CALIBRATORS for CRP - hsCRP ELISA (REF 740001 - REF 740011)

SECTION 2: Hazards identification

Classification of the substance or mixture These components of the Demeditec CRP – hsCRP ELISA kit are not classified as hazardous mixtures according to EC Regulation 1272/2008/EC They contain no dangerous substances in concentrations equal to, or exceeding the concentration limits specified in EC regulation 1272/2008/EC The usual precautionary measures are to be adhered to when handling chemicals

2.2 Label elements

These products do not need to be labelled in accordance with EC Regulation 1272/2008/EC (EU-GHS/CLP)

Hazard pictograms

Not applicable.

Signal word

Not applicable.

Hazard statements

Not applicable.

Precautionary statements

Not applicable.

Supplemental label elements

EUH210: Safety Data Sheet available on request.

2.3 Other hazards

 Some ingredients of the CALIBRATORS mixture are derived from materials of biological origin. No known tests can guarantee that such materials are completely free from infectious agents. Caution should be exercised while handling the product: treat as potentially infectious.  These products contain sodium azide as a preservative. Sodium azide is toxic and may react with lead and copper plumbing to form explosive compounds. It is harmful to aquatic organisms and may cause long-term adverse effects in the aquatic environment.  None of the components are listed as PBT (Persistent/Bio-accumulative/Toxic)or vPvB (very Persistent/very Bio-accumulative).

2.1 Classification of the substance or mixture

These components of the Demeditec CRP – hsCRP ELISA kit are not classified as hazardous mixtures according to EC Regulation 1272/2008/EC. They contain no dangerous substances in concentrations equal to, or exceeding the concentration limits specified in EC regulation 1272/2008/EC. The usual precautionary measures are to be adhered to when handling chemicals. 2.2. Label elements These products do not need to be labelled in accordance with EC Regulation 1272/2008/EC (EU-GHS/CLP): Pictogram : Not applicable. Signal word : Not applicable. Hazard Statement(s) : Not applicable. Precautionary Statement(s) : Not applicable. Supplemental Hazard Statement(s) : EUH210: Safety Data Sheet available on request. 2.3. Other hazards  Some ingredients of the CALIBRATORS mixture are derived from materials of biological origin. No known tests can guarantee that such materials are completely free from infectious agents. Caution should be exercised while handling the product: treat as potentially infectious.  These products contain sodium azide as a preservative. Sodium azide is toxic and may react with lead and copper plumbing to form explosive compounds. It is harmful to aquatic organisms and may cause long-term adverse effects in the aquatic environment.  None of the components are listed as PBT (Persistent/Bio-accumulative/Toxic)or vPvB (very Persistent/very Bio-accumulative). SECTION 3 - COMPOSITION/INFORMATION ON INGREDIENTS 3.1. Substances Not applicable. 3.2. Mixtures Human source material (positive serum or plasma) used in the preparation of the CALIBRATORS has been tested and found non-reactive for HIV-1/2 antibodies, HCV and HbsAg. Bovine material (Fetal Bovine Serum) used in the buffer preparation is from sources where origin information is available. It is derived from US origin or processed in USDA licensed facilities. Areas of origin are categorized by the World Organization for Animal Health (O.I.E.) as a controlled risk for BSE. The following substances used in the CALIBRATORS are considered hazardous. At the indicated applied concentrations, it does not warrant hazard labelling. Hazardous Ingredient REACH EC N° CAS N° Classification + Concen- Registration N° H- and P-Statements tration Kit Component: CALIBRATORS ProClin® 300 Not listed – 55965-84-9 Acute Tox. 3 – H301 0,025 % (Mixture 3:1 of: Acute Tox. 3 – H311 (v/v)  5-chloro-2-methyl- Acute Tox. 3 – H331 [~ 0,0008 % 2H-isothiazol-3-one Skin Corr. 1B – H314 (w/v)]  2-methyl-2H- Skin Sens. 1 – H317 Aquatic Acute 1 – H400 isothiazol-3-one) Aquatic Chronic 1 – H410 P273, P280, P310, P305+P351+P338 5-Bromo-5-nitro-1,3- Not listed 250-001-7 30007-47-7 Acute Tox. 4 – H302 0,21 % dioxane (Bronidox L) Skin Irrit. 2 – H315 (v/v)