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AlerTox ELISA - Allergen Detection - Hygiena

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SDS-GlutenTox Sticks Plus-KIT3005-CA-en
Bill of materials Name of substance
UGES Extraction Solution
Dilution Solution
Positive Control Negative Control

GlutenTox Sticks Plus KIT3005

Date of compilation: 2021-11-05

Identifier
Internal code ASY3028 ASY3036 ASY3040 ASY3191 ASY3192
Internal code ASY3037 ASY3010 ASY3012 ASY3039 ASY3189 ASY3193
Internal code ASY3052
Internal code ASY3051

Classification acc. to GHS
Flam. Liq. 2 / H225

Pictograms

Page 2­16
17­29
30­39 40­51

Canada
Hygiena 549 KIT-22

Safety Data Sheet
acc. to Hazardous Products Regulations (HPR)

UGES Extraction Solution

Version number: 2.0 Replaces version of: (1. 0)

Revision: 2021-07-01

SECTION 1: Identification

1.1 Product identifier Trade name Alternative name(s)
Product code(s)

UGES Extraction Solution
UGES Extraction Solution GlutenTox ELISA, UGES Extraction Solution GlutenTox Pro, UGES Extraction Solution GlutenTox Home, UGES Extraction Solution GlutenTox Sticks Plus, UGES Extraction Solution GlutenTox Sticks Plus for Reader
ASY3028, ASY3036, ASY3040, ASY3191, ASY3192

1.2 Relevant identified uses of the substance or mixture and uses advised against

Relevant identified uses

Laboratory and analytical use

1.3 Details of the supplier of the safety data sheet
Hygiena USA 941 Avenida Acaso Camarillo California 93012 United States

Telephone: +1 (805) 388-8007 Telefax: +1 (805) 388-5531 e-mail: info@hygiena.com
e-mail (competent person)
1.4 Emergency telephone number
Emergency information service

info@hygiena.com
1-888-494-4362 This number is only available during the following office hours: Mon-Fri 08:00 AM - 05:00 PM

SECTION 2: Hazard identification 2.1 Classification of the substance or mixture
Classification acc. to GHS

Section 2.6

Hazard class flammable liquid

Category 2

Hazard class and category
Flam. Liq. 2

Hazard statement
H225

For full text of abbreviations: see SECTION 16.
The most important adverse physicochemical, human health and environmental effects
The product is combustible and can be ignited by potential ignition sources.

2.2 Label elements Labeling - Signal word

danger

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- Pictograms
GHS02

Safety Data Sheet
acc. to Hazardous Products Regulations (HPR)
UGES Extraction Solution

Revision: 2021-07-01

- Hazard statements

H225

Highly flammable liquid and vapour.

- Precautionary statements

P210

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P233

Keep container tightly closed.

P240

Ground and bond container and receiving equipment.

P241

Use explosion-proof electrical/ventilating/lighting equipment.

P242

Use non-sparking tools.

P243

Take action to prevent static discharges.

P280

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

P303+P361+P353

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water or shower.

P370+P378

In case of fire: Use sand, carbon dioxide or powder extinguisher to extinguish.

P403+P235

Store in a well-ventilated place. Keep cool.

P501

Dispose of contents/container to industrial combustion plant.

2.3 Other hazards
of no significance

SECTION 3: Composition/information on ingredients
3.1 Substances
Not relevant (mixture)
3.2 Mixtures Description of the mixture

Name of substance Pyrogen Free Water
Ethyl alcohol
L-Arginine monohydrochloride
Domiphen bromide
TCEP

Identifier
CAS No 7732-18-5
CAS No 64-17-5
CAS No 1119-34-2
CAS No 538-71-6
CAS No 51805-45-9

Wt% 75­<90 10­<25 5­<10
<0.1 <0.1

Classification acc. to GHS Skin Corr. 1 / H314

Pictograms

For full text of abbreviations: see SECTION 16.

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Safety Data Sheet
acc. to Hazardous Products Regulations (HPR)

UGES Extraction Solution

Version number: 2.0 Replaces version of: (1. 0)

Revision: 2021-07-01

SECTION 4: First-aid measures

4.1 Description of first-aid measures General notes
Do not leave affected person unattended. Remove victim out of the danger area. Keep affected person warm, still and covered. Take off immediately all contaminated clothing. In all cases of doubt, or when symptoms persist, seek medical advice. In case of unconsciousness place person in the recovery position. Never give anything by mouth.
Following inhalation
If breathing is irregular or stopped, immediately seek medical assistance and start first aid actions. Provide fresh air.
Following skin contact
Wash with plenty of soap and water.
Following eye contact
Remove contact lenses, if present and easy to do. Continue rinsing. Irrigate copiously with clean, fresh water for at least 10 minutes, holding the eyelids apart.
Following ingestion
Rinse mouth with water (only if the person is conscious). Do NOT induce vomiting.
4.2 Most important symptoms and effects, both acute and delayed
Symptoms and effects are not known to date.
4.3 Indication of any immediate medical attention and special treatment needed
none

SECTION 5: Fire-fighting measures
5.1 Extinguishing media Suitable extinguishing media
Water spray, BC-powder, Carbon dioxide (CO2)
Unsuitable extinguishing media
Water jet
5.2 Special hazards arising from the substance or mixture
In case of insufficient ventilation and/or in use, may form flammable/explosive vapor-air mixture. Solvent vapors are heavier than air and may spread along floors. Places which are not ventilated, e.g. unventilated below ground level areas such as trenches, conduits and shafts, are particularly prone to the presence of flammable substances or mixtures.
Hazardous combustion products
Carbon monoxide (CO), Carbon dioxide (CO2)
5.3 Advice for firefighters
In case of fire and/or explosion do not breathe fumes. Coordinate firefighting measures to the fire surroundings. Do not allow firefighting water to enter drains or water courses. Collect contaminated firefighting water separately. Fight fire with normal precautions from a reasonable distance.

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Safety Data Sheet
acc. to Hazardous Products Regulations (HPR)

UGES Extraction Solution

Version number: 2.0 Replaces version of: (1. 0)

Revision: 2021-07-01

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures For non-emergency personnel
Remove persons to safety.
For emergency responders
Wear breathing apparatus if exposed to vapors/dust/aerosols/gases.
6.2 Environmental precautions
Keep away from drains, surface and ground water. Retain contaminated washing water and dispose of it.
6.3 Methods and material for containment and cleaning up Advice on how to contain a spill
Covering of drains
Advice on how to clean up a spill
Wipe up with absorbent material (e.g. cloth, fleece). Collect spillage: sawdust, kieselgur (diatomite), sand, universal binder
Appropriate containment techniques
Use of adsorbent materials.
Other information relating to spills and releases
Place in appropriate containers for disposal. Ventilate affected area.
6.4 Reference to other sections
Hazardous combustion products: see section 5. Personal protective equipment: see section 8. Incompatible materials: see section 10. Disposal considerations: see section 13.

SECTION 7: Handling and storage
7.1 Precautions for safe handling
Recommendations
- Measures to prevent fire as well as aerosol and dust generation
Use local and general ventilation. Avoidance of ignition sources. Keep away from sources of ignition - No smoking. Take precautionary measures against static discharge. Use only in well-ventilated areas. Due to danger of explosion, prevent leakage of vapours into cellars, flues and ditches. Ground/bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting/equipment. Use only non-sparking tools.
- Specific notes/details
Places which are not ventilated, e.g. unventilated below ground level areas such as trenches, conduits and shafts, are particularly prone to the presence of flammable substances or mixtures. Vapors are heavier than air, spread along floors and form explosive mixtures with air. Vapors may form explosive mixtures with air.
Advice on general occupational hygiene
Wash hands after use. Do not eat, drink and smoke in work areas. Remove contaminated clothing and protective equipment before entering eating areas. Never keep food or drink in the vicinity of chemicals. Never place chemicals in containers that are normally used for food or drink. Keep away from food, drink and animal feedingstuffs.

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UGES Extraction Solution

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Revision: 2021-07-01

7.2 Conditions for safe storage, including any incompatibilities Managing of associated risks - Explosive atmospheres
Keep container tightly closed and in a well-ventilated place. Use local and general ventilation. Keep cool. Protect from sunlight.
- Flammability hazards
Keep away from sources of ignition - No smoking. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Take precautionary measures against static discharge. Protect from sunlight.
Control of the effects Protect against external exposure, such as
frost
- Ventilation requirements
Use local and general ventilation. Ground/bond container and receiving equipment.
- Packaging compatibilities
Only packagings which are approved (e.g. acc. to the Dangerous Goods Regulations) may be used.

7.3 Specific end use(s)
See section 16 for a general overview.

SECTION 8: Exposure controls/personal protection 8.1 Control parameters

Occupational exposure limit values (Workplace Exposure Limits)

Coun- Name of agent try

CAS No Identi- TWA

TWA

STEL

STEL Ceiling-C Ceiling-C Nota- Source

fier [ppm] [mg/m³] [ppm] [mg/m³] [ppm] [mg/m³] tion

CA

ethanol

64-17-5 OEL

(BC)

1,000

"BC Regulation"

CA

ethanol

64-17-5 OEL

(ON-

MoL)

1,000

MoL

CA ethanol (ethyl alco- 64-17-5 OEL 1,000 1,880

hol)

(AB)

OHS Code

CA

ethyl alcohol

64-17-5 PEV/ 1,000 1,880

VEA

Regulation OHS

Notation Ceiling-C STEL
TWA

ceiling value is a limit value above which exposure should not occur short-term exposure limit: a limit value above which exposure should not occur and which is related to a 15-minute period (unless otherwise specified) time-weighted average (long-term exposure limit): measured or calculated in relation to a reference period of 8 hours timeweighted average (unless otherwise specified

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Safety Data Sheet
acc. to Hazardous Products Regulations (HPR)

Version number: 2.0 Replaces version of: (1. 0)

UGES Extraction Solution

Revision: 2021-07-01

Relevant DNELs of components of the mixture

Name of substance
L-Arginine monohydrochloride
L-Arginine monohydrochloride

CAS No 1119-34-2 1119-34-2

Endpoint Threshold Protection goal,

level

route of exposure

DNEL 668.2 mg/m³ human, inhalatory

DNEL

947.5 mg/kg human, dermal bw/day

Used in

Exposure time

worker (industry) chronic - systemic effects
worker (industry) chronic - systemic effects

Relevant PNECs of components of the mixture

Name of substance
L-Arginine monohydrochloride
L-Arginine monohydrochloride
L-Arginine monohydrochloride
L-Arginine monohydrochloride
L-Arginine monohydrochloride

CAS No 1119-34-2 1119-34-2 1119-34-2 1119-34-2 1119-34-2

Endpoint Threshold level

Organism

Environmental com- Exposure time partment

PNEC

2.2 mg/l

aquatic organisms

freshwater

short-term (single instance)

PNEC

0.22 mg/l aquatic organisms

marine water

short-term (single instance)

PNEC

12 g/l

aquatic organisms sewage treatment short-term (single in-

plant (STP)

stance)

PNEC

4.437 mg/kg aquatic organisms freshwater sediment short-term (single instance)

PNEC

0.444 mg/kg aquatic organisms

marine sediment short-term (single instance)

8.2 Exposure controls
Appropriate engineering controls
General ventilation.
Individual protection measures (personal protective equipment)
Eye/face protection
Wear eye/face protection.
Skin protection
- Hand protection
Wear suitable gloves. Chemical protection gloves are suitable, which are tested according to EN 374. Check leak-tightness/impermeability prior to use. In the case of wanting to use the gloves again, clean them before taking off and air them well. For special purposes, it is recommended to check the resistance to chemicals of the protective gloves mentioned above together with the supplier of these gloves.
- Other protection measures
Take recovery periods for skin regeneration. Preventive skin protection (barrier creams/ointments) is recommended. Wash hands thoroughly after handling.
Respiratory protection
In case of inadequate ventilation wear respiratory protection.
Environmental exposure controls
Use appropriate container to avoid environmental contamination. Keep away from drains, surface and ground water.

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acc. to Hazardous Products Regulations (HPR)

UGES Extraction Solution

Version number: 2.0 Replaces version of: (1. 0)

SECTION 9: Physical and chemical properties 9.1 Information on basic physical and chemical properties
Appearance

Physical state

liquid

Color

not determined

Revision: 2021-07-01

Particle

not relevant (liquid)

Odor Other safety parameters pH (value) Melting point/freezing point Initial boiling point and boiling range Flash point Evaporation rate Flammability (solid, gas) Explosive limits - Lower explosion limit (LEL) - Upper explosion limit (UEL)

characteristic
not determined not determined 64.7 °C at 1,013 hPa 9.7 °C at 1,013 hPa Not determined not relevant, (fluid)
2.5 vol% 13.5 vol%

Vapor pressure Density Vapor density Relative density Solubility(ies) Partition coefficient - n-octanol/water (log KOW)

169.3 hPa at 25 °C not determined this information is not available Information on this property is not available not determined
this information is not available

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UGES Extraction Solution

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Auto-ignition temperature

455 °C (auto-ignition temperature (liquids and gases))

Viscosity

not determined

Explosive properties

not explosive (GHS of the United Nations, annex 4)

Oxidizing properties

none

9.2 Other information Solvent content

91.47 %

Solid content

8.531 %

Temperature class (USA, acc. to NEC 500)

T1 (maximum permissible surface temperature on the equipment:
450°C)

SECTION 10: Stability and reactivity

10.1

Reactivity
Concerning incompatibility: see below "Conditions to avoid" and "Incompatible materials". The mixture contains reactive substance(s). Risk of ignition.
If heated:
Risk of ignition

10.2 Chemical stability
See below "Conditions to avoid".

10.3 Possibility of hazardous reactions
No known hazardous reactions.

10.4

Conditions to avoid
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
Hints to prevent fire or explosion
Use explosion-proof electrical/ventilating/lighting/equipment. Use only non-sparking tools. Take precautionary measures against static discharge.

10.5 Incompatible materials
Oxidizers

10.6

Hazardous decomposition products
Reasonably anticipated hazardous decomposition products produced as a result of use, storage, spill and heating are not known. Hazardous combustion products: see section 5.

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acc. to Hazardous Products Regulations (HPR)

UGES Extraction Solution

Version number: 2.0 Replaces version of: (1. 0)

Revision: 2021-07-01

SECTION 11: Toxicological information

11.1

Information on toxicological effects
Test data are not available for the complete mixture.
Classification procedure
The method for classification of the mixture is based on ingredients of the mixture (additivity formula).
Classification acc. to GHS Acute toxicity
Shall not be classified as acutely toxic.
Skin corrosion/irritation
Shall not be classified as corrosive/irritant to skin.
Serious eye damage/eye irritation
Shall not be classified as seriously damaging to the eye or eye irritant.
Respiratory or skin sensitization
Shall not be classified as a respiratory or skin sensitizer.
Germ cell mutagenicity
Shall not be classified as germ cell mutagenic.
Carcinogenicity
Shall not be classified as carcinogenic.
Reproductive toxicity
Shall not be classified as a reproductive toxicant.
Specific target organ toxicity - single exposure
Shall not be classified as a specific target organ toxicant (single exposure).
Specific target organ toxicity - repeated exposure
Shall not be classified as a specific target organ toxicant (repeated exposure).
Aspiration hazard
Shall not be classified as presenting an aspiration hazard.

SECTION 12: Ecological information
12.1 Toxicity
Shall not be classified as hazardous to the aquatic environment.
12.2 Persistence and degradability
Data are not available.
12.3 Bioaccumulative potential
Data are not available.
12.4 Mobility in soil
Data are not available.

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12.5 Results of PBT and vPvB assessment
Data are not available.
12.6 Endocrine disrupting properties
None of the ingredients are listed.
12.7 Other adverse effects
Data are not available.

Revision: 2021-07-01

SECTION 13: Disposal considerations

13.1

Waste treatment methods Waste treatment-relevant information
Solvent reclamation/regeneration.
Sewage disposal-relevant information
Do not empty into drains. Avoid release to the environment. Refer to special instructions/safety data sheets.
Waste treatment of containers/packages
Only packagings which are approved (e.g. acc. to the Dangerous Goods Regulations) may be used. Completely emptied packages can be recycled. Handle contaminated packages in the same way as the substance itself.

Remarks
Please consider the relevant national or regional provisions. Waste shall be separated into the categories that can be handled separately by the local or national waste management facilities.

SECTION 14: Transport information

14.1

UN number UN RTDG IMDG-Code ICAO-TI

14.2

UN proper shipping name UN RTDG IMDG-Code ICAO-TI

14.3

Transport hazard class(es) UN RTDG IMDG-Code ICAO-TI

14.4

Packing group UN RTDG IMDG-Code ICAO-TI

UN 1170 UN 1170 UN 1170
ETHANOL ETHANOL Ethanol
3 3 3
II II II

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14.5 Environmental hazards

non-environmentally hazardous acc. to the dangerous goods regulations

14.6 Special precautions for user
There is no additional information.

14.7 Transport in bulk according to Annex II of MARPOL and the IBC Code
The cargo is not intended to be carried in bulk.

Information for each of the UN Model Regulations

Transport information - National regulations - Additional information (UN RTDG)

UN number

1170

Class

3

Packing group

II

Danger label(s)

3

Special provisions (SP)

144 (UN RTDG)

Excepted quantities (EQ)

E2 (UN RTDG)

Limited quantities (LQ)

1 L (UN RTDG)

International Maritime Dangerous Goods Code (IMDG) - Additional information

Marine pollutant

-

Danger label(s)

3

Special provisions (SP)

144

Excepted quantities (EQ)

E2

Limited quantities (LQ)

1 L

EmS

F-E, S-D

Stowage category

A

International Civil Aviation Organization (ICAO-IATA/DGR) - Additional information

Danger label(s)

3

Special provisions (SP) Excepted quantities (EQ) Limited quantities (LQ)

A3, A58, A180 E2 1 L

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UGES Extraction Solution

Version number: 2.0 Replaces version of: (1. 0)

Revision: 2021-07-01

SECTION 15: Regulatory information

15.1

Safety, health and environmental regulations specific for the product in question National regulations (United States) Superfund Amendment and Reauthorization Act (SARA TITLE III ) - The List of Extremely Hazardous Substances and Their Threshold Planning Quantities (EPCRA Section 302, 304)
none of the ingredients are listed
- Specific Toxic Chemical Listings (EPCRA Section 313)
none of the ingredients are listed
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) - List of Hazardous Substances and Reportable Quantities (CERCLA section 102a) (40 CFR 302.4)
none of the ingredients are listed
Clean Air Act
none of the ingredients are listed
Right to Know Hazardous Substance List - Hazardous Substance List (NJ-RTK)

Name of substance Ethyl alcohol

Legend
CA F3 MU TE

Carcinogenic Flammable - Third Degree Mutagenic Teratogenic

CAS No 64-17-5

Remarks

Classifications
CA MU TE F3

California Environmental Protection Agency (Cal/EPA): Proposition 65 - Safe Drinking Water and Toxic Enforcement Act of 1987

Proposition 65 List of chemicals
Name acc. to inventory ethanol (ethyl alcohol)

CAS No 64-17-5

Remarks in alcoholic beverages

Type of the toxicity developmental

Industry or sector specific available guidance(s) NPCA-HMIS® III
Hazardous Materials Identification System. American Coatings Association.

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Category Chronic Health Flammability Physical hazard
Personal protection

Rating * 0 3 0
-

Description chronic (long-term) health effects may result from repeated overexposure
no significant risk to health material that can be ignited under almost all ambient temperature conditions material that is normally stable, even under fire conditions, and will not react with water,
polymerize, decompose, condense, or self-react. Non-explosive

NFPA® 704
National Fire Protection Association: Standard System for the Identification of the Hazards of Materials for Emergency Response (United States).

Category
Flammability Health
Instability Special hazard

Degree of hazard 3 0
0

Description
material that can be ignited under almost all ambient temperature conditions material that, under emergency conditions, would offer no hazard beyond that of ordin-
ary combustible material material that is normally stable, even under fire conditions

National inventories

Country

Inventory

AU

AICS

CA

DSL

CN

IECSC

EU

ECSI

EU

REACH Reg.

JP

CSCL-ENCS

JP

ISHA-ENCS

KR

KECI

MX

INSQ

NZ

NZIoC

PH

PICCS

TR

CICR

TW

TCSI

US

TSCA

Legend AICS

Australian Inventory of Chemical Substances

Status not all ingredients are listed not all ingredients are listed not all ingredients are listed not all ingredients are listed not all ingredients are listed not all ingredients are listed not all ingredients are listed not all ingredients are listed not all ingredients are listed not all ingredients are listed not all ingredients are listed not all ingredients are listed
all ingredients are listed not all ingredients are listed

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Legend
CICR CSCL-ENCS DSL ECSI IECSC INSQ ISHA-ENCS KECI NZIoC PICCS REACH Reg. TCSI TSCA

Chemical Inventory and Control Regulation List of Existing and New Chemical Substances (CSCL-ENCS) Domestic Substances List (DSL) EC Substance Inventory (EINECS, ELINCS, NLP) Inventory of Existing Chemical Substances Produced or Imported in China National Inventory of Chemical Substances Inventory of Existing and New Chemical Substances (ISHA-ENCS) Korea Existing Chemicals Inventory New Zealand Inventory of Chemicals Philippine Inventory of Chemicals and Chemical Substances (PICCS) REACH registered substances Taiwan Chemical Substance Inventory Toxic Substance Control Act

Revision: 2021-07-01

15.2 Chemical Safety Assessment
Chemical safety assessments for substances in this mixture were not carried out.

SECTION 16: Other information Abbreviations and acronyms

Abbr.

Descriptions of used abbreviations

"BC Regulation"

OHS Regulation: Section 5.48 (British Columbia)

CAS

Chemical Abstracts Service (service that maintains the most comprehensive list of chemical substances)

Ceiling-C

Ceiling value

DGR

Dangerous Goods Regulations (see IATA/DGR)

DNEL

Derived No-Effect Level

EINECS

European Inventory of Existing Commercial Chemical Substances

ELINCS

European List of Notified Chemical Substances

EmS

Emergency Schedule

GHS

"Globally Harmonized System of Classification and Labelling of Chemicals" developed by the United Nations

IATA

International Air Transport Association

IATA/DGR

Dangerous Goods Regulations (DGR) for the air transport (IATA)

ICAO

International Civil Aviation Organization

ICAO-TI

Technical instructions for the safe transport of dangerous goods by air

IMDG

International Maritime Dangerous Goods Code

IMDG-Code

International Maritime Dangerous Goods Code

MARPOL

International Convention for the Prevention of Pollution from Ships (abbr. of "Marine Pollutant")

MoL

Ministry of Labor: Current Occupational Exposure Limits for Ontario Workplaces Required under Regulation 833

NLP

No-Longer Polymer

NPCA-HMIS® III National Paint and Coatings Association: Hazardous Materials Identification System - HMIS® III, Third Edition

OHS Code

Occupational Health and Safety Code: Occupational exposure limits for chemical substances (Alberta)

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Abbr. PBT PNEC ppm Regulation OHS
RTECS Skin Corr. Skin Irrit.
STEL TWA UN RTDG vPvB

UGES Extraction Solution

Revision: 2021-07-01

Descriptions of used abbreviations Persistent, Bioaccumulative and Toxic
Predicted No-Effect Concentration Parts per million
Regulation respecting occupational health and safety: Permissible exposure values for airborne contaminants (Quebec)
Registry of Toxic Effects of Chemical Substances (database of NIOSH with toxicological information) Corrosive to skin Irritant to skin
Short-term exposure limit Time-weighted average
UN Recommendations on the Transport of Dangerous Good Very Persistent and very Bioaccumulative

Key literature references and sources for data
Hazardous Products Regulations (HPR).
UN Recommendations on the Transport of Dangerous Good. International Maritime Dangerous Goods Code (IMDG). Dangerous Goods Regulations (DGR) for the air transport (IATA).
Classification procedure
Physical and chemical properties: The classification is based on tested mixture. Health hazards, Environmental hazards: The method for classification of the mixture is based on ingredients of the mixture (additivity formula).
List of relevant phrases (code and full text as stated in chapter 2 and 3)

Code H225 H314

Text Highly flammable liquid and vapour. Causes severe skin burns and eye damage.

Disclaimer
This information is based upon the present state of our knowledge. This SDS has been compiled and is solely intended for this product.

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Dilution Solution

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Revision: 2021-07-01

SECTION 1: Identification

1.1 Product identifier Trade name Alternative name(s)
Product code(s)

Dilution Solution
Dilution Solution GlutenTox Pro, Dilution Solution GlutenTox Pro Surface, Dilution Solution GlutenTox Pro Surface Fast, Dilution Solution GlutenTox Sticks Plus, Dilution Solution GlutenTox Sticks Plus for Reader, Dilution Solution GlutenTox Home
ASY3037, ASY3010, ASY3012, ASY3039, ASY3189, ASY3193

1.2 Relevant identified uses of the substance or mixture and uses advised against

Relevant identified uses

Laboratory and analytical use

1.3 Details of the supplier of the safety data sheet
Hygiena USA 941 Avenida Acaso Camarillo California 93012 United States

Telephone: +1 (805) 388-8007 Telefax: +1 (805) 388-5531 e-mail: info@hygiena.com
e-mail (competent person)
1.4 Emergency telephone number
Emergency information service

info@hygiena.com
1-888-494-4362 This number is only available during the following office hours: Mon-Fri 08:00 AM - 05:00 PM

SECTION 2: Hazard identification
2.1 Classification of the substance or mixture Classification acc. to GHS
This mixture does not meet the criteria for classification.
2.2 Label elements Labeling
not required
2.3 Other hazards
of no significance

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Dilution Solution

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SECTION 3: Composition/information on ingredients
3.1 Substances
Not relevant (mixture)
3.2 Mixtures Description of the mixture

Name of substance Pyrogen Free Water
Sodium Chloride Tris HCl Tween 20
EDTA disodium dihydrate Polyvinylpyrrolidone Sodium Hydroxide

Identifier
CAS No 7732-18-5
CAS No 7647-14-5
CAS No 1185-53-1
CAS No 9005-64-5
CAS No 6381-92-6
CAS No 9003-39-8
CAS No 1310-73-2

Wt% 90 1­<3 1­<3 1­<3 0.1­<1 0.1­<1 <0.1

Classification acc. to GHS

For full text of abbreviations: see SECTION 16.

Revision: 2021-07-01 Pictograms

SECTION 4: First-aid measures
4.1 Description of first-aid measures General notes
Do not leave affected person unattended. Remove victim out of the danger area. Keep affected person warm, still and covered. Take off immediately all contaminated clothing. In all cases of doubt, or when symptoms persist, seek medical advice. In case of unconsciousness place person in the recovery position. Never give anything by mouth.
Following inhalation
If breathing is irregular or stopped, immediately seek medical assistance and start first aid actions. Provide fresh air.
Following skin contact
Wash with plenty of soap and water.
Following eye contact
Remove contact lenses, if present and easy to do. Continue rinsing. Irrigate copiously with clean, fresh water for at least 10 minutes, holding the eyelids apart.
Following ingestion
Rinse mouth with water (only if the person is conscious). Do NOT induce vomiting.
4.2 Most important symptoms and effects, both acute and delayed
Symptoms and effects are not known to date.

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4.3 Indication of any immediate medical attention and special treatment needed
none

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SECTION 5: Fire-fighting measures
5.1 Extinguishing media Suitable extinguishing media
Water spray, BC-powder, Carbon dioxide (CO2)
Unsuitable extinguishing media
Water jet
5.2 Special hazards arising from the substance or mixture Hazardous combustion products
Nitrogen oxides (NOx), Carbon monoxide (CO), Carbon dioxide (CO2)
5.3 Advice for firefighters
In case of fire and/or explosion do not breathe fumes. Coordinate firefighting measures to the fire surroundings. Do not allow firefighting water to enter drains or water courses. Collect contaminated firefighting water separately. Fight fire with normal precautions from a reasonable distance.

SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures For non-emergency personnel
Remove persons to safety.
For emergency responders
Wear breathing apparatus if exposed to vapors/dust/aerosols/gases.
6.2 Environmental precautions
Keep away from drains, surface and ground water. Retain contaminated washing water and dispose of it.
6.3 Methods and material for containment and cleaning up Advice on how to contain a spill
Covering of drains
Advice on how to clean up a spill
Wipe up with absorbent material (e.g. cloth, fleece). Collect spillage: sawdust, kieselgur (diatomite), sand, universal binder
Appropriate containment techniques
Use of adsorbent materials.
Other information relating to spills and releases
Place in appropriate containers for disposal. Ventilate affected area.
6.4 Reference to other sections
Hazardous combustion products: see section 5. Personal protective equipment: see section 8. Incompatible materials: see section 10. Disposal considerations: see section 13.

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SECTION 7: Handling and storage

7.1 Precautions for safe handling Recommendations - Measures to prevent fire as well as aerosol and dust generation
Use local and general ventilation. Use only in well-ventilated areas.
Advice on general occupational hygiene
Wash hands after use. Do not eat, drink and smoke in work areas. Remove contaminated clothing and protective equipment before entering eating areas. Never keep food or drink in the vicinity of chemicals. Never place chemicals in containers that are normally used for food or drink. Keep away from food, drink and animal feedingstuffs.
7.2 Conditions for safe storage, including any incompatibilities Control of the effects Protect against external exposure, such as
frost
7.3 Specific end use(s)
See section 16 for a general overview.

SECTION 8: Exposure controls/personal protection 8.1 Control parameters

Occupational exposure limit values (Workplace Exposure Limits)

Coun- Name of agent try

CAS No Identi- TWA

TWA

STEL

STEL Ceiling-C Ceiling-C Nota- Source

fier [ppm] [mg/m³] [ppm] [mg/m³] [ppm] [mg/m³] tion

CA sodium hydroxide 1310-73-2 OEL (AB)

2

OHS

Code

CA sodium hydroxide 1310-73-2 OEL (BC)

2

"BC Reg-

ulation"

CA sodium hydroxide 1310-73-2 OEL (ONMoL)

2

MoL

CA sodium hydroxide 1310-73-2 PEV/ VEA

2

Regula-

tion OHS

Notation Ceiling-C STEL
TWA

ceiling value is a limit value above which exposure should not occur short-term exposure limit: a limit value above which exposure should not occur and which is related to a 15-minute period (unless otherwise specified) time-weighted average (long-term exposure limit): measured or calculated in relation to a reference period of 8 hours timeweighted average (unless otherwise specified

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Relevant DNELs of components of the mixture

Name of substance
Tris HCl
Tris HCl
EDTA disodium dihydrate
EDTA disodium dihydrate
EDTA disodium dihydrate
EDTA disodium dihydrate
Sodium Hydroxide

CAS No 1185-53-1 1185-53-1 6381-92-6 6381-92-6 6381-92-6

Endpoint Threshold Protection goal,

level

route of exposure

DNEL 152.8 mg/m³ human, inhalatory

DNEL DNEL

216.6 mg/kg human, dermal bw/day
1.5 mg/m³ human, inhalatory

DNEL

3 mg/m³ human, inhalatory

DNEL 1.5 mg/m³ human, inhalatory

Used in

Exposure time

worker (industry) chronic - systemic effects

worker (industry) chronic - systemic effects

worker (industry) chronic - systemic effects

worker (industry)

acute - systemic effects

worker (industry) chronic - local effects

6381-92-6

DNEL

3 mg/m³ human, inhalatory worker (industry) acute - local effects

1310-73-2

DNEL

1 mg/m³ human, inhalatory worker (industry) chronic - local effects

Relevant PNECs of components of the mixture

Name of substance
Tween 20
Tween 20
Tween 20
Tween 20
EDTA disodium dihydrate
EDTA disodium dihydrate
EDTA disodium dihydrate
EDTA disodium dihydrate

CAS No 9005-64-5 9005-64-5 9005-64-5 9005-64-5 6381-92-6 6381-92-6 6381-92-6 6381-92-6

Endpoint Threshold level

Organism

Environmental com- Exposure time partment

PNEC

0.2 mg/l

aquatic organisms

freshwater

short-term (single instance)

PNEC

0.02 mg/l aquatic organisms

marine water

short-term (single instance)

PNEC

1.141 mg/kg aquatic organisms freshwater sediment short-term (single instance)

PNEC

1,000 mg/kg aquatic organisms

marine sediment short-term (single instance)

PNEC

2.5 mg/l

aquatic organisms

freshwater

short-term (single instance)

PNEC

0.25 mg/l aquatic organisms

marine water

short-term (single instance)

PNEC

50 mg/l

aquatic organisms sewage treatment short-term (single in-

plant (STP)

stance)

PNEC

1.1 mg/kg

terrestrial organisms

soil

short-term (single in-

stance)

8.2 Exposure controls Appropriate engineering controls
General ventilation.

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Individual protection measures (personal protective equipment)
Eye/face protection
Wear eye/face protection.
Skin protection
- Hand protection
Wear suitable gloves. Chemical protection gloves are suitable, which are tested according to EN 374. Check leak-tightness/impermeability prior to use. In the case of wanting to use the gloves again, clean them before taking off and air them well. For special purposes, it is recommended to check the resistance to chemicals of the protective gloves mentioned above together with the supplier of these gloves.
- Other protection measures
Take recovery periods for skin regeneration. Preventive skin protection (barrier creams/ointments) is recommended. Wash hands thoroughly after handling.
Respiratory protection
In case of inadequate ventilation wear respiratory protection.
Environmental exposure controls
Use appropriate container to avoid environmental contamination. Keep away from drains, surface and ground water.

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties Appearance

Physical state

liquid

Color

not determined

Particle

not relevant (liquid)

Odor Other safety parameters pH (value) Melting point/freezing point Initial boiling point and boiling range Flash point Evaporation rate Flammability (solid, gas) Vapor pressure Density

characteristic
not determined not determined 225 °C at 1,013 hPa not determined Not determined not relevant, (fluid) 0 Pa at 20 °C not determined

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Vapor density Relative density Solubility(ies) Partition coefficient - n-octanol/water (log KOW)

this information is not available Information on this property is not available not determined
this information is not available

Auto-ignition temperature Viscosity Explosive properties Oxidizing properties 9.2 Other information Solvent content Solid content

not determined not determined not explosive (GHS of the United Nations, annex 4) none
94.66 % 5.343 %

SECTION 10: Stability and reactivity

10.1 Reactivity
Concerning incompatibility: see below "Conditions to avoid" and "Incompatible materials".

10.2

Chemical stability
The material is stable under normal ambient and anticipated storage and handling conditions of temperature and pressure.

10.3 Possibility of hazardous reactions
No known hazardous reactions.

10.4 Conditions to avoid
There are no specific conditions known which have to be avoided.

10.5 Incompatible materials
Oxidizers

10.6

Hazardous decomposition products
Reasonably anticipated hazardous decomposition products produced as a result of use, storage, spill and heating are not known. Hazardous combustion products: see section 5.

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SECTION 11: Toxicological information

11.1

Information on toxicological effects
Test data are not available for the complete mixture.
Classification procedure
The method for classification of the mixture is based on ingredients of the mixture (additivity formula).
Classification acc. to GHS
This mixture does not meet the criteria for classification.
Acute toxicity
Shall not be classified as acutely toxic.
Skin corrosion/irritation
Shall not be classified as corrosive/irritant to skin.
Serious eye damage/eye irritation
Shall not be classified as seriously damaging to the eye or eye irritant.
Respiratory or skin sensitization
Shall not be classified as a respiratory or skin sensitizer.
Germ cell mutagenicity
Shall not be classified as germ cell mutagenic.
Carcinogenicity
Shall not be classified as carcinogenic.
Reproductive toxicity
Shall not be classified as a reproductive toxicant.
Specific target organ toxicity - single exposure
Shall not be classified as a specific target organ toxicant (single exposure).
Specific target organ toxicity - repeated exposure
Shall not be classified as a specific target organ toxicant (repeated exposure).
Aspiration hazard
Shall not be classified as presenting an aspiration hazard.

SECTION 12: Ecological information
12.1 Toxicity 12.2 Persistence and degradability
Data are not available.
12.3 Bioaccumulative potential
Data are not available.
12.4 Mobility in soil
Data are not available.

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12.5 Results of PBT and vPvB assessment
Data are not available.
12.6 Endocrine disrupting properties
None of the ingredients are listed.
12.7 Other adverse effects
Data are not available.

Revision: 2021-07-01

SECTION 13: Disposal considerations

13.1

Waste treatment methods Sewage disposal-relevant information
Do not empty into drains. Avoid release to the environment. Refer to special instructions/safety data sheets.
Waste treatment of containers/packages
Completely emptied packages can be recycled. Handle contaminated packages in the same way as the substance itself.

Remarks
Please consider the relevant national or regional provisions. Waste shall be separated into the categories that can be handled separately by the local or national waste management facilities.

SECTION 14: Transport information

14.1 UN number 14.2 UN proper shipping name 14.3 Transport hazard class(es) 14.4 Packing group 14.5 Environmental hazards
14.6 Special precautions for user
There is no additional information.

not subject to transport regulations not relevant not assigned not assigned non-environmentally hazardous acc. to the dangerous goods regulations

14.7 Transport in bulk according to Annex II of MARPOL and the IBC Code
The cargo is not intended to be carried in bulk.

Information for each of the UN Model Regulations Transport information - National regulations - Additional information (UN RTDG)
Not subject to transport regulations: UN RTDG
International Maritime Dangerous Goods Code (IMDG) - Additional information
Not subject to IMDG.
International Civil Aviation Organization (ICAO-IATA/DGR) - Additional information
Not subject to ICAO-IATA.

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SECTION 15: Regulatory information

15.1

Safety, health and environmental regulations specific for the product in question National regulations (United States) Superfund Amendment and Reauthorization Act (SARA TITLE III ) - The List of Extremely Hazardous Substances and Their Threshold Planning Quantities (EPCRA Section 302, 304)
none of the ingredients are listed
- Specific Toxic Chemical Listings (EPCRA Section 313)
none of the ingredients are listed
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) - List of Hazardous Substances and Reportable Quantities (CERCLA section 102a) (40 CFR 302.4)

Name of substance

CAS No

Remarks

Statutory code

Sodium Hydroxide

1310-73-2

1

Legend

1

"1" indicates that the statutory source is section 311(b)(2) of the Clean Water Act

Final RQ pounds (Kg) 1000 (454)

Clean Air Act
none of the ingredients are listed
Right to Know Hazardous Substance List - Hazardous Substance List (NJ-RTK)

Name of substance Sodium Hydroxide

CAS No 1310-73-2

Legend

CO

Corrosive

R1

Reactive - First Degree

Remarks

Classifications
CO R1

California Environmental Protection Agency (Cal/EPA): Proposition 65 - Safe Drinking Water and Toxic Enforcement Act of 1987
none of the ingredients are listed

Industry or sector specific available guidance(s) NPCA-HMIS® III
Hazardous Materials Identification System. American Coatings Association.

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Category Chronic Health Flammability Physical hazard
Personal protection

Rating / 0 1 0
-

Description none
no significant risk to health material that must be preheated before ignition can occur material that is normally stable, even under fire conditions, and will not react with water, polymerize, decompose, condense, or self-react. Non-explosive

NFPA® 704
National Fire Protection Association: Standard System for the Identification of the Hazards of Materials for Emergency Response (United States).

Category
Flammability Health
Instability Special hazard

Degree of hazard 1 0
0

Description
material that must be preheated before ignition can occur material that, under emergency conditions, would offer no hazard beyond that of ordin-
ary combustible material material that is normally stable, even under fire conditions

National inventories

Country

Inventory

Status

AU

AICS

not all ingredients are listed

CA

DSL

not all ingredients are listed

CN

IECSC

not all ingredients are listed

EU

ECSI

not all ingredients are listed

EU

REACH Reg.

not all ingredients are listed

JP

CSCL-ENCS

not all ingredients are listed

KR

KECI

not all ingredients are listed

MX

INSQ

not all ingredients are listed

NZ

NZIoC

not all ingredients are listed

PH

PICCS

not all ingredients are listed

TR

CICR

not all ingredients are listed

TW

TCSI

not all ingredients are listed

US

TSCA

not all ingredients are listed

Legend
AICS CICR CSCL-ENCS

Australian Inventory of Chemical Substances Chemical Inventory and Control Regulation List of Existing and New Chemical Substances (CSCL-ENCS)

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Legend
DSL ECSI IECSC INSQ KECI NZIoC PICCS REACH Reg. TCSI TSCA

Domestic Substances List (DSL) EC Substance Inventory (EINECS, ELINCS, NLP) Inventory of Existing Chemical Substances Produced or Imported in China National Inventory of Chemical Substances Korea Existing Chemicals Inventory New Zealand Inventory of Chemicals Philippine Inventory of Chemicals and Chemical Substances (PICCS) REACH registered substances Taiwan Chemical Substance Inventory Toxic Substance Control Act

Revision: 2021-07-01

15.2 Chemical Safety Assessment
Chemical safety assessments for substances in this mixture were not carried out.

SECTION 16: Other information Abbreviations and acronyms

Abbr.

Descriptions of used abbreviations

"BC Regulation"

OHS Regulation: Section 5.48 (British Columbia)

CAS

Chemical Abstracts Service (service that maintains the most comprehensive list of chemical substances)

Ceiling-C

Ceiling value

DGR

Dangerous Goods Regulations (see IATA/DGR)

DNEL

Derived No-Effect Level

EINECS

European Inventory of Existing Commercial Chemical Substances

ELINCS

European List of Notified Chemical Substances

GHS

"Globally Harmonized System of Classification and Labelling of Chemicals" developed by the United Nations

IATA

International Air Transport Association

IATA/DGR

Dangerous Goods Regulations (DGR) for the air transport (IATA)

ICAO

International Civil Aviation Organization

IMDG

International Maritime Dangerous Goods Code

MARPOL

International Convention for the Prevention of Pollution from Ships (abbr. of "Marine Pollutant")

MoL

Ministry of Labor: Current Occupational Exposure Limits for Ontario Workplaces Required under Regulation 833

NLP

No-Longer Polymer

NPCA-HMIS® III National Paint and Coatings Association: Hazardous Materials Identification System - HMIS® III, Third Edition

OHS Code

Occupational Health and Safety Code: Occupational exposure limits for chemical substances (Alberta)

PBT

Persistent, Bioaccumulative and Toxic

PNEC

Predicted No-Effect Concentration

ppm

Parts per million

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Abbr. Regulation OHS
RTECS STEL TWA UN RTDG vPvB

Descriptions of used abbreviations Regulation respecting occupational health and safety: Permissible exposure values for airborne contamin-
ants (Quebec) Registry of Toxic Effects of Chemical Substances (database of NIOSH with toxicological information)
Short-term exposure limit Time-weighted average
UN Recommendations on the Transport of Dangerous Good Very Persistent and very Bioaccumulative

Key literature references and sources for data
Hazardous Products Regulations (HPR).
UN Recommendations on the Transport of Dangerous Good. International Maritime Dangerous Goods Code (IMDG). Dangerous Goods Regulations (DGR) for the air transport (IATA).
Classification procedure
Physical and chemical properties: The classification is based on tested mixture. Health hazards, Environmental hazards: The method for classification of the mixture is based on ingredients of the mixture (additivity formula).
Disclaimer
This information is based upon the present state of our knowledge. This SDS has been compiled and is solely intended for this product.

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SECTION 1: Identification

1.1 Product identifier Trade name

Positive Control

Alternative name(s)

Positive Control GlutenTox Sticks Plus, Positive Control GlutenTox Sticks Plus for Reader

Product code(s)

ASY3052

1.2 Relevant identified uses of the substance or mixture and uses advised against

Relevant identified uses

Laboratory and analytical use

1.3 Details of the supplier of the safety data sheet

Hygiena USA 941 Avenida Acaso Camarillo California 93012 United States

Telephone: +1 (805) 388-8007 Telefax: +1 (805) 388-5531 e-mail: info@hygiena.com
e-mail (competent person)
1.4 Emergency telephone number
Emergency information service

info@hygiena.com
1-888-494-4362 This number is only available during the following office hours: Mon-Fri 08:00 AM - 05:00 PM

SECTION 2: Hazard identification
2.1 Classification of the substance or mixture Classification acc. to GHS
This mixture does not meet the criteria for classification.
2.2 Label elements Labeling
not required
2.3 Other hazards
of no significance

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SECTION 3: Composition/information on ingredients
3.1 Substances
Not relevant (mixture)
3.2 Mixtures Description of the mixture

Name of substance Oat Flour

Identifier
CAS No 134134-86-4

Wt% 10­<25

Classification acc. to GHS

For full text of abbreviations: see SECTION 16.

Revision: 2021-10-05 Pictograms

SECTION 4: First-aid measures
4.1 Description of first-aid measures General notes
Do not leave affected person unattended. Remove victim out of the danger area. Keep affected person warm, still and covered. Take off immediately all contaminated clothing. In all cases of doubt, or when symptoms persist, seek medical advice. In case of unconsciousness place person in the recovery position. Never give anything by mouth.
Following inhalation
If breathing is irregular or stopped, immediately seek medical assistance and start first aid actions. Provide fresh air.
Following skin contact
Wash with plenty of soap and water.
Following eye contact
Remove contact lenses, if present and easy to do. Continue rinsing. Irrigate copiously with clean, fresh water for at least 10 minutes, holding the eyelids apart.
Following ingestion
Rinse mouth with water (only if the person is conscious). Do NOT induce vomiting.
4.2 Most important symptoms and effects, both acute and delayed
Symptoms and effects are not known to date.
4.3 Indication of any immediate medical attention and special treatment needed
none

SECTION 5: Fire-fighting measures
5.1 Extinguishing media Suitable extinguishing media
Water spray, BC-powder, Carbon dioxide (CO2)
Unsuitable extinguishing media
Water jet

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5.2 Special hazards arising from the substance or mixture Hazardous combustion products
Carbon monoxide (CO), Carbon dioxide (CO2)

5.3 Advice for firefighters
In case of fire and/or explosion do not breathe fumes. Coordinate firefighting measures to the fire surroundings. Do not allow firefighting water to enter drains or water courses. Collect contaminated firefighting water separately. Fight fire with normal precautions from a reasonable distance.

SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures For non-emergency personnel
Remove persons to safety.
For emergency responders
Wear breathing apparatus if exposed to vapors/dust/aerosols/gases.
6.2 Environmental precautions
Keep away from drains, surface and ground water. Retain contaminated washing water and dispose of it.
6.3 Methods and material for containment and cleaning up Advice on how to contain a spill
Covering of drains
Advice on how to clean up a spill
Wipe up with absorbent material (e.g. cloth, fleece). Collect spillage: sawdust, kieselgur (diatomite), sand, universal binder
Appropriate containment techniques
Use of adsorbent materials.
Other information relating to spills and releases
Place in appropriate containers for disposal. Ventilate affected area.
6.4 Reference to other sections
Hazardous combustion products: see section 5. Personal protective equipment: see section 8. Incompatible materials: see section 10. Disposal considerations: see section 13.

SECTION 7: Handling and storage
7.1 Precautions for safe handling Recommendations
- Measures to prevent fire as well as aerosol and dust generation
Use local and general ventilation. Use only in well-ventilated areas.
Advice on general occupational hygiene
Wash hands after use. Do not eat, drink and smoke in work areas. Remove contaminated clothing and protective equipment before entering eating areas. Never keep food or drink in the vicinity of chemicals. Never place chemicals in containers that are normally used for food or drink. Keep away from food, drink and animal feedingstuffs.

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7.2 Conditions for safe storage, including any incompatibilities 7.3 Specific end use(s)
See section 16 for a general overview.

Revision: 2021-10-05

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
This information is not available.
8.2 Exposure controls Appropriate engineering controls
General ventilation.
Individual protection measures (personal protective equipment)
Eye/face protection
Wear eye/face protection.
Skin protection - Hand protection
Wear suitable gloves. Chemical protection gloves are suitable, which are tested according to EN 374. Check leak-tightness/impermeability prior to use. In the case of wanting to use the gloves again, clean them before taking off and air them well. For special purposes, it is recommended to check the resistance to chemicals of the protective gloves mentioned above together with the supplier of these gloves.
- Other protection measures
Take recovery periods for skin regeneration. Preventive skin protection (barrier creams/ointments) is recommended. Wash hands thoroughly after handling.
Respiratory protection
In case of inadequate ventilation wear respiratory protection.
Environmental exposure controls
Use appropriate container to avoid environmental contamination. Keep away from drains, surface and ground water.

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties Appearance

Physical state

liquid

Color

not determined

Particle

not relevant (liquid)

Odor

characteristic

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Other safety parameters
pH (value)

Positive Control
not determined

Revision: 2021-10-05

Melting point/freezing point

not determined

Initial boiling point and boiling range

not determined

Flash point

not determined

Evaporation rate

Not determined

Flammability (solid, gas)

not relevant, (fluid)

Vapor pressure

not determined

Density

not determined

Vapor density

this information is not available

Relative density

Information on this property is not available

Solubility(ies) Partition coefficient - n-octanol/water (log KOW)

not determined this information is not available

Auto-ignition temperature Viscosity Explosive properties Oxidizing properties 9.2 Other information Solvent content Solid content

not determined not determined not explosive (GHS of the United Nations, annex 4) none
10 % 0 %

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SECTION 10: Stability and reactivity

10.1 Reactivity
Concerning incompatibility: see below "Conditions to avoid" and "Incompatible materials".

10.2

Chemical stability
The material is stable under normal ambient and anticipated storage and handling conditions of temperature and pressure.

10.3 Possibility of hazardous reactions
No known hazardous reactions.

10.4 Conditions to avoid
There are no specific conditions known which have to be avoided.

10.5 Incompatible materials
Oxidizers

10.6

Hazardous decomposition products
Reasonably anticipated hazardous decomposition products produced as a result of use, storage, spill and heating are not known. Hazardous combustion products: see section 5.

SECTION 11: Toxicological information
11.1 Information on toxicological effects
Test data are not available for the complete mixture.
Classification procedure
The method for classification of the mixture is based on ingredients of the mixture (additivity formula).
Classification acc. to GHS
This mixture does not meet the criteria for classification.
Acute toxicity
Shall not be classified as acutely toxic.
Skin corrosion/irritation
Shall not be classified as corrosive/irritant to skin.
Serious eye damage/eye irritation
Shall not be classified as seriously damaging to the eye or eye irritant.
Respiratory or skin sensitization
Shall not be classified as a respiratory or skin sensitizer.
Germ cell mutagenicity
Shall not be classified as germ cell mutagenic.
Carcinogenicity
Shall not be classified as carcinogenic.
Reproductive toxicity
Shall not be classified as a reproductive toxicant.

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Specific target organ toxicity - single exposure
Shall not be classified as a specific target organ toxicant (single exposure).
Specific target organ toxicity - repeated exposure
Shall not be classified as a specific target organ toxicant (repeated exposure).
Aspiration hazard
Shall not be classified as presenting an aspiration hazard.

Revision: 2021-10-05

SECTION 12: Ecological information
12.1 Toxicity 12.2 Persistence and degradability
Data are not available.
12.3 Bioaccumulative potential
Data are not available.
12.4 Mobility in soil
Data are not available.
12.5 Results of PBT and vPvB assessment
Data are not available.
12.6 Endocrine disrupting properties
None of the ingredients are listed.
12.7 Other adverse effects
Data are not available.

SECTION 13: Disposal considerations

13.1

Waste treatment methods Sewage disposal-relevant information
Do not empty into drains. Avoid release to the environment. Refer to special instructions/safety data sheets.
Waste treatment of containers/packages
Completely emptied packages can be recycled. Handle contaminated packages in the same way as the substance itself.

Remarks
Please consider the relevant national or regional provisions. Waste shall be separated into the categories that can be handled separately by the local or national waste management facilities.

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SECTION 14: Transport information

14.1 UN number

not subject to transport regulations

14.2 UN proper shipping name

not relevant

14.3 Transport hazard class(es)

not assigned

14.4 Packing group

not assigned

14.5 Environmental hazards

non-environmentally hazardous acc. to the dangerous goods regulations

14.6 Special precautions for user
There is no additional information.

14.7 Transport in bulk according to Annex II of MARPOL and the IBC Code
The cargo is not intended to be carried in bulk.

Information for each of the UN Model Regulations Transport information - National regulations - Additional information (UN RTDG)
Not subject to transport regulations: UN RTDG
International Maritime Dangerous Goods Code (IMDG) - Additional information
Not subject to IMDG.
International Civil Aviation Organization (ICAO-IATA/DGR) - Additional information
Not subject to ICAO-IATA.
SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations specific for the product in question National regulations (United States) Superfund Amendment and Reauthorization Act (SARA TITLE III ) - The List of Extremely Hazardous Substances and Their Threshold Planning Quantities (EPCRA Section 302, 304)
none of the ingredients are listed
- Specific Toxic Chemical Listings (EPCRA Section 313)
none of the ingredients are listed
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) - List of Hazardous Substances and Reportable Quantities (CERCLA section 102a) (40 CFR 302.4)
none of the ingredients are listed
Clean Air Act
none of the ingredients are listed
Right to Know Hazardous Substance List

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- Hazardous Substance List (NJ-RTK)
none of the ingredients are listed

California Environmental Protection Agency (Cal/EPA): Proposition 65 - Safe Drinking Water and Toxic Enforcement Act of 1987
none of the ingredients are listed

Industry or sector specific available guidance(s) NPCA-HMIS® III
Hazardous Materials Identification System. American Coatings Association.

Category Chronic Health Flammability Physical hazard
Personal protection

Rating / 0 1 0
-

Description none
no significant risk to health material that must be preheated before ignition can occur material that is normally stable, even under fire conditions, and will not react with water, polymerize, decompose, condense, or self-react. Non-explosive

NFPA® 704
National Fire Protection Association: Standard System for the Identification of the Hazards of Materials for Emergency Response (United States).

Category
Flammability Health
Instability Special hazard

Degree of hazard 1 0
0

Description
material that must be preheated before ignition can occur material that, under emergency conditions, would offer no hazard beyond that of ordin-
ary combustible material material that is normally stable, even under fire conditions

National regulations (Canada) Domestic Substances List (DSL)
All ingredients are listed.
National inventories

Country

Inventory

CA

DSL

NZ

NZIoC

Legend
DSL NZIoC

Domestic Substances List (DSL) New Zealand Inventory of Chemicals

Status all ingredients are listed all ingredients are listed

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15.2 Chemical Safety Assessment
Chemical safety assessments for substances in this mixture were not carried out.

Revision: 2021-10-05

SECTION 16: Other information Abbreviations and acronyms

Abbr.

Descriptions of used abbreviations

CAS

Chemical Abstracts Service (service that maintains the most comprehensive list of chemical substances)

DGR

Dangerous Goods Regulations (see IATA/DGR)

GHS

"Globally Harmonized System of Classification and Labelling of Chemicals" developed by the United Nations

IATA

International Air Transport Association

IATA/DGR

Dangerous Goods Regulations (DGR) for the air transport (IATA)

ICAO

International Civil Aviation Organization

IMDG

International Maritime Dangerous Goods Code

MARPOL

International Convention for the Prevention of Pollution from Ships (abbr. of "Marine Pollutant")

NPCA-HMIS® III National Paint and Coatings Association: Hazardous Materials Identification System - HMIS® III, Third Edition

PBT

Persistent, Bioaccumulative and Toxic

RTECS

Registry of Toxic Effects of Chemical Substances (database of NIOSH with toxicological information)

UN RTDG

UN Recommendations on the Transport of Dangerous Good

vPvB

Very Persistent and very Bioaccumulative

Key literature references and sources for data
Hazardous Products Regulations (HPR).
UN Recommendations on the Transport of Dangerous Good. International Maritime Dangerous Goods Code (IMDG). Dangerous Goods Regulations (DGR) for the air transport (IATA).
Classification procedure
Physical and chemical properties: The classification is based on tested mixture. Health hazards, Environmental hazards: The method for classification of the mixture is based on ingredients of the mixture (additivity formula).
Disclaimer
This information is based upon the present state of our knowledge. This SDS has been compiled and is solely intended for this product.

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SECTION 1: Identification

1.1 Product identifier Trade name Alternative name(s)
Product code(s)

Negative Control
Negative Control GlutenTox Sticks Plus, Negative Control GlutenTox Sticks Plus for Reader
ASY3051

1.2 Relevant identified uses of the substance or mixture and uses advised against

Relevant identified uses

Laboratory and analytical use

1.3 Details of the supplier of the safety data sheet
Hygiena USA 941 Avenida Acaso Camarillo California 93012 United States

Telephone: +1 (805) 388-8007 Telefax: +1 (805) 388-5531 e-mail: info@hygiena.com
e-mail (competent person)
1.4 Emergency telephone number
Emergency information service

info@hygiena.com
1-888-494-4362 This number is only available during the following office hours: Mon-Fri 08:00 AM - 05:00 PM

SECTION 2: Hazard identification
2.1 Classification of the substance or mixture Classification acc. to GHS
This mixture does not meet the criteria for classification.
2.2 Label elements Labeling
not required
2.3 Other hazards
of no significance

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SECTION 3: Composition/information on ingredients
3.1 Substances
Not relevant (mixture)
3.2 Mixtures Description of the mixture

Name of substance Corn Flour (Maicena)

Identifier
CAS No 9005-25-8

Wt% 10­<25

Classification acc. to GHS

For full text of abbreviations: see SECTION 16.

Revision: 2021-09-20 Pictograms

SECTION 4: First-aid measures
4.1 Description of first-aid measures General notes
Do not leave affected person unattended. Remove victim out of the danger area. Keep affected person warm, still and covered. Take off immediately all contaminated clothing. In all cases of doubt, or when symptoms persist, seek medical advice. In case of unconsciousness place person in the recovery position. Never give anything by mouth.
Following inhalation
If breathing is irregular or stopped, immediately seek medical assistance and start first aid actions. Provide fresh air.
Following skin contact
Wash with plenty of soap and water.
Following eye contact
Remove contact lenses, if present and easy to do. Continue rinsing. Irrigate copiously with clean, fresh water for at least 10 minutes, holding the eyelids apart.
Following ingestion
Rinse mouth with water (only if the person is conscious). Do NOT induce vomiting.
4.2 Most important symptoms and effects, both acute and delayed
Symptoms and effects are not known to date.
4.3 Indication of any immediate medical attention and special treatment needed
none

SECTION 5: Fire-fighting measures
5.1 Extinguishing media Suitable extinguishing media
Water spray, BC-powder, Carbon dioxide (CO2)
Unsuitable extinguishing media
Water jet

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5.2 Special hazards arising from the substance or mixture Hazardous combustion products
Carbon monoxide (CO), Carbon dioxide (CO2)

5.3 Advice for firefighters
In case of fire and/or explosion do not breathe fumes. Coordinate firefighting measures to the fire surroundings. Do not allow firefighting water to enter drains or water courses. Collect contaminated firefighting water separately. Fight fire with normal precautions from a reasonable distance.

SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures For non-emergency personnel
Remove persons to safety.
For emergency responders
Wear breathing apparatus if exposed to vapors/dust/aerosols/gases.
6.2 Environmental precautions
Keep away from drains, surface and ground water. Retain contaminated washing water and dispose of it.
6.3 Methods and material for containment and cleaning up Advice on how to contain a spill
Covering of drains
Advice on how to clean up a spill
Wipe up with absorbent material (e.g. cloth, fleece). Collect spillage: sawdust, kieselgur (diatomite), sand, universal binder
Appropriate containment techniques
Use of adsorbent materials.
Other information relating to spills and releases
Place in appropriate containers for disposal. Ventilate affected area.
6.4 Reference to other sections
Hazardous combustion products: see section 5. Personal protective equipment: see section 8. Incompatible materials: see section 10. Disposal considerations: see section 13.

SECTION 7: Handling and storage
7.1 Precautions for safe handling Recommendations - Measures to prevent fire as well as aerosol and dust generation
Use local and general ventilation. Use only in well-ventilated areas.
Advice on general occupational hygiene
Wash hands after use. Do not eat, drink and smoke in work areas. Remove contaminated clothing and protective equipment before entering eating areas. Never keep food or drink in the vicinity of chemicals. Never place chemicals in containers that are normally used for food or drink. Keep away from food, drink and animal feedingstuffs.

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7.2 Conditions for safe storage, including any incompatibilities 7.3 Specific end use(s)
See section 16 for a general overview.

Revision: 2021-09-20

SECTION 8: Exposure controls/personal protection 8.1 Control parameters

Occupational exposure limit values (Workplace Exposure Limits)

Coun- Name of agent try

CAS No Identi- TWA

TWA

STEL

STEL Ceiling-C Ceiling-C Nota- Source

fier [ppm] [mg/m³] [ppm] [mg/m³] [ppm] [mg/m³] tion

CA

starch

9005-25-8 OEL

10

(AB)

OHS Code

CA

starch

9005-25-8 OEL

10

(ON-

MoL)

MoL

CA

starch

9005-25-8 OEL

10

(BC)

i "BC Regulation"

CA

starch

9005-25-8 PEV/

10

VEA

noAsb_l Regulaess1Sil tion OHS

CA

starch

9005-25-8 OEL

3

(BC)

r "BC Regulation"

Notation

Ceiling-C ceiling value is a limit value above which exposure should not occur

i

inhalable fraction

noAsb_less1S contains no asbestos and less than 1% free crystalline silica

il

r

respirable fraction

STEL

short-term exposure limit: a limit value above which exposure should not occur and which is related to a 15-minute period

(unless otherwise specified)

TWA

time-weighted average (long-term exposure limit): measured or calculated in relation to a reference period of 8 hours time-

weighted average (unless otherwise specified

8.2 Exposure controls
Appropriate engineering controls
General ventilation.
Individual protection measures (personal protective equipment)
Eye/face protection
Wear eye/face protection.
Skin protection
- Hand protection
Wear suitable gloves. Chemical protection gloves are suitable, which are tested according to EN 374. Check leak-tightness/impermeability prior to use. In the case of wanting to use the gloves again, clean them before taking off and air them well. For special purposes, it is recommended to check the resistance to chemicals of the protective gloves mentioned above together with the supplier of these gloves.

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- Other protection measures
Take recovery periods for skin regeneration. Preventive skin protection (barrier creams/ointments) is recommended. Wash hands thoroughly after handling.
Respiratory protection
In case of inadequate ventilation wear respiratory protection.
Environmental exposure controls
Use appropriate container to avoid environmental contamination. Keep away from drains, surface and ground water.

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties Appearance

Physical state

liquid

Color

not determined

Particle

not relevant (liquid)

Odor Other safety parameters pH (value) Melting point/freezing point Initial boiling point and boiling range Flash point Evaporation rate Flammability (solid, gas) Vapor pressure Density Vapor density Relative density Solubility(ies) Partition coefficient - n-octanol/water (log KOW)

characteristic
not determined not determined not determined not determined Not determined not relevant, (fluid) not determined not determined this information is not available Information on this property is not available not determined
this information is not available

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Auto-ignition temperature

not determined

Viscosity

not determined

Explosive properties

not explosive (GHS of the United Nations, annex 4)

Oxidizing properties

none

9.2 Other information Solvent content

10 %

Solid content

0 %

SECTION 10: Stability and reactivity

10.1 Reactivity
Concerning incompatibility: see below "Conditions to avoid" and "Incompatible materials".

10.2

Chemical stability
The material is stable under normal ambient and anticipated storage and handling conditions of temperature and pressure.

10.3 Possibility of hazardous reactions
No known hazardous reactions.

10.4 Conditions to avoid
There are no specific conditions known which have to be avoided.

10.5 Incompatible materials
Oxidizers

10.6

Hazardous decomposition products
Reasonably anticipated hazardous decomposition products produced as a result of use, storage, spill and heating are not known. Hazardous combustion products: see section 5.

SECTION 11: Toxicological information

11.1

Information on toxicological effects
Test data are not available for the complete mixture.
Classification procedure
The method for classification of the mixture is based on ingredients of the mixture (additivity formula).
Classification acc. to GHS
This mixture does not meet the criteria for classification.
Acute toxicity
Shall not be classified as acutely toxic.
Skin corrosion/irritation
Shall not be classified as corrosive/irritant to skin.

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Serious eye damage/eye irritation
Shall not be classified as seriously damaging to the eye or eye irritant.
Respiratory or skin sensitization
Shall not be classified as a respiratory or skin sensitizer.
Germ cell mutagenicity
Shall not be classified as germ cell mutagenic.
Carcinogenicity
Shall not be classified as carcinogenic.
Reproductive toxicity
Shall not be classified as a reproductive toxicant.
Specific target organ toxicity - single exposure
Shall not be classified as a specific target organ toxicant (single exposure).
Specific target organ toxicity - repeated exposure
Shall not be classified as a specific target organ toxicant (repeated exposure).
Aspiration hazard
Shall not be classified as presenting an aspiration hazard.
SECTION 12: Ecological information
12.1 Toxicity 12.2 Persistence and degradability
Data are not available.
12.3 Bioaccumulative potential
Data are not available.
12.4 Mobility in soil
Data are not available.
12.5 Results of PBT and vPvB assessment
Data are not available.
12.6 Endocrine disrupting properties
None of the ingredients are listed.
12.7 Other adverse effects
Data are not available.

Revision: 2021-09-20

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SECTION 13: Disposal considerations

13.1

Waste treatment methods Sewage disposal-relevant information
Do not empty into drains. Avoid release to the environment. Refer to special instructions/safety data sheets.

Waste treatment of containers/packages
Completely emptied packages can be recycled. Handle contaminated packages in the same way as the substance itself.

Remarks
Please consider the relevant national or regional provisions. Waste shall be separated into the categories that can be handled separately by the local or national waste management facilities.

SECTION 14: Transport information

14.1 UN number 14.2 UN proper shipping name 14.3 Transport hazard class(es) 14.4 Packing group 14.5 Environmental hazards
14.6 Special precautions for user
There is no additional information.

not subject to transport regulations not relevant not assigned not assigned non-environmentally hazardous acc. to the dangerous goods regulations

14.7 Transport in bulk according to Annex II of MARPOL and the IBC Code
The cargo is not intended to be carried in bulk.

Information for each of the UN Model Regulations Transport information - National regulations - Additional information (UN RTDG)
Not subject to transport regulations: UN RTDG
International Maritime Dangerous Goods Code (IMDG) - Additional information
Not subject to IMDG.
International Civil Aviation Organization (ICAO-IATA/DGR) - Additional information
Not subject to ICAO-IATA.

SECTION 15: Regulatory information

15.1

Safety, health and environmental regulations specific for the product in question

National regulations (United States)

Toxic Substance Control Act (TSCA)

all ingredients are listed

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Superfund Amendment and Reauthorization Act (SARA TITLE III ) - The List of Extremely Hazardous Substances and Their Threshold Planning Quantities (EPCRA Section 302, 304)
none of the ingredients are listed
- Specific Toxic Chemical Listings (EPCRA Section 313)
none of the ingredients are listed
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) - List of Hazardous Substances and Reportable Quantities (CERCLA section 102a) (40 CFR 302.4)
none of the ingredients are listed
Clean Air Act
none of the ingredients are listed
Right to Know Hazardous Substance List - Hazardous Substance List (NJ-RTK)
none of the ingredients are listed
California Environmental Protection Agency (Cal/EPA): Proposition 65 - Safe Drinking Water and Toxic Enforcement Act of 1987
none of the ingredients are listed

Industry or sector specific available guidance(s) NPCA-HMIS® III
Hazardous Materials Identification System. American Coatings Association.

Category Chronic Health Flammability Physical hazard
Personal protection

Rating / 0 1 0
-

Description none
no significant risk to health material that must be preheated before ignition can occur material that is normally stable, even under fire conditions, and will not react with water, polymerize, decompose, condense, or self-react. Non-explosive

NFPA® 704
National Fire Protection Association: Standard System for the Identification of the Hazards of Materials for Emergency Response (United States).

Category Flammability
Health Instability

Degree of hazard 1 0
0

Description
material that must be preheated before ignition can occur material that, under emergency conditions, would offer no hazard beyond that of ordin-
ary combustible material material that is normally stable, even under fire conditions

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Category Special hazard

Degree of hazard

Description

National regulations (Canada) Domestic Substances List (DSL)
All ingredients are listed.
National inventories

Country

Inventory

Status

AU

AICS

all ingredients are listed

CA

DSL

all ingredients are listed

CN

IECSC

all ingredients are listed

EU

ECSI

all ingredients are listed

JP

CSCL-ENCS

all ingredients are listed

KR

KECI

all ingredients are listed

MX

INSQ

all ingredients are listed

NZ

NZIoC

all ingredients are listed

PH

PICCS

all ingredients are listed

TR

CICR

all ingredients are listed

TW

TCSI

all ingredients are listed

US

TSCA

all ingredients are listed

Legend
AICS CICR CSCL-ENCS DSL ECSI IECSC INSQ KECI NZIoC PICCS TCSI TSCA

Australian Inventory of Chemical Substances Chemical Inventory and Control Regulation List of Existing and New Chemical Substances (CSCL-ENCS) Domestic Substances List (DSL) EC Substance Inventory (EINECS, ELINCS, NLP) Inventory of Existing Chemical Substances Produced or Imported in China National Inventory of Chemical Substances Korea Existing Chemicals Inventory New Zealand Inventory of Chemicals Philippine Inventory of Chemicals and Chemical Substances (PICCS) Taiwan Chemical Substance Inventory Toxic Substance Control Act

15.2 Chemical Safety Assessment
Chemical safety assessments for substances in this mixture were not carried out.

Revision: 2021-09-20

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SECTION 16: Other information Abbreviations and acronyms

Abbr.

Descriptions of used abbreviations

"BC Regulation"

OHS Regulation: Section 5.48 (British Columbia)

CAS

Chemical Abstracts Service (service that maintains the most comprehensive list of chemical substances)

Ceiling-C

Ceiling value

DGR

Dangerous Goods Regulations (see IATA/DGR)

EINECS

European Inventory of Existing Commercial Chemical Substances

ELINCS

European List of Notified Chemical Substances

GHS

"Globally Harmonized System of Classification and Labelling of Chemicals" developed by the United Nations

IATA

International Air Transport Association

IATA/DGR

Dangerous Goods Regulations (DGR) for the air transport (IATA)

ICAO

International Civil Aviation Organization

IMDG

International Maritime Dangerous Goods Code

MARPOL

International Convention for the Prevention of Pollution from Ships (abbr. of "Marine Pollutant")

MoL

Ministry of Labor: Current Occupational Exposure Limits for Ontario Workplaces Required under Regulation 833

NLP

No-Longer Polymer

NPCA-HMIS® III National Paint and Coatings Association: Hazardous Materials Identification System - HMIS® III, Third Edition

OHS Code

Occupational Health and Safety Code: Occupational exposure limits for chemical substances (Alberta)

PBT

Persistent, Bioaccumulative and Toxic

ppm

Parts per million

Regulation OHS

Regulation respecting occupational health and safety: Permissible exposure values for airborne contaminants (Quebec)

RTECS

Registry of Toxic Effects of Chemical Substances (database of NIOSH with toxicological information)

STEL

Short-term exposure limit

TWA

Time-weighted average

UN RTDG

UN Recommendations on the Transport of Dangerous Good

vPvB

Very Persistent and very Bioaccumulative

Key literature references and sources for data
Hazardous Products Regulations (HPR).
UN Recommendations on the Transport of Dangerous Good. International Maritime Dangerous Goods Code (IMDG). Dangerous Goods Regulations (DGR) for the air transport (IATA).

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Classification procedure
Physical and chemical properties: The classification is based on tested mixture. Health hazards, Environmental hazards: The method for classification of the mixture is based on ingredients of the mixture (additivity formula).

Disclaimer
This information is based upon the present state of our knowledge. This SDS has been compiled and is solely intended for this product.

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