MSDS 8429324190 Elecsys TSH Cobas e 411
MSDS 8429324190 Elecsys TSH Cobas e 411
1.2 Relevant identified uses of the substance or mixture and uses advised against
Recommended restrictions : For professional users only.
on use
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
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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
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
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
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M-Factor (Acute
aquatic toxicity): 1
M-Factor (Chronic
aquatic toxicity): 1
specific concentration
limit
Skin Sens. 1A; H317
>= 0,0015 %
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
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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 %
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;
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
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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 %
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
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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.
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SAFETY DATA SHEET
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Elecsys TSH
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Hygiene measures : Wash hands before breaks and at the end of workday.
R1
Contains no substances with occupational exposure limit values.
R2
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SAFETY DATA SHEET
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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
Hand protection
In case of contact through splashing:
Material : Nitrile rubber
Break through time : > 30 min
Glove thickness : > 0,11 mm
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Elecsys TSH
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Colour : colourless
Odour : none
Viscosity
Viscosity, dynamic : No data available
Solubility(ies)
Water solubility : completely miscible
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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
Viscosity
Viscosity, dynamic : No data available
Solubility(ies)
Water solubility : completely miscible
SA Coat-Beads
Physical state : liquid, Beads
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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
pH : 7,1 - 7,4
Viscosity
Viscosity, dynamic : No data available
Solubility(ies)
Water solubility : completely miscible
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
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R2
Explosives : No data available
SA Coat-Beads
Explosives : Not explosive
Expert judgement
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.
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SAFETY DATA SHEET
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Version Revision Date: Date of last issue: 16.08.2021
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2-methyl-2H-isothiazol-3-one hydrochloride:
Acute oral toxicity : LD50 Oral (Rat, female): 175 mg/kg
Method: OECD Test Guideline 425
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
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.
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SAFETY DATA SHEET
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Elecsys TSH
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2-methyl-2H-isothiazol-3-one hydrochloride:
Result : Risk of serious damage to eyes.
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.
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
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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
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
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
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
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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
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.
2-methyl-2H-isothiazol-3-one hydrochloride:
Result : Risk of serious damage to eyes.
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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
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.
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
Carcinogenicity
Not classified based on available information.
Reproductive toxicity
Not classified based on available information.
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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
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 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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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
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.
2-methyl-2H-isothiazol-3-one hydrochloride:
Result : Risk of serious damage to eyes.
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.
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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:
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
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
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
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
3.0 08.02.2022 Date of first issue: 22.03.2018
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
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
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Elecsys TSH
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3.0 08.02.2022 Date of first issue: 22.03.2018
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
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
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according to Regulation (EC) No. 1907/2006
Elecsys TSH
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Ecotoxicology Assessment
Acute 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
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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
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
2-methyl-2H-isothiazol-3-one hydrochloride:
Bioaccumulation : Remarks: No bioaccumulation is to be expected (log Pow <=
4).
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
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R2
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Bioaccumulation : Remarks: No bioaccumulation is to be expected (log Pow <=
4).
SA Coat-Beads
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Bioaccumulation : Remarks: No bioaccumulation is to be expected (log Pow <=
4).
Product:
Assessment : The substance/mixture does not contain components consid-
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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
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.
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according to Regulation (EC) No. 1907/2006
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15.1 Safety, health and environmental regulations/legislation specific for the substance or mix-
ture
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
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SAFETY DATA SHEET
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Other regulations:
Take note of Directive 94/33/EC on the protection of young people at work or stricter national
regulations, where applicable.
DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.
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SAFETY DATA SHEET
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Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
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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
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
Other regulations:
Take note of Directive 94/33/EC on the protection of young people at work or stricter national
regulations, where applicable.
DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.
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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
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
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
DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.
hydroxyl-2-pyridone
Beads
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
Version Revision Date: Date of last issue: 16.08.2021
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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-
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys TSH
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3.0 08.02.2022 Date of first issue: 22.03.2018
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