GAMAZYME 700 FN

Wilhelmsen Ships Service AS

Catalogue number: 8068-34 Issue Date: 06/17/2024
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 700 FN

Synonyms Product Part Number: 571711 (12 kg), 8068-34

Other means of
8068-34, 571711
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 wss.rotterdam@wilhelmsen.com wss.rotterdam@wilhelmsen.com 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 Not Applicable
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GAMAZYME 700 FN

regulation (EC) No
[1]
1272/2008 [CLP]

2.2. Label elements

CLP label elements Not Applicable

SIGNAL WORD NOT APPLICABLE

Hazard statement(s)
Not Applicable

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

Not Applicable

Precautionary statement(s) Storage

Not Applicable

Precautionary statement(s) Disposal

Not Applicable
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.Not Available
2.Not Available
5-10 Viable bacterial cultures Not Applicable
3.Not Available
4.Not Available

1.Not Available
2.Not Available
60-100 Other non classified ingredients Not Applicable
3.Not Available
4.Not Available

1.Not Available
2.Not Available
5-10 Viable bacterial cultures Not Applicable
3.Not Available
4.Not Available

1.Not Available
2.Not Available
60-100 Other non classified ingredients Not Applicable
3.Not Available
4.Not Available

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

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If skin or hair contact occurs:

Flush skin and hair with running water (and soap if available).
Seek medical attention in event of irritation.
Generally not applicable.
General
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.

Eye Contact Generally not applicable.

If skin or hair contact occurs:

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

Fire Fighting Slight hazard when exposed to heat, flame and oxidisers.

Non combustible.
Fire/Explosion Hazard
Not considered a significant fire risk, however containers may burn.

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

Clean up all spills immediately.
Minor Spills
Secure load if safe to do so.

Minor hazard.
Major Spills
Clear area of personnel.

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

Limit all unnecessary personal contact.
Safe handling
Wear protective clothing when risk of exposure occurs.

Fire and explosion

See section 5
protection
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Store away from incompatible materials.

Other information

7.2. Conditions for safe storage, including any incompatibilities

Polyethylene or polypropylene container.
Suitable container
Packing as recommended by manufacturer.

Storage Avoid contamination of water, foodstuffs, feed or seed.

incompatibility None known

+ + + + + + +

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 700 FN Not Available Not Available Not Available Not Available

Ingredient Original IDLH Revised IDLH

Viable bacterial cultures Not Available Not Available

Other non classified

Not Available Not Available
ingredients
Viable bacterial cultures Not Available Not Available

Other non classified

Not Available Not Available
ingredients

MATERIAL DATA

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

Safety glasses.
Safety glasses with side shields.
Eye and face No special equipment for minor exposure i.e. when handling small quantities.
protection OTHERWISE:
Safety glasses with side shields.
Safety glasses with side shields
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Chemical goggles.
Contact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants.
No special equipment required due to the physical form of the product.
Skin protection See Hand protection below
Wear general protective gloves, eg. light weight rubber gloves.
Hands/feet protection
No special equipment required due to the physical form of the product.

Body protection See Other protection below

No special equipment needed when handling small quantities.

OTHERWISE:
Other protection
Overalls.
No special equipment required due to the physical form of the product.

Thermal hazards Not Available

Respiratory protection
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 fibres, tan, partly soluble in water

Relative density
Physical state Manufactured 0.7
(Water = 1)
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%) ~7
(g/L)
Vapour density (Air =
Not Available VOC g/L Not Available
1)

9.2. Other information

Not Available
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SECTION 10 STABILITY AND REACTIVITY

10.1.Reactivity See section 7.2

10.2. Chemical
Product is considered stable and hazardous polymerisation will not occur.
stability
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
Inhaled 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.

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.
The material is not thought to produce adverse health effects or skin irritation following contact (as classified by EC
Skin Contact Directives using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that
suitable gloves be used in an occupational setting.

Eye Although the material is not thought to be an irritant (as classified by EC Directives), direct contact with the eye may
produce transient discomfort characterised by tearing or conjunctival redness (as with windburn).

Long-term exposure to the product is not thought to produce chronic effects adverse to health (as classified by EC
Chronic
Directives using animal models); nevertheless exposure by all routes should be minimised as a matter of course.

TOXICITY IRRITATION
GAMAZYME 700 FN
Not Available Not Available

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

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

Not Available Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable

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
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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

Product / Packaging Recycle wherever possible or consult manufacturer for recycling options.
disposal 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
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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

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
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
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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
National Inventory Status
Australia - AICS Y

Canada - DSL Y
Canada - NDSL Y

China - IECSC Y
Europe - EINEC /
Y
ELINCS / NLP
Japan - ENCS Y

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: WSS.GLOBAL.SDSINFO@wilhelmsen.com - Telephone: Tel.: +31 10
4877775

Full text Risk and Hazard codes

Other information
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

This document is copyright.

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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.