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MSDS 8429324190 Elecsys TSH Cobas e 411

The document is a Safety Data Sheet for Elecsys TSH, detailing identification, hazards, composition, first aid measures, firefighting measures, accidental release measures, handling and storage, and exposure controls. It highlights that the product may cause allergic skin reactions and provides emergency contact information. The supplier is Roche Diagnostics Deutschland GmbH, and the product is intended for professional use only.
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
100% found this document useful (1 vote)
84 views34 pages

MSDS 8429324190 Elecsys TSH Cobas e 411

The document is a Safety Data Sheet for Elecsys TSH, detailing identification, hazards, composition, first aid measures, firefighting measures, accidental release measures, handling and storage, and exposure controls. It highlights that the product may cause allergic skin reactions and provides emergency contact information. The supplier is Roche Diagnostics Deutschland GmbH, and the product is intended for professional use only.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 34

SAFETY DATA SHEET

according to Regulation (EC) No. 1907/2006


Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

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

1.1 Product identifier


Trade name : Elecsys TSH

Product code : 08429324190

1.2 Relevant identified uses of the substance or mixture and uses advised against
Recommended restrictions : For professional users only.
on use

1.3 Details of the supplier of the safety data sheet


Company : Roche Diagnostics Deutschland GmbH
-
Sandhoferstrasse 116
68305 Mannheim
Deutschland

Telephone : +496217590
Telefax : +496217592890
Responsible Department : +49(0)621-759-4223
E-mail address : [email protected]
1.4 Emergency telephone number
In case of emergencies: : Central Works Security +49(0)621-759-2203
Roche Diagnostics GmbH

Centre for detoxification: : Mainz +49(0)6131-19240


Munich +49(0)89-19240

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture


The product is a kit consisting of individual ingredients. The classification of the ingredients can be
obtained from section 3. Section Label elements contains the resulting labelling for the kit.

2.2 Label elements

Labelling (REGULATION (EC) No 1272/2008)


Hazard pictograms :

Signal word : Warning

1 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Hazard statements : H317 May cause an allergic skin reaction.

Precautionary statements : Prevention:


P261 Avoid breathing mist or vapours.
P272 Contaminated work clothing should not be allowed out
of the workplace.
P280 Wear protective gloves.
Response:
P333 + P313 If skin irritation or rash occurs: Get medical
advice/ attention.
P362 + P364 Take off contaminated clothing and wash it
before reuse.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

2.3 Other hazards


Ecological information: The substance/mixture does not contain components considered to have
endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regu-
lation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.

Toxicological information: The substance/mixture does not contain components considered to


have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated
regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.

SECTION 3: Composition/information on ingredients

R1
Classification (REGULATION (EC) No 1272/2008)
Skin sensitisation, Category 1 H317: May cause an allergic skin reaction.

Components
Chemical name CAS-No. Classification Concentration
EC-No. (% w/w)
Index-No.
Registration number
2-methyl-2H-isothiazol-3-one hy- 26172-54-3 Acute Tox. 3; H301 >= 0,0025 - <
drochloride 247-499-3 Acute Tox. 2; H330 0,025
01-2120764168-47 Acute Tox. 3; H311
Skin Corr. 1A; H314
Eye Dam. 1; H318
Skin Sens. 1A; H317
Aquatic Acute 1;
H400
Aquatic Chronic 1;
H410
EUH071

2 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

M-Factor (Acute
aquatic toxicity): 1
M-Factor (Chronic
aquatic toxicity): 1

specific concentration
limit
Skin Sens. 1A; H317
>= 0,0015 %

Acute toxicity esti-


mate

Acute oral toxicity:


175 mg/kg
Acute inhalation tox-
icity (dust/mist): 0,11
mg/l
Acute dermal toxicity:
246 mg/kg
For explanation of abbreviations see section 16.

R2
Classification (REGULATION (EC) No 1272/2008)
Skin sensitisation, Category 1 H317: May cause an allergic skin reaction.

Components
Chemical name CAS-No. Classification Concentration
EC-No. (% w/w)
Index-No.
Registration number
2-methyl-2H-isothiazol-3-one hy- 26172-54-3 Acute Tox. 3; H301 >= 0,0025 - <
drochloride 247-499-3 Acute Tox. 2; H330 0,025
01-2120764168-47 Acute Tox. 3; H311
Skin Corr. 1A; H314
Eye Dam. 1; H318
Skin Sens. 1A; H317
Aquatic Acute 1;
H400
Aquatic Chronic 1;
H410
EUH071

M-Factor (Acute
aquatic toxicity): 1
M-Factor (Chronic

3 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

aquatic toxicity): 1

specific concentration
limit
Skin Sens. 1A; H317
>= 0,0015 %

Acute toxicity esti-


mate

Acute oral toxicity:


175 mg/kg
Acute inhalation tox-
icity (dust/mist): 0,11
mg/l
Acute dermal toxicity:
246 mg/kg
Thermo-BSA-Streptavidin, inact., Not Assigned < 0,1
rec.
Acute toxicity esti-
mate

Acute oral toxicity: >


5.001 mg/kg
Acute inhalation tox-
icity (dust/mist): > 30
mg/l
Acute dermal toxicity:
> 5.001 mg/kg
For explanation of abbreviations see section 16.

SA Coat-Beads
Classification (REGULATION (EC) No 1272/2008)
Skin sensitisation, Category 1 H317: May cause an allergic skin reaction.

Components
Chemical name CAS-No. Classification Concentration
EC-No. (% w/w)
Index-No.
Registration number
2-methyl-2H-isothiazol-3-one hy- 26172-54-3 Acute Tox. 3; H301 >= 0,0025 - <
drochloride 247-499-3 Acute Tox. 2; H330 0,025
01-2120764168-47 Acute Tox. 3; H311
Skin Corr. 1A; H314
Eye Dam. 1; H318
Skin Sens. 1A; H317
Aquatic Acute 1;
H400
Aquatic Chronic 1;

4 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

H410
EUH071

M-Factor (Acute
aquatic toxicity): 1
M-Factor (Chronic
aquatic toxicity): 1

specific concentration
limit
Skin Sens. 1A; H317
>= 0,0015 %

Acute toxicity esti-


mate

Acute oral toxicity:


175 mg/kg
Acute inhalation tox-
icity (dust/mist): 0,11
mg/l
Acute dermal toxicity:
246 mg/kg
For explanation of abbreviations see section 16.

SECTION 4: First aid measures

4.1 Description of first aid measures


General advice : Move out of dangerous area.
Show this safety data sheet to the doctor in attendance.
Do not leave the victim unattended.

If inhaled : Move to fresh air.


If unconscious, place in recovery position and seek medical
advice.
If symptoms persist, call a physician.

In case of skin contact : If on skin, rinse well with water.

In case of eye contact : Immediately flush eye(s) with plenty of water.


Remove contact lenses.
Protect unharmed eye.
Keep eye wide open while rinsing.
If eye irritation persists, consult a specialist.

If swallowed : Keep respiratory tract clear.


Do not give milk or alcoholic beverages.
Never give anything by mouth to an unconscious person.
If symptoms persist, call a physician.

5 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Rinse mouth with water.

4.2 Most important symptoms and effects, both acute and delayed
None known.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment : The first aid procedure should be established in consultation
with the doctor responsible for industrial medicine.

SECTION 5: Firefighting measures

5.1 Extinguishing media


Suitable extinguishing media : Use extinguishing measures that are appropriate to local cir-
cumstances and the surrounding environment.

Unsuitable extinguishing : High volume water jet


media

5.2 Special hazards arising from the substance or mixture


Specific hazards during fire- : No information available.
fighting

5.3 Advice for firefighters


Special protective equipment : Wear self-contained breathing apparatus for firefighting if nec-
for firefighters essary.

Further information : Standard procedure for chemical fires.


Use extinguishing measures that are appropriate to local cir-
cumstances and the surrounding environment.

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures


Personal precautions : Use personal protective equipment.
Refer to protective measures listed in sections 7 and 8.

6.2 Environmental precautions


Environmental precautions : Prevent product from entering drains.
Prevent further leakage or spillage if safe to do so.
Local authorities should be advised if significant spillages
cannot be contained.

6.3 Methods and material for containment and cleaning up


Methods for cleaning up : Soak up with inert absorbent material (e.g. sand, silica gel,
acid binder, universal binder, sawdust).
Keep in suitable, closed containers for disposal.

6 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

6.4 Reference to other sections


Treat recovered material as described in the section "Disposal considerations".

SECTION 7: Handling and storage

7.1 Precautions for safe handling


Advice on safe handling : Do not breathe vapours/dust.
Avoid exposure - obtain special instructions before use.
Avoid contact with skin and eyes.
For personal protection see section 8.
Smoking, eating and drinking should be prohibited in the ap-
plication area.
Dispose of rinse water in accordance with local and national
regulations.
Persons susceptible to skin sensitisation problems or asthma,
allergies, chronic or recurrent respiratory disease should not
be employed in any process in which this mixture is being
used.

Advice on protection against : Normal measures for preventive fire protection.


fire and explosion

Hygiene measures : Wash hands before breaks and at the end of workday.

7.2 Conditions for safe storage, including any incompatibilities


Requirements for storage : Keep container tightly closed in a dry and well-ventilated
areas and containers place. Electrical installations / working materials must comply
with the technological safety standards.

Further information on stor- : See label, package insert or internal guidelines


age conditions

Storage class (TRGS 510) : 12, Non Combustible Liquids

Further information on stor- : No decomposition if stored and applied as directed.


age stability

7.3 Specific end use(s)


Specific use(s) : Laboratory chemicals

SECTION 8: Exposure controls/personal protection

8.1 Control parameters

R1
Contains no substances with occupational exposure limit values.

R2

7 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Occupational Exposure Limits


Components CAS-No. Value type (Form Control parameters Basis
of exposure)
Thermo-BSA- Not As- IOEL 50 nanogram per cubic Category 3B
Streptavidin, inact., signed meter (Roche Group
rec. Directive K1,
Annex 3):
OEL = 0.05
µg/m3

SA Coat-Beads
Contains no substances with occupational exposure limit values.
8.2 Exposure controls

Engineering measures
No data available
Personal protective equipment
Eye protection : Eye wash bottle with pure water
Tightly fitting safety goggles

Use eye protection according to EN 166.

Hand protection
In case of contact through splashing:
Material : Nitrile rubber
Break through time : > 30 min
Glove thickness : > 0,11 mm

In case of full contact:


Material : butyl-rubber
Break through time : > 480 min
Glove thickness : > 0,4 mm

Remarks : The selected protective gloves have to satisfy the specifica-


tions of Regulation (EU) 2016/425 and the standard EN 374
derived from it. This recommendation is only valid for the
product mentioned in the safety data sheet and provided by
us and for the application specified by us. Please observe the
instructions regarding permeability and breakthrough time
which are provided by the supplier of the gloves. Also take
into consideration the specific local conditions under which
the product is used, such as the danger of cuts, abrasion,
and the contact time. The suitability for a specific workplace
should be discussed with the producers of the protective
gloves.

Skin and body protection : Impervious clothing


Choose body protection according to the amount and con-
centration of the dangerous substance at the work place.

8 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties


R1
Physical state : liquid

Colour : colourless

Odour : none

Odour Threshold : No data available

Melting point/range : No data available

Boiling point/boiling range : No data available

Upper explosion limit / Upper : No data available


flammability limit

Lower explosion limit / Lower : No data available


flammability limit

Flash point : does not flash

Auto-ignition temperature : No data available

Decomposition temperature : No data available

pH : 7,1 - 7,3 (25 °C)

Viscosity
Viscosity, dynamic : No data available

Viscosity, kinematic : No data available

Solubility(ies)
Water solubility : completely miscible

Solubility in other solvents : No data available

Partition coefficient: n- : No data available


octanol/water

Vapour pressure : No data available

Relative density : No data available

Density : 1,025 g/cm3

Relative vapour density : No data available

9 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

R2
Physical state : liquid

Colour : colourless

Odour : none

Odour Threshold : No data available

Melting point/range : No data available

Boiling point/boiling range : No data available

Upper explosion limit / Upper : No data available


flammability limit

Lower explosion limit / Lower : No data available


flammability limit

Flash point does not flash

Auto-ignition temperature : No data available

Decomposition temperature : No data available

pH : 7,1 - 7,3 (25 °C)

Viscosity
Viscosity, dynamic : No data available

Viscosity, kinematic : No data available

Solubility(ies)
Water solubility : completely miscible

Solubility in other solvents : No data available

Partition coefficient: n- : No data available


octanol/water

Vapour pressure : No data available

Relative density : No data available

Density : 1,025 g/cm3

Relative vapour density : No data available

SA Coat-Beads
Physical state : liquid, Beads

Colour : clear, colourless, red brown

10 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Odour : odourless

Odour Threshold : No data available

Melting point/range : No data available

Boiling point/boiling range : No data available

Flammability : The product is not flammable., Does not sustain combustion.

Upper explosion limit / Upper : No data available


flammability limit

Lower explosion limit / Lower : No data available


flammability limit

Flash point does not flash

Auto-ignition temperature : No data available

Decomposition temperature : No data available

pH : 7,1 - 7,4

Viscosity
Viscosity, dynamic : No data available

Viscosity, kinematic : No data available

Solubility(ies)
Water solubility : completely miscible

Solubility in other solvents : No data available

Partition coefficient: n- : No data available


octanol/water

Vapour pressure : No data available

Relative density : No data available

Density : 1,01 g/cm3 (20 °C)

Relative vapour density : No data available

9.2 Other information


R1
Explosives : No data available

Oxidizing properties : The substance or mixture is not classified as oxidizing.

11 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Flammability (liquids) : Does not sustain combustion.

Self-ignition : Not applicable

Evaporation rate : No data available

R2
Explosives : No data available

Oxidizing properties : The substance or mixture is not classified as oxidizing.

Flammability (liquids) : Does not sustain combustion.

Self-ignition : Not applicable

Evaporation rate : No data available

SA Coat-Beads
Explosives : Not explosive
Expert judgement

Oxidizing properties : The substance or mixture is not classified as oxidizing.

Flammability (liquids) : Does not sustain combustion.

Self-ignition : Not applicable

Evaporation rate : No data available

Miscibility with water : No data available

SECTION 10: Stability and reactivity

10.1 Reactivity
No dangerous reaction known under conditions of normal use.
10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions : No decomposition if stored and applied as directed.

10.4 Conditions to avoid


No data available

12 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

10.5 Incompatible materials


Materials to avoid : Strong oxidizing agents

10.6 Hazardous decomposition products


No decomposition if stored and applied as directed.

SECTION 11: Toxicological information

11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008


R1
Acute toxicity
Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Acute oral toxicity : LD50 Oral (Rat, female): 175 mg/kg
Method: OECD Test Guideline 425

Acute toxicity estimate: 175 mg/kg


Method: Calculation method

Acute inhalation toxicity : LC50 (Rat, male and female): 0,11 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 403
Assessment: Corrosive to the respiratory tract.
Remarks: Based on data from similar materials

Acute toxicity estimate: 0,11 mg/l


Test atmosphere: dust/mist
Method: Calculation method

Acute dermal toxicity : LD50 Dermal (Rat, male): 246 mg/kg


Method: OECD Test Guideline 402
Remarks: Based on data from similar materials

Acute toxicity estimate: 246 mg/kg


Method: Calculation method

Skin corrosion/irritation
Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Species : reconstructed human epidermis (RhE)
Method : OECD Test Guideline 431
Result : Causes severe burns.

13 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Serious eye damage/eye irritation


Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Result : Risk of serious damage to eyes.

Respiratory or skin sensitisation

Skin sensitisation
May cause an allergic skin reaction.
Respiratory sensitisation
Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Test Type : Local lymph node assay (LLNA)
Method : OECD Test Guideline 429
Result : The product is a skin sensitiser, sub-category 1A.

Test Type : Maximisation Test


Species : Guinea pig
Method : OECD Test Guideline 406
Result : positive
Remarks : Based on data from similar materials

Germ cell mutagenicity


Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Genotoxicity in vitro : Test Type: Microbial mutagenesis assay (Ames test)
Test system: Salmonella typhimurium
Metabolic activation: with and without metabolic activation
Method: OECD Test Guideline 471
Result: negative

Test Type: In vitro mammalian cell gene mutation test


Test system: Chinese hamster ovary cells
Method: OECD Test Guideline 476
Result: negative

Genotoxicity in vivo : Test Type: Micronucleus test


Species: Mouse (male and female)
Application Route: Oral
Method: OECD Test Guideline 474
Result: negative

Test Type: unscheduled DNA synthesis assay


Species: Rat (male and female)
Application Route: Oral

14 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Method: OECD Test Guideline 486


Result: negative

Carcinogenicity
Not classified based on available information.
Reproductive toxicity
Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Effects on foetal develop- : Species: Rat
ment Application Route: Oral
Dose: 40 mg/kg bw/day
Result: No effects on foetal development

STOT - single exposure


Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.
Repeated dose toxicity

Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Species : Rat
NOEL : 94 mg/kg bw/day
Application Route : Oral
Exposure time : 90 d
Method : OECD Test Guideline 408
Remarks : No significant adverse effects were reported
No human information is available.

Species : Dog
NOAEL : 40,9 mg/kg bw/day
Application Route : Oral
Exposure time : 90 d
Method : OECD Test Guideline 409

Aspiration toxicity
Not classified based on available information.
R2
Acute toxicity
Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Acute oral toxicity : LD50 Oral (Rat, female): 175 mg/kg
Method: OECD Test Guideline 425

15 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Acute toxicity estimate: 175 mg/kg


Method: Calculation method

Acute inhalation toxicity : LC50 (Rat, male and female): 0,11 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 403
Assessment: Corrosive to the respiratory tract.
Remarks: Based on data from similar materials

Acute toxicity estimate: 0,11 mg/l


Test atmosphere: dust/mist
Method: Calculation method

Acute dermal toxicity : LD50 Dermal (Rat, male): 246 mg/kg


Method: OECD Test Guideline 402
Remarks: Based on data from similar materials

Acute toxicity estimate: 246 mg/kg


Method: Calculation method

Thermo-BSA-Streptavidin, inact., rec.:


Acute oral toxicity : Acute toxicity estimate: > 5.001 mg/kg
Method: Expert judgement

Acute inhalation toxicity : Acute toxicity estimate: > 30 mg/l


Test atmosphere: dust/mist
Method: Expert judgement

Acute dermal toxicity : Acute toxicity estimate: > 5.001 mg/kg


Method: Expert judgement

Skin corrosion/irritation
Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Species : reconstructed human epidermis (RhE)
Method : OECD Test Guideline 431
Result : Causes severe burns.

Serious eye damage/eye irritation


Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Result : Risk of serious damage to eyes.

16 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Respiratory or skin sensitisation

Skin sensitisation
May cause an allergic skin reaction.
Respiratory sensitisation
Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Test Type : Local lymph node assay (LLNA)
Method : OECD Test Guideline 429
Result : The product is a skin sensitiser, sub-category 1A.

Test Type : Maximisation Test


Species : Guinea pig
Method : OECD Test Guideline 406
Result : positive
Remarks : Based on data from similar materials

Germ cell mutagenicity


Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Genotoxicity in vitro : Test Type: Microbial mutagenesis assay (Ames test)
Test system: Salmonella typhimurium
Metabolic activation: with and without metabolic activation
Method: OECD Test Guideline 471
Result: negative

Test Type: In vitro mammalian cell gene mutation test


Test system: Chinese hamster ovary cells
Method: OECD Test Guideline 476
Result: negative

Genotoxicity in vivo : Test Type: Micronucleus test


Species: Mouse (male and female)
Application Route: Oral
Method: OECD Test Guideline 474
Result: negative

Test Type: unscheduled DNA synthesis assay


Species: Rat (male and female)
Application Route: Oral
Method: OECD Test Guideline 486
Result: negative

Carcinogenicity
Not classified based on available information.
Reproductive toxicity
Not classified based on available information.

17 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Effects on foetal develop- : Species: Rat
ment Application Route: Oral
Dose: 40 mg/kg bw/day
Result: No effects on foetal development

STOT - single exposure


Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.
Repeated dose toxicity

Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Species : Rat
NOEL : 94 mg/kg bw/day
Application Route : Oral
Exposure time : 90 d
Method : OECD Test Guideline 408
Remarks : No significant adverse effects were reported
No human information is available.

Species : Dog
NOAEL : 40,9 mg/kg bw/day
Application Route : Oral
Exposure time : 90 d
Method : OECD Test Guideline 409

Aspiration toxicity
Not classified based on available information.
SA Coat-Beads
Acute toxicity
Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Acute oral toxicity : LD50 Oral (Rat, female): 175 mg/kg
Method: OECD Test Guideline 425

Acute toxicity estimate: 175 mg/kg


Method: Calculation method

Acute inhalation toxicity : LC50 (Rat, male and female): 0,11 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 403
Assessment: Corrosive to the respiratory tract.

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according to Regulation (EC) No. 1907/2006
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Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Remarks: Based on data from similar materials

Acute toxicity estimate: 0,11 mg/l


Test atmosphere: dust/mist
Method: Calculation method

Acute dermal toxicity : LD50 Dermal (Rat, male): 246 mg/kg


Method: OECD Test Guideline 402
Remarks: Based on data from similar materials

Acute toxicity estimate: 246 mg/kg


Method: Calculation method

Skin corrosion/irritation
Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Species : reconstructed human epidermis (RhE)
Method : OECD Test Guideline 431
Result : Causes severe burns.

Serious eye damage/eye irritation


Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Result : Risk of serious damage to eyes.

Respiratory or skin sensitisation

Skin sensitisation
May cause an allergic skin reaction.
Respiratory sensitisation
Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Test Type : Local lymph node assay (LLNA)
Method : OECD Test Guideline 429
Result : The product is a skin sensitiser, sub-category 1A.

Test Type : Maximisation Test


Species : Guinea pig
Method : OECD Test Guideline 406
Result : positive
Remarks : Based on data from similar materials

Germ cell mutagenicity


Not classified based on available information.

19 / 34
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Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Genotoxicity in vitro : Test Type: Microbial mutagenesis assay (Ames test)
Test system: Salmonella typhimurium
Metabolic activation: with and without metabolic activation
Method: OECD Test Guideline 471
Result: negative

Test Type: In vitro mammalian cell gene mutation test


Test system: Chinese hamster ovary cells
Method: OECD Test Guideline 476
Result: negative

Genotoxicity in vivo : Test Type: Micronucleus test


Species: Mouse (male and female)
Application Route: Oral
Method: OECD Test Guideline 474
Result: negative

Test Type: unscheduled DNA synthesis assay


Species: Rat (male and female)
Application Route: Oral
Method: OECD Test Guideline 486
Result: negative

Carcinogenicity
Not classified based on available information.
Reproductive toxicity
Not classified based on available information.
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Effects on foetal develop- : Species: Rat
ment Application Route: Oral
Dose: 40 mg/kg bw/day
Result: No effects on foetal development

STOT - single exposure


Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.
Repeated dose toxicity

Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Species : Rat
NOEL : 94 mg/kg bw/day
Application Route : Oral
Exposure time : 90 d

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
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Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Method : OECD Test Guideline 408


Remarks : No significant adverse effects were reported
No human information is available.

Species : Dog
NOAEL : 40,9 mg/kg bw/day
Application Route : Oral
Exposure time : 90 d
Method : OECD Test Guideline 409

Aspiration toxicity
Not classified based on available information.
11.2 Information on other hazards

Endocrine disrupting properties

Product:
Assessment : The substance/mixture does not contain components consid-
ered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation
(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

R1
Endocrine disrupting properties

Product:
Assessment : The substance/mixture does not contain components consid-
ered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation
(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

R2
Endocrine disrupting properties

Product:
Assessment : The substance/mixture does not contain components consid-
ered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation
(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

SA Coat-Beads
Endocrine disrupting properties

Product:
Assessment : The substance/mixture does not contain components consid-
ered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation

21 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at


levels of 0.1% or higher.

SECTION 12: Ecological information

12.1 Toxicity
R1
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Toxicity to fish : LC50 (Oncorhynchus mykiss (rainbow trout)): 4,77 mg/l
Exposure time: 96 h
Test Type: flow-through test
Method: OECD Test Guideline 203

Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 2,33 mg/l
aquatic invertebrates Exposure time: 48 h
Test Type: static test
Method: OECD Test Guideline 202

Toxicity to algae/aquatic : ErC50 (Pseudokirchneriella subcapitata (green algae)): 0,289


plants mg/l
Exposure time: 72 h
Test Type: static test
Method: OECD Test Guideline 201

M-Factor (Acute aquatic tox- : 1


icity)

Toxicity to daphnia and other : NOEC: 0,0442 mg/l


aquatic invertebrates (Chron- Exposure time: 21 d
ic toxicity) Species: Daphnia magna (Water flea)
Method: OECD Test Guideline 211

M-Factor (Chronic aquatic : 1


toxicity)

R2
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Toxicity to fish : LC50 (Oncorhynchus mykiss (rainbow trout)): 4,77 mg/l
Exposure time: 96 h
Test Type: flow-through test
Method: OECD Test Guideline 203

Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 2,33 mg/l
aquatic invertebrates Exposure time: 48 h
Test Type: static test
Method: OECD Test Guideline 202

22 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Toxicity to algae/aquatic : ErC50 (Pseudokirchneriella subcapitata (green algae)): 0,289


plants mg/l
Exposure time: 72 h
Test Type: static test
Method: OECD Test Guideline 201

M-Factor (Acute aquatic tox- : 1


icity)

Toxicity to daphnia and other : NOEC: 0,0442 mg/l


aquatic invertebrates (Chron- Exposure time: 21 d
ic toxicity) Species: Daphnia magna (Water flea)
Method: OECD Test Guideline 211

M-Factor (Chronic aquatic : 1


toxicity)

Thermo-BSA-Streptavidin, inact., rec.:


Toxicity to fish : LC50 : > 100 mg/l
Exposure time: 96 h

Toxicity to fish (Chronic tox- : > 1 mg/l


icity)

Ecotoxicology Assessment
Acute aquatic toxicity : This product has no known ecotoxicological effects.

Chronic aquatic toxicity : This product has no known ecotoxicological effects.

SA Coat-Beads
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Toxicity to fish : LC50 (Oncorhynchus mykiss (rainbow trout)): 4,77 mg/l
Exposure time: 96 h
Test Type: flow-through test
Method: OECD Test Guideline 203

Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 2,33 mg/l
aquatic invertebrates Exposure time: 48 h
Test Type: static test
Method: OECD Test Guideline 202

Toxicity to algae/aquatic : ErC50 (Pseudokirchneriella subcapitata (green algae)): 0,289


plants mg/l
Exposure time: 72 h
Test Type: static test
Method: OECD Test Guideline 201

M-Factor (Acute aquatic tox- : 1


icity)

23 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Toxicity to daphnia and other : NOEC: 0,0442 mg/l


aquatic invertebrates (Chron- Exposure time: 21 d
ic toxicity) Species: Daphnia magna (Water flea)
Method: OECD Test Guideline 211

M-Factor (Chronic aquatic : 1


toxicity)

12.2 Persistence and degradability


R1
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Biodegradability : Test Type: aerobic
Result: Not readily biodegradable.
Biodegradation: 0 %
Exposure time: 28 d
Method: OECD Test Guideline 301B

R2
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Biodegradability : Test Type: aerobic
Result: Not readily biodegradable.
Biodegradation: 0 %
Exposure time: 28 d
Method: OECD Test Guideline 301B

SA Coat-Beads
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Biodegradability : Test Type: aerobic
Result: Not readily biodegradable.
Biodegradation: 0 %
Exposure time: 28 d
Method: OECD Test Guideline 301B

12.3 Bioaccumulative potential


R1
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Bioaccumulation : Remarks: No bioaccumulation is to be expected (log Pow <=
4).

24 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
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Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Partition coefficient: n- : log Pow: ca. -0,44 (20 °C)


octanol/water Method: OECD Test Guideline 107

R2
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Bioaccumulation : Remarks: No bioaccumulation is to be expected (log Pow <=
4).

Partition coefficient: n- : log Pow: ca. -0,44 (20 °C)


octanol/water Method: OECD Test Guideline 107

Thermo-BSA-Streptavidin, inact., rec.:


Partition coefficient: n- : Remarks: No data available
octanol/water

SA Coat-Beads
Components:

2-methyl-2H-isothiazol-3-one hydrochloride:
Bioaccumulation : Remarks: No bioaccumulation is to be expected (log Pow <=
4).

Partition coefficient: n- : log Pow: ca. -0,44 (20 °C)


octanol/water Method: OECD Test Guideline 107

12.4 Mobility in soil


R1
No data available
R2
No data available
SA Coat-Beads
No data available
12.5 Results of PBT and vPvB assessment
R1
Not relevant
R2
Not relevant
SA Coat-Beads
Not relevant
12.6 Endocrine disrupting properties

Product:
Assessment : The substance/mixture does not contain components consid-

25 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

ered to have endocrine disrupting properties according to


REACH Article 57(f) or Commission Delegated regulation
(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

R1
Product:
Assessment : The substance/mixture does not contain components consid-
ered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation
(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

R2
Assessment : The substance/mixture does not contain components consid-
ered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation
(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

SA Coat-Beads
Assessment : The substance/mixture does not contain components consid-
ered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation
(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

12.7 Other adverse effects


R1
No data available
R2
No data available
SA Coat-Beads
No data available

SECTION 13: Disposal considerations

13.1 Waste treatment methods


Product : Do not contaminate ponds, waterways or ditches with chemi-
cal or used container.
Send to a licensed waste management company.
Can be disposed as waste water, when in compliance with
local regulations.

Contaminated packaging : Empty remaining contents.


Dispose of as unused product.

26 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Empty containers should be taken to an approved waste han-


dling site for recycling or disposal.
Do not re-use empty containers.

SECTION 14: Transport information

14.1 UN number or ID number


Not regulated as a dangerous good
14.2 UN proper shipping name
Not regulated as a dangerous good
14.3 Transport hazard class(es)
Not regulated as a dangerous good
14.4 Packing group
Not regulated as a dangerous good
14.5 Environmental hazards
Not regulated as a dangerous good
14.6 Special precautions for user
Remarks : Not dangerous goods in the meaning of ADR/RID, ADN,
IMDG-Code, ICAO/IATA-DGR

14.7 Maritime transport in bulk according to IMO instruments


Remarks : Not applicable

SECTION 15: Regulatory information

15.1 Safety, health and environmental regulations/legislation specific for the substance or mix-
ture

Seveso III: Directive : Not applicable


2012/18/EU of the European
Parliament and of the Council
on the control of major-
accident hazards involving
dangerous substances.

Water hazard class (Germa- : WGK 1 slightly hazardous to water


ny)

R1
REACH - Restrictions on the manufacture, placing on : Conditions of restriction for the fol-
the market and use of certain dangerous substances, lowing entries should be considered:
preparations and articles (Annex XVII) Number on list 3

REACH - Candidate List of Substances of Very High : Not applicable


Concern for Authorisation (Article 59).

27 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Regulation (EC) No 1005/2009 on substances that de- : Not applicable


plete the ozone layer

Regulation (EU) 2019/1021 on persistent organic pollu- : Not applicable


tants (recast)

Regulation (EC) No 649/2012 of the European Parlia- : Not applicable


ment and the Council concerning the export and import
of dangerous chemicals

REACH - List of substances subject to authorisation : Not applicable


(Annex XIV)

Other regulations:
Take note of Directive 94/33/EC on the protection of young people at work or stricter national
regulations, where applicable.

The components of this product are reported in the following inventories:


AIIC : Not in compliance with the inventory

DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.

Albumins, beef serum


PAK<->R-IGG(DET)
hydroxyl-2-pyridone
Antibodies

NZIoC : On the inventory, or in compliance with the inventory

ENCS : Not in compliance with the inventory

ISHL : Not in compliance with the inventory

KECI : Not in compliance with the inventory

PICCS : Not in compliance with the inventory

IECSC : Not in compliance with the inventory

TCSI : Not in compliance with the inventory

TSCA : Product contains substance(s) not listed on TSCA inventory.

TECI : Not in compliance with the inventory

Volatile organic compounds : Directive 2010/75/EU of 24 November 2010 on industrial


emissions (integrated pollution prevention and control)
Volatile organic compounds (VOC) content: 0,2 %

28 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Labelling (REGULATION (EC) No 1272/2008)


Hazard pictograms :

Signal word : Warning

Hazard statements : H317 May cause an allergic skin reaction.

Precautionary statements : Prevention:


P261 Avoid breathing mist or vapours.
P272 Contaminated work clothing should not be allowed out
of the workplace.
P280 Wear protective gloves.
Response:
P333 + P313 If skin irritation or rash occurs: Get medical
advice/ attention.
P362 + P364 Take off contaminated clothing and wash it
before reuse.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Hazardous components which must be listed on the label:


26172-54-3 2-methyl-2H-isothiazol-3-one hydrochloride

R2
REACH - Restrictions on the manufacture, placing on : Conditions of restriction for the fol-
the market and use of certain dangerous substances, lowing entries should be considered:
preparations and articles (Annex XVII) Number on list 3

REACH - Candidate List of Substances of Very High : Not applicable


Concern for Authorisation (Article 59).

Regulation (EC) No 1005/2009 on substances that de- : Not applicable


plete the ozone layer

Regulation (EU) 2019/1021 on persistent organic pollu- : Not applicable


tants (recast)

Regulation (EC) No 649/2012 of the European Parlia- : Not applicable


ment and the Council concerning the export and import
of dangerous chemicals

29 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

REACH - List of substances subject to authorisation : Not applicable


(Annex XIV)

Other regulations:
Take note of Directive 94/33/EC on the protection of young people at work or stricter national
regulations, where applicable.

The components of this product are reported in the following inventories:


AIIC : Not in compliance with the inventory

DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.

Albumins, beef serum


PAK<->R-IGG(DET)
Antibodies
hydroxyl-2-pyridone
SA-rec.-Mutein pSA15
Thermo-BSA-Streptavidin, inact., rec.

NZIoC : On the inventory, or in compliance with the inventory

ENCS : Not in compliance with the inventory

ISHL : Not in compliance with the inventory

KECI : Not in compliance with the inventory

PICCS : Not in compliance with the inventory

IECSC : Not in compliance with the inventory

TCSI : Not in compliance with the inventory

TSCA : Product contains substance(s) not listed on TSCA inventory.

TECI : Not in compliance with the inventory

Volatile organic compounds : Directive 2010/75/EU of 24 November 2010 on industrial


emissions (integrated pollution prevention and control)
Volatile organic compounds (VOC) content: 0,2 %

Labelling (REGULATION (EC) No 1272/2008)


Hazard pictograms :

Signal word : Warning

30 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

Hazard statements : H317 May cause an allergic skin reaction.

Precautionary statements : Prevention:


P261 Avoid breathing mist or vapours.
P272 Contaminated work clothing should not be allowed out
of the workplace.
P280 Wear protective gloves.
Response:
P333 + P313 If skin irritation or rash occurs: Get medical
advice/ attention.
P362 + P364 Take off contaminated clothing and wash it
before reuse.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Hazardous components which must be listed on the label:


26172-54-3 2-methyl-2H-isothiazol-3-one hydrochloride

SA Coat-Beads
REACH - Restrictions on the manufacture, placing on : Conditions of restriction for the fol-
the market and use of certain dangerous substances, lowing entries should be considered:
preparations and articles (Annex XVII) Number on list 3

REACH - Candidate List of Substances of Very High : Not applicable


Concern for Authorisation (Article 59).

Regulation (EC) No 1005/2009 on substances that de- : Not applicable


plete the ozone layer

Regulation (EU) 2019/1021 on persistent organic pollu- : Not applicable


tants (recast)

Regulation (EC) No 649/2012 of the European Parlia- : Not applicable


ment and the Council concerning the export and import
of dangerous chemicals

REACH - List of substances subject to authorisation : Not applicable


(Annex XIV)

Other regulations:
Take note of Directive 94/33/EC on the protection of young people at work or stricter national
regulations, where applicable.

31 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

The components of this product are reported in the following inventories:


AIIC : Not in compliance with the inventory

DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.

hydroxyl-2-pyridone
Beads

NZIoC : On the inventory, or in compliance with the inventory

ENCS : Not in compliance with the inventory

ISHL : Not in compliance with the inventory

KECI : Not in compliance with the inventory

PICCS : Not in compliance with the inventory

IECSC : Not in compliance with the inventory

TCSI : Not in compliance with the inventory

TSCA : Product contains substance(s) not listed on TSCA inventory.

TECI : Not in compliance with the inventory

Volatile organic compounds : Directive 2010/75/EU of 24 November 2010 on industrial


emissions (integrated pollution prevention and control)
Volatile organic compounds (VOC) content: 0,1 %

Labelling (REGULATION (EC) No 1272/2008)


Hazard pictograms :

Signal word : Warning

Hazard statements : H317 May cause an allergic skin reaction.

Precautionary statements : Prevention:


P261 Avoid breathing mist or vapours.
P272 Contaminated work clothing should not be allowed out
of the workplace.
P280 Wear protective gloves.
Response:
P333 + P313 If skin irritation or rash occurs: Get medical
advice/ attention.

32 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

P362 + P364 Take off contaminated clothing and wash it


before reuse.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Hazardous components which must be listed on the label:


26172-54-3 2-methyl-2H-isothiazol-3-one hydrochloride

15.2 Chemical safety assessment


Chemical Safety Assessments for all substances in this product are either Complete or Not applicable.

SECTION 16: Other information

Full text of H-Statements


H301 : Toxic if swallowed.
H311 : Toxic in contact with skin.
H314 : Causes severe skin burns and eye damage.
H317 : May cause an allergic skin reaction.
H318 : Causes serious eye damage.
H330 : Fatal if inhaled.
H400 : Very toxic to aquatic life.
H410 : Very toxic to aquatic life with long lasting effects.
Full text of other abbreviations
Acute Tox. : Acute toxicity
Aquatic Acute : Short-term (acute) aquatic hazard
Aquatic Chronic : Long-term (chronic) aquatic hazard
Eye Dam. : Serious eye damage
Skin Corr. : Skin corrosion
Skin Sens. : Skin sensitisation

ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - European Agreement concerning the International Carriage of Dangerous
Goods by Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for
the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation;
Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN -
Standard of the German Institute for Standardisation; DSL - Domestic Substances List (Canada);
ECHA - European Chemicals Agency; EC-Number - European Community number; ECx - Con-
centration associated with x% response; ELx - Loading rate associated with x% response; EmS -
Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concen-
tration associated with x% growth rate response; GHS - Globally Harmonized System; GLP -
Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - Interna-
tional Air Transport Association; IBC - International Code for the Construction and Equipment of
Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO
- International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in
China; IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organiza-
tion; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Stand-
ardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a
test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL -
International Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Speci-

33 / 34
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018

fied; NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse)


Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory of
Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office
of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic sub-
stance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quanti-
tative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Re-
striction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of Very High Concern; TCSI - Taiwan Chemical Substance Inventory; TECI -
Thailand Existing Chemicals Inventory; TRGS - Technical Rule for Hazardous Substances; TSCA
- Toxic Substances Control Act (United States); UN - United Nations; vPvB - Very Persistent and
Very Bioaccumulative

Further information

The information provided in this Safety Data Sheet is correct to the best of our knowledge, infor-
mation and belief at the date of its publication. The information given is designed only as a guid-
ance for safe handling, use, processing, storage, transportation, disposal and release and is not
to be considered a warranty or quality specification. The information relates only to the specific
material designated and may not be valid for such material used in combination with any other
materials or in any process, unless specified in the text.

DE / EN / 2104

34 / 34

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