GAMAZYME DPC

Wilhelmsen Ships Service AS

Catalogue number: 7613-64 Issue Date: 06/16/2024
Version No: 1.1 Print Date: 08/02/2024
Safety Data Sheet (Conforms to Regulation (EC) No 2015/830) L.REACH.NLD.EN

SECTION 1 IDENTIFICATION OF THE SUBSTANCE / MIXTURE AND OF THE COMPANY / UNDERTAKING

1.1. Product Identifier

Product name GAMAZYME DPC

Synonyms Product Part Number: 587055 (4 kg), 7613-64

Other means of
7613-64, 587055
identification

1.2. Relevant identified uses of the substance or mixture and uses advised against
Relevant identified
Use according to manufacturer's directions.
uses
Uses advised against Not Applicable

1.3. Details of the supplier of the safety data sheet

For quotations or product
Registered company
Wilhelmsen Ships Service AS Wilhelmsen Ships Service AS* information contact your local
name
Customer Services
Other offices:
Willem Barentszstraat 50 Rotterdam Willem Barentszstraat 50 Rotterdam
Address http://wssdirectory.wilhelmsen.com
3165AB Netherlands 3165AB Netherlands
/#/networkdirectory Norway

Telephone +31 4877 777 +31 10 4877 777 Not Available

Fax Not Available +31 10 4877888 Not Available

http://www.wilhelmsen.com/services
Website http://www.wilhelmsen.com Not Available
/maritime/compan

Email [email protected] [email protected] Not Available

1.4. Emergency telephone number

Association /
Not Available Not Available Not Available
Organisation
Emergency telephone
+ 31 30 274 88 88 + 44 1865 407333 Not Available
numbers
Other emergency
Not Available + 31 30 274 88 88 Not Available
telephone numbers

SECTION 2 HAZARDS IDENTIFICATION

2.1. Classification of the substance or mixture

Classification
according to Serious Eye Damage Category 1, Respiratory Sensitizer Category 1
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GAMAZYME DPC

regulation (EC) No
[1]
1272/2008 [CLP]
1. Classified by Chemwatch; 2. Classification drawn from EC Directive 67/548/EEC - Annex I ; 3. Classification drawn from EC
Legend:
Directive 1272/2008 - Annex VI

2.2. Label elements

CLP label elements

SIGNAL WORD DANGER

Hazard statement(s)
H318 Causes serious eye damage.

H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled.

Supplementary statement(s)
Not Applicable

CLP classification (additional)

Not Applicable

Precautionary statement(s) Prevention

P101 If medical advice is needed, have product container or label at hand.

P102 Keep out of reach of children.

Precautionary statement(s) Response

P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
P305+P351+P338
rinsing.

Precautionary statement(s) Storage

Not Applicable

Precautionary statement(s) Disposal

P501 Dispose of contents/container in accordance with local regulations.

REACh - Art.57-59: The mixture does not contain Substances of Very High Concern (SVHC) at the SDS print date.

SECTION 3 COMPOSITION / INFORMATION ON INGREDIENTS

3.1.Substances
See 'Composition on ingredients' in Section 3.2

3.2.Mixtures
1.CAS No
2.EC No
%[weight] Name Classification according to regulation (EC) No 1272/2008 [CLP]
3.Index No
4.REACH No
1.9014-01-1
Specific target organ toxicity - single exposure Category 3 (respiratory tract irritation), Skin
2.232-752-2
1-5 subtilisins Corrosion/Irritation Category 2, Serious Eye Damage Category 1, Respiratory Sensitizer
3.647-012-00-8 [3]
Category 1; H335, H315, H318, H334
4.01-2119480434-38-XXXX

Legend: 1. Classified by Chemwatch; 2. Classification drawn from EC Directive 67/548/EEC - Annex I ; 3. Classification drawn from EC
Directive 1272/2008 - Annex VI 4. Classification drawn from C&L

SECTION 4 FIRST AID MEASURES

4.1. Description of first aid measures

General If skin contact occurs:
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Immediately remove all contaminated clothing, including footwear.

Flush skin and hair with running water (and soap if available).
Seek medical attention in event of irritation.

If this product comes in contact with the eyes:

Immediately hold eyelids apart and flush the eye continuously with running water.
Ensure complete irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionally
lifting the upper and lower lids.
Continue flushing until advised to stop by the Poisons Information Centre or a doctor, or for at least 15 minutes.
Transport to hospital or doctor without delay.
Removal of contact lenses after an eye injury should only be undertaken by skilled personnel.
If fumes, aerosols or combustion products are inhaled remove from contaminated area.
Other measures are usually unnecessary.
Immediately give a glass of water.
First aid is not generally required. If in doubt, contact a Poisons Information Centre or a doctor.

If this product comes in contact with the eyes:

Immediately hold eyelids apart and flush the eye continuously with running water.
Ensure complete irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionally
Eye Contact
lifting the upper and lower lids.
Continue flushing until advised to stop by the Poisons Information Centre or a doctor, or for at least 15 minutes.
Transport to hospital or doctor without delay.
Removal of contact lenses after an eye injury should only be undertaken by skilled personnel.
If skin contact occurs:
Immediately remove all contaminated clothing, including footwear.
Skin Contact
Flush skin and hair with running water (and soap if available).
Seek medical attention in event of irritation.

If fumes, aerosols or combustion products are inhaled remove from contaminated area.
Inhalation
Other measures are usually unnecessary.

Immediately give a glass of water.

Ingestion
First aid is not generally required. If in doubt, contact a Poisons Information Centre or a doctor.

4.2 Most important symptoms and effects, both acute and delayed
See Section 11

4.3. Indication of any immediate medical attention and special treatment needed
Treat symptomatically.

SECTION 5 FIREFIGHTING MEASURES

5.1. Extinguishing media

There is no restriction on the type of extinguisher which may be used.
Use extinguishing media suitable for surrounding area.

5.2. Special hazards arising from the substrate or mixture

Fire Incompatibility None known.

5.3. Advice for firefighters

Alert Fire Brigade and tell them location and nature of hazard.
Fire Fighting
Wear breathing apparatus plus protective gloves in the event of a fire.
Non combustible.
Not considered a significant fire risk, however containers may burn.
Fire/Explosion Hazard
Decomposition may produce toxic fumes of:, hydrogen cyanide, nitrogen oxides (NOx) May emit poisonous fumes. May emit
corrosive fumes.

SECTION 6 ACCIDENTAL RELEASE MEASURES

6.1. Personal precautions, protective equipment and emergency procedures

See section 8

6.2. Environmental precautions

See section 12

6.3. Methods and material for containment and cleaning up

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Clean up all spills immediately.

Minor Spills
Avoid breathing dust and contact with skin and eyes.

Moderate hazard.
Major Spills
CAUTION: Advise personnel in area.

6.4. Reference to other sections

Personal Protective Equipment advice is contained in Section 8 of the SDS.

SECTION 7 HANDLING AND STORAGE

7.1. Precautions for safe handling

Avoid all personal contact, including inhalation.
Safe handling
Wear protective clothing when risk of exposure occurs.

Fire and explosion

See section 5
protection
Store in original containers.
Other information
Keep containers securely sealed.

7.2. Conditions for safe storage, including any incompatibilities

Polyethylene or polypropylene container.
Suitable container
Check all containers are clearly labelled and free from leaks.

Storage
None known
incompatibility

+ X + O + + +

X — Must not be stored together

0 — May be stored together with specific preventions
+ — May be stored together

7.3. Specific end use(s)

See section 1.2

SECTION 8 EXPOSURE CONTROLS / PERSONAL PROTECTION

8.1. Control parameters

DERIVED NO EFFECT LEVEL (DNEL)

Not Available

PREDICTED NO EFFECT LEVEL (PNEC)

Not Available

OCCUPATIONAL EXPOSURE LIMITS (OEL)

INGREDIENT DATA

Source Ingredient Material name TWA STEL Peak Notes

Not Available Not Available Not Available Not Available Not Available Not Available Not Available

EMERGENCY LIMITS

Ingredient Material name TEEL-1 TEEL-2 TEEL-3

GAMAZYME DPC Not Available Not Available Not Available Not Available

Ingredient Original IDLH Revised IDLH

subtilisins Not Available Not Available

MATERIAL DATA
for subtilisins:
The TLV-TWA is thought to be sufficiently low to minimise the potential for allergic respiratory sensitisation for the majority of normotypic persons. It is
also expected that the TLV will minimise skin irritation and sensitisation.
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8.2. Exposure controls

Engineering controls are used to remove a hazard or place a barrier between the worker and the hazard. Well-designed
8.2.1. Appropriate
engineering controls can be highly effective in protecting workers and will typically be independent of worker interactions to
engineering controls
provide this high level of protection.

8.2.2. Personal
protection

Eye and face Safety glasses with side shields.

protection Chemical goggles.

Skin protection See Hand protection below

NOTE:
The material may produce skin sensitisation in predisposed individuals. Care must be taken, when removing gloves and
other protective equipment, to avoid all possible skin contact.
The selection of suitable gloves does not only depend on the material, but also on further marks of quality which vary from
Hands/feet protection manufacturer to manufacturer. Where the chemical is a preparation of several substances, the resistance of the glove
material can not be calculated in advance and has therefore to be checked prior to the application.
Experience indicates that the following polymers are suitable as glove materials for protection against undissolved, dry
solids, where abrasive particles are not present.
polychloroprene.

Body protection See Other protection below

Overalls.
Other protection
P.V.C.

Thermal hazards Not Available

Respiratory protection
Particulate. (AS/NZS 1716 & 1715, EN 143:000 & 149:001, ANSI Z88 or national equivalent)

Required Minimum Protection Factor Half-Face Respirator Full-Face Respirator Powered Air Respirator
P1 - PAPR-P1
up to 10 x ES
Air-line* - -
up to 50 x ES Air-line** P2 PAPR-P2

up to 100 x ES - P3 -

Air-line* -
100+ x ES - Air-line** PAPR-P3

* - Negative pressure demand ** - Continuous flow

A(All classes) = Organic vapours, B AUS or B1 = Acid gasses, B2 = Acid gas or hydrogen cyanide(HCN), B3 = Acid gas or hydrogen cyanide(HCN), E =
Sulfur dioxide(SO2), G = Agricultural chemicals, K = Ammonia(NH3), Hg = Mercury, NO = Oxides of nitrogen, MB = Methyl bromide, AX = Low boiling point
organic compounds(below 65 degC)

Respirators may be necessary when engineering and administrative controls do not adequately prevent exposures.
The decision to use respiratory protection should be based on professional judgment that takes into account toxicity information, exposure measurement
data, and frequency and likelihood of the worker's exposure - ensure users are not subject to high thermal loads which may result in heat stress or
distress due to personal protective equipment (powered, positive flow, full face apparatus may be an option).
Published occupational exposure limits, where they exist, will assist in determining the adequacy of the selected respiratory protection. These may be
government mandated or vendor recommended.
Certified respirators will be useful for protecting workers from inhalation of particulates when properly selected and fit tested as part of a complete
respiratory protection program.
Use approved positive flow mask if significant quantities of dust becomes airborne.
Try to avoid creating dust conditions.

8.2.3. Environmental exposure controls

See section 12

SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES

9.1. Information on basic physical and chemical properties

Appearance Brown powder with characteristic odour; soluble in water.

Relative density
Physical state Divided Solid Not Available
(Water = 1)
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Partition coefficient
Odour Not Available Not Available
n-octanol / water

Auto-ignition
Odour threshold Not Available Not Available
temperature (°C)
Decomposition
pH (as supplied) Not Available Not Available
temperature

Melting point /
Not Applicable Viscosity (cSt) Not Available
freezing point (°C)

Initial boiling point Molecular weight

Not Applicable Not Available
and boiling range (°C) (g/mol)
Flash point (°C) Not Available Taste Not Available

Evaporation rate Not Available Explosive properties Not Available

Flammability Not Available Oxidising properties Not Available

Upper Explosive Limit Surface Tension

Not Available Not Applicable
(%) (dyn/cm or mN/m)

Lower Explosive Limit Volatile Component

Not Available Not Available
(%) (%vol)

Vapour pressure (kPa) Not Available Gas group Not Available

Solubility in water
Miscible pH as a solution (1%) Not Available
(g/L)
Vapour density (Air =
Not Available VOC g/L Not Available
1)

9.2. Other information

Not Available

SECTION 10 STABILITY AND REACTIVITY

10.1.Reactivity See section 7.2

10.2. Chemical Unstable in the presence of incompatible materials.

stability Product is considered stable.

10.3. Possibility of
See section 7.2
hazardous reactions

10.4. Conditions to
See section 7.2
avoid
10.5. Incompatible
See section 7.2
materials
10.6. Hazardous
decomposition See section 5.3
products

SECTION 11 TOXICOLOGICAL INFORMATION

11.1. Information on toxicological effects

The material is not thought to produce adverse health effects or irritation of the respiratory tract (as classified by EC
Directives using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that
suitable control measures be used in an occupational setting.
Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, may
Inhaled
incur further disability if excessive concentrations of particulate are inhaled.
If prior damage to the circulatory or nervous systems has occurred or if kidney damage has been sustained, proper
screenings should be conducted on individuals who may be exposed to further risk if handling and use of the material result
in excessive exposures.

The material has NOT been classified by EC Directives or other classification systems as "harmful by ingestion". This is
Ingestion
because of the lack of corroborating animal or human evidence.

Skin contact is not thought to have harmful health effects (as classified under EC Directives); the material may still produce
health damage following entry through wounds, lesions or abrasions.

Limited evidence exists, or practical experience predicts, that the material either produces inflammation of the skin in a
Skin Contact substantial number of individuals following direct contact, and/or produces significant inflammation when applied to the
healthy intact skin of animals, for up to four hours, such inflammation being present twenty-four hours or more after the end
of the exposure period. Skin irritation may also be present after prolonged or repeated exposure; this may result in a form of
contact dermatitis (nonallergic).
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Open cuts, abraded or irritated skin should not be exposed to this material
Entry into the blood-stream through, for example, cuts, abrasions, puncture wounds or lesions, may produce systemic injury
with harmful effects. Examine the skin prior to the use of the material and ensure that any external damage is suitably
protected.
When applied to the eye(s) of animals, the material produces severe ocular lesions which are present twenty-four hours or
Eye
more after instillation.
Practical evidence shows that inhalation of the material is capable of inducing a sensitisation reaction in a substantial number
of individuals at a greater frequency than would be expected from the response of a normal population.
Pulmonary sensitisation, resulting in hyperactive airway dysfunction and pulmonary allergy may be accompanied by fatigue,
malaise and aching.
Practical experience shows that skin contact with the material is capable either of inducing a sensitisation reaction in a
substantial number of individuals, and/or of producing a positive response in experimental animals.
Chronic

Long term exposure to high dust concentrations may cause changes in lung function (i.e. pneumoconiosis) caused by
particles less than 0.5 micron penetrating and remaining in the lung. A prime symptom is breathlessness.
There is a possibility that unintended contact with this product (such as through a cut, needle stick, eye or mucous
membrane, or inhalation) could result in allergic or hypersensitivity reactions. Such reactions are more likely following
repeated exposures or in persons with a pre-existing allergy to certain proteins.

TOXICITY IRRITATION
GAMAZYME DPC
Not Available Not Available

TOXICITY IRRITATION
[2] Eye (rabbit): 3 mg moderate
subtilisins Oral (rat) LD50: 3700 mg/kg

Eye (rabbit): 3 mg SEVERE

Legend: 1. Value obtained from Europe ECHA Registered Substances - Acute toxicity 2.* Value obtained from manufacturer's SDS.
Unless otherwise specified data extracted from RTECS - Register of Toxic Effect of chemical Substances

The following information refers to contact allergens as a group and may not be specific to this product.
Contact allergies quickly manifest themselves as contact eczema, more rarely as urticaria or Quincke's oedema. The
pathogenesis of contact eczema involves a cell-mediated (T lymphocytes) immune reaction of the delayed type. Other
allergic skin reactions, e.g. contact urticaria, involve antibody-mediated immune reactions. The significance of the contact
GAMAZYME DPC
allergen is not simply determined by its sensitisation potential: the distribution of the substance and the opportunities for
contact with it are equally important. A weakly sensitising substance which is widely distributed can be a more important
allergen than one with stronger sensitising potential with which few individuals come into contact. From a clinical point of view,
substances are noteworthy if they produce an allergic test reaction in more than 1% of the persons tested.

Asthma-like symptoms may continue for months or even years after exposure to the material ceases. This may be due to a
non-allergenic condition known as reactive airways dysfunction syndrome (RADS) which can occur following exposure to high
levels of highly irritating compound. Key criteria for the diagnosis of RADS include the absence of preceding respiratory
disease, in a non-atopic individual, with abrupt onset of persistent asthma-like symptoms within minutes to hours of a
documented exposure to the irritant. A reversible airflow pattern, on spirometry, with the presence of moderate to severe
bronchial hyperreactivity on methacholine challenge testing and the lack of minimal lymphocytic inflammation, without
eosinophilia, have also been included in the criteria for diagnosis of RADS. RADS (or asthma) following an irritating inhalation
SUBTILISINS
is an infrequent disorder with rates related to the concentration of and duration of exposure to the irritating substance.
Industrial bronchitis, on the other hand, is a disorder that occurs as result of exposure due to high concentrations of irritating
substance (often particulate in nature) and is completely reversible after exposure ceases. The disorder is characterised by
dyspnea, cough and mucus production.

The material may produce severe irritation to the eye causing pronounced inflammation. Repeated or prolonged exposure to
irritants may produce conjunctivitis.
as CAS RN 9014-01-1

Allergic reactions which develop in the respiratory passages as bronchial asthma or rhinoconjunctivitis, are mostly the result
of reactions of the allergen with specific antibodies of the IgE class and belong in their reaction rates to the manifestation of
the immediate type. In addition to the allergen-specific potential for causing respiratory sensitisation, the amount of the
GAMAZYME DPC &
allergen, the exposure period and the genetically determined disposition of the exposed person are likely to be decisive.
SUBTILISINS
Factors which increase the sensitivity of the mucosa may play a role in predisposing a person to allergy. They may be
genetically determined or acquired, for example, during infections or exposure to irritant substances. Immunologically the low
molecular weight substances become complete allergens in the organism either by binding to peptides or proteins (haptens) or
after metabolism (prohaptens).

GAMAZYME DPC & Particular attention is drawn to so-called atopic diathesis which is characterised by an increased susceptibility to allergic
SUBTILISINS rhinitis, allergic bronchial asthma and atopic eczema (neurodermatitis) which is associated with increased IgE synthesis.

Exogenous allergic alveolitis is induced essentially by allergen specific immune-complexes of the IgG type; cell-mediated
GAMAZYME DPC &
reactions (T lymphocytes) may be involved. Such allergy is of the delayed type with onset up to four hours following
SUBTILISINS
exposure.
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Acute Toxicity Carcinogenicity

Skin
Reproductivity
Irritation/Corrosion

Serious Eye STOT - Single

Damage/Irritation Exposure

Respiratory or Skin STOT - Repeated

sensitisation Exposure
Mutagenicity Aspiration Hazard

Legend: – Data available but does not fill the criteria for classification
– Data required to make classification available
– Data Not Available to make classification

SECTION 12 ECOLOGICAL INFORMATION

12.1. Toxicity
Ingredient Endpoint Test Duration (hr) Species Value Source

subtilisins LC50 96 Fish 8.2mg/L 2

subtilisins EC50 48 Crustacea 0.09mg/L 2

subtilisins EC50 48 Crustacea 0.17mg/L 2

subtilisins NOEC 504 Crustacea 0.0008mg/L 2

subtilisins EC50 72 Algae or other aquatic plants 0.29mg/L 2

Extracted from 1. IUCLID Toxicity Data 2. Europe ECHA Registered Substances - Ecotoxicological Information - Aquatic Toxicity
3. EPIWIN Suite V3.12 - Aquatic Toxicity Data (Estimated) 4. US EPA, Ecotox database - Aquatic Toxicity Data 5. ECETOC
Legend:
Aquatic Hazard Assessment Data 6. NITE (Japan) - Bioconcentration Data 7. METI (Japan) - Bioconcentration Data 8. Vendor
Data

Proteins are generally easily biodegradable.

DO NOT discharge into sewer or waterways.

12.2. Persistence and degradability

Ingredient Persistence: Water/Soil Persistence: Air
No Data available for all ingredients No Data available for all ingredients

12.3. Bioaccumulative potential

Ingredient Bioaccumulation
No Data available for all ingredients

12.4. Mobility in soil

Ingredient Mobility
No Data available for all ingredients

12.5.Results of PBT and vPvB assessment

P B T
Relevant available data Not Available Not Available Not Available

PBT Criteria fulfilled? Not Available Not Available Not Available

12.6. Other adverse effects

No data available

SECTION 13 DISPOSAL CONSIDERATIONS

13.1. Waste treatment methods

Containers may still present a chemical hazard/ danger when empty.
Product / Packaging Return to supplier for reuse/ recycling if possible.
disposal Legislation addressing waste disposal requirements may differ by country, state and/ or territory. Each user must refer to
laws operating in their area.
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DO NOT allow wash water from cleaning or process equipment to enter drains.
It may be necessary to collect all wash water for treatment before disposal.
Recycle wherever possible or consult manufacturer for recycling options.
Consult State Land Waste Management Authority for disposal.
Waste treatment
Not Available
options
Sewage disposal
Not Available
options

SECTION 14 TRANSPORT INFORMATION

Labels Required
Marine Pollutant NO

Land transport (ADR): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS

14.1.UN number Not Applicable

14.2.UN proper
Not Applicable
shipping name

14.3. Transport hazard Class Not Applicable

class(es) Subrisk Not Applicable

14.4.Packing group Not Applicable

14.5.Environmental
Not Applicable
hazard

Hazard identification (Kemler) Not Applicable

Classification code Not Applicable
14.6. Special
Hazard Label Not Applicable
precautions for user
Special provisions Not Applicable
Limited quantity Not Applicable

Air transport (ICAO-IATA / DGR): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS
14.1. UN number Not Applicable

14.2. UN proper
Not Applicable
shipping name

ICAO/IATA Class Not Applicable

14.3. Transport hazard
ICAO / IATA Subrisk Not Applicable
class(es)
ERG Code Not Applicable

14.4. Packing group Not Applicable

14.5. Environmental
Not Applicable
hazard

Special provisions Not Applicable

Cargo Only Packing Instructions Not Applicable

Cargo Only Maximum Qty / Pack Not Applicable

14.6. Special
Passenger and Cargo Packing Instructions Not Applicable
precautions for user
Passenger and Cargo Maximum Qty / Pack Not Applicable

Passenger and Cargo Limited Quantity Packing Instructions Not Applicable

Passenger and Cargo Limited Maximum Qty / Pack Not Applicable

Sea transport (IMDG-Code / GGVSee): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS
14.1. UN number Not Applicable

14.2. UN proper
Not Applicable
shipping name

14.3. Transport hazard IMDG Class Not Applicable

class(es) IMDG Subrisk Not Applicable
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14.4. Packing group Not Applicable

14.5. Environmental
Not Applicable
hazard

EMS Number Not Applicable

14.6. Special
Special provisions Not Applicable
precautions for user
Limited Quantities Not Applicable

Inland waterways transport (ADN): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS
14.1. UN number Not Applicable

14.2. UN proper
Not Applicable
shipping name
14.3. Transport hazard
Not Applicable Not Applicable
class(es)
14.4. Packing group Not Applicable

14.5. Environmental
Not Applicable
hazard

Classification code Not Applicable

Special provisions Not Applicable
14.6. Special
Limited quantity Not Applicable
precautions for user
Equipment required Not Applicable

Fire cones number Not Applicable

Transport in bulk according to Annex II of MARPOL and the IBC code

Not Applicable

SECTION 15 REGULATORY INFORMATION

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

SUBTILISINS(9014-01-1) IS FOUND ON THE FOLLOWING REGULATORY LISTS

European Customs Inventory of Chemical Substances ECICS (English) European Union (EU) Annex I to Directive 67/548/EEC on Classification
European Trade Union Confederation (ETUC) Priority List for REACH and Labelling of Dangerous Substances - updated by ATP: 31
Authorisation European Union (EU) Regulation (EC) No 1272/2008 on Classification,
European Union - European Inventory of Existing Commercial Chemical Labelling and Packaging of Substances and Mixtures - Annex VI
Substances (EINECS) (English)

This safety data sheet is in compliance with the following EU legislation and its adaptations - as far as applicable - : 67/548/EEC, 1999/45/EC, 98/24/EC,
92/85/EC, 94/33/EC, 91/689/EEC, 1999/13/EC, Commission Regulation (EU) 2015/830, Regulation (EC) No 1272/2008 and their amendments as well as
the following British legislation: - The Control of Substances Hazardous to Health Regulations (COSHH) 2002 - COSHH Essentials - The Management of
Health and Safety at Work Regulations 1999

15.2. Chemical safety assessment

For further information please look at the Chemical Safety Assessment and Exposure Scenarios prepared by your Supply Chain if available.

ECHA SUMMARY
Ingredient CAS number Index No ECHA Dossier
subtilisins 9014-01-1 647-012-00-8 01-2119480434-38-XXXX

Harmonisation (C&L Pictograms Signal Hazard Statement

Hazard Class and Category Code(s)
Inventory) Word Code(s) Code(s)
GHS07, GHS05,
1 Skin Irrit. 2, Eye Dam. 1, Resp. Sens. 1, STOT SE 3 H315, H318, H334, H335
GHS08, Dgr

Acute Tox. 4, Skin Irrit. 2, Eye Dam. 1, Resp. Sens. 1, STOT SE 3, GHS09, GHS05, H302, H315, H334,
2
Aquatic Acute 1, Aquatic Chronic 2, Resp. Sens. 1B GHS08, Dgr H335, H318, H332

Harmonisation Code 1 = The most prevalent classification. Harmonisation Code 2 = The most severe classification.

National Inventory Status

Australia - AICS Y
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Canada - DSL Y

Canada - NDSL N (subtilisins)

China - IECSC N (subtilisins)
Europe - EINEC /
Y
ELINCS / NLP

Japan - ENCS N (subtilisins)

Korea - KECI Y
New Zealand - NZIoC Y

Philippines - PICCS Y
USA - TSCA Y

Y = All ingredients are on the inventory

Legend: N = Not determined or one or more ingredients are not on the inventory and are not exempt from listing(see specific ingredients
in brackets)

SECTION 16 OTHER INFORMATION

CONTACT POINT
- For quotations contact your local Customer Services - http://wssdirectory.wilhelmsen.com/#/customerservices - - Responsible for safety data sheet
Wilhelmsen Ships Service AS - Prepared by: Product HSE Manager, - Email: Email: [email protected] - Telephone: Tel.: +31 10
4877775

Full text Risk and Hazard codes

H302 Harmful if swallowed.

H315 Causes skin irritation.

H332 Harmful if inhaled.

H335 May cause respiratory irritation.

Other information

Ingredients with multiple cas numbers

Name CAS No
subtilisins 1395-21-7, 9014-01-1

Classification of the preparation and its individual components has drawn on official and authoritative sources as well as independent review by the
Chemwatch Classification committee using available literature references.
A list of reference resources used to assist the committee may be found at:
www.chemwatch.net

The SDS is a Hazard Communication tool and should be used to assist in the Risk Assessment. Many factors determine whether the reported Hazards are
Risks in the workplace or other settings.

For detailed advice on Personal Protective Equipment, refer to the following EU CEN Standards:
EN 166 Personal eye-protection
EN 340 Protective clothing
EN 374 Protective gloves against chemicals and micro-organisms
EN 13832 Footwear protecting against chemicals
EN 133 Respiratory protective devices

Definitions and abbreviations

PC－TWA: Permissible Concentration-Time Weighted Average
PC－STEL: Permissible Concentration-Short Term Exposure Limit
IARC: International Agency for Research on Cancer
ACGIH: American Conference of Governmental Industrial Hygienists
STEL: Short Term Exposure Limit
TEEL: Temporary Emergency Exposure Limit。
IDLH: Immediately Dangerous to Life or Health Concentrations
OSF: Odour Safety Factor
NOAEL :No Observed Adverse Effect Level
LOAEL: Lowest Observed Adverse Effect Level
TLV: Threshold Limit Value
LOD: Limit Of Detection
OTV: Odour Threshold Value
BCF: BioConcentration Factors
BEI: Biological Exposure Index
Catalogue number: 7613-64 Page 12 of 12 Issue Date: 06/16/2024
Version No: 1.1 Print Date: 08/02/2024
GAMAZYME DPC

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Apart from any fair dealing for the purposes of private study, research, review or criticism, as permitted under the Copyright Act, no part may be
reproduced by any process without written permission from CHEMWATCH.