ELASTOSIL^® eco LR 5040/30 A/B

ELASTOSIL^® eco LR 5040/30 A/B is designed for the automated, high volume production of injection moulded articles.

Properly cured vulcanizates of ELASTOSIL^® eco LR 5040/30 A/B 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.

Properly cured materials meet the limit of 0.5 % for volatile substances in accordance with BfR “XV. Silicones”, DIN EN 1400:2014-07 and DIN EN 14350-2:2004-11, respectively. Consequently, post-curing may not be necessary, however, as the results may vary with the processing conditions and the geometry of the finished article, it is the responsibility of the person placing the article on the market to verify compliance with all relevant requirements and regulations. Since the measured volatile content increases with decreasing thickness of a part, in particular very thin-walled articles have to be carefully checked for compliance with any relevant limitations for volatile matter.

The following studies were performed on vulcanizates of ELASTOSIL^® LR 5040/30 A/B according to ISO 10993 and are also representative for ELASTOSIL^® eco LR 5040/30 A/B :
    - Hemocombatibility (Hemolysis and Thrombogenicity) (ISO 10993-4)
    - Cytotoxicity (ISO 10993-5)
    - Sensitation LLNA (ISO 10993-10)
    - Pyrogenicity (ISO 10993-11)

The following studies were performed on vulcanizates of ELASTOSIL^® LR 5040/30 A/B according to USP class VI and are also representative for ELASTOSIL^® eco LR 5040/30 A/B :
    - Acute systemic toxicity
    - Intracutaneous toxicity
    - Implantation test
No adverse effects have been detected at any of the studies performed.