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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)621-759-2012, +49(0)621-759-4848
+49(0)8856-60-2629
E-mail address : mannheim.umweltschutz@roche.com
1.4 Emergency telephone number
In case of emergencies: : Central Works Security +49(0)621-759-2203
Roche Diagnostics GmbH
1 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Precautionary statements :
Prevention:
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
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.
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
XXXX Skin Corr. 1A; H314
Eye Dam. 1; H318
Skin Sens. 1A; H317
Aquatic Acute 1;
H400
Aquatic Chronic 1;
H410
M-Factor (Acute
aquatic toxicity): 1
M-Factor (Chronic
aquatic toxicity): 1
For explanation of abbreviations see section 16.
R2
2 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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
XXXX Skin Corr. 1A; H314
Eye Dam. 1; H318
Skin Sens. 1A; H317
Aquatic Acute 1;
H400
Aquatic Chronic 1;
H410
M-Factor (Acute
aquatic toxicity): 1
M-Factor (Chronic
aquatic toxicity): 1
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
XXXX Skin Corr. 1A; H314
Eye Dam. 1; H318
Skin Sens. 1A; H317
Aquatic Acute 1;
H400
Aquatic Chronic 1;
H410
M-Factor (Acute
aquatic toxicity): 1
M-Factor (Chronic
aquatic toxicity): 1
3 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Cal 1
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 >= 0,025 - <
drochloride 247-499-3 Acute Tox. 2; H330 0,1
01-2120764168-47- Acute Tox. 3; H311
XXXX Skin Corr. 1A; H314
Eye Dam. 1; H318
Skin Sens. 1A; H317
Aquatic Acute 1;
H400
Aquatic Chronic 1;
H410
M-Factor (Acute
aquatic toxicity): 1
M-Factor (Chronic
aquatic toxicity): 1
For explanation of abbreviations see section 16.
Cal 2
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 >= 0,025 - <
drochloride 247-499-3 Acute Tox. 2; H330 0,1
01-2120764168-47- Acute Tox. 3; H311
XXXX Skin Corr. 1A; H314
Eye Dam. 1; H318
Skin Sens. 1A; H317
4 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Aquatic Acute 1;
H400
Aquatic Chronic 1;
H410
M-Factor (Acute
aquatic toxicity): 1
M-Factor (Chronic
aquatic toxicity): 1
For explanation of abbreviations see section 16.
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.
5 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
used.
Hygiene measures : When using do not eat or drink. When using do not smoke.
Wash hands before breaks and at the end of workday.
R1
Contains no substances with occupational exposure limit values.
R2
Occupational Exposure Limits
Components CAS-No. Value type (Form Control parameters Basis
of exposure)
Streptavidin 9013-20-1 50 nanogram per cubic Category 3B
meter (Roche Group
Directive K1,
Annex 3):
OEL = 0.05
µg/m3
SA Coat-Beads
Contains no substances with occupational exposure limit values.
Cal 1
Contains no substances with occupational exposure limit values.
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Cal 2
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 : 480 min
Glove thickness : 0,11 mm
Respiratory protection : In the case of vapour formation use a respirator with an ap-
proved filter.
Colour : colourless
8 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Odour : none
Solubility(ies)
Water solubility : completely miscible
Viscosity
Viscosity, dynamic : No data available
R2
Appearance : liquid
9 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Odour : none
Solubility(ies)
Water solubility : completely miscible
Viscosity
Viscosity, dynamic : No data available
SA Coat-Beads
Appearance : liquid, Beads
10 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Odour : none
pH : 7,4
Solubility(ies)
Water solubility : completely miscible
Viscosity
Viscosity, dynamic : No data available
Cal 1
Appearance : liquid
11 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Colour : yellow
Odour : characteristic
Solubility(ies)
Water solubility : completely miscible
Viscosity
Viscosity, dynamic : No data available
Cal 2
Appearance : liquid
12 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Colour : yellow
Odour : characteristic
Solubility(ies)
Water solubility : completely miscible
Viscosity
Viscosity, dynamic : No data available
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
R2
Flammability (liquids) : Does not sustain combustion.
SA Coat-Beads
Flammability (liquids) : The product is not flammable., Does not sustain combustion.
Cal 1
Flammability (liquids) : Does not sustain combustion.
Cal 2
Flammability (liquids) : Does not sustain combustion.
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
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
2-methyl-2H-isothiazol-3-one hydrochloride:
Acute oral toxicity : LD50 Oral (Rat): 175 mg/kg
Method: OECD Test Guideline 425
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.
Skin sensitisation
May cause an allergic skin reaction.
Respiratory sensitisation
Not classified based on available information.
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Test Type : Local lymph node assay (LLNA)
Assessment : May cause sensitisation by skin contact.
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: 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.
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Remarks : No data available
Reproductive toxicity
Not classified based on available information.
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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): 175 mg/kg
Method: OECD Test Guideline 425
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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.
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)
Assessment : May cause sensitisation by skin contact.
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: 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 Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Carcinogenicity
Not classified based on available information.
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Remarks : No data available
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.
SA Coat-Beads
19 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Acute toxicity
Not classified based on available information.
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Acute oral toxicity : LD50 Oral (Rat): 175 mg/kg
Method: OECD Test Guideline 425
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.
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)
Assessment : May cause sensitisation by skin contact.
Method : OECD Test Guideline 429
Result : The product is a skin sensitiser, sub-category 1A.
20 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Genotoxicity in vitro : Test Type: 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.
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Remarks : No data available
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:
21 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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.
Cal 1
Acute toxicity
Not classified based on available information.
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Acute oral toxicity : LD50 Oral (Rat): 175 mg/kg
Method: OECD Test Guideline 425
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.
Skin sensitisation
May cause an allergic skin reaction.
22 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Respiratory sensitisation
Not classified based on available information.
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Test Type : Local lymph node assay (LLNA)
Assessment : May cause sensitisation by skin contact.
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: 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.
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Remarks : No data available
Reproductive toxicity
Not classified based on available information.
23 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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.
Cal 2
Acute toxicity
Not classified based on available information.
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Acute oral toxicity : LD50 Oral (Rat): 175 mg/kg
Method: OECD Test Guideline 425
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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.
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)
Assessment : May cause sensitisation by skin contact.
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: Ames test
Test system: Salmonella typhimurium
Metabolic activation: with and without metabolic activation
Method: OECD Test Guideline 471
Result: negative
25 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Carcinogenicity
Not classified based on available information.
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Remarks : No data available
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.
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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
SA Coat-Beads
28 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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
Cal 1
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
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SAFETY DATA SHEET
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Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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
Cal 2
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
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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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
2-methyl-2H-isothiazol-3-one hydrochloride:
Biodegradability : Test Type: aerobic
Result: Not readily biodegradable.
Biodegradation: 0 %
Exposure time: 28 d
31 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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
Cal 1
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
Cal 2
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).
32 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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).
Cal 1
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Bioaccumulation : Remarks: No bioaccumulation is to be expected (log Pow <=
4).
Cal 2
Components:
2-methyl-2H-isothiazol-3-one hydrochloride:
Bioaccumulation : Remarks: No bioaccumulation is to be expected (log Pow <=
4).
33 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
SA Coat-Beads
No data available
Cal 1
No data available
Cal 2
No data available
12.5 Results of PBT and vPvB assessment
R1
Not relevant
R2
Not relevant
SA Coat-Beads
Not relevant
Cal 1
Not relevant
Cal 2
Not relevant
12.6 Other adverse effects
R1
No data available
R2
No data available
SA Coat-Beads
No data available
Cal 1
No data available
Cal 2
No data available
34 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
14.1 UN 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 Transport in bulk according to Annex II of Marpol and the IBC Code
Remarks : Not applicable
15.1 Safety, health and environmental regulations/legislation specific for the substance or mix-
ture
Seveso III: Directive 2012/18/EU of the European Parliament and of the Council on the control of
major-accident hazards involving dangerous substances.
Not applicable
R1
Regulation (EC) No 649/2012 of the European Parlia- : Not applicable
ment and the Council concerning the export and import
of dangerous chemicals
35 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
lutants
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
Precautionary statements :
Prevention:
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
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
36 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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.
R2
Regulation (EC) No 649/2012 of the European Parlia- : Not applicable
ment and the Council concerning the export and import
of dangerous chemicals
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
37 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Precautionary statements :
Prevention:
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
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.
SA Coat-Beads
REACH - Candidate List of Substances of Very High : Not applicable
Concern for Authorisation (Article 59).
38 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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
hydroxyl-2-pyridone
Beads
Precautionary statements :
Prevention:
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
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.
39 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Cal 1
Regulation (EC) No 649/2012 of the European Parlia- : Not applicable
ment and the Council concerning the export and import
of dangerous chemicals
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
40 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
Precautionary statements :
Prevention:
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
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.
Cal 2
Regulation (EC) No 649/2012 of the European Parlia- : Not applicable
ment and the Council concerning the export and import
of dangerous chemicals
REACH - Restrictions on the manufacture, placing on : Conditions of restriction for the fol-
41 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
the market and use of certain dangerous substances, lowing entries should be considered:
preparations and articles (Annex XVII) Number on list 3
Precautionary statements :
Prevention:
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
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:
42 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
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; AICS - Australian Inventory of Chemical Substances; ASTM - American Society
for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regula-
tion; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN
- Standard of the German Institute for Standardisation; DSL - Domestic Substances List (Cana-
da); ECHA - European Chemicals Agency; EC-Number - European Community number; ECx -
Concentration associated with x% response; ELx - Loading rate associated with x% response;
EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx -
Concentration associated with x% growth rate response; GHS - Globally Harmonized System;
GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - In-
ternational Air Transport Association; IBC - International Code for the Construction and Equip-
ment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentra-
tion; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical
Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International Mari-
time Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisa-
tion for Standardization; 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 Specified; 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 Develop-
ment; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumu-
lative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substanc-
es; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
43 / 44
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys Anti-SARS-CoV-2
Version Revision Date: Date of last issue: 28.04.2020
1.2 30.04.2020 Date of first issue: 17.04.2020
1907/2006 of the European Parliament and of the Council concerning the Registration, Evalua-
tion, Authorisation and Restriction 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; TRGS - Technical Rule for Hazardous Substances; TSCA - Toxic Sub-
stances Control Act (United States); UN - United Nations; vPvB - Very Persistent and Very Bioac-
cumulative
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 / 1810
44 / 44