SAFETY DATA SHEET

according to Regulation (EC) No. 1907/2006

Elecsys total PSA
Version Revision Date: Date of last issue: 16.08.2021
4.0 09.02.2022 Date of first issue: 06.11.2018

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

1.1 Product identifier

Trade name : Elecsys total PSA

Product code : 08791732190

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 : info.dia-sds@roche.com
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

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys total PSA
Version Revision Date: Date of last issue: 16.08.2021
4.0 09.02.2022 Date of first issue: 06.11.2018

Hazard statements : H317 May cause an allergic skin reaction.

H412 Harmful to aquatic life with long lasting effects.

Precautionary statements : Prevention:

P261 Avoid breathing mist or vapours.
P273 Avoid release to the environment.
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.

Long-term (chronic) aquatic hazard, Cat- H412: Harmful to aquatic life with long lasting ef-
egory 3 fects.

Components
Chemical name CAS-No. Classification Concentration
EC-No. (% w/w)
Index-No.
Registration number
Polidocanol 9002-92-0 Acute Tox. 4; H302 >= 0,25 - < 1,0
500-002-6 Eye Irrit. 2; H319
01-2119968561-30 Aquatic Acute 1;
H400
Aquatic Chronic 1;
H410

M-Factor (Acute

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SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys total PSA
Version Revision Date: Date of last issue: 16.08.2021
4.0 09.02.2022 Date of first issue: 06.11.2018

aquatic toxicity): 1

Acute toxicity esti-

mate

Acute oral toxicity:

1.000 mg/kg
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
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
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.

Long-term (chronic) aquatic hazard, Cat- H412: Harmful to aquatic life with long lasting ef-
egory 3 fects.

Components

3 / 39
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Elecsys total PSA
Version Revision Date: Date of last issue: 16.08.2021
4.0 09.02.2022 Date of first issue: 06.11.2018

Chemical name CAS-No. Classification Concentration

EC-No. (% w/w)
Index-No.
Registration number
Polidocanol 9002-92-0 Acute Tox. 4; H302 >= 0,25 - < 1,0
500-002-6 Eye Irrit. 2; H319
01-2119968561-30 Aquatic Acute 1;
H400
Aquatic Chronic 1;
H410

M-Factor (Acute
aquatic toxicity): 1

Acute toxicity esti-

mate

Acute oral toxicity:

1.000 mg/kg
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
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
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

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