None identified

Hazard statements (CLP)

H315, H317, H319, H334, H340, H351, H360FD, H372

Code

Statements

H315

Causes skin irritation

2.1 Classification of the substance or mixture

Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labelling listed below is for bulk Carboplatin 10 mg/mL. …continued Regulation (EC) 1272/ Irritant (skin) - Category 2. Irritant (eye) - Category 2. Respiratory sensitizer - 2008 [GHS] Category 1. Skin Sensitizer - Category 1. Germ Cell Mutagenicity - Category 1B. Carcinogenic - Category 2. Reproductive Toxicity - Category 1B. Specific Target Organ Toxicity (repeated exposure) - Category 1. Directive 67/548/EEC T - R48/25, R36/38, R42/43, R40 (Carc. Cat. 3), R46 (Muta. Cat. 2), R60 (Repr. or 1999/45/EC Cat. 2), R61 (Repr. Cat. 2)

Signal word

Danger Danger US Hazard overview Contains the cytotoxic drug, carboplatin. Causes eye/skin irritation. May cause respiratory tract irritation. May cause allergic skin/respiratory reaction. Harmful if swallowed. May cause myelosuppression, hematological toxicity, gastrointestinal toxicity, nephrotoxicity, nervous system toxicity and reproductive organ toxicity. Genotoxic. Possible cancer hazard - Contains material which may cause cancer.Reproductive/Developmental Hazard - May adversely affect the developing fetus or cause adverse reproductive effects. Birth Defect Hazard - May cause birth defects. Note This mixture is classified as dangerous/hazardous according to directive 1999/45/ EC, Regulation (EC) No 1272/2008 (EU CLP) and applicable US regulations. The EU symbol/indicator of danger, R Phrases and Safety Advice are based on Directive 67/548/EEC or 1999/45/EC. See Section 16 for full text of EU and GHS classifications.

CLP CLASSIFICATION

H315 - Causes skin irritation. H319 - Causes serious eye irritation. H334 - May

Hazard statements

cause allergy or asthma symptoms or breathing difficulties if inhaled. H317 - May cause allergic skin reaction. H340 - May cause genetic defects. H351 - Suspected of causing cancer. H360FD - May damage fertility. May damage the unborn child. H372 - Causes damage to bone marrow, hematological system, kidney, reproductive system, gastrointestinal tract and nervous system through prolonged or repeated exposure. CLP/GHS P201 - Obtain special instructions before use. P260 - Do not breathe mist/vapors/

Precautionary statements

spray. P281 - Use personal protective equipment as required. 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. P308 + P313 - If exposed or concerned: 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. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations. EU symbol/indication of danger T- Toxic. …continued Risk (R) Phrase(s) R36/38 - Irritating to eyes and skin. R48/25 - Toxic: Danger of serious damage to health by prolonged exposure if swallowed. R42/43 - May cause sensitization by inhalation and skin contact. R40 - Limited evidence of a carcinogenic effect. R46 - May cause heritable genetic damage. R60 - May impair fertility. R61 - May cause harm to the unborn child. S23 - Do not breathe spray. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37 - Wear suitable protective clothing and gloves. S53 - Avoid exposure - Obtain special instructions before use.

2.3 Other hazards

Contains carboplatin, a cytotoxic agent. The dose-limiting adverse effect seen with therapeutic use of carboplatin is myelosuppression. Other adverse effects may include hematological toxicity, gastrointestinal toxicity, nephrotoxicity, peripheral neurotoxicity, electrolyte disturbance, hearing loss and increased liver enzymes. Additionally, allergic reactions (including anaphylactic-type reactions) have been reported and may occur within minutes of therapeutic administration. Allergic reactions following occupational exposures to soluble platinum salts have also been reported. Carboplatin can also cause eye/skin/respiratory tract irritation. Secondary malignancies have been reported in association with multi-drug therapy. There are scientific studies that suggest personnel (e.g., nurses, pharmacists) who prepare and administer parenteral antineoplastics may be at some risk due to potential mutagenicity, adverse effects on reproduction and/or carcinogenicity if these materials in the workplace if exposures are not properly controlled. The actual risk in the workplace is not known.