GDF-9 ELISA (RUO)

SECTION 2: Hazards identification

• Classification according to Regulation (EC) No 1272/2008 Classification of the substance

Hazard pictograms

None required

Signal word

None

Hazard statements

None

Additional information

EUH208 – Contains ProClin™ 300 (CMIT/MIT, 3:1) and sodium azide. May produce an allergic reaction.

Hazardous Ingredients

Isothiazolinones (CMIT/MIT 3:1) and Sodium azide.

Precautionary statements

P264 – Wash hands thoroughly after handling. P273 – Avoid release to the environment. P280 – Wear protective gloves/eye protection. P305 + P351 + P338 – IF IN EYES: Rinse cautiously with water for several minutes; remove contact lenses if present and easy to do. Continue rinsing. P501 – Dispose of contents/container in accordance with local regulations. • Justification for classification: Based on available data and concentrations of hazardous constituents, the mixture does not meet classification thresholds under CLP.

2.3 Other hazards

• PBT / vPvB assessment: The mixture does not contain any substances identified as PBT or vPvB according to Annex XIII of REACH. • Endocrine-disrupting properties: None of the components are identified as having endocrine-disrupting properties under REACH or CLP. • Biological origin: Some kit components may contain materials of human origin (e.g., serum-based buffers). These are tested and found non-reactive for known pathogens but should be handled using Biosafety Level 2 precautions per CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. The product also contains proteins of bovine or equine origin sourced from OIE-classified negligible BSE-risk herds in accordance with Reg. (EC) No 999/2001 and Commission Decision 2007/453/EC. • Contains trace concentrations of isothiazolinones (< 0.25 %) and sodium azide (< 0.1 %) which are below classification thresholds but may cause sensitization in susceptible individuals. Under normal conditions of use, the mixture does not present any additional physical, health, or environmental hazards.

2.1 Classification of the substance or mixture

According to Regulation (EC) No 1272/2008 (CLP) as or mixture: amended: This mixture is not classified as hazardous under the criteria of Regulation (EC) No 1272/2008 (CLP). It contains trace concentrations of preservatives (isothiazolinones ≤ 0.25%, sodium azide ≤ 0.1%) and dilute sulfuric acid (< 2%), all present below the concentration limits for classification. The mixture does not meet the criteria for physical, health, or environmental hazard classification under CLP. Intended use: For research use only (RUO); not for diagnostic or therapeutic applications.