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GAMAZYME BTC

Wilhelmsen Ships Service AS


Catalogue number: 589945 Issue Date: 28/05/2019
Version No: 5.16 Print Date: 02/11/2019
Safety Data Sheet (Conforms to Regulation (EU) No 2015/830) L.REACH.NOR.EN

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

1.1. Product Identifier


Product name GAMAZYME BTC

Synonyms Not Available


Other means of
589945, 589945
identification

1.2. Relevant identified uses of the substance or mixture and uses advised against
Product Category
PC35 Washing and cleaning products (including solventbased products)
Chemical

SU22 Professional uses: Public domain (administration, education, entertainment, services, craftsmen)
Sectors of Use
SU3 Industrial uses: Uses of substances as such or in preparations* at industrial sites

Relevant identified uses Cleaning Agent Pr No: 51876 (Norway)

Uses advised against Not Applicable

1.3. Details of the supplier of the safety data sheet


Outback (M)SDS portal:
Registered company name Wilhelmsen Ships Service AS http://jr.chemwatch.net/outb/account Wilhelmsen Ships Service AS*
/autologin?login=wilhelmsen

--------Use our Outback portal to obtain our


(M)SDSs in other languages and/or
Strandveien 20 Lysaker 1366 format.--------- For questions relating to our Willem Barentszstraat 50 Rotterdam
Address
Norway SDSs please use Email: Netherlands
[email protected]
--------- Norway
Telephone +47 67 58 40 00 Not Available +31 10 4877 777
Fax Not Available Not Available +31 10 4877888

Website http://www.wilhelmsen.com/ Not Available http://www.wilhelmsen.com


Email [email protected] Not Available [email protected]

1.4. Emergency telephone number


American Chemistry Council 24hrs
Association / Organisation Giftinformasjonssentralen - 24 timer Dutch nat. poison centre
- Chemtrec
Emergency telephone
+47 22591300 +1 703 527 3887 + 31 30 274 88 88
numbers
Other emergency
Not Available (800) 424 9300 Not Available
telephone numbers
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GAMAZYME BTC

SECTION 2 HAZARDS IDENTIFICATION

2.1. Classification of the substance or mixture

Considered a hazardous mixture according to Reg. (EC) No 1272/2008 and their amendments. Not classified as Dangerous Goods for
transport purposes.

Classification according to
regulation (EC) No H318 - Serious Eye Damage Category 1
1272/2008 [CLP] [1]

Legend: 1. Classified by Chemwatch; 2. Classification drawn from Regulation (EU) No 1272/2008 - Annex VI

2.2. Label elements

Hazard pictogram(s)

SIGNAL WORD DANGER

Hazard statement(s)
H318 Causes serious eye damage.

Supplementary statement(s)
EUH208 Contains (R)-p-Mentha-1,8-diene. May produce an allergic reaction.

CLP classification (additional)


Not Applicable

Precautionary statement(s) Prevention


P280 Wear protective gloves/protective clothing/eye protection/face protection.

Precautionary statement(s) Response


P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310 Immediately call a POISON CENTER/doctor/physician/first aider.

Precautionary statement(s) Storage


Not Applicable

Precautionary statement(s) Disposal


Not Applicable

2.3. Other hazards


Eye contact may produce serious damage*.

(R)-p-Mentha-1,8-diene Listed in the Europe Regulation (EC) No 1907/2006 - Annex XVII (Restrictions may apply)

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
1.5989-27-5*
Skin Corrosion/Irritation Category 2, Acute Aquatic Hazard Category 1, Skin Sensitizer
2.227-813-5 (R)-p-Mentha-
<1 Category 1B, Flammable Liquid Category 3, Chronic Aquatic Hazard Category 1; H315,
3.601-029-00-7 1,8-diene
H400, H317, H226, H410 [1]
4.01-2119529223-47-XXXX

1.Not Available
Viable bacterial
2.Not Available 1-5 Not Applicable
cultures
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GAMAZYME BTC

3.Not Available
4.Not Available
1.68439-46-3*
2.Not Available
alcohols c9-11
3.Not Available 1-3 Eye Irritation Category 2; H319 [1]
ethoxylated
4.01-2119980051-45-
XXXX|01-2119979533-26-XXXX

1.160875-66-1*
2.Not Available fatty alcohol
1-3 Serious Eye Damage Category 1, Acute Toxicity (Oral) Category 4; H318, H302 [1]
3.Not Available ethoxylates
4.Not Available

Legend: 1. Classified by Chemwatch; 2. Classification drawn from Regulation (EU) No 1272/2008 - Annex VI; 3. Classification drawn from
C&L; * EU IOELVs available

SECTION 4 FIRST AID MEASURES

4.1. Description of first aid measures

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 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


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.
Prevent, by any means available, spillage from entering drains or water courses.

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


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GAMAZYME BTC

See section 12

6.3. Methods and material for containment and cleaning up


Clean up all spills immediately.
Minor Spills Avoid breathing vapours and contact with skin and eyes.
Control personal contact with the substance, by using protective equipment.
Moderate hazard.
Major Spills Clear area of personnel and move upwind.
Alert Fire Brigade and tell them location and nature of hazard.

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.
Use in a well-ventilated area.

Fire and explosion


See section 5
protection
Other information

7.2. Conditions for safe storage, including any incompatibilities


Polyethylene or polypropylene container.
Suitable container Packing as recommended by manufacturer.
Check all containers are clearly labelled and free from leaks.
Storage incompatibility None known

+ 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


DNELs PNECs
Ingredient
Exposure Pattern Worker Compartment

Dermal 9.5 mg/kg bw/day (Systemic, Chronic)


Inhalation 66.7 mg/m³ (Systemic, Chronic)
0.13 mg/kg sediment dw (Sediment (Marine))
(R)-p-Mentha-1,8-diene Dermal 4.8 mg/kg bw/day (Systemic, Chronic) *
3.33 mg/kg food (Oral)
Inhalation 16.6 mg/m³ (Systemic, Chronic) *
Oral 4.8 mg/kg bw/day (Systemic, Chronic) *

* Values for General Population

OCCUPATIONAL EXPOSURE LIMITS (OEL)

INGREDIENT DATA

Source Ingredient Material name TWA STEL Peak Notes

Norway regulations on action


rvalues o​ a nd limitf values ​
physical and chemical
factors in the work (R)-p-Mentha-1,8-diene d-limonen 25 ppm / 140 mg/m3 Not Available Not Available A
environment and infection
risk groups for biological
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GAMAZYME BTC

factors (Norwegian)

EMERGENCY LIMITS

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


(R)-p-Mentha-1,8-diene Limonene, d- 15 ppm 67 ppm 170 ppm

Ingredient Original IDLH Revised IDLH

(R)-p-Mentha-1,8-diene Not Available Not Available

alcohols c9-11 ethoxylated Not Available Not Available

fatty alcohol ethoxylates Not Available Not Available

OCCUPATIONAL EXPOSURE BANDING

Ingredient Occupational Exposure Band Rating Occupational Exposure Band Limit

alcohols c9-11 ethoxylated E ≤ 0.1 ppm


fatty alcohol ethoxylates E ≤ 0.1 ppm

Occupational exposure banding is a process of assigning chemicals into specific categories or bands based on a chemical's
Notes: potency and the adverse health outcomes associated with exposure. The output of this process is an occupational exposure
band (OEB), which corresponds to a range of exposure concentrations that are expected to protect worker health.

MATERIAL DATA
Sensory irritants are chemicals that produce temporary and undesirable side-effects on the eyes, nose or throat. Historically occupational exposure standards for
these irritants have been based on observation of workers' responses to various airborne concentrations. Present day expectations require that nearly every
individual should be protected against even minor sensory irritation and exposure standards are established using uncertainty factors or safety factors of 5 to 10 or
more.

8.2. Exposure controls


Engineering controls are used to remove a hazard or place a barrier between the worker and the hazard. Well-designed
engineering controls can be highly effective in protecting workers and will typically be independent of worker interactions to
8.2.1. Appropriate
provide this high level of protection.
engineering controls
The basic types of engineering controls are:
Process controls which involve changing the way a job activity or process is done to reduce the risk.

8.2.2. Personal protection

Safety glasses with side shields.


Eye and face protection Chemical goggles.
Contact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants.

Skin protection See Hand protection below


The selection of suitable gloves does not only depend on the material, but also on further marks of quality which vary from
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.
Hands/feet protection The exact break through time for substances has to be obtained from the manufacturer of the protective gloves and.has to be
observed when making a final choice.
Wear chemical protective gloves, e.g. PVC.
Wear safety footwear or safety gumboots, e.g. Rubber
Body protection See Other protection below

Overalls.
Other protection
P.V.C. apron.

Recommended material(s)
GLOVE SELECTION INDEX
Glove selection is based on a modified presentation of the:
"Forsberg Clothing Performance Index".
The effect(s) of the following substance(s) are taken into account in the computer-generated selection:
GAMAZYME BTC

Material CPI
NITRILE A
PVA A
VITON A
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GAMAZYME BTC

* CPI - Chemwatch Performance Index


A: Best Selection
B: Satisfactory; may degrade after 4 hours continuous immersion
C: Poor to Dangerous Choice for other than short term immersion
NOTE: As a series of factors will influence the actual performance of the glove, a final selection must be based on detailed observation. -
* Where the glove is to be used on a short term, casual or infrequent basis, factors such as "feel" or convenience (e.g. disposability), may dictate a choice of
gloves which might otherwise be unsuitable following long-term or frequent use. A qualified practitioner should be consulted.

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 Green

Relative density (Water =


Physical state Liquid 1-1.01
1)
Partition coefficient
Odour Not Available Not Available
n-octanol / water
Auto-ignition temperature
Odour threshold Not Available Not Available
(°C)
Decomposition
pH (as supplied) 8.5 Not Available
temperature
Melting point / freezing
Not Available Viscosity (cSt) Not Available
point (°C)
Initial boiling point and
~100 Molecular weight (g/mol) Not Available
boiling range (°C)

Flash point (°C) Not Available Taste Not Available


Evaporation rate Not Available Explosive properties Not Available
Flammability Not Available Oxidising properties Not Available

Surface Tension (dyn/cm


Upper Explosive Limit (%) Not Available Not Available
or mN/m)

Lower Explosive Limit (%) Not Available Volatile Component (%vol) Not Available
Vapour pressure (kPa) Not Available Gas group Not Available
Solubility in water Miscible pH as a solution (1%) Not Available

Vapour density (Air = 1) Not Available VOC g/L Not Available

9.2. Other information


Not Available

SECTION 10 STABILITY AND REACTIVITY

10.1.Reactivity See section 7.2

Unstable in the presence of incompatible materials.


10.2. Chemical stability Product is considered stable.
Hazardous polymerisation will not occur.

10.3. Possibility of
See section 7.2
hazardous reactions

10.4. Conditions to avoid See section 7.2


10.5. Incompatible
See section 7.2
materials
10.6. Hazardous
See section 5.3
decomposition 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
Inhaled using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable control
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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 because
Ingestion of the lack of corroborating animal or human evidence. The material may still be damaging to the health of the individual,
following ingestion, especially where pre-existing organ (e.g liver, kidney) damage is evident.
The material is not thought to produce adverse health effects or skin irritation following contact (as classified by EC Directives
Skin Contact 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.

When applied to the eye(s) of animals, the material produces severe ocular lesions which are present twenty-four hours or more
Eye
after instillation.

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

TOXICITY IRRITATION
GAMAZYME BTC
Not Available Not Available

TOXICITY IRRITATION

Dermal (rabbit) LD50: >5000 mg/kg[2] Eye: no adverse effect observed (not irritating)[1]

(R)-p-Mentha-1,8-diene Inhalation (rat) LC50: 90860 mg/m3[2] Skin (rabbit): 500mg/24h moderate

Oral (rat) LD50: 4400 mg/kg[2] Skin: no adverse effect observed (not irritating)[1]

Oral (rat) LD50: 5300 mg/kg[2]

TOXICITY IRRITATION

Dermal (rabbit) LD50: >2000 mg/kg[2] Eye (human): SEVERE

Dermal (rabbit) LD50: >5000 mg/kg *[2] Eye: adverse effect observed (irritating)[1]
alcohols c9-11 ethoxylated
Oral (rat) LD50: 1378 mg/kg[2] Skin: no adverse effect observed (not irritating)[1]

Oral (rat) LD50: 1400 mg/kg *[2] Skin: SEVERE

Oral (rat) LD50: 2700 mg/kg *[2]

TOXICITY IRRITATION
fatty alcohol ethoxylates
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

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.
d-Limonene is readily absorbed by inhalation and ingestion. Dermal absorption is reported to be lower than by the inhalation
route. d-Limonene is rapidly distributed to different tissues in the body, readily metabolised and eliminated primarily through the
urine.
Adverse reactions to fragrances in perfumes and in fragranced cosmetic products include allergic contact dermatitis, irritant
contact dermatitis, photosensitivity, immediate contact reactions (contact urticaria), and pigmented contact dermatitis. Airborne
and connubial contact dermatitis occur.
Intolerance to perfumes, by inhalation, may occur if the perfume contains a sensitising principal.
Fragrance allergens act as haptens, i.e. low molecular weight chemicals that are immunogenic only when attached to a carrier
protein. However, not all sensitising fragrance chemicals are directly reactive, but require previous activation. A prehapten is a
(R)-p-Mentha-1,8-diene chemical that itself is non- or low-sensitising, but that is transformed into a hapten outside the skin by simple chemical
transformation (air oxidation, photoactivation) and without the requirement of specific enzymatic systems.
The substance is classified by IARC as Group 3:
NOT classifiable as to its carcinogenicity to humans.
Evidence of carcinogenicity may be inadequate or limited in animal testing.
Monomethyltin chloride, thioglycolate esters, and tall oil ester reaction product:
Monomethyltin trichloride (MMTC, CAS RN: 993-16-8), monomethyltin tris[2-ethylhexylmercaptoacetate (MMT (EHTG; MMT
(2-EHMA), CAS RN: 57583-34-3), monomethyltin tris[isooctylmercaptoacetate (MMT(IOTG), CAS RN: 54849-38-6) and methyltin
reverse ester tallate reaction product (TERP, CAS RNs: 201687-58-3, 201687-57-2, 68442-12-6, 151436-98-5) are considered
one category of compounds for mammalian studies via the oral route. The justification for this category is based on structural
similarities and the demonstrated rapid conversion of all of the esters to the MMTC when placed in simulated mammalian gastric
contents [0.07M HCl] under physiological conditions. For the MMT(EHTG) >90% conversion to MMTC occurred within 0.5 hours.
Tumorigenic by RTECS criteria

Human beings have regular contact with alcohol ethoxylates through a variety of industrial and consumer products such as
soaps, detergents, and other cleaning products . Exposure to these chemicals can occur through ingestion, inhalation, or contact
alcohols c9-11 ethoxylated with the skin or eyes. Studies of acute toxicity show that volumes well above a reasonable intake level would have to occur to
produce any toxic response.
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Alcohol ethoxylates are according to CESIO (2000) classified as Irritant or Harmful depending on the number of EO-units:
EO < 5 gives Irritant (Xi) with R38 (Irritating to skin) and R41 (Risk of serious damage to eyes)
EO > 5-15 gives Harmful (Xn) with R22 (Harmful if swallowed) - R38/41
EO > 15-20 gives Harmful (Xn) with R22-41
>20 EO is not classified (CESIO 2000)
Oxo-AE, C13 EO10 and C13 EO15, are Irritating (Xi) with R36/38 (Irritating to eyes and skin) .
AE are not included in Annex 1 of the list of dangerous substances of the Council Directive 67/548/EEC

In general, alcohol ethoxylates (AE) are readily absorbed through the skin of guinea pigs and rats and through the
gastrointestinal mucosa of rats. AE are quickly eliminated from the body through the urine, faeces, and expired air (CO2).Orally
dosed AE was absorbed rapidly and extensively in rats, and more than 75% of the dose was absorbed.
For high boiling ethylene glycol ethers (typically triethylene- and tetraethylene glycol ethers):
Skin absorption: Available skin absorption data for triethylene glycol ether (TGBE), triethylene glycol methyl ether (TGME), and
triethylene glycol ethylene ether (TGEE) suggest that the rate of absorption in skin of these three glycol ethers is 22 to 34
micrograms/cm2/hr, with the methyl ether having the highest permeation constant and the butyl ether having the lowest. The
rates of absorption of TGBE, TGEE and TGME are at least 100-fold less than EGME, EGEE, and EGBE, their ethylene glycol
monoalkyl ether counterparts, which have absorption rates that range from 214 to 2890 micrograms/ cm2/hr . Therefore, an
increase in either the chain length of the alkyl substituent or the number of ethylene glycol moieties appears to lead to a
decreased rate of percutaneous absorption.

The material may produce severe irritation to the eye causing pronounced inflammation. Repeated or prolonged exposure to
irritants may produce conjunctivitis.
The material may produce severe skin irritation after prolonged or repeated exposure, and may produce a contact dermatitis
(nonallergic). This form of dermatitis is often characterised by skin redness (erythema) thickening of the epidermis.
Histologically there may be intercellular oedema of the spongy layer (spongiosis) and intracellular oedema of the epidermis.
Dermal (rabbit): 4000 mg/kg * Somnolence, ataxia, diarrhoea recorded.

Acute Toxicity Carcinogenicity


Skin Irritation/Corrosion Reproductivity

Serious Eye
STOT - Single Exposure
Damage/Irritation

Respiratory or Skin
STOT - Repeated Exposure
sensitisation
Mutagenicity Aspiration Hazard

Legend: – Data either not available or does not fill the criteria for classification
– Data available to make classification

SECTION 12 ECOLOGICAL INFORMATION

12.1. Toxicity

ENDPOINT TEST DURATION (HR) SPECIES VALUE SOURCE


GAMAZYME BTC Not Not Not
Not Available Not Available
Available Available Available

ENDPOINT TEST DURATION (HR) SPECIES VALUE SOURCE

LC50 96 Fish 0.199mg/L 3

(R)-p-Mentha-1,8-diene EC50 48 Crustacea 0.307mg/L 2

EC50 96 Algae or other aquatic plants 0.212mg/L 3


NOEC 504 Crustacea 0.05mg/L 2

ENDPOINT TEST DURATION (HR) SPECIES VALUE SOURCE

LC50 96 Fish 8.5mg/L 4

EC50 48 Crustacea 2.5mg/L 2


alcohols c9-11 ethoxylated
EC50 96 Algae or other aquatic plants 1.4mg/L 2
EC20 72 Algae or other aquatic plants 0.711mg/L 2

NOEC 240 Fish 0.16mg/L 2

ENDPOINT TEST DURATION (HR) SPECIES VALUE SOURCE


fatty alcohol ethoxylates Not Not Not
Not Available Not Available
Available Available Available

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

Harmful to aquatic organisms.

12.2. Persistence and degradability


Ingredient Persistence: Water/Soil Persistence: Air

(R)-p-Mentha-1,8-diene HIGH HIGH

12.3. Bioaccumulative potential


Ingredient Bioaccumulation

(R)-p-Mentha-1,8-diene HIGH (LogKOW = 4.8275)

12.4. Mobility in soil


Ingredient Mobility
(R)-p-Mentha-1,8-diene LOW (KOC = 1324)

12.5.Results of PBT and vPvB assessment


P B T

Relevant available data Not Applicable Not Applicable Not Applicable


PBT Criteria fulfilled? Not Applicable Not Applicable Not Applicable

12.6. Other adverse effects


No data available

SECTION 13 DISPOSAL CONSIDERATIONS

13.1. Waste treatment methods


Legislation addressing waste disposal requirements may differ by country, state and/ or territory. Each user must refer to laws
operating in their area. In some areas, certain wastes must be tracked.
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.
Product / Packaging In all cases disposal to sewer may be subject to local laws and regulations and these should be considered first.
disposal Recycle wherever possible.
Consult manufacturer for recycling options or consult local or regional waste management authority for disposal if no suitable
treatment or disposal facility can be identified.
Dispose of by: burial in a land-fill specifically licensed to accept chemical and / or pharmaceutical wastes or incineration in a
licensed apparatus (after admixture with suitable combustible material).
Waste treatment options Not Available

Sewage disposal options Not Available

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 shipping


Not Applicable
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
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Hazard identification (Kemler) Not Applicable


Classification code Not Applicable

14.6. Special precautions Hazard Label Not Applicable


for user Special provisions Not Applicable

Limited quantity Not Applicable


Tunnel Restriction Code Not Applicable

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

14.2. UN proper shipping


Not Applicable
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 precautions
Passenger and Cargo Packing Instructions Not Applicable
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 shipping
Not Applicable
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 precautions
Special provisions Not Applicable
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 shipping


Not Applicable
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


14.6. Special precautions
Special provisions Not Applicable
for user
Limited quantity Not Applicable
Catalogue number: 589945 Page 11 of 12 Issue Date: 28/05/2019
Version No: 5.16 Print Date: 02/11/2019
GAMAZYME BTC

Equipment required Not Applicable

Fire cones number Not Applicable

14.7. 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

(R)-P-MENTHA-1,8-DIENE IS FOUND ON THE FOLLOWING REGULATORY LISTS


EU Regulation (EC) No 1223/2009 of the European Parliament and of the European Union (EU) Annex I to Directive 67/548/EEC on Classification and
Council of 30 November 2009 on cosmetic products - Annex III - List of Labelling of Dangerous Substances - updated by ATP: 31
Substances which cosmetic products must not contain except subject to the European Union (EU) Regulation (EC) No 1272/2008 on Classification,
restrictions laid down Labelling and Packaging of Substances and Mixtures - Annex VI
EU REACH Regulation (EC) No 1907/2006 - Annex XVII - Restrictions on the European Union (EU) Transport of Dangerous Goods by Road - Dangerous
manufacture, placing on the market and use of certain dangerous substances, Goods List
mixtures and articles GESAMP/EHS Composite List - GESAMP Hazard Profiles
Europe ADN - European Agreement concerning the International Carriage of International Agency for Research on Cancer (IARC) - Agents Classified by
Dangerous Goods by Inland Waterways the IARC Monographs
Europe EC Inventory International Air Transport Association (IATA) Dangerous Goods Regulations
Europe ECHA Registered Substances - Classification and Labelling - International Maritime Dangerous Goods Requirements (IMDG Code)
DSD-DPD
dNorway regulations on n action values ​ and limit
a values ​ for physical
Europe European Agreement concerning the International Carriage of chemical factors in the work environment and infection risk groups for
Dangerous Goods by Road biological factors (Norwegian)
Europe European Customs Inventory of Chemical Substances Regulations concerning the International Carriage of Dangerous Goods by
European Chemical Agency (ECHA) Classification & Labelling Inventory - Rail - Table A: Dangerous Goods List - RID 2019 (English)
Chemwatch Harmonised classification United Nations Recommendations on the Transport of Dangerous Goods
European Trade Union Confederation (ETUC) Priority List for REACH Model Regulations
Authorisation
European Union - European Inventory of Existing Commercial Chemical
Substances (EINECS)

ALCOHOLS C9-11 ETHOXYLATED IS FOUND ON THE FOLLOWING REGULATORY LISTS


Europe ADN - European Agreement concerning the International Carriage of International Air Transport Association (IATA) Dangerous Goods Regulations
Dangerous Goods by Inland Waterways International Maritime Dangerous Goods Requirements (IMDG Code)
Europe European Agreement concerning the International Carriage of Regulations concerning the International Carriage of Dangerous Goods by
Dangerous Goods by Road Rail - Table A: Dangerous Goods List - RID 2019 (English)
European Chemical Agency (ECHA) Classification & Labelling Inventory - United Nations Recommendations on the Transport of Dangerous Goods
Chemwatch Harmonised classification Model Regulations
European Union (EU) Transport of Dangerous Goods by Road - Dangerous
Goods List

FATTY ALCOHOL ETHOXYLATES IS FOUND ON THE FOLLOWING REGULATORY LISTS


European Chemical Agency (ECHA) Classification & Labelling Inventory -
Chemwatch Harmonised classification

This safety data sheet is in compliance with the following EU legislation and its adaptations - as far as applicable - : Directives 98/24/EC, - 92/85/EEC, - 94/33/EC,
- 2008/98/EC, - 2010/75/EU; Commission Regulation (EU) 2015/830; Regulation (EC) No 1272/2008 as updated through ATPs.

15.2. Chemical safety assessment


No Chemical Safety Assessment has been carried out for this substance/mixture by the supplier.

National Inventory Status


National Inventory Status

Australia - AICS Yes


Canada - DSL No (fatty alcohol ethoxylates)

Canada - NDSL No (alcohols c9-11 ethoxylated; (R)-p-Mentha-1,8-diene; fatty alcohol ethoxylates)

China - IECSC Yes


Europe - EINEC / ELINCS /
No (alcohols c9-11 ethoxylated; fatty alcohol ethoxylates)
NLP
Japan - ENCS No (alcohols c9-11 ethoxylated; fatty alcohol ethoxylates)

Korea - KECI Yes

New Zealand - NZIoC Yes


Catalogue number: 589945 Page 12 of 12 Issue Date: 28/05/2019
Version No: 5.16 Print Date: 02/11/2019
GAMAZYME BTC

Philippines - PICCS No (fatty alcohol ethoxylates)


USA - TSCA Yes

Taiwan - TCSI Yes


Mexico - INSQ No (fatty alcohol ethoxylates)

Vietnam - NCI Yes


Russia - ARIPS No (alcohols c9-11 ethoxylated; fatty alcohol ethoxylates)

Yes = All CAS declared ingredients are on the inventory


Legend: No = One or more of the CAS listed ingredients are not on the inventory and are not exempt from listing(see specific ingredients
in brackets)

SECTION 16 OTHER INFORMATION

Revision Date 28/05/2019

Initial Date 04/01/2018

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


H226 Flammable liquid and vapour.
H302 Harmful if swallowed.
H315 Causes skin irritation.

H317 May cause an allergic skin reaction.


H319 Causes serious eye irritation.
H400 Very toxic to aquatic life.

H410 Very toxic to aquatic life with long lasting effects.

SDS Version Summary


Version Issue Date Sections Updated
4.16.1.1.1 28/05/2019 Ingredients, Synonyms, Use

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.

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. Risks may be determined by reference to Exposures Scenarios.

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

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