Silicone for sex toys: which grades are body-safe
Short answer: no silicone you can buy off the shelf is certified safe inside a body. Platinum cure silicone, sold as skin safe, is the material home casters use, and the maker of the toy carries the risk. Everything below explains why that sentence is worded the way it is.
This page is not medical advice. It reports what the manufacturers, the standards and the health sources say, and where they stop. For adults (18+).
- Platinum cure or tin cure
- What the labels certify
- "Medical grade" and "body safe"
- How soft: reading a shore number
- Pigments, additives, release agent
- Picking one
- Sources
Platinum cure or tin cure
Two-part casting silicones are named after the metal that starts the cure. Tin cure costs less. Platinum cure shrinks less and keeps its shape for decades. [Smooth-On FAQ 184] For anything that touches a person, platinum is the one to use: it needs no post-bake to drive off cure by-products, so it leaves fewer extractables behind, and the medical grades in that family are the ones that meet food-contact and biocompatibility tests. [SSP]
Platinum has one awkward habit: it refuses to cure against the wrong surface. Sulfur, amines and amides, tin salts, phosphorus compounds and some primers all stop it, leaving the surface sticky. [Dow] [FAQ 104] Tin cure and platinum cure will not cure against each other either. That is why the prepare step asks for a test patch in a corner of the mould before you pour the whole thing.
What the labels certify
Four labels turn up on silicone sold to hobbyists. None of them says "safe inside a body". Here is what each one actually covers.
- Skin safe. A manufacturer's category, tested by an independent lab for contact with skin. Smooth-On applies it to cured Ecoflex 00-30 and Dragon Skin 10, gives no warranty with it, and leaves suitability to you. [FAQ 205] No page we read extends it to mucous membranes.
- Food contact, 21 CFR 177.2600. A US rule for rubber articles in repeated contact with food. It lists the polymers and sets extraction limits for aqueous and fatty foods. [Cornell LII] It is a food rule, not a body rule, and Smooth-On says plainly that complying with it is not FDA approval. [FAQ 126]
- USP Class VI. Three animal tests on the material: systemic injection, intracutaneous, implantation. Pass or fail, on the material alone. It does not judge a finished device and does not replace approval. [Elastostar]
- ISO 10993. The one that does look at a finished device, under its real conditions of use, risk by risk. [Elastostar] A home cast has never been through it.
The European counterpart to the food rule, LFGB, cannot be self-certified and adds sensory testing, where FDA food-contact compliance can be self-attested. That comes from a retailer page, so treat it as a pointer rather than a citation. [Greenvyne, retailer]
"Medical grade" and "body safe"
Neither phrase has a legal definition in the sex-toy trade. A toy maker saying "body safe" is telling you what they believe, not what a body has tested; the trade runs on trust, and the honest move is to ask for third-party test reports. [Dame] Sex toys largely escape regulation and are still sold "for novelty use only" in places. [Public Health Post] Health writing that does name materials puts medical-grade silicone, borosilicate glass and stainless steel on the usable list, and warns that porous rubber and vinyl hold bacteria. [WebMD, medically reviewed]
So a home cast in skin-safe platinum silicone is not a certified body-safe toy. It is a home cast in skin-safe platinum silicone. That is the whole claim, and it is the reason this site never makes a bigger one.
How soft: reading a shore number
Hardness is measured on scales that run 00 (softest), then A, then D. They overlap: 95A is roughly 45D. [Smooth-On] For a cast you want to pull out of a mould, 70A is already too stiff; 30A and below bends out of detail without tearing. [FAQ 138]
- Ecoflex 00-10 to 00-50. The soft end. Very soft, very stretchy; 00-10 cures with a tacky surface. [00-10] [00-30]
- Dragon Skin 10 Medium. Shore 10 A, 20 minutes of pot life, 5 hours to cure, and it can be turned inside out without tearing. Do not cure it below 18 °C. [DS 10]
- Dragon Skin 30. Shore 30 A, 45 minutes of pot life, 16 hours to cure. Firmer, slower. [DS 30]
Those numbers come from the product pages and change with the product. Take yours from the datasheet in the box, not from this page.
Pigments, additives, release agent
Whatever a silicone was tested as, you change it when you add to it. Colour pigments need their own testing and are not covered by the base material's certificates. [SSP] The same goes for thinners, accelerators and any release agent left on the surface of the cast. A rinse and a full wash before first use is the minimum, and it is in the clean and store step.
Picking one
A working default, not a recommendation: a platinum cure silicone sold as skin safe, in the 10 A to 30 A range, bought fresh from a supplier who publishes datasheets. Read the datasheet for the mix ratio, the pot life and the cure time before you open anything, because the pot life starts the moment the two parts meet.
Then the practical side: the casting guide walks the whole process, from printing the mould to the first wash. The designer works out how much silicone your shape needs, in millilitres, while you draw it. The gallery shows what other people have drawn.
Sources
Read on 2026-09-20. Pages change; check the current datasheet. Manufacturer pages: Smooth-On, Dow, SSP. Standards: Cornell LII for 21 CFR 177.2600, Elastostar for USP Class VI and ISO 10993. Health: WebMD (medically reviewed), Public Health Post. Trade: Dame. Retailer pages are marked as such in the text. The full list, with what each page says and where sources disagree, is in docs/GUIDE-SOURCES.md in the project.