QF502.03 (2.

0)

Document Security
Technical Document Secret
Type Classification
Document No. Z-004D-026 P. Code 004D
Print
Color Black
Requirement

ESR 清洁液物质安全数据表（国际 IVDR）

Safety Data Sheet of ESR Solution Reagent

Reference Document(s)

Document No. Description

Document dispatch department: (according to the following

explanation)
国际体外诊断产品营销部、试剂质量部
1. Tooling, Fixture, all-purpose & Reagent doc must be filled in. （血球）、试剂生产部（血球）、试剂供
2. Confidential & Top secret doc. must be filled in, but only for 应部、物流部
needing to release.

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 Security Classification: Secret Z-004D-026-1.0

Revision Record
Ver Software Ver Summary of Revision Reviser Effective Date

1.0 / Initial version Peng Silun

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 Security Classification: Secret Z-004D-026-1.0

ESR Solution Reagent

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Chemwatch Hazard Alert Code: 1
Version No: 1.1 Issue Date: 23/11/2021
Safety Data Sheet (Conforms to Annex II of REACH (1907/2006) - Regulation 2020/878) Print Date: 23/11/2021
S.REACH.DEU.EN

SECTION 1 Identification of the substance / mixture and of the company / undertaking

1.1. Product Identifier

Product name ESR Solution Reagent

Chemical Name Not Applicable

Synonyms Not Available

Other means of 105-026688-00（EN/1L×1）

identification 105-026689-00（EN/1L×4）
1.2. Relevant identified uses of the substance or mixture and uses advised against

Relevant identified
The ESR Solution Reagent is used to clean the ESR measurement channels.
uses

Uses advised against Not Applicable

1.3. Details of the supplier of the safety data sheet

Registered company Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
name

Address Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan, Shenzhen, 518057, P.R. China

Telephone +86 755 81888998

Fax +86 755 26582680

Website www.mindray.com

Email [email protected]

1.4. Emergency telephone number

Association / Not Available
Organisation

Emergency telephone
numbers Not Available

Other emergency telephone

numbers Not Available

SECTION 2 Hazards identification

2.1. Classification of the substance or mixture

Classification according
to regulation (EC) No
1272/2008 [CLP] and Not Applicable
[1]
amendments

2.2. Label elements

Hazard pictogram(s) Not Applicable

Signal word Not Applicable

Hazard statement(s)
Not Applicable

Supplementary statement(s)
Not Applicable

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Precautionary statement(s) Prevention

Not Applicable

Precautionary statement(s) Response

Not Applicable

Precautionary statement(s) Storage

Not Applicable

Precautionary statement(s) Disposal

Not Applicable

2.3. Other hazards

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

SECTION 3 Composition / information on ingredients

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

3.2.Mixtures
1.CAS No
2.EC No Classification according to regulation (EC) No 1272/2008 Nanoform Particle
3.Index No %[weight] Name
[CLP] and amendments Characteristics
4.REACH No

1.77-86-1
Skin Corrosion/Irritation Category 2, Serious Eye Damage/Eye
2.201-064-4
≤1 tris(hydroxymethyl)aminomethane Irritation Category 2, Specific Target Organ Toxicity - Single Not Available
3.Not Available
4.Not Available Exposure Category 3; H315, H319, H335 [3]

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; [e] Substance identified as having endocrine disrupting properties

SECTION 4 First aid measures

4.1. Description of first aid measures

If this product comes in contact with eyes:
Wash out immediately with water.
Eye Contact
If irritation continues, seek medical attention.
Removal of contact lenses after an eye injury should only be undertaken by skilled personnel.

If skin contact occurs:

Immediately remove all contaminated clothing, including footwear.
Skin Contact
Flush skin and hair with running water (and soap if available).
Seek medical attention in event of irritation.

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

Immediately give a glass of water.

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

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

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

SECTION 5 Firefighting measures

5.1 . Extinguishing media

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

5.2 . Special hazards arising from the substrate or mixture

Fire Incompatibility None known.

5.3. Advice for firefighters

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Alert Fire Brigade and tell them location and nature of hazard.
Wear breathing apparatus plus protective gloves in the event of a fire.
Prevent, by any means available, spillage from entering drains or water courses.
Use fire fighting procedures suitable for surrounding area.
Fire Fighting
DO NOT approach containers suspected to be hot.
Cool fire exposed containers with water spray from a protected location.
If safe to do so, remove containers from path of fire.
Equipment should be thoroughly decontaminated after use.

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

SECTION 6 Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures

See section 8
6.2. Environmental precautions
See section 12

6.3. Methods and material for containment and cleaning up

Clean up all spills immediately.
Avoid breathing vapours and contact with skin and eyes.
Control personal contact with the substance, by using protective equipment.
Minor Spills
Contain and absorb spill with sand, earth, inert material or vermiculite.
Wipe up.
Place in a suitable, labelled container for waste disposal.
Moderate hazard.
Clear area of personnel and move upwind.
Alert Fire Brigade and tell them location and nature of hazard.
Wear breathing apparatus plus protective gloves.
Prevent, by any means available, spillage from entering drains or water course.
Stop leak if safe to do so.
Major Spills Contain spill with sand, earth or vermiculite.
Collect recoverable product into labelled containers for recycling.
Neutralise/decontaminate residue (see Section 13 for specific agent).
Collect solid residues and seal in labelled drums for disposal.
Wash area and prevent runoff into drains.
After clean up operations, decontaminate and launder all protective clothing and equipment before storing and re-using.
If contamination of drains or waterways occurs, advise emergency services.
6.4. Reference to other sections
Personal Protective Equipment advice is contained in Section 8 of the SDS.

SECTION 7 Handling and storage

7.1. Precautions for safe handling

Avoid all personal contact, including inhalation.
Wear protective clothing when risk of exposure occurs.
Use in a well-ventilated area.
Avoid contact with moisture.
Avoid contact with incompatible materials.
When handling, DO NOT eat, drink or smoke.
Keep containers securely sealed when not in use.
Safe handling
Avoid physical damage to containers.
Always wash hands with soap and water after handling.
Work clothes should be laundered separately. Launder contaminated clothing before re-use.
Use good occupational work practice.
Observe manufacturer's storage and handling recommendations contained within this SDS.
Atmosphere should be regularly checked against established exposure standards to ensure safe working conditions are maintained.
DO NOT allow clothing wet with material to stay in contact with skin

Fire and explosion See section 5

protection

Other information

7.2. Conditions for safe storage, including any incompatibilities

Polyethylene or polypropylene container.
Suitable container Packing as recommended by manufacturer.
Check all containers are clearly labelled and free from leaks.

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Storage
None known
incompatibility
7.3. Specific end use(s)
See section 1.2

SECTION 8 Exposure controls / personal protection

8.1. Control parameters

DNELs PNECs
Ingredient Exposure Pattern Worker Compartment

Dermal 166.7 mg/kg bw/day (Systemic, Chronic)

Inhalation 117.5 mg/m³ (Systemic, Chronic)
tris(hydroxymethyl)aminomethane Dermal 83.3 mg/kg bw/day (Systemic, Chronic) * 300 mg/L (STP)
Inhalation 29 mg/m³ (Systemic, Chronic) *
Oral 8.3 mg/kg bw/day (Systemic, Chronic) *
* Values for General Population

Occupational Exposure Limits (OEL)

INGREDIENT DATA
Source Ingredient Material name TWA STEL Peak Notes

Source Ingredient Material name TWA STEL Peak Notes

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

Not Applicable

Emergency Limits
Ingredient TEEL-1 TEEL-2 TEEL-3

tris(hydroxymethyl)aminomethane 18 mg/m3 190 mg/m3 1,200 mg/m3

Ingredient Original IDLH Revised IDLH

tris(hydroxymethyl)aminomethane Not Available Not Available

Occupational Exposure Banding

Ingredient Occupational Exposure Band Rating Occupational Exposure Band Limit

tris(hydroxymethyl)aminomethane E ≤ 0.01 mg/m³

Notes: Occupational exposure banding is a process of assigning chemicals into specific categories or bands based on a chemical's 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.

8.2. Exposure controls

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Engineering controls are used to remove a hazard or place a barrier between the worker and the hazard. Well-designed engineering controls
can be highly effective in protecting workers and will typically be independent of worker interactions to provide this high level of protection.
The basic types of engineering controls are:
Process controls which involve changing the way a job activity or process is done to reduce the risk.
Enclosure and/or isolation of emission source which keeps a selected hazard 'physically' away from the worker and ventilation that
strategically 'adds' and 'removes' air in the work environment. Ventilation can remove or dilute an air contaminant if designed properly. The
design of a ventilation system must match the particular process and chemical or contaminant in use. Employers may need to use multiple
types of controls to prevent employee overexposure.

General exhaust is adequate under normal operating conditions. If risk of overexposure exists, wear SAA approved respirator. Correct fit is
essential to obtain adequate protection. Provide adequate ventilation in warehouse or closed storage areas. Air contaminants generated in the
workplace possess varying 'escape' velocities which, in turn, determine the 'capture velocities' of fresh circulating air required to effectively
remove the contaminant.

Type of Contaminant: Air Speed:

0.25-0.5 m/s
solvent, vapours, degreasing etc., evaporating from tank (in still air) (50-100 f/min)

aerosols, fumes from pouring operations, intermittent container filling, low speed conveyer transfers, welding, spray 0.5-1 m/s (100-200
drift, plating acid fumes, pickling (released at low velocity into zone of active generation) f/min.)

8.2.1. Appropriate direct spray, spray painting in shallow booths, drum filling, conveyer loading, crusher dusts, gas discharge (active 1-2.5 m/s (200-500
engineering controls generation into zone of rapid air motion) f/min)

grinding, abrasive blasting, tumbling, high speed wheel generated dusts (released at high initial velocity into zone of 2.5-10 m/s
very high rapid air motion). (500-2000 f/min.)

Within each range the appropriate value depends on:

Lower end of the range Upper end of the range

1: Room air currents minimal or favourable to capture 1: Disturbing room air currents

2: Contaminants of low toxicity or of nuisance value 2: Contaminants of high toxicity

only

3: Intermittent, low production. 3: High production, heavy use

4: Large hood or large air mass in motion 4: Small hood - local control
only
Simple theory shows that air velocity falls rapidly with distance away from the opening of a simple extraction pipe. Velocity generally
decreases with the square of distance from the extraction point (in simple cases). Therefore the air speed at the extraction point should be
adjusted, accordingly, after reference to distance from the contaminating source. The air velocity at the extraction fan, for example, should be
a minimum of 1-2 m/s (200-400 f/min.) for extraction of solvents generated in a tank 2 meters distant from the extraction point. Other
mechanical considerations, producing performance deficits within the extraction apparatus, make it essential that theoretical air velocities are
multiplied by factors of 10 or more when extraction systems are installed or used.

8.2.2. Personal
protection

Safety glasses with side shields.

Chemical goggles.
Contact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants. A written policy document, describing
Eye and face the wearing of lenses or restrictions on use, should be created for each workplace or task. This should include a review of lens absorption
protection and adsorption for the class of chemicals in use and an account of injury experience. Medical and first-aid personnel should be trained in
their removal and suitable equipment should be readily available. In the event of chemical exposure, begin eye irrigation immediately and
remove contact lens as soon as practicable. Lens should be removed at the first signs of eye redness or irritation - lens should be removed
in a clean environment only after workers have washed hands thoroughly. [CDC NIOSH Current Intelligence Bulletin 59], [AS/NZS 1336 or
national equivalent]

Skin protection See Hand protection below

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Wear chemical protective gloves, e.g. PVC.

Wear safety footwear or safety gumboots, e.g. Rubber
The selection of suitable gloves does not only depend on the material, but also on further marks of quality which vary from manufacturer to
manufacturer. Where the chemical is a preparation of several substances, the resistance of the glove material can not be calculated in
advance and has therefore to be checked prior to the application.
The exact break through time for substances has to be obtained from the manufacturer of the protective gloves and has to be observed when
making a final choice.
Personal hygiene is a key element of effective hand care. Gloves must only be worn on clean hands. After using gloves, hands should be
washed and dried thoroughly. Application of a non-perfumed moisturiser is recommended.
Suitability and durability of glove type is dependent on usage. Important factors in the selection of gloves include:
· frequency and duration of contact,
· chemical resistance of glove material,
· glove thickness and
· dexterity
Select gloves tested to a relevant standard (e.g. Europe EN 374, US F739, AS/NZS 2161.1 or national equivalent).
· When prolonged or frequently repeated contact may occur, a glove with a protection class of 5 or higher (breakthrough time greater than
240 minutes according to EN 374, AS/NZS 2161.10.1 or national equivalent) is recommended.
· When only brief contact is expected, a glove with a protection class of 3 or higher (breakthrough time greater than 60 minutes according
to EN 374, AS/NZS 2161.10.1 or national equivalent) is recommended.
· Some glove polymer types are less affected by movement and this should be taken into account when considering gloves for long-term
Hands/feet protection use.
· Contaminated gloves should be replaced.
As defined in ASTM F-739-96 in any application, gloves are rated as:
· Excellent when breakthrough time > 480 min
· Good when breakthrough time > 20 min
· Fair when breakthrough time < 20
min · Poor when glove material
degrades
For general applications, gloves with a thickness typically greater than 0.35 mm, are recommended.
It should be emphasised that glove thickness is not necessarily a good predictor of glove resistance to a specific chemical, as the permeation
efficiency of the glove will be dependent on the exact composition of the glove material. Therefore, glove selection should also be based on
consideration of the task requirements and knowledge of breakthrough times.
Glove thickness may also vary depending on the glove manufacturer, the glove type and the glove model. Therefore, the manufacturers’
technical data should always be taken into account to ensure selection of the most appropriate glove for the task.
Note: Depending on the activity being conducted, gloves of varying thickness may be required for specific tasks. For example:
· Thinner gloves (down to 0.1 mm or less) may be required where a high degree of manual dexterity is needed. However, these gloves
are only likely to give short duration protection and would normally be just for single use applications, then disposed of.
· Thicker gloves (up to 3 mm or more) may be required where there is a mechanical (as well as a chemical) risk i.e. where there is
abrasion or puncture potential
Gloves must only be worn on clean hands. After using gloves, hands should be washed and dried thoroughly. Application of a non-perfumed
moisturiser is recommended.

Body protection See Other protection below

Overalls.
P.V.C apron.
Barrier cream.
Other protection
Skin cleansing cream.
Eye wash unit.

8.2.3. Environmental exposure controls

See section 12

SECTION 9 Physical and chemical properties

9.1. Information on basic physical and chemical properties

Appearance Not Available

Relative density (Water =

Physical state Liquid Not Available
1)
Partition coefficient n-
Odour Not Available octanol Not Available
/ water
Auto-ignition temperature
Odour threshold Not Available Not Available
(°C)
Decomposition
pH (as supplied) 9.55±0.10 Not Available
temperature
Melting point / freezing
point Not Available Viscosity (cSt) Not Available
(°C)
Initial boiling point and Molecular weight
boiling range (°C) Not Available Not Available
(g/mol)

Flash point (°C) Not Available Taste Not Available

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Evaporation rate Not Available Explosive properties Not Available

Flammability Not Available Oxidising properties Not Available

Upper Explosive Limit Surface Tension (dyn/cm or

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

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

1)
Nanoform Particle
Nanoform Solubility Not Available Characteristics Not Available

Particle Size Not Available

9.2. Other information

Not Available

SECTION 10 Stability and reactivity

10.1.Reactivity See section 7.2

Unstable in the presence of incompatible materials.

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

10.3. Possibility of hazardous

reactions See section 7.2

10.4. Conditions to
See section 7.2
avoid

10.5. Incompatible
See section 7.2
materials

10.6. Hazardous
decomposition products See section 5.3

SECTION 11 Toxicological information

11.1. Information on toxicological effects

The material is not thought to produce adverse health effects or irritation of the respiratory tract (as classified by EC Directives using animal
Inhaled models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an
occupational setting.

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

Skin contact is not thought to have harmful health effects (as classified under EC Directives); the material may still produce health damage
Skin Contact following entry through wounds, lesions or abrasions.
There is some evidence to suggest that this material can cause inflammation of the skin on contact in some persons.

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

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

TOXICITY IRRITATION
ESR Solution Reagent
Not Available Not Available

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TOXICITY IRRITATION

tris(hydroxymethyl)aminomethane
dermal (rat) LD50: >5000 mg/kg[1] Eye: no adverse effect observed (not irritating)[1]

Oral(Rat) LD50; >5000 mg/kg[1] Skin: no adverse effect observed (not irritating)[1]

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

Asthma-like symptoms may continue for months or even years after exposure to the material ends. This may be due to a non-
allergic condition known as reactive airways dysfunction syndrome (RADS) which can occur after exposure to high levels of
highly irritating compound. Main criteria for diagnosing RADS include the absence of previous airways disease in a non-atopic
individual, with sudden onset of persistent asthma-like symptoms within minutes to hours of a documented exposure to the
irritant. Other criteria for diagnosis of RADS include a reversible airflow pattern on lung function tests, moderate to severe
bronchial hyperreactivity on methacholine challenge testing, and the lack of minimal lymphocytic inflammation, without
eosinophilia. RADS (or
TRIS(HYDROXYMETHYL)AMINOMETHANE asthma) following an irritating inhalation is an infrequent disorder with rates related to the concentration of and duration of exposure
to the irritating substance. On the other hand, industrial bronchitis is a disorder that occurs as a result of exposure due to high
concentrations of irritating substance (often particles) and is completely reversible after exposure ceases. The disorder is
characterized by difficulty breathing, cough and mucus production.
TRIS AMINO and its surrogate chemicals have very little, if any, toxicity. They are mildly irritating to eyes at moderate
concentrations, and do not cause allergic skin reactions. Ingestion of relatively high dosages can cause liver changes. Patients
with decreased liver function should not be given these substances over extended treatment periods. They have been known to
have a

harmful effect on the foetus if taken during pregnancy.

Acute Toxicity Carcinogenicity

Skin Irritation/Corrosion Reproductivity

Serious Eye Damage/Irritation STOT - Single Exposure

Respiratory or Skin sensitisation STOT - Repeated Exposure

Mutagenicity Aspiration Hazard

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

✔– Data available to make classification

11.2.1. Endocrine Disruption Properties

Not Available

SECTION 12 Ecological information

12.1. Toxicity

Endpoint Test Duration (hr) Species Value Source

ESR Solution Reagent
Not Available Not Available Not Available Not Available Not Available

Endpoint Test Duration (hr) Species Value Source

NOEC(ECx) 72h Algae or other aquatic plants 100mg/l 2

tris(hydroxymethyl)aminomethane
EC50 72h Algae or other aquatic plants 397mg/l 2

EC50 48h Crustacea >980mg/l 2

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

12.2. Persistence and degradability

Ingredient Persistence: Water/Soil Persistence: Air

tris(hydroxymethyl)aminomethane LOW LOW

12.3. Bioaccumulative potential

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Ingredient Bioaccumulation

tris(hydroxymethyl)aminomethane LOW (LogKOW = -1.5606)

12.4. Mobility in soil

Ingredient Mobility

tris(hydroxymethyl)aminomethane HIGH (KOC = 1)

12.5. Results of PBT and vPvB assessment

P B T

Relevant available data Not Available Not Available Not Available

PBT

vPvB

PBT Criteria fulfilled? No

vPvB No

12.6. Endocrine Disruption Properties

Not Available

12.7. Other adverse effects

Not Available

SECTION 13 Disposal considerations

13.1. Waste treatment methods

Legislation addressing waste disposal requirements may differ by country, state and/ or territory. Each user must refer to laws operating in
their area. In some areas, certain wastes must be tracked.
Product / Packaging A Hierarchy of Controls seems to be common - the user should investigate:
disposal Reduction
Reuse
Recycling

Disposal (if all else fails)

This material may be recycled if unused, or if it has not been contaminated so as to make it unsuitable for its intended use. If it has been
contaminated, it may be possible to reclaim the product by filtration, distillation or some other means. Shelf life considerations should also be
applied in making decisions of this type. Note that properties of a material may change in use, and recycling or reuse may not always be
appropriate.
DO NOT allow wash water from cleaning or process equipment to enter drains.
It may be necessary to collect all wash water for treatment before disposal.
In all cases disposal to sewer may be subject to local laws and regulations and these should be considered first.
Where in doubt contact the responsible authority.
Recycle wherever possible.
Consult manufacturer for recycling options or consult local or regional waste management authority for disposal if no suitable treatment or
disposal facility can be identified.
Dispose of by: burial in a land-fill specifically licensed to accept chemical and / or pharmaceutical wastes or incineration in a licensed
apparatus (after admixture with suitable combustible material).
Decontaminate empty containers. Observe all label safeguards until containers are cleaned and destroyed.
Waste treatment Not Available
options
Sewage disposal Not Available
options
SECTION 14 Transport information

Labels Required
Marine Pollutant NO

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

14.1. UN number Not Applicable

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14.2. UN proper shipping

name Not Applicable

14.3. Transport hazard Class Not Applicable

class(es)
Subrisk Not Applicable

14.4. Packing group Not Applicable

14.5. Environmental hazard Not Applicable

Hazard identification Not Applicable

(Kemler)
Classification code Not Applicable

14.6. Special precautions for Hazard Label Not Applicable

user
Special provisions Not Applicable

Limited quantity Not Applicable

Tunnel Restriction Code Not Applicable

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

14.2. UN proper shipping

name Not Applicable

ICAO/IATA Class Not Applicable

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

14.4. Packing group Not Applicable

14.5. Environmental hazard Not Applicable

Special provisions Not Applicable

Cargo Only Packing Instructions Not Applicable

Cargo Only Maximum Qty / Pack Not Applicable

14.6. Special precautions for
user Passenger and Cargo Packing Instructions Not Applicable

Passenger and Cargo Maximum Qty / Pack Not Applicable

Passenger and Cargo Limited Quantity Packing Not Applicable

Instructions
Passenger and Cargo Limited Maximum Qty / Pack Not Applicable

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

14.2. UN proper shipping

name Not Applicable

14.3. Transport hazard IMDG Class Not Applicable

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

14.5. Environmental hazard Not Applicable

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EMS Number Not Applicable

14.6. Special precautions for
Special Not Applicable
user
provisions
Limited Not Applicable
Quantities
Inland waterways transport (ADN): NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS
14.1. UN number Not Applicable

14.2. UN proper shipping

name Not Applicable

14.3. Transport hazard

class(es) Not Applicable Not Applicable

14.4. Packing group Not Applicable

14.5. Environmental hazard Not Applicable

Classification code Not Applicable

Special provisions Not Applicable

14.6. Special precautions for
user Limited quantity Not Applicable

Equipment Not Applicable

required
Fire cones number Not Applicable

14.7. Transport in bulk according to Annex II of MARPOL and the IBC code
Not Applicable

14.8. Transport in bulk in accordance with MARPOL Annex V and the IMSBC Code
Product name Group

tris(hydroxymethyl)aminomethane Not Available

14.9. Transport in bulk in accordance with the ICG Code

Product name Ship Type

tris(hydroxymethyl)aminomethane Not Available

SECTION 15 Regulatory information

15.1. Safety, health and environmental regulations / legislation specific for the substance or mixture
tris(hydroxymethyl)aminomethane is found on the following regulatory lists
Europe EC Inventory FEI Equine Prohibited Substances List (EPSL)

European Union - European Inventory of Existing Commercial Chemical Substances Germany Classification of Substances Hazardous to Waters (WGK)
(EINECS)
FEI Equine Prohibited Substances List - Controlled Medication

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) 2020/878; Regulation (EC) No 1272/2008 as updated through ATPs.

15.2. Chemical safety assessment

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

ECHA SUMMARY
Ingredient CAS number Index No ECHA Dossier

tris(hydroxymethyl)aminomethane 77-86-1 Not Available Not Available

Harmonisation (C&L Pictograms Signal Hazard Statement

Inventory) Hazard Class and Category Code(s) Word Code(s) Code(s)

1 Skin Irrit. 2; Eye Irrit. 2; STOT SE 3 GHS07; Wng H315; H319; H335

Skin Irrit. 2; Eye Irrit. 2; STOT SE 3; STOT SE 3; STOT SE 3; STOT SE 3; STOT SE 3; H315; H319;
2 STOT SE 3; STOT SE 3; STOT SE 3; STOT SE 3; STOT SE 3; STOT SE 3; STOT SE 3; GHS07; Wng H335;
Acute Tox. 4; Acute Tox. 4; Eye Irrit. 2A H312; H332
Harmonisation Code 1 = The most prevalent classification. Harmonisation Code 2 = The most severe classification.

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15.3. Classification of Substances and Mixtures into Water Hazard Classes

Preparation is WGK non-hazardous to waters

Name WGK Score Source

TRIS(HYDROXYMETHYL)AMINOMETHANE 1 From Regulation

National Inventory Status

National Inventory Status

Australia - AIIC / Australia

Non-Industrial Use Yes

National Inventory Status

Canada - DSL Yes

Canada - NDSL No (tris(hydroxymethyl)aminomethane)

China - IECSC Yes

Europe - EINEC / ELINCS / NLP Yes

Japan - ENCS Yes

Korea - KECI Yes

New Zealand - NZIoC Yes

Philippines - PICCS Yes

USA - TSCA Yes

Taiwan - TCSI Yes

Mexico - INSQ Yes

Vietnam - NCI Yes

Russia - FBEPH Yes

Yes = All CAS declared ingredients are on the inventory

Legend: No = One or more of the CAS listed ingredients are not on the inventory. These ingredients may be exempt or will require registration.

SECTION 16 Other information

Revision Date 23/11/2021

Initial Date 23/11/2021

Full text Risk and Hazard codes

H312 Harmful in contact with skin.

H315 Causes skin irritation.

H319 Causes serious eye irritation.

H332 Harmful if inhaled.

H335 May cause respiratory irritation.

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. Scale of use, frequency of use and current or available engineering controls must
be considered. For detailed advice on Personal Protective Equipment, refer to the following EU CEN Standards:
EN 166 Personal eye-protection
EN 340 Protective clothing
EN 374 Protective gloves against chemicals and micro-organisms
EN 13832 Footwear protecting against chemicals
EN 133 Respiratory protective devices

Definitions and abbreviations

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PC－TWA: Permissible Concentration-Time Weighted Average

PC－STEL: Permissible Concentration-Short Term Exposure Limit
IARC: International Agency for Research on Cancer
ACGIH: American Conference of Governmental Industrial Hygienists
STEL: Short Term Exposure Limit
TEEL: Temporary Emergency Exposure Limit。
IDLH: Immediately Dangerous to Life or Health Concentrations
ES: Exposure Standard
OSF: Odour Safety Factor
NOAEL :No Observed Adverse Effect Level
LOAEL: Lowest Observed Adverse Effect Level
TLV: Threshold Limit Value
LOD: Limit Of Detection
OTV: Odour Threshold Value
BCF: BioConcentration Factors
BEI: Biological Exposure Index
AIIC: Australian Inventory of Industrial Chemicals
DSL: Domestic Substances List
NDSL: Non-Domestic Substances List
IECSC: Inventory of Existing Chemical Substance in China
EINECS: European INventory of Existing Commercial chemical Substances
ELINCS: European List of Notified Chemical Substances
NLP: No-Longer Polymers
ENCS: Existing and New Chemical Substances Inventory
KECI: Korea Existing Chemicals Inventory
NZIoC: New Zealand Inventory of Chemicals
PICCS: Philippine Inventory of Chemicals and Chemical Substances
TSCA: Toxic Substances Control Act
TCSI: Taiwan Chemical Substance Inventory
INSQ: Inventario Nacional de Sustancias Químicas
NCI: National Chemical Inventory
FBEPH: Russian Register of Potentially Hazardous Chemical and Biological Substances

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