Lugol"s solution

TestLine Clinical Diagnostics s.r.o

Revision date : 2021-05-26

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GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

7681-11-0

Name of the chemical

potassium iodide

Concentration

N/A

EC/CAS

7553-56-2

Name of the chemical

Iodine (I)

Concentration

N/A

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

EC/CAS

231-442-4

Name of the chemical

Iodine

Concentration

N/A

EC/CAS

231-791-2

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

General Information

Revision date

2021-05-26

Product name

Lugol"s solution

1.2.1 Relevant identified uses

Preparation for in vitro diagnostic use

1.2.2. Uses advised against

Any other than the above mentioned

supplier name

TestLine Clinical Diagnostics s.r.o

Emergency telephone

+420 224 919 293 or +420 224 915 402;

Icons in SDS

Company Information

company name

TestLine Clinical Diagnostics s.r.o

e-mail address of the competent person responsible for the Safety Data Sheet

pospisiljar@testlinecd.com, bl@studio2k.cz

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H373

Hazard statements

Code

Statements

H373

May cause damage to organs through prolonged or repeated exposure

Section 2

2.1 Classification of the substance or mixture

The product is an in vitro diagnostic medical device in accordance with Directive 98/79/EC of the European Parliament and of the Council, is in the finished state and intended for the final user. It therefore does not apply to its Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) according to Article 1, par. 5d). They need not be classified, labelled or packaged in accordance with this Regulation.

CLP CLASSIFICATION

The product is classified as dangerous in the terms of the Regulation (EC) No 1272/2008 (CLP). STOT RE 2 H373 May cause damage to the thyroid through prolonged or repeated exposure. Route of exposure: Oral.

2.2 Label elements

Labelling according to Regulation (EC) No 1272/2008: The product is classified and labelled according to the CLP regulation.

Hazard pictograms

d ~ GHS08

Hazardous Ingredients

potassium iodide

Hazard statements

H373 May cause damage to the thyroid through prolonged or repeated exposure. Route of exposure: Oral.

Precautionary statements

P260 Do not breathe vapours. P314 Get medical advice/attention if you feel unwell. P501 Dispose of contents/container to hazardous or special waste collection point.

Additional information

Restricted to professional users.

PBT Substances

The mixture does not contain substances classified at the date of preparation of the safety data sheet as PBT according to Regulation (EC) No 1907/2006 (REACH) in a concentration equal to or greater than 0.1 % by weight.

vPvB Substances

The mixture does not contain substances classified at the date of preparation of the safety data sheet as vPvB according to Regulation (EC) No 1907/2006 (REACH) in a concentration equal to or greater than 0.1 % by weight. Determination of endocrine-disrupting properties The mixture does not contain substances that have been identified as having endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at a concentration equal to or greater than 0.1 % by weight.

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