Silicon carbide

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Additional information

Short description of key information:

Silicon carbide is a chemically inert mineral substance. Due to its physico-chemical characteristics (the determination of water solubility showed that the substance “can be considered as practically insoluble in water”; see chapter 4.8) it can be inferred that the substance is unlikely to be taken up into the blood stream, let alone to cross the placental, blood-brain or blood-testes barriers.

As demonstrated by oral, dermal and cytotoxicity studies conducted with silicon carbide, the substance exhibits a low toxicological activity (see chapters 7.2.1, 7.2.3, 7.9.3). In standard OECD tests 423 and 402 silicon carbide exhibited no orally toxic characteristics and no acute dermal toxic characteristics. Besides, in a very sensitive test normally used for biological evaluation of medical devices, an extract of silicon carbide was tested for cytotoxic properties (see chapter 7.9.3). The test showed that no compounds with clear cytotoxic potential (i.e. leading to a cell growth inhibition of more that 30%) are released from silicon carbide.

Furthermore, the available animal studies with silicon carbide, including a 10-day repeated-dose inhalation toxicity study (J. Bruch, 1993; see chapter 7.2.2), report no adverse effects on the reproductive organs. Likewise the available epidemiological studies (see chapter 7.10) indicate no association between exposure to silicon carbide and adverse effects on reproduction.

Against this background, based on the low bioavailability of silicon carbide and its and low toxicological activity, it can be assumed that the substance has no adverse effects on sexual function and fertility in adults, and no effects interfering with the normal development of their offspring. Consequently tests on reproductive and developmental toxicity of silicon carbide appear to be dispensable.