Gamazyme BTC
Gamazyme BTC
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
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
Hazard pictogram(s)
Hazard statement(s)
H318 Causes serious eye damage.
Supplementary statement(s)
EUH208 Contains (R)-p-Mentha-1,8-diene. May produce an allergic reaction.
(R)-p-Mentha-1,8-diene Listed in the Europe Regulation (EC) No 1907/2006 - Annex XVII (Restrictions may apply)
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
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.
Non combustible.
Fire/Explosion Hazard Not considered a significant fire risk, however containers may burn.
May emit corrosive fumes.
See section 12
+ X + O + + +
INGREDIENT DATA
factors (Norwegian)
EMERGENCY LIMITS
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.
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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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
10.3. Possibility of
See section 7.2
hazardous reactions
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]
TOXICITY IRRITATION
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]
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.
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
12.1. Toxicity
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
Labels Required
Marine Pollutant NO
14.5. Environmental
Not Applicable
hazard
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Air transport (ICAO-IATA / DGR): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS
14.1. UN number 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
Inland waterways transport (ADN): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS
14.1. UN number Not Applicable
14.5. Environmental
Not Applicable
hazard
14.7. Transport in bulk according to Annex II of MARPOL and the IBC code
Not Applicable
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 - : 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.
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
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