CEDIA Gentamicin

Hazard statements (CLP)

H315, H317, H319, H334

Code

Statements

H315

Causes skin irritation

2.1 Classification of the substance or mixture

Regulation (EC) Irritant (skin) - Category 2. Irritant (eye) - Category 2. Respiratory Sensitizer - 1272/2008 [GHS] Category 1. Skin Sensitizer - Category 1. Mixture not yet fully tested. SECTION 2 - HAZARDS IDENTIFICATION …continued

Signal word

Danger

CLP CLASSIFICATION

H315 - Causes skin irritation. H317 - May cause allergic skin reaction. H319 -

Hazard statements

Causes serious eye irritation. H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled. EUH032 - Contact with acids liberates very toxic gas. CLP/GHS precautionary P261 - Avoid breathing mist or vapor. P264 - Wash hands thoroughly after handling. P272 - Contaminated work clothing should not be allowed out of the workplace. P280 - Wear protective gloves/eye protection/face protection. P285 - In case of inadequate ventilation wear respiratory protection. P302 + P352 - If on skin Wash with plenty of soap and water. P304 + P341 - IF INHALED If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing. P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P333 + P313 - If skin irritation or rash occurs: Get medical advice/attention. P337 + P313 - If eye irritation persists: Get medical advice/ attention. P342 + P311 - If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. P362 - Take off contaminated clothing and wash before reuse. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations.

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. 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, 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 is low, due to the rapid breakdown of proteins in the digestive tract. Although antibody particles are fairly large proteins, it is not known if systemic effects can occur following accidental inhalation. Proteins, in general, can cause skin and/or respiratory sensitization. SECTION 2 - HAZARDS IDENTIFICATION …continued 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.