SILPURAN® AUX 8251 RO is used as an additive to get a radio opaque addition cure high consistency silicone rubber.
The following studies were performed on vulcanizates containing SILPURAN® AUX 8251 RO according to ISO 10993:
- Cytotoxicity (ISO 10993-5)
- Sensitation LLNA (ISO 10993-10)
- Pyrogenicity (ISO 10993-11)
The following studies were performed on vulcanizates containing SILPURAN® AUX 8251 RO according to USP class VI:
- Acute systemic toxicity
- Intracutaneous toxicity
- Implantation test
No adverse effects have been detected at any of the studies performed.
Properly cured and post-cured vulcanizates of a suited HTV and SILPURAN® AUX 8251 RO can be used for food contact applications and are suitable for use under the Recommendation "XV. Silicones" of the BfR and FDA 21 CFR §177.2600 "Rubber Articles Intended for Repeated Use" considering any given limitations on extractable and volatile substances.