EU safety data sheet

Trade name: STROMATOLYSER-4DS

Current version : 1.2.0, issued: 04.05.2022 Replaced version: 1.1.0, issued: 30.04.2020 Region: GB

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

1.1 Product identifier
Trade name

STROMATOLYSER-4DS
1.2 Relevant identified uses of the substance or mixture and uses advised against
Relevant identified uses of the substance or mixture
For in-vitro diagnosis
Uses advised against
No data available.

1.3 Details of the supplier of the safety data sheet

Address
SYSMEX LTD
Sysmex House
Garamonde Drive
Wymbush
Milton Keynes
Buckinghamshire MK8 8DF
United Kingdom
Telephone no. +44 (0)333 320 3460
Fax no. +44 (0)1908 267 901
Advice on Safety Data Sheet
[email protected]

1.4 Emergency telephone number

For medical advice (in German and English):
+49 (0)551 192 40 (Giftinformationszentrum Nord)

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture
Classification in accordance with Regulation (EC) No 1272/2008 (CLP)
Acute Tox. 4; H302
Classification information
This product is assessed and classified using the methods and criteria below referred to in Article 9 of Regulation (EC)
n° 1272/2008:
Physical hazards: determined through assessment data based on the methods or standards referred to in part 2 of
Annex I to CLP
Health hazards and environmental hazards: determined through toxicological and ecotoxicological assessment data
based on the methods or standards referred to in Part 3, 4 and 5 of Annex I to CLP.

2.2 Label elements

Labelling according to Regulation (EC) No 1272/2008 (CLP Regulation)

Hazard pictograms

GHS07
Signal word
Warning
Hazardous component(s) to be indicated on label:
ethanediol
Hazard statement(s)
H302 Harmful if swallowed.

Page 1 of 9
EU safety data sheet
Trade name: STROMATOLYSER-4DS

Current version : 1.2.0, issued: 04.05.2022 Replaced version: 1.1.0, issued: 30.04.2020 Region: GB

Precautionary statement(s)
P301+P312 IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell.
P501 Dispose of contents/container to a facility in accordance with local and national
regulations.

2.3 Other hazards

PBT assessment
No data available.
vPvB assessment
No data available.

SECTION 3: Composition/information on ingredients

3.1 Substances
Not applicable. The product is not a substance.

3.2 Mixtures
Hazardous ingredients
No Substance name Additional information
CAS / EC / Index / Classification (EC) 1272/2008 (CLP) Concentration %
REACH no
1 ethanediol
107-21-1 Acute Tox. 4*; H302 < 100.00 wt%
203-473-3
603-027-00-1
-
2 methanol
67-56-1 Acute Tox. 3*; H301 < 5.00 wt%
200-659-6 Acute Tox. 3*; H311
603-001-00-X Acute Tox. 3*; H331
- Flam. Liq. 2; H225
STOT SE 1; H370**
Full Text for all H-phrases and EUH-phrases: pls. see section 16
(*,**,***,****) Detailed explanation pls. refer to CLP regulation No. 1272/2008, annex VI, 1.2

No Note Specific concentration limits M-factor M-factor

(acute) (chronic)
2 - STOT SE 2; H371: C >= 3% - -
STOT SE 1; H370: C >= 10%

SECTION 4: First aid measures

4.1 Description of first aid measures
General information
In case of persisting adverse effects, consult a physician. Remove contaminated clothing and shoes immediately, and
launder thoroughly before reusing.
After inhalation
Remove affected person from the immediate area. Ensure supply of fresh air.
After skin contact
Wash off immediately with soap and water.
After eye contact
Separate eyelids, wash the eyes thoroughly with water (15 min.).
After ingestion
Call a doctor immediately. Do not induce vomiting. Never give anything by mouth to an unconscious person.

4.2 Most important symptoms and effects, both acute and delayed
No data available.

4.3 Indication of any immediate medical attention and special treatment needed
No data available.

Page 2 of 9
EU safety data sheet
Trade name: STROMATOLYSER-4DS

Current version : 1.2.0, issued: 04.05.2022 Replaced version: 1.1.0, issued: 30.04.2020 Region: GB

SECTION 5: Firefighting measures

5.1 Extinguishing media
Suitable extinguishing media
Foam; Extinguishing powder; Carbon dioxide; Water spray jet
Unsuitable extinguishing media
High power water jet

5.2 Special hazards arising from the substance or mixture

In the event of fire, the following can be released: Carbon dioxide (CO2); Carbon monoxide (CO); Sulphur oxides
(SxOy); halogenated compounds

5.3 Advice for firefighters

Use self-contained breathing apparatus. Wear protective clothing.

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures
For non-emergency personnel
Refer to protective measures listed in sections 7 and 8. Ensure adequate ventilation. Avoid contact with skin, eyes and
clothing. Do not inhale vapours. Keep away from ignition sources.
For emergency responders
No data available. Personal protective equipment (PPE) - see Section 8.

6.2 Environmental precautions

Do not discharge into the drains/surface waters/groundwater. Do not discharge into the subsoil/soil.

6.3 Methods and material for containment and cleaning up

Take up with absorbent material (e.g., sand, kieselguhr, universal binder). When collected, handle material as
described under the section heading "Disposal considerations".

6.4 Reference to other sections

No data available.

SECTION 7: Handling and storage

7.1 Precautions for safe handling
Advice on safe handling
Risks inherent to handling the product must be minimised by applying the appropriate protective and preventive
measures. Working processes should - so far as possible, according to the state of the art - be designed to rule out
bodily contact or the release of hazardous substances.
General protective and hygiene measures
Do not eat, drink or smoke during work time. Keep away from food, drink and animal feeding stuffs. Wash hands and
skin before breaks and after work. Do not inhale vapours. Avoid contact with eyes and skin. Remove soiled or soaked
clothing immediately. Have emergency shower available.
Advice on protection against fire and explosion
Keep away from sources of heat and ignition. Vapours can form an explosive mixture with air.

7.2 Conditions for safe storage, including any incompatibilities

Technical measures and storage conditions
Keep container tightly closed in a cool, well-ventilated place.
Recommended storage temperature
Value 2 - 35 °C
Requirements for storage rooms and vessels
Containers which are opened must be carefully closed and kept upright to prevent leakage.
Incompatible products
Do not store together with: Aluminium; Chromyl chloride; alkaline hydroxides; Perchloric acid; oxidizing agents

7.3 Specific end use(s)

Page 3 of 9
EU safety data sheet
Trade name: STROMATOLYSER-4DS

Current version : 1.2.0, issued: 04.05.2022 Replaced version: 1.1.0, issued: 30.04.2020 Region: GB

No data available.

SECTION 8: Exposure controls/personal protection

8.1 Control parameters
Occupational exposure limit values
No Substance name CAS no. EC no.
1 ethanediol 107-21-1 203-473-3
2000/39/EC
Ethylene glycol
WEL short-term (15 min reference period) 104 mg/m³ 40 ppm
WEL long-term (8-hr TWA reference period) 52 mg/m³ 20 ppm
Skin resorption / sensibilisation Skin
List of approved workplace exposure limits (WELs) / EH40
Ethane-1,2-diol vapour
WEL short-term (15 min reference period) 104 mg/m³ 40 ppm
WEL long-term (8-hr TWA reference period) 52 mg/m³ 20 ppm
Comments Sk
List of approved workplace exposure limits (WELs) / EH40
Ethane-1,2-diol particulate
WEL long-term (8-hr TWA reference period) 10 mg/m³
Comments Sk
2 methanol 67-56-1 200-659-6
2006/15/EC
Methanol
WEL long-term (8-hr TWA reference period) 260 mg/m³ 200 ppm
Skin resorption / sensibilisation Skin
List of approved workplace exposure limits (WELs) / EH40
Methanol
WEL short-term (15 min reference period) 333 mg/m³ 250 ppm
WEL long-term (8-hr TWA reference period) 266 mg/m³ 200 ppm
true
Comments Sk

8.2 Exposure controls

Appropriate engineering controls
No data available.
Personal protective equipment
Respiratory protection
If workplace exposure limits are exceeded, a respiration protection approved for this particular job must be worn. In
case of aerosol and mist formation, take appropriate measures for breathing protection in the event workplace
threshold values are not specified.
Eye / face protection
Safety glasses with side protection shield (EN 166)
Hand protection
Sufficient protection is given wearing suitable protective gloves checked according to i.e. EN 374, in the event of risk of
skin contact with the product. Before use, the protective gloves should be tested in any case for its specific work-
station suitability (i.e. mechanical resistance, product compatibility and antistatic properties). Adhere to the
manufacturer’s instructions and information relating to the use, storage, care and replacement of protective gloves.
Protective gloves shall be replaced immediately when physically damaged or worn. Design operations thus to avoid
permanent use of protective gloves.
Other
Normal chemical work clothing.
Environmental exposure controls
No data available.

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties

Page 4 of 9
EU safety data sheet
Trade name: STROMATOLYSER-4DS

Current version : 1.2.0, issued: 04.05.2022 Replaced version: 1.1.0, issued: 30.04.2020 Region: GB

State of aggregation
2038
liquid
Form/Colour
liquid
270
blue
190

Odour
20
odourless
pH value
No data available
Boiling point / boiling range
No data available
Melting point/freezing point
No data available
Decomposition temperature
No data available
Flash point
Value 63 °C 63

Ignition temperature
No data available
Flammability
No data available
Lower explosion limit
No data available
Upper explosion limit
No data available
Vapour pressure
No data available
Relative vapour density
No data available
Relative density
No data available
Density
Value 1.09 g/ml
Reference temperature 20 °C 1.09

Solubility in water
Value 100 %
Reference temperature 20 °C 100

Solubility
No data available
Partition coefficient n-octanol/water (log value)
No data available
Kinematic viscosity
No data available
Particle characteristics
No data available

9.2 Other information

Other information
No data available.

Page 5 of 9
EU safety data sheet
Trade name: STROMATOLYSER-4DS

Current version : 1.2.0, issued: 04.05.2022 Replaced version: 1.1.0, issued: 30.04.2020 Region: GB

SECTION 10: Stability and reactivity

10.1 Reactivity
Dangerous reactions are not expected if the product is handled according to its intended use.

10.2 Chemical stability

Stable under recommended storage and handling conditions (See section 7).

10.3 Possibility of hazardous reactions

None, when used as directed.

10.4 Conditions to avoid

None, if handled according to intended use.

10.5 Incompatible materials

Aluminium; Chromyl chloride; alkaline hydroxides; Perchloric acid; Oxidizing agents

10.6 Hazardous decomposition products

Formaldehyde

SECTION 11: Toxicological information

11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008
Acute oral toxicity (result of the ATE calculation for the mixture)
No Product Name
1 STROMATOLYSER-4DS
ATE (Mixture) 446.45 mg/kg
Method Calculation method according Regulation (EC) No 1272/2008,
ATE (Mixture) 446.45
(CLP), annex I, part 3, section 3.1.3.6.
Calculation method according Regulation (EC) No 1272/2008, (CLP), annex I, part 3, section 3.1.3.6.

Acute oral toxicity

No data available
Acute dermal toxicity (result of the ATE calculation for the mixture)
No Product Name
1 STROMATOLYSER-4DS
Comments The result of the applied calculation method according to the
European Regulation (EC) 1272/2008 (CLP), Paragraph 3.1.3.6, Part
3 of Annex I is outside the values that imply a classification / labelling
of this mixture according to table 3.1.1 defining the respective
categories (ATE dermal > 2000 mg/kg).
Acute dermal toxicity
No data available
Acute inhalational toxicity (result of the ATE calculation for the mixture)
No Product Name
1 STROMATOLYSER-4DS
Comments The result of the applied calculation method according to the
European Regulation (EC) 1272/2008 (CLP), Paragraph 3.1.3.6, Part
3 of Annex I is outside the values that imply a classification / labelling
of this mixture according to table 3.1.1 defining the respective
categories (ATE for inhalation: > 20.000 ppmV (gases), > 20 mg/l
(vapours), > 5 mg/l (dusts/mists).
Acute inhalational toxicity
No data available
Skin corrosion/irritation
No data available
Serious eye damage/irritation
No data available
Respiratory or skin sensitisation

Page 6 of 9
EU safety data sheet
Trade name: STROMATOLYSER-4DS

Current version : 1.2.0, issued: 04.05.2022 Replaced version: 1.1.0, issued: 30.04.2020 Region: GB

No data available
Germ cell mutagenicity
No data available
Reproduction toxicity
No data available
Carcinogenicity
No data available
STOT - single exposure
No data available
STOT - repeated exposure
No data available
Aspiration hazard
No data available
Delayed and immediate effects as well as chronic effects from short and long-term exposure
Inhalation of the vapours causes irritation of the respiratory tract and mucous membrane, headaches, nausea,
giddiners, vomiting. Eye contact with the product may lead to irritation. Frequent persistent contact with the skin can
61
cause skin irritation.

11.2 Information on other hazards

Endocrine disrupting properties
No data available.
Other information
No data available.

SECTION 12: Ecological information

12.1 Toxicity
Toxicity to fish (acute)
No data available
Toxicity to fish (chronic)
No data available
Toxicity to Daphnia (acute)
No data available
Toxicity to Daphnia (chronic)
No data available
Toxicity to algae (acute)
No data available
Toxicity to algae (chronic)
No data available
Bacteria toxicity
No data available

12.2 Persistence and degradability

No data available.

12.3 Bioaccumulative potential

No data available.

12.4 Mobility in soil

No data available.

12.5 Results of PBT and vPvB assessment

Results of PBT and vPvB assessment
PBT assessment No data available.

Page 7 of 9
EU safety data sheet
Trade name: STROMATOLYSER-4DS

Current version : 1.2.0, issued: 04.05.2022 Replaced version: 1.1.0, issued: 30.04.2020 Region: GB

Lk.2377
vPvB assessment
Lk.2386
No data available.

12.6 Endocrine disrupting properties

No data available.

12.7 Other adverse effects

No data available.

12.8 Other information

Other information
710
Do not discharge product unmonitored into the environment.

SECTION 13: Disposal considerations

13.1 Waste treatment methods
Product
Allocation of a waste code number, according to the European Waste Catalogue, should be carried out in agreement
with the regional waste disposal company.
Packaging
Residues must be removed from packaging and when emptied completely disposed of in accordance with the
regulations for waste removal. Incompletely emptied packaging must be disposed of in the form of disposal specified
by the regional disposer.

SECTION 14: Transport information

14.1 Transport ADR/RID/ADN
The product is not subject to ADR/RID/ADN regulations.

14.2 Transport IMDG

The product is not subject to IMDG regulations.

14.3 Transport ICAO-TI / IATA

The product is not subject to ICAO-TI / IATA regulations.

14.4 Other information

No data available.

14.5 Environmental hazards

Information on environmental hazards, if relevant, please see 14.1 - 14.3.

14.6 Special precautions for user

No data available.

14.7 Maritime transport in bulk according to IMO instruments

Not relevant

SECTION 15: Regulatory information

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
EU regulations

Regulation (EC) No 1907/2006 (REACH) Annex XIV (List of substances subject to authorisation)
According to the data available and/or specifications supplied by upstream suppliers, this product does not contain any
substances considered as substances requiring authorisation as listed on Annex XIV of the REACH regulation (EC)
1907/2006.
REACH candidate list of substances of very high concern (SVHC) for authorisation
According to available data and the information provided by preliminary suppliers, the product does not contain
substances that are considered substances meeting the criteria for inclusion in annex XIV (List of Substances Subject
to Authorisation) as laid down in Article 57 and article 59 of REACH (EC) 1907/2006.
Regulation (EC) No 1907/2006 (REACH) Annex XVII: RESTRICTIONS ON THE MANUFACTURE, PLACING ON
THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES
The product is considered being subject to REACH regulation (EC) 1907/2006 annex XVII. No 3

Page 8 of 9
EU safety data sheet
Trade name: STROMATOLYSER-4DS

Current version : 1.2.0, issued: 04.05.2022 Replaced version: 1.1.0, issued: 30.04.2020 Region: GB

The product contains following substance(s) that are considered being subject to REACH regulation (EC) 1907/2006
annex XVII.
No Substance name CAS no. EC no. No
1 methanol 67-56-1 200-659-6 69, 75
Directive 2012/18/EU on the control of major-accident hazards involving dangerous substances
This product is not subject to Part 1 or 2 of Annex I.

15.2 Chemical safety assessment

No data available.

SECTION 16: Other information

Sources of key data used to compile the data sheet:
Regulation (EC) No 1907/2006 (REACH), 1272/2008 (CLP) as amended in each case.
Directives 2000/39/EC, 2006/15/EC, 2009/161/EU, (EU) 2017/164.
National Threshold Limit Values of the corresponding countries as amended in each case.
Transport regulations according to ADR, RID, IMDG, IATA as amended in each case.
The data sources used to determine physical, toxic and ecotoxic data, are indicated directly in the corresponding
section.
Full text of the H- and EUH- phrases drawn up in sections 2 and 3 (provided not already drawn up in these
sections)
H225 Highly flammable liquid and vapour.
H301 Toxic if swallowed.
H311 Toxic in contact with skin.
H331 Toxic if inhaled.
H370 Causes damage to organs.
Creation of the safety data sheet
UMCO GmbH
Georg-Wilhelm-Str. 187, D-21107 Hamburg
Tel.: +49 40 / 555 546 300 Fax: +49 40 / 555 546 357 e-mail: [email protected]
This information is based on our present knowledge and experience.
The safety data sheet describes products with a view to safety requirements.
It does not however, constitute a guarantee for any specific product properties and shall not establish a legally valid
contractual relationship.

Alterations/supplements:
Alterations to the previous edition are marked in the left-hand margin.
Document protected by copyright. Alterations or reproductions require the express written permission of UMCO GmbH.
.
Prod-ID 641859

Page 9 of 9