CEDIA LSD Calibrators

Hazard statements (CLP)

H302, H317, H334, H412

Code

Statements

H302

Harmful if swallowed

2.1 Classification of the substance or mixture

Globally Harmonized Respiratory sensitizer - Category 1. Skin sensitizer - Category 1. Acute Toxicity System [GHS] (Oral) Category 4. Aquatic toxicity (chronic) - Category 3. Other/Supplemental Mixture not yet fully tested.

2.2 Label elements

SECTION 2 - HAZARDS IDENTIFICATION …continued

Signal word

Danger

Hazard statements

H302 - Harmful if swallowed. H317 - May cause allergic skin reaction. H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled. H412 - Harmful to aquatic life with long lasting effects. EUH032 - Contact with acids liberates very toxic gas handling. P270 - Do not eat, drink or smoke when using this product. P272 - Contaminated work clothing should not be allowed out of the workplace. P273 - Avoid release to the environment. P280 - Wear protective gloves/eye protection/face protection. P285 - In case of inadequate ventilation wear respiratory protection. P301+P312 IF SWALLOWED Call a Poison Center or doctor/physician if you feel unwell. P302 + P352 - If on skin: Wash with plenty of soap and water. P330 - Rinse mouth. P304 + P341 - IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing. P333 + P313 - If skin irritation or rash occurs: Get medical advice/attention. P342 + P311 - If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. P363 - Wash contaminated clothing before reuse. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations.

Precautionary statements

P261 - Avoid breathing mist or vapor. P264 - Wash hands thoroughly after

2.3 Other hazards

The potential health hazards associated with exposure/handling of this mixture are unknown; no data specific for the mixture were identified. The following data describe the hazards of individual ingredients, where applicable. This product/mixture contains human urine and should be treated/handled as a potential biohazard. All such human urine has been derived from donors tested individually and shown by FDA approved methods to be free from antibodies to Human Immune Deficiency Virus and Hepatitis B and C. As no test method can offer complete assurance that these or other infectious agents are not present, this product should be handled using standard biosafety precautions. The mixture contains bovine serum albumin which has been associated with occupational sensitization. Material produced in compliance with USDA and/or CPMP/BWP/1230/98 (Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products). This is a CPMP/ BWP/1230/98 Category IV material: it does not contain nor is it derived from specified risk materials as defined in Commission decision 97/534/EC (or successive amendments). Because the mixture contains a protein (bovine serum albumin) it may cause an allergic skin or respiratory reaction (e.g., potential to cause anaphylaxis). In a workplace setting, the likelihood of systemic effects following accidental ingestion SECTION 2 - HAZARDS IDENTIFICATION …continued Other hazards …continued is low, due to the rapid breakdown of proteins in the digestive tract. Proteins, in general, can cause skin and/or respiratory sensitization. Note This mixture is classified as hazardous according to Regulation EC No 1272/2008 (EU CLP) and Hazard Communication Standard No. 1910.1200 (US OSHA). The pharmacological, toxicological and ecological properties of this mixture have not been fully characterized.