Adult industry (48)

Silicone is well suited to reproducing body parts, whether that is a breast or genitals. This category brings together everything involved, from sculpting an original to casting a finished product. ⚠️ Read this first: not every product here is for the finished item The products in this category have different...

Silicone is well suited to reproducing body parts, whether that is a breast or genitals. This category brings together everything involved, from sculpting an original to casting a finished product.

⚠️ Read this first: not every product here is for the finished item

The products in this category have different roles. Some are for sculpting your original, some for casting and mould making, some for the finished product, and some for filling or building up the inside, such as silicone foam and padding gel. There are also auxiliaries here such as silicone oils and pigment.

Only a limited part of this range is a candidate for the side that touches the body, and even then only under conditions. Read below which product is meant for what before you order.

What is in this category and what it is for

1. Sculpting and making an original

Plasticine and Monster Clay. This is what you sculpt your model from. It never ends up in the finished product. Note that sulphur bearing clay can inhibit the cure of platinum silicone, see the section on cure inhibition below.

2. Body casting and mould making

Alginate 3D Gel for a single use impression of a body part, plaster bandage for a support shell, and the mould silicones: Samsil Semi Clear 25, Elastosil Vario 15 and Vario 40, Silicone Addition Colourless 25 and 50, Yellow 25, Green 30, Transparent 25 and Cenusil Pink 10. These materials end up in the mould, not in the product you make.

3. Silicone for the finished product

Zhermack SFX 00-20 and SFX 00-30, PlatSil Gel-25, Gel-OO and Gel-0030, Wacker Elastosil FX 10, FX 20 and FX 28, Silicone Addition Colourless 5, Soft Flex 00-35 and Semsil HTV. This is the group you choose the contact side material from. Read the next section before deciding, because the differences in supporting evidence are large.

4. Filling and internal build up

Silicone foam in open cell and closed cell versions, Silpadding filling gel and Silicone Addition Gel 840. These sit on the inside, behind a closed outer skin, and give a soft or lifelike feel.

Important: open cell foam is porous, absorbs moisture and cannot be cleaned. Closed cell foam is also open at any cut face. Never use foam as the outer layer of a product that touches the body, only as a core behind a fully closed silicone skin.

5. Auxiliaries

Silicone oils (Wacker AK 35, AK 100 and AK 350, Atoro 100 to 100,000 cSt, pharma grade dimethicone), silicone pigment and LSR Topcoat. The oils are in this category for lubrication, release and lowering viscosity in mould making. They are explicitly not intended as a softener in the contact side material. See Can I use silicone oil as a release agent.

Which silicones are candidates for the contact side

The supporting evidence differs greatly per brand. Do not just check whether a report exists, check above all which tissue and which contact duration that report was drawn up for.

Zhermack SFX 0020, the only one with a mucosal assessment

Zhermack has had ZA SFX 0020 evaluated to ISO 10993-1 in two contact categories: surface medical device with intact skin for more than 30 days, and surface medical device with mucosa for a contact duration up to 24 hours. Endpoints tested: cytotoxicity (ISO 10993-5), sensitisation (ISO 10993-10) and skin irritation (ISO 10993-23). No relevant biological effects, study completed August 2023. Zhermack also states that no organic plasticisers are involved.

Shore 00-20, translucent, 1:1 by weight, 25 minutes working time, elongation at break 770 %. Within our range this is the only material with an assessment that explicitly names mucosal contact. The assessment does not cover SFX 00-30 and does not cover SkinForm.

Shore 00-20 is very soft for a solid product. The logical build is a soft contact layer of SFX 0020 over a firmer core, so that the material with the assessment is the layer that actually touches the body.

CHT True Skin 20 and 30

Tested to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitisation) at Pacific BioLabs, with FDA 21 CFR 177.2600 compliance. For True Skin 30 a REACH SVHC statement and a RoHS 3 statement are also available. This evaluation is aimed at skin contact and says nothing about mucosal contact.

Note on availability: True Skin 20 is currently difficult to obtain. Do not count on it for a production run; contact us for the current lead time, or plan around True Skin 30.

Polytek PlatSil Gel

Independently assessed as skin safe under FHSA, ASTM D4236 and FDA requirements. That is a toxicological assessment for skin contact, not an ISO 10993 test series, and it says nothing about mucous membranes.

Wacker Elastosil FX and Vario, read the Health Care Policy first

Wacker issues a skin statement for FX 10, FX 20 and FX 28, but no toxicological tests have been carried out on those products themselves. The statement rests on analogy with comparable addition-curing silicones and applies only to intact skin.

⚠️ The WACKER SILICONES HEALTH CARE POLICY excludes this application in principle. Wacker generally does not permit use in contact with the genital mucosa, generally excludes applications of more than 30 days single or repeated use, and assesses contraceptive and reproductive devices case by case. Because silicone elastomers may contain significant amounts of silicone fluid, the conformity of the chosen Wacker product for that application must be verified with Wacker, and the customer must inform Wacker before purchasing.

We therefore do not recommend Wacker for the contact side of this kind of product. For the mould, Wacker is excellent. If you still want that route, contact us and we will put your application to Wacker in writing.

In every case: a report on the raw material does not automatically make your finished product safe. As soon as you add pigment, use a release agent, do not mix exactly by weight, do not cure fully or do not post-cure, the result changes. You remain responsible for correct processing and for assessing and testing your own finished product.

Background: USP Class VI, ISO 10993 and food contact. For the right softness: Shore hardness explained.

In most cases, use a condom

With a self-made toy we advise using a condom. This is not excessive caution, it is the simplest way to limit the risk of an untested product. We recommend it in any case when:

  • ✓ the product has not been post-cured
  • ✓ it contains or carries pigment, filling, foam or release agent residue
  • ✓ the surface is not completely smooth and closed, because every pore, air bubble or cut edge holds dirt and bacteria
  • ✓ you have no test report for your own finished product
  • ✓ the product is shared between people

A condom does not repair a poorly cured or porous product, but it limits direct contact. Do not use a silicone based lubricant on silicone products, it can attack the surface. Choose a water based lubricant.

Adjusting hardness without silicone oil

For products that come into contact with the body we advise against adjusting hardness with silicone oil. Silicone oil is a non reactive polymer that is not incorporated into the cured network. It stays mobile, migrates to the surface and leaves the product during use. The consequences are an oily film on the product, progressive hardening and dimensional change over time, and a migration result you cannot defend in a safety file.

The correct route is to blend grades of the same chemistry with the same mix ratio, for example CHT True Skin 20 with True Skin 30, or PlatSil Gel OO with PlatSil Gel 25. Everything you add is then chemically bound into the network. Validate your blend ratios on your own test pieces, because hardness does not scale linearly.

If you want a soft feel without losing mechanical integrity, use a build in two hardnesses, with a firmer core and a soft outer layer. Or work with a closed silicone skin around a core of padding gel or foam.

Moulds and body casting

For casting body parts you normally use a single use mould of alginate 3D gel, into which silicone is then poured.

You can make your own model quickly with plasticine and alginate 3D gel. Sculpt the model, place it in a cup, pour alginate around it, let it set, carefully remove the model and pour silicone into the cavity. The result is ready in a few hours. For repeat production you work with a reusable silicone mould or a rigid mould.

You can also make a silicone balloon and fill it with a silicone gel. This is normally used for lifelike fake breasts.

Points to watch when casting

  • ✓ Addition cure silicone can bond to addition cure silicone, particularly with a fresh mould, a smooth surface or a thin layer. Do not assume it will release on its own. Use a release agent, or run a small test cast first.
  • ✓ At the same time, a release agent is itself a point of concern for this kind of product: it leaves residue on exactly the surface that touches the body. So prefer a mould design that needs little or no release, for example a rigid mould with sufficient draft angle, and clean the product thoroughly after demoulding. Do not use silicone oil as a release agent for this application.
  • ✓ Do not use a condensation cure mould. Residual tin inhibits the cure of platinum silicone, leaving a tacky or incompletely cured surface.
  • ✓ Mix exactly by weight and stir slowly, right into the corners of the cup. A wrong ratio or a poorly stirred mix will not cure fully in places.
  • Cure inhibition, or poisoning of silicone. Sulphur bearing clay and plasticine, latex gloves, PVC, uncured polyurethane and epoxy, cyanoacrylate and many SLA 3D prints can inhibit the cure of platinum silicone. On a toy, an incompletely cured surface is not a cosmetic flaw but a safety problem. Read how to prevent it in Poisoning of silicone (cure inhibition) and, for printed models, in SLA 3D prints and platinum silicones. Always run a small test cure on a piece of your model or mould first.

Post-curing, and how to do it

Curing at room temperature is never chemically complete. Residual volatiles and unreacted low molecular weight siloxanes stay behind in the rubber. Those are exactly the substances that can migrate, and exactly what an extractables or migration test picks up. Post-curing drives them out, completes the network further and also removes residual odour. For a product with prolonged body contact, post-curing is strongly recommended.

  1. First let the product cure fully at room temperature as stated in the TDS, usually 24 hours. Never post-cure a half cured product.
  2. Demould and remove all release agent residue with warm water and a neutral detergent. Let it dry properly.
  3. Place the product in the oven supported and free of tension, on baking paper or a silicone mat. Soft material deforms if it hangs over an edge.
  4. Post-cure typically 2 to 4 hours at 100 to 150 °C. Always stay below the maximum service temperature of the specific product as stated in its TDS. If in doubt, choose a lower temperature and a longer time.
  5. Heat up slowly and cool down slowly, which limits stress and dimensional change.
  6. Ensure ventilation or extraction, and do not use an oven that is also used for food.
  7. To check whether it is enough, weigh a test piece before and after. If a second cycle produces almost no further weight loss, the post-cure is sufficient.

Note that products with a foam or gel filling and products with a built in core do not always tolerate these temperatures. In that case post-cure the silicone part before you assemble.

Cleanability and service life

A product that touches the body has to be cleanable. That requires a closed, smooth surface with no pores, no open cut edges and no air bubbles reaching the surface. Remove air bubbles by degassing under vacuum or by pouring slowly in a thin stream, and finish cut edges properly. Inspect your products regularly and stop using them as soon as the surface becomes damaged, porous or tacky.

⚠️ Important for commercial production

We are a raw material supplier. We do not issue a declaration that a silicone is suitable for prolonged contact with genitalia, the anus or mucous membranes. That declaration does not exist at raw material level, not from us and not from the material manufacturers.

ISO 3533:2021 is a product standard, not a material standard. The requirements for risk management, your own restricted substance list, biocompatibility and cleanability sit with the manufacturer of the finished article. Non electrical products in this category are not CE marked and fall under the General Product Safety Regulation (EU) 2023/988, with REACH applying to the substances. Responsibility for the risk analysis and the technical file sits with the party placing the product on the market. Electrical or battery powered versions additionally fall under CE, RoHS, the Battery Regulation and WEEE.

We supply SDS, TDS and the declarations the manufacturer issues itself. CHT documentation is supplied on request. Have the cured finished product tested by an accredited laboratory, as a minimum to ISO 10993-5 and ISO 10993-10, together with a chemical screening against your own restricted substance list.

For series production, cast RTV-2 is rarely the end route. The industry standard is LSR injection or HTV compression moulding in rigid tooling, because that gives a repeatable process without hand mixing variability, without air entrapment and without release agent residue.

The information on this page is technical advice and not a conformity assessment.

Not sure which option is right?

Our technical specialists can advise on material choice, hardness build up, the moulding route, post-curing and which documentation does and does not exist. Contact us at info@siliconesandmore.com.

Login

Forgot your password?

Don't have an account yet?
Create account