Emergency Telephone Number: ORFILA: GIGASEPT PA. Schülke & Mayr UK Ltd Jenkin road, Meadowhall, Sheffield S9 1AT.

Transcription

1 SAFETY DATA SHEET LABORATOIRES ANIOS Laboratoires Pharmaceutiques No. F 9218 Pavé du Moulin F LILLE-HELLEMMES FRANCE Tel : Fax : In Compliance with Directive 91/155/EEC Emergency Telephone Number: ORFILA: IDENTIFICATION 1.1 Product (Trade) Name: 1.2 Supplier: GIGASEPT PA Schülke & Mayr UK Ltd Jenkin road, Meadowhall, Sheffield S9 1AT. : COMPOSITION 2.1 General Chemical Description Oxydising agents catalysor, glycolic derivatives, non ionic surfactants, isopropylic alcohol and colouring. Hydrogen peroxide, corrosion inhibitors, stabilizating agents. Activated solution : The activated solution corresponds to a mix of both above products, with production of peracetic acid, with 0.15% maximal concentration. 2.2 Possible hazardous ingredients Isopropylic alcohol F+, R11, R 36, R67 CAS n Hydrogen peroxide C,O R8-R34 CAS n SDS n /10/09 - page 1/7

2 3 - IDENTIFICATION OF HAZARDS 3.1 Specific risks R22 : Harmfull if swallowed. R36 : Irritating to eyes. R11 : easily flammable. Generator and activated solution : The product is not classified like "hazardous preparation" according to the 88/379/EC Directive relative to classification, labelling and packaging of hazardous substances. 4 - FIRST AID - If projection in eyes, wash immediately with plenty of water, even under eyelids, for at least 15 minutes. Take off lenses, when it can be easily done. Make complementary cures at ophtalmologist. - If spilled on skin, remove soiled clothing and wash with water and soap. If irritation or allergic reaction occur, seek medical advice. - If swallowed, do not provoke vomiting. Use a gastric demulcent and seek immediately medical device. Show him the label where possible. 5 - SPECIAL FIRE FIGHTING PROCEDURES 5.1 Extinguishing Media - Recommended Special fire-fighting methods Special equipment for fire-fighters Appropriated extinguishing agents : broken or full jet, extinguishing foam. Unappropriated extinguishing agents : extinguishing powder, carbon dioxide. The product is not combustible. In case of peripheric fire decomposition hazard with oxygen release. Oxygen release can favour combustion. Surpression and explosion hazard in case of decomposition in closed recipies. In case of fire, cool menaced recipies with water or flood them with water. Wear a self-contained breathing apparatus and a complete protective suit when fire-fighting. SDS n /10/09 - page 2/7

3 6 - SPILL OR LEAK PROCEDURES 6.1 Personal protection 6.2 Precautions to take to protect the environment 6.3 Cleaning methods Wear suitable gloves and an eye / face protective mask. Look afterthe protection of rivers and floors. In case of spillage, spread absorbant material. Collect and eliminate in barrels, cover them. Rinse the stained area with water. Complementary indication : never reintroduce a spilled product in the origin packaging in order to reuse it. (decomposition hazard). 7 - HANDLING AND STORAGE 7.1 Handling 7.2 Storage Do not smoke during use. Do not mix with other products than those provided for the activation of the solution. Avoid spilling the product on skin or splashing in eyes. Ensure a good aeration of room. Provide the installation of safety shower and ocular fountain. Store the product in its original packaging. Store, in areas efficiently ventilated, in a cool place. away from heat sources and combustible products. Do not exceed the shelf-life date marked on the packaging. 8 - EXPOSURE CONTROL / INDIVIDUAL PROTECTION Protection of hands : Suitable gloves. Other protective steps : Provide an eye bath and safety shower. All stained protective equipments have to be cleaned before their reuse. Compounds of which limit values related to the work post have to be checked : Hydrogen peroxide Limit value VME (F) 1 ppm = 1.4 mg/m 3 (1994) General protection and hygiene steps: Observe standard practices and care applicable during the use of a chemical product. SDS n /10/09 - page 3/7

4 9 - PHYSICAL AND CHEMICAL DATA 9.1 Appearance 9.2 ph 9.3 Specific Gravity 9.4 Flammability 9.1 Appearance 9.2 ph 9.3 Specific Gravity 9.4 Flash point 9.5 Flammability Physical state at +20 C...: liquid, clear Colour...: colourless Odour...: characteristic Pure product...: 7.0 ± 0.5 at +20 C ± g/cc at +20 C Non-flammable Physical state at +20 C...: liquid, clear Colour...: orange Odour...: slight Pure product...: 5.0 ± 0.5 at +20 C ± g/cc at +20 C < 21 C retort (estimation) Easily flammable 10 - STABILITY AND REACTIVITY DATA 10.1 Stability 10.2 Conditions to avoid 10.3 Materials to avoid The product is an oxidising stable at room temperature. Avoid the exposure to heat and sunlight. Combustible substances, alcali, chlorhydric acid, reductors, solvants. Do never mix with other products than those provided for the activation of the solution TOXICOLOGICAL INFORMATION 11.1 Skin irritation 11.2 Eye irritation 11.3 If swallowed Activated solution : Assessment of skin tolerance in rabbits. Skin primary irritation index. IPC = slightly irritating. Assessment of eye tolerance in rabbits. Eye irritation index. IOMa = 23.3 (24 hours later instillation) slightly irritating. May provide moderate irritation of alimentary canal ECOLOGICAL INFORMATION Quick biotic degradation after hydrolisis, decomposition, reduction. No dangerous effect for the environment is to be expected on the basis of current knowledge. Preparation biodegrades easily. Weak concentrations do not affect the biological cycle of activated sludge and may be degraded in a waste water treatment system. SDS n /10/09 - page 4/7

5 13 - OBSERVATIONS ON DISPOSAL In compliance with current regulations, contaminated packaging must be taken to an approved incineration centre for specific waste TRANSPORTATION INFORMATION Road-transport RTMDR/ADR Transport by vessel - IMDG Air transport - IATA Not listed as a dangerous material with regard to transport regulations. Goods description : Flammable liquid, NSA Class... : 3 Hazard code... : 33 Number or letter... : 3 b UN No... : 1993 Label no.... : 3 Goods description: Flammable liquid, NSA Class... : 3.3 UN Number... : 1993 Packaging group.... : II Page/IMDG code... : 3230 SDS Number... : 3-07 GSMU table Number... : see section 4.2 Goods description: Flammable liquid, NSA (ethylic alcohol solution) Class... : 3 UN Number... : 1993 Label... : Flammable Packaging group.... : II SDS n /10/09 - page 5/7

6 15 - REGULATORY INFORMATION Safety data sheet Classification/Labelling EC 91/155/EC Directive modified by 93/112/EC Directive : hazardous preparations and substances. 88/379/EC Directive modified by 96/54/EC Directive (22 nd version). Hazard symbol : none Safety phrases: S 2: Keep out of the reach of children. S 3 : Keep in a cool place. S 24/25: Avoid contact with eyes and skin. S 26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S 37: Wear suitable gloves. Hazard symbols : F : Easily flammable Xn : Harmful Hazard phrases: R22 : Harmful if swallowed. R36 : Irritating to eyes Safety phrases: S 2: Keep out of the reach of children. S 16 : Keep away from sources of ignition. No smoking. S 24/25: Avoid contact with eyes and skin. S 26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S 37: Wear suitable gloves. SDS n /10/09 - page 6/7

7 16 - OTHER INFORMATION Recommended use and restrictions of use: Indications: Cold sterilizant for thermosensitive medical devices. Preparation protocol of GIGASEPT PA : The initial product comprises a 5 liter can (generator) and a flask (activator). - Introduce the contain of the activator flask in the 5 liter can. - Put the activated solution in the disinfection bath (which ensures the GIGASEPT PA homogeneization) minutes after mixing, GIGASEPT PA is ready to use. Validate the peracetic acid rate produced with a test strip. - Immerse the medical device in the GIGASEPT PA bath. - Regularly, check the peracetic acid rate. Renew the solution when the test strip does no more react (the preparation can be done the night before). This data sheet considers all potential hazards susceptible to be due to the manipulation and the use of the preparations when they are distributed, but not necessarly when they are on whatever use presentation, for exemple after dilution. The attention of the user is drawn to the regulatory obligations to which he is committed in accordance with the clauses below. The user is also reminded of the risks linked to using a product for a purpose other than that for which it is intended. "This data sheet does not replace but completes the information contained in our technical instructions, and is based on our current degree of knowledge of the product concerned at the time of its drafting. The user is in no case exempt from becoming aware of and applying all regulatory texts specific to his sector of activity. He will be held fully responsible for taking all precautionary measures required and specific to his use of the product." NOTE: "The sole aim of these specifications is to assist the recipient in fulfilling his obligations. This list should not be considered as exhaustive". SDS n /10/09 - page 7/7