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Who are Danisco? Danisco are the world’s largest producer of food emulsifiers with a non-food section dedicated to taking safe, non- contentious food ingredient chemistry into the polymer industry. What is 'SOFT-N-SAFE'? GRINDSTED ® SOFT-N-SAFE is a bio- based plasticiser originating from natural plant oils, specifically Castor. It has been developed to replace phthalates and other ‘chemicals of concern’ in PVC and offers a unique combination of safety, processing and sustainability, unmatched by any other product. In terms of its processing capabilities this vegetable-based acetylated mono- glyceride (CAS # 736150-63-3) is the closest ‘drop-in’ replacement for the Cat. 2-labelled DEHP (DOP or dioctyl phtha- late), offering similar processing charac- teristics, efficiency and improvements in clarity and extraction resistance. Additionally, significantly lower VOCs (volatile organic compounds) are achieved and other improvements in physical and mechanical properties over DEHP and several other phthalates/quasi-phthalates lead to a product that is unique in its properties and capabilities. Its global regulatory profile for food contact plastics and its current usage in medical devices to safely substitute DEHP set it apart from any other plasticiser on the market and make it a natural choice for Processors and Brand- owners contemplating a strategic move into safe, non-irritant medical devices where previously phthalates have been employed. Biocompatibility GRINDSTED ® SOFT-N-SAFE has an outstanding toxicological profile, which has not been matched by any other DEHP substitute. Guideline tests have shown that it is not an eye or skin irritant, nor a skin sensitiser. There are no signs of acute or chronic toxicity and no repro- ductive or hormone-disrupting effects. Furthermore, it has no genotoxic effects. It has been assigned a NOAEL of 5,000 mg/kg bw/day and NOEL of 1,000 mg/kg bw/day. Toxicological testing is being carried out according to REACH legislation. The BN EN ISO 10993 testing of the polymer plasticised with GRINDSTED ® SOFT-N-SAFE showed no in vitro cytotoxicity and no haemolytic activity when tested with human blood as neat extract. Please find below a few of the extensive tests that have been successfully conducted: BS EN ISO 10993-5 In vitro cytotoxicity BS EN ISO 10993-4 Blood compatibility OECD 474 In vivo micronucleus OECD 452 Chronic toxicity OECD 414 Developmental toxicity OECD 416/426 Reproduction/develop- mental neurotoxicity REACH GRINDSTED ® SOFT-N-SAFE is REACH compliant.
