ASEPTIM - PAD Plus Normal solution
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SAFETY DATA SHEET According to EU Directive 91/151/EEC as amended by Directive 2001/58/EC Date of issue: March 2015. 1. Identification of the substance and of the company 1.1 Product Identifier/Trade name PAD Plus Normal solution 1.2. Relevant Identified Use(s) and uses advised against. Only for use in dentistry to treat bacterial infections in the mouth when activated with red light at 635nm during a PAD procedure. Advised against all other uses. Denfotex Research Ltd., Floor 5, Henriette Raphael House, Kings College London, Guys Hospital Campus, London, SE11UL, United Kingdom. 1.4 Emergency telephone and contact information. 2. Hazards identification 2.1 Classification of substance Not a hazardous substance or mixture according to Regulation no. 1272/2008. This substance is not classified as dangerous according to directive 67/548/EEC. As required by Medical Device Directive 2.3 Other hazard information Ingestion Supplied in syringes containing 1.2ml of solution with ingestion of 28L necessary to reach NOAEL equivalent to 23,333 syringes. Skin contact Will stain skin pale blue which can be washed-off with soap and water. Flush out solution with water and seek medical advice. No vapour is released from solution so there is no inhalation. Enviroment: vPvB/PBT Additional information No other risks known. Tolonium chloride, buffer, sterile water Other information Description: Pale blue liquid Hazardous components: REACH Number A registration number is not available as the substance or its uses are exempted from 1

SAFETY DATA SHEET According to EU Directive 91/151/EEC as amended by Directive 2001/58/EC Date of issue: March 2015. registration, the annual tonnage does not require registration or the registration is envisaged for a later registration deadline. Synonyms Toluidine Blue O Methylene Blue T50 or Textra Blutene chloride Basic Blue 17 Formula Molecular Weight EC-No. : 4. First Aid Measures 4.1 Description of First Aid measures Ingestion Swallow 1L of water. Rinse mouth and wash around lips to remove pale blue stain. Wash- off with soap and water to remove pale blue stain. Flush out solution...

SAFETY DATA SHEET According to EU Directive 91/151/EEC as amended by Directive 2001/58/EC Date of issue: March 2015. 5.3.Special protective actions for fire-fighters 6. Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Avoid ingestion and contact with eyes. For personal protection see section 8. 6.2.Environmental precautions Do not let product enter drains. 6.3 Methods and materials for containment and cleaning up Cover spillage with sand or other suitable material to absorb solution. Sweep up and shovel. Keep in suitable, closed containers...

SAFETY DATA SHEET According to EU Directive 91/151/EEC as amended by Directive 2001/58/EC Date of issue: March 2015. Change in condition Becomes paler on exposure to light or heat Melting point/melting range Boiling point/boiling range: Freezing point Evaporation rate As water leaving blue stain Flash point Auto ignition temperature Explosive properties Upper/lower flammability Oxidising properties Decomposition temperature Vapour pressure: Solubility in/miscibility with water: Aqueous solution 20mg/L: Miscible Content of solvents Organic content: Water content: Other information 10....

SAFETY DATA SHEET According to EU Directive 91/151/EEC as amended by Directive 2001/58/EC Date of issue: March 2015. exposed to light Serious eye damage/irritanion Respiratory/skin sensitisation: May cause sensitisation in susceptible individuals Germ cell mutagenicity No known mutagenicity below NOAEL of 28L No known mutagenicity below NOAEL of 28L Reproductive toxicity No known mutagenicity below NOAEL of 28L STOT – single exposure No known effect below NOAEL of 28L STOT – repeated exposure No known effect below NOAEL of 28L Aspiration hazard 12. Ecological information 12.1 Toxicity...

SAFETY DATA SHEET According to EU Directive 91/151/EEC as amended by Directive 2001/58/EC Date of issue: March 2015. 14.7 Transport in bulk 15. Regulatory information 15.1 Safety, health and This safety datasheet complies with the environmental requirements of Regulation (EC) No. 1907/2006 regulations/legislation specific for substance Chemical safety assessment Contains no known hazard. The above information is based on our present day knowledge and relates solely to the safety requirements of the product. It does not constitute a guarantee for any specific property users of the product...