Matulane

Hazard statements (CLP)

H302, H315, H340, H350, H360FD, H372, H412

Code

Statements

H302

Harmful if swallowed

SECTION 2: Hazards identification

GHS Classification 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 labeling listed below is for bulk Matulane® Procarbazine Hydrochloride) Capsules Regulation (EC) 1272/ 2008 [GHS] Acute toxicity - oral - Category 4. Irritant (skin) - Category 2. Reproductive Toxicity - Category 1A. Germ Cell Mutagenicity - Category 1B. Carcinogenic - Category 1B. Specific Target Organ Toxicity (repeated exposure) - Category 1 Aquatic toxicity (chronic) - Category 3 Directive 67/548/EEC T - R22, R38, R45 (Carc. Cat. 2), R46 (Muta. Cat. 2), R60 (Repr. Cat. 1), R61 or 1999/45/EC Repr. Cat. 1), R52/53 HAZARDS IDENTIFICATION …continued

2.2 Label elements

CLP/GHS hazard

Signal word

Danger CLP/GHS hazard H302 - Harmful if swallowed. H315 - Causes skin irritation. H340 - May cause US Hazard overview Caution Contains procarbazine - a potent anticancer agent. May be harmful if swallowed. May cause skin irritation. Reproductive/Developmental/Birth defect hazard - can cause adverse reproductive (male and female) effects, developmental effects, and birth defects. Can cause blood, bone marrow, gastrointestinal, nervous system, and testicular damage. Genotoxic. Harmful to aquatic life with long-lasting effects. Note This product/mixture is classified as dangerous/hazardous according to directive

Hazard statements

genetic defects. H350 - May cause cancer. H360FD - May damage fertility. May damage the unborn child. H372 - Causes damage to the blood, bone marrow, gastrointestinal tract, nervous system, and testes through prolonged or repeated exposure. H412 - Harmful to aquatic life with long lasting effects. CLP/GHS P201 - Obtain special instructions before use. P260 - Do not breathe dust. P270 -

Precautionary statements

Do not eat, drink or smoke when using this product. P273 - Avoid release to the environment. P281 - Use personal protective equipment as required. P302 + P352 - If on skin: Wash with plenty of soap and water. P308 + P313 - If exposed or concerned: get medical advice/attention. P321 - Specific treatment (see First Aid information on product label and/or Section 4 of the SDS). 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. Risk (R) Phrase(s) R22 - Harmful if swallowed. R38 - Irritating to skin. R45 - May cause cancer. R46 - May cause heritable genetic damage. R60 - May impair fertility. R61 - May cause harm to the unborn child. R52/53 - Harmful to aquatic organisms. May cause long-term adverse effects in the aquatic environment. S24 - Avoid contact with skin. S36/37 - Wear suitable protective clothing and gloves. S61 - Avoid release to the environment. Refer to special instructions/safety data sheets.

2.3 Other hazards

Procarbazine is an anti-cancer agent that inhibits DNA, RNA, and protein synthesis, and can affect normal, rapidly proliferating cells. It also exhibits monoamine oxidase inhibitory (MAOI) activity. The most common adverse effects associated with use of procarbazine include gastrointestinal disturbances and bone marrow suppression, characterized by decreases in platelets and white and red blood cells. Various central nervous system (CNS) effects, resulting from the drug's MAOI activity, may also occur (e.g., dizziness, drowsiness, weakness, SECTION 2 - HAZARDS IDENTIFICATION …continued

Other hazards

sleep disturbances, tremors, changes in blood pressure or heart rate, and numbness …continued in the extremities). Overdosage may cause additional CNS-associated symptoms, which may manifest 12 hours post exposure and peak at 24-48 hours. Procarbazine exposure has been identified as an independent risk factor for acute ovarian failure and acute amenorrhea (absence of menstruation) in women. There are case reports of malformations in the offspring of women taking this drug as a part of a combination therapy regimen. Azoospermia (absence of sperm in semen), which can be prolonged, has also been reported in men with procarbazine when used in combination therapy. Secondary malignancies (including lung cancer and leukemias) have been reported in patients treated with procarbazine in combination therapies. Talc is irritating to the respiratory system, causing cough, shortness of breath, rapid breathing, sneezing, vomiting, and pulmonary edema - cardiorespiratory arrest may also occur following severe aspiration.

2.1 Classification of the substance or mixture

Drugs in the finished state and intended for the final user are not subject to substance or mixture