating to eyes.
Symptoms Irritation. Redness.
First Aid Hold eye open and rinse slowly and gently with water for 15-20 min. Remove contact lenses, if present,
after the first five minutes, then continue rinsing eye. If symptoms persist, call a doctor. Show this
safety data sheet to the doctor in attendance.

Ingestion
Effects Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea.
Symptoms Irritation.
First Aid Rinse mouth with water and drink plenty of water. If symptoms persist, call a doctor. Show this safety
data sheet to the doctor in attendance..

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5. FIRE-FIGHTING MEASURES

Flammable Properties Slightly flammable according to HMIS criteria.

Suitable Extinguishing Media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

Unsuitable Extinguishing Media None.

Hazardous Combustion Products None.

Specific Hazards Arising from the Chemical May cause allergic respiratory reaction

Protective Equipment and Precautions for Self-contained breathing apparatus and standard turn-out apparel
Firefighters

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6. ACCIDENTAL RELEASE MEASURES

Personal Precautions For personal protection see section 8

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Environmental Precautions Collect spillage.

Methods for cleaning up Avoid formation of dust and aerosols.

Spilled preparation should be removed immediately to avoid formation of dust from dried preparation.
Take up by mechanical means preferably by a vacuum cleaner equipped with a HEPA (High Efficiency
Particulate Air) filter. Flush remainder carefully with plenty of water. Avoid splashing, high pressure
washing or compressed air cleaning to avoid formation of aerosols. Ensure sufficient ventilation. Wash
contaminated clothing.

Other Information For personal protection see section 8.

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7. HANDLING AND STORAGE

Handling Avoid formation of dust and aerosols.

Ensure adequate ventilation.
Liquid enzyme preparations are dustfree preparations
However, inappropriate handling may cause formation of dust or aerosols

Storage Keep tightly closed in a dry and cool place. Temperature 0-25 °C (32-77 °F)

Storage Conditions In unbroken packaging - dry and protect from the sun. The product has been formulated for optimal
stability. Extended storage or adverse conditions such as higher temperatures or higher humidity may
lead to a higher dosage requirement.

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8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Chemical name ACGIH TLV

Protease (Subtilisin) (aep.) Ceiling: 0.00006 mg/m3 Ceiling (as crystalline active enzyme, listed under Subtilisins)

Chemical name DNEL Dermal Acute Local (Workers) DMEL Inhalation Long term Local (Workers)
Protease (Subtilisin) (aep.) DMEL = 60 ng/m³
Cellulase (aep.) - DMEL = 60 ng/m³
Lipase (aep) - DMEL = 60 ng/m³
Alpha-amylase (aep.) - DMEL = 60 ng/m³

Chemical name DMEL Inhalation Long term Local DNEL Dermal Acute Local
(Professionals/Consumers) (Professional/Consumers)
Protease (Subtilisin) (aep.) DMEL = 15 ng/m³

Derived No Effect Level (DNEL)

Derived Minimal Effect Level (DMEL)
When enzymes are used for spray products or hard surface cleaning, exposure of enzymes may exceed the safety level (15 ng/m³ DMEL). If you
intend to develop such products, please contact Novozymes for further safety evaluation.

Occupational exposure controls

Engineering Controls Ensure adequate ventilation, especially in confined areas.
Maintain good conditions of industrial hygiene. Some processes may require enclosures, local exhaust
ventilation, or other engineering controls to control airborne levels. Additional handling and
healthy/safety information is available upon request

Personal Protective Equipment

Respiratory protection In case of insufficient ventilation wear suitable respiratory equipment that meets HEPA/P100
specifications

Eye Protection Wear safety glasses with side shields (or goggles)
Skin and body protection Wear protective gloves and protective clothing
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General Hygiene Considerations Handle in accordance with good industrial hygiene and safety practice
Environmental exposure controls Local authorities should be advised if significant spillages cannot be contained

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9. PHYSICAL AND CHEMICAL PROPERTIES

Information on basic physical and chemical properties

Physical State Liquid

Color Light yellow
Odor Slight fermentation odor
pH Adjusted to the range where active enzyme is stable – typically pH 4 – 9
Melting point / freezing point No data available
Boiling Point/Range No data available
Flash Point Not determined
Evaporation rate Not available
Flammability (solid, gas) Not determined
Upper/lower flammability or explosive limitsNot available
Vapor Pressure No data available
Vapor density Not available
Density (g/ml) 1.15
Solubility Readily soluble in application-relevant solutions at all levels of concentration, temperature and pH
which may occur in normal usage.
Partition Coefficient (n-octanol/water) No data available
Autoignition temperature Not available
Decomposition temperature Not available
Viscosity Not available

Other information No information available

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10. STABILITY AND REACTIVITY

Reactivity Not relevant

Chemical stability Stable under recommended storage conditions

Possibility of hazardous reactions None under normal processing

Conditions to Avoid None

Incompatible materials None

Hazardous Decomposition Products None

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11. TOXICOLOGICAL INFORMATION

Information on toxicological effects

Repeated inhalation of enzyme dust or aerosols resulting from improper handling may induce sensitization and may cause allergic type 1 reactions
in sensitized individuals
Mild skin irritation
May cause eye irritation
Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea
Actual Product Data An eye irritation study, Isolated Chicken Eye (ICE) on similar mixture concluded the classification as Eye
Cat. 2
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Chemical name Acute oral toxicity Acute inhalation toxicity Skin corrosion/irritation Serious eye damage/eye
irritation
Protease (Subtilisin) (aep.) LD50: 504 mg aep/kg bw Exposure based waiving Slightly irritating (OECD TG Slightly irritating (OECD TG
(OECD401/423) 404) 405)
Cellulase (aep.) LD50: > 2000 mg/kg bw Not irritating (OECD TG 404) Not irritating (OECD TG 405)
(OECD TG 401, 420)
Lipase (aep) LD50: > 2000 mg/kg bw Not irritating (OECD TG 404) Not irritating (OECD TG 405)
(OECD TG 401, 420)
Alpha-amylase (aep.) LD50: > 2000 mg/kg bw Not irritating (OECD TG 404) Not irritating (OECD TG 405)
(OECD TG 401, 420)

Chemical name Specific target organ toxicity Genetic toxicity Skin sensitization Respiratory sensitization
(single exposure)
Protease (Subtilisin) (aep.) Irritating, respiratory tract No indication of mutagenic Sensitizer (Human
(ACGIH 2001) effects (OECD TG 471, 473, experience)
476)
Cellulase (aep.) No indication of mutagenic Sensitizer (Human
effects (OECD TG 471, 476) experience)
Lipase (aep) No data available No indication of mutagenic Sensitizer (Human
effects (OECD TG 471, 476) experience)
Alpha-amylase (aep.) No indication of mutagenic Sensitizer (Human
effects (OECD TG 471, 476) experience)

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12. ECOLOGICAL INFORMATION

Toxicity

Chemical name Daphnia, acute Algae, acute Fish, acute

Protease (Subtilisin) (aep.) EC50 (48 hours):586 µg aep/l (OECD ErC50 (72 hours): 830 µg aep/l LC50 (96 hours): 8.2 mg aep/l (OECD
TG 202) (OECD TG 201) TG 203)
Cellulase (aep.) EC50 (48 hours): >39.5 mg aep/l - LC50 (96 hours): >39.5 mg aep/l
(OECD TG 202) (OECD TG 203)
Lipase (aep) EC50 (48 hours): >7.4 mg aep/l ErC50 (72 hours): > 18 mg aep/l LC50 (96 hours): >68.3 mg aep/l
(OECD TG 202) (OECD TG 201) (OECD TG 203)
Alpha-amylase (aep.) EC50 (48 hours): 31.7 - 457 mg ErC50 (72 hours): >= 5.2 mg aep/l LC50 (96 hours): 58.3 - 326.7 mg
aep/l (OECD TG 202) (OECD TG 201) aep/l (OECD TG 203)

Persistence/Degradability

Chemical name Persistence and degradability Partition coefficient

(n-octanol/water)
Protease (Subtilisin) (aep.) Readily biodegradable (OECD TG 301B) LogPow: <0
Cellulase (aep.) Readily biodegradable (OECD 301E/F) LogPow: <0
Lipase (aep) Readily biodegradable (OECD 301) LogPow: <0
Alpha-amylase (aep.) Readily biodegradable (OECD 301F) LogPow: <0

Chemical name Bioaccumulative Potential

Protease (Subtilisin) (aep.) Does not bioaccumulate
Cellulase (aep.) Does not bioaccumulate
Lipase (aep) Does not bioaccumulate
Alpha-amylase (aep.) Does not bioaccumulate

Mobility in soil Not relevant

Other adverse effects No information available

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13. DISPOSAL CONSIDERATIONS

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Disposal of wastes Dispose of in accordance with local regulations.

Contaminated Packaging Dispose of wastes in an approved waste disposal facility.

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14. TRANSPORT INFORMATION

Transport Regulations
No dangerous goods according to transport regulations
No special precautions required
UN-No Not applicable
Proper Shipping Name Not applicable
Packing Group Not applicable
Reportable Quantity (RQ) Not applicable
Marine Pollutant Not applicable

International Regulations
IATA Not regulated
IMDG Not regulated
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15. REGULATORY INFORMATION

USA, Federal Regulations

TSCA Inventory
The active ingredient and all components of the enzyme preparation are listed on the TSCA inventory
Disubstituted alaninamide is listed on TSCA inventory with CAS RN 1189108-44-8. CAS RN 2940997-67-9 covers the non-specific form of the
isomeric substance.
SARA 313
Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any chemicals which
are subject to the reporting requirements of the Act and 40 CFR Part 372.

SARA 311/312 Hazardous Categorization

Acute health hazard No

Chronic Health Hazard No
Fire hazard No
Sudden Release of Pressure Hazard No
Reactive Hazard No

USA, State Regulations

California Proposition 65
This product does not contain any intentionally added Proposition 65 chemicals.

Canada

DSL/NDSL
All components are listed either on the DSL or NDSL

WHMIS Statement
This product has been classified in accordance with the hazard criteria of the Hazardous Products Regulations (HPR) and the SDS contains all the
information required by WHMIS 2015.

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16. OTHER INFORMATION

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Training advice Details on the safe handling of this product are located in the Novozymes Customer Center Document
Library on www.mynovozymes.com

GHS-Classification The classification of eye effects is based on testing of a similar mixture. The GHS calculation method
has been used for classification of this mixture.

Disclaimer The information provided on this SDS is correct to the best of our knowledge, information and belief at
the date of its publication. The information given is designed only as a guide for safe handling, use,
processing, storage, transportation, disposal and release and is not to be considered as 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 material or in any process, unless specified
in the text. Furthermore, as the conditions of use are beyond the control of Novozymes, it is the
responsibility of the customer to determine the conditions of safe use of these products.

End of Safety Data Sheet

Version No: 3 / ANSI / 2023/10/01