Testopel (testosterone pellets)

Hazard statements (CLP)

H350, H361

Code

Statements

H350

May cause cancer

SECTION 2: Hazards identification

GHS US classification Classification of the substance or mixture GHS-US classification Carc. 1B H350 - May cause cancer Repr. 2 H361 - Suspected of damaging fertility or the unborn child Full text of H-statements: see section 16

2.2 Label elements

GHS-US labelling

Hazard pictograms

GHS08

Signal word

Danger

Hazard statements

H350 - May cause cancer H361 - Suspected of damaging fertility or the unborn child

Precautionary statements

P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P280 - Wear protective gloves, eye protection, protective clothing P308+P313 - If exposed or concerned: Get medical advice/attention P405 - Store locked up P501 - Dispose of contents/container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation

Other hazards which do not result in classification

Clinical use has caused effects on reproductive system, including prolonged erection (priapism), breast development in males (gynecomastia), decreased sperm count, impairment of male fertility, development of male characteristics (masculinization), development of male characteristics in the female fetus, impairment of female fertility. This drug is Pregnancy Category X. There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

Ingredient(s) with unknown acute toxicity

Not applicable

2.1 Classification of the substance or mixture

GHS-US classification Carc. 1B H350 - May cause cancer Repr. 2 H361 - Suspected of damaging fertility or the unborn child Full text of H-statements: see section 16