SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Print Date 08.07.2015 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Trade name : gigasept® FF (new) 1.2 Relevant identified uses of the substance or mixture and uses advised against Use of the Substance/Mixture Recommended restrictions on use : Disinfectants : Restricted to professional users. 1.3 Details of the supplier of the safety data sheet Producer/Supplier : Schülke & Mayr GmbH Robert-Koch-Str. 2 22851 Norderstedt Germany Telephone: +4940521000 Telefax: +494052100318 mail@schuelke.com www.schuelke.com Contact person : Application Department HI +49 (0)40/ 521 00 544 (Schülke UK +44 114 254 3500) pab@schuelke.com 1.4 Emergency telephone number Emergency telephone number Emergency telephone number : UK Poisons Emergency number: 0870 600 6266 : +49 (0)40 / 52 100 –0 SECTION 2: Hazards identification 2.1 Classification of the substance or mixture Classification (67/548/EEC, 1999/45/EC) Harmful R20/21/22: Harmful by inhalation, in contact with skin and if swallowed. R36: Irritating to eyes. R68/20/21/22: Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed. Irritant Harmful 2.2 Label elements Labelling according to EC Directives (1999/45/EC): Hazard symbols Z11255 ZSDB_P_SG EN : Page 1/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Print Date 08.07.2015 Harmful R-phrase(s) : R20/21/22 R36 R68/20/21/22 S-phrase(s) : S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing and gloves. S36/37 Further information Harmful by inhalation, in contact with skin and if swallowed. Irritating to eyes. Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed. : In the EU, this product falls under the Directive medical devices 93/42/EEC. The product is classified and labelled in accordance with EC directives or respective national laws. Hazardous components which must be listed on the label: 638-37-9 Succindialdehyde 67-56-1 Methanol Special labelling of certain mixtures : Labelling according to Regulation (EC) No. 648/2004: (< 5 % Phosphonates, < 5% anionic surfactants,, < 5% non-ionic surfactants,, perfumes) Methylisothiazolinone Further information : The product is classified in accordance with Annex VI (2.2.5) to Directive 67/548/EEC. 2.3 Other hazards This mixture contains no substance considered to be persistent, bioaccumulating nor toxic (PBT). Do not breathe vapour. SECTION 3: Composition/information on ingredients 3.2 Mixtures Chemical nature : Solution of the following substances with harmless additives. Hazardous components Chemical Name Succindialdehyde Index-Number Classification CAS-No. (67/548/EEC) EC-No. Registration number 638-37-9 T; R25 211-333-8 Xi; R36/37 Dimethoxytetrahydrofu- 696-59-3 rane 211-797-1 Z11255 ZSDB_P_SG EN R10 Xn; R20 Xi; R36 Page 2/14 Classification (REGULATION (EC) No 1272/2008) Concentration [%] Acute Tox. 3; H301 Eye Irrit. 2; H319 STOT SE 3; H335 11,9 % Flam. Liq. 3; H226 Acute Tox. 3; H331 Eye Dam. 2; H319 3,2 % 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Ethanol 603-002-00-5 64-17-5 200-578-6 01211945761043-XXXX Methanol Alkyl-polyethylenglycolpolypropylenglycolether 2-(2-hexyloxyethoxy)ethanol F; R11 Print Date 08.07.2015 Flam. Liq. 2; H225 Eye Irrit. 2; H319 5 - 15 % 603-001-00-X F; R11 67-56-1 T; R23/24/25 200-659-6 T; R39/23/24/25 Flam. Liq. 2; H225 Acute Tox. 3; H331 Acute Tox. 3; H311 Acute Tox. 3; H301 STOT SE 1; H370 5 - 10 % 127036-24-2 Xi; R41 Eye Dam. 1; H318 1- 5% 112-59-4 203-988-3 Xn; R21 Xi; R41 Acute Tox. 4; H312 Eye Dam. 1; H318 1- 5% For the full text of the R-phrases mentioned in this Section, see Section 16. For the full text of the H-Statements mentioned in this Section, see Section 16. SECTION 4: First aid measures 4.1 Description of first aid measures General advice : Take off all contaminated clothing immediately. If inhaled : Move the victim to fresh air and keep him calm. No artificial respiration, mouth-to-mouth or mouth to nose. Use suitable instruments/apparatus. If symptoms persist, call a physician. In case of skin contact : Wash off immediately with plenty of water. If symptoms persist, call a physician. In case of eye contact : In case of eye contact, remove contact lens and rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. If eye irritation persists, consult a specialist. If swallowed : Do NOT induce vomiting. Clean mouth with water and drink afterwards plenty of water. Call a physician immediately. 4.2 Most important symptoms and effects, both acute and delayed Symptoms : Treat symptomatically. 4.3 Indication of any immediate medical attention and special treatment needed Treatment Z11255 ZSDB_P_SG EN : For specialist advice physicians should contact the Poisons Information Service. Page 3/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Print Date 08.07.2015 SECTION 5: Firefighting measures 5.1 Extinguishing media Suitable extinguishing media : Dry powder, Foam, Water spray jet, Carbon dioxide (CO2) Unsuitable extinguishing media : High volume water jet 5.2 Special hazards arising from the substance or mixture Specific hazards during firefighting : No information available. Specific risk from the substance or the product itself, its combustion products or evolved gases : Carbon dioxide (CO2), carbon monoxide (CO), oxides of nitrogen (NOx) 5.3 Advice for firefighters Special protective equipment for firefighters : In the event of fire, wear self-contained breathing apparatus. SECTION 6: Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Personal precautions : Ensure adequate ventilation. Use personal protective equipment. 6.2 Environmental precautions Environmental precautions : Avoid subsoil penetration. Do not flush into surface water or sanitary sewer system. 6.3 Methods and materials for containment and cleaning up Methods for cleaning up : Wipe up with absorbent material (e.g. cloth, fleece). Soak up with inert absorbent material (e.g. sand, silica gel, acid binder, universal binder, sawdust). 6.4 Reference to other sections See chapter 8 + 13 SECTION 7: Handling and storage 7.1 Precautions for safe handling Advice on safe handling : Provide sufficient air exchange and/or exhaust in work rooms. Wear personal protective equipment. Advice on protection against fire and explosion : No special protective measures against fire required. Hygiene measures : When using do not eat, drink or smoke. Z11255 ZSDB_P_SG EN Page 4/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Print Date 08.07.2015 7.2 Conditions for safe storage, including any incompatibilities Requirements for storage areas and containers : Store at room temperature in the original container. Keep at temperature not exceeding 25 °C. Further information on storage conditions : Keep away from heat. Keep away from direct sunlight. Keep container tightly closed. Recommended storage temperature: 5 - 25°C Advice on common storage : Keep away from food and drink. 7.3 Specific end use(s) Specific use(s) : none SECTION 8: Exposure controls/personal protection 8.1 Control parameters Components CAS-No. Ethanol 64-17-5 Ethanol 64-17-5 Ethanol 64-17-5 Methanol 67-56-1 Value type (Form of exposure) Permissible exposure limit Ceiling Limit Value Permissible exposure limit Permissible exposure limit Control parameters 500 ppm 960 mg/m3 1.000 ppm 1.920 mg/m3 1.000 ppm 1.900 mg/m3 200 ppm 260 mg/m3 Basis TRGS 900 TRGS 900 OSHA EC/2000/39 8.2 Exposure controls Personal protective equipment Eye protection : Tightly fitting safety goggles Hand protection : Splash protection: disposable nitrile rubber gloves e.g. Dermatril (layer thickness: 0,11 mm) made by KCL or gloves from other manufacturers offering the same protection. Prolonged contact: Nitrile rubber gloves e.g. Camatril (>480 Min., layer thickness: 0,40 mm) or butyl rubber gloves e.g. Butoject (>480 Min., layer thickness: 0,70 mm) made by KCL or gloves from other manufacturers offering the same protection. Protective measures : Avoid contact with skin and eyes. Do not breathe vapour. Environmental exposure controls General advice Z11255 ZSDB_P_SG EN : Avoid subsoil penetration. Do not flush into surface water or sanitary sewer system. Page 5/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Print Date 08.07.2015 SECTION 9: Physical and chemical properties 9.1 Information on basic physical and chemical properties Appearance Colour Odour Flash point Ignition temperature Auto-ignition temperature Lower explosion limit Upper explosion limit Flammability Explosive properties Oxidizing properties pH Melting point/freezing point Decomposition temperature Boiling point/boiling range Vapour pressure Relative vapour density Density Water solubility Viscosity, dynamic Evaporation rate : : : : : : : : : : : : : : : : : : : : liquid green characteristic 38,5 °C, DIN 51755 Part 1 Ethanol: > 360 °C not applicable Ethanol: 3,1 %(V) Ethanol: 15 %(V) Does not sustain combustion. Not explosive not applicable ca. 6,5, 20 °C, concentrate < -5 °C no data available ca. 90 °C no data available no data available ca. 1,01 g/cm3, 20 °C in all proportions, 20 °C no data available no data available 9.2 Other information no data available SECTION 10: Stability and reactivity 10.1 Reactivity No dangerous reaction known under conditions of normal use. 10.2 Chemical stability The product is chemically stable. 10.3 Possibility of hazardous reactions None reasonably foreseeable. 10.4 Conditions to avoid Extremes of temperature and direct sunlight. 10.5 Incompatible materials Strong acids and strong bases 10.6 Hazardous decomposition products None reasonably foreseeable. Z11255 ZSDB_P_SG EN Page 6/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Print Date 08.07.2015 SECTION 11: Toxicological information 11.1 Information on toxicological effects Acute toxicity Product Acute oral toxicity Acute toxicity (other routes of administration) Components: Succindialdehyde: Acute inhalation toxicity Acute dermal toxicity Dimethoxytetrahydrofurane: Acute inhalation toxicity Acute dermal toxicity Ethanol: Acute inhalation toxicity Acute dermal toxicity Methanol: Acute inhalation toxicity Acute dermal toxicity : LD50: 1990 mg/kg, rat, The following toxicological data shown are those obtained from tests on products of similar composition. : LD50 intravenous: 363 mg/kg, rat, The following toxicological data shown are those obtained from tests on products of similar composition. : no data available : LD50: > 2000 mg/kg, rat : LC50: > 6,2 mg/l, 4 h, rat, vapour : LD50: > 400 mg/kg, rabbit : LC50: 39 mg/l, 4 h, mouse : LD50: 20000 mg/kg, rabbit : LC50: 83,8 mg/l, 4 h, rat : LD50: 15800 mg/kg, rabbit LD0: 393 mg/kg, Monkey Alkyl-polyethylen-glycolpolypropylen-glycolether: Acute inhalation toxicity : no data available Acute dermal toxicity : no data available 2-(2-hexyloxy-ethoxy)ethanol: Acute inhalation toxicity : LC0: 8 h, rat, vapour , Due to the viscosity, this product does not present an aspiration hazard. Acute dermal toxicity : LD50: 2001 - 2216 mg/kg, rabbit Skin corrosion/irritation Components: Succindialdehyde: no data available Dimethoxytetrahydrofurane: No skin irritation, rabbit Ethanol: No skin irritation, rabbit Methanol: Mild skin irritation, rabbit Alkyl-polyethylen-glycolpolypropylen-glycolether: No skin irritation, rabbit 2-(2-hexyloxy-ethoxy)ethanol: Skin irritation Serious eye damage/eye irritation Components: Succindialdehyde: Irritating to eyes. Dimethoxytetrahydrofurane: Irritating to eyes., rabbit Z11255 ZSDB_P_SG EN Page 7/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Print Date 08.07.2015 Ethanol: Mild eye irritation, rabbit Methanol: Mild eye irritation, rabbit Alkyl-polyethylen-glycolpolypropylen-glycolether: Risk of serious damage to eyes., rabbit 2-(2-hexyloxy-ethoxy)ethanol: Risk of serious damage to eyes. Respiratory or skin sensitisation Components: Succindialdehyde: no data available Dimethoxytetrahydrofurane: According to experience not expected Ethanol: Did not cause sensitisation on laboratory animals. Maximisation Test guinea pig Methanol: Did not cause sensitisation on laboratory animals. Maximisation Test guinea pig Alkyl-polyethylen-glycolpolypropylen-glycolether: Did not cause sensitisation on laboratory animals. guinea pig OECD Test Guideline 406 2-(2-hexyloxy-ethoxy)ethanol: Did not cause sensitisation on laboratory animals. Germ cell mutagenicity Components: Succindialdehyde: Germ cell mutagenicity- As: no data available sessment Dimethoxytetrahydrofurane: Germ cell mutagenicity- As: Tests on bacterial or mammalian cell cultures did not show sessment mutagenic effects. Ethanol: Genotoxicity in vitro : Not mutagenic in Ames Test. OECD Test Guideline 471 Genotoxicity in vivo : not mutagenic Germ cell mutagenicity- As: Tests on bacterial or mammalian cell cultures did not show sessment mutagenic effects. Methanol: Germ cell mutagenicity- As: no data available sessment Alkyl-polyethylen-glycolpolypropylen-glycolether: Germ cell mutagenicity- As: Not mutagenic in Ames Test. sessment 2-(2-hexyloxy-ethoxy)ethanol: Genotoxicity in vitro : Did not show mutagenic effects in animal experiments. Germ cell mutagenicity- As: Did not show mutagenic effects in animal experiments. sessment Carcinogenicity Components: Succindialdehyde: Carcinogenicity - Assess: no data available ment Dimethoxytetrahydrofurane: Carcinogenicity - Assess: no data available ment Z11255 ZSDB_P_SG EN Page 8/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Print Date 08.07.2015 Ethanol: Carcinogenicity - Assess: Did not show carcinogenic effects in animal experiments. ment Methanol: Carcinogenicity - Assess: no data available ment Alkyl-polyethylen-glycolpolypropylen-glycolether: Carcinogenicity - Assess: no data available ment 2-(2-hexyloxy-ethoxy)ethanol: Carcinogenicity - Assess: no data available ment Reproductive toxicity Components: Succindialdehyde: Reproductive toxicity - As: no data available sessment Dimethoxytetrahydrofurane: Reproductive toxicity - As: no data available sessment Ethanol: Reproductive toxicity - As: In animal testing, risk of impaired fertility was shown only after sessment administration of very high doses of this substance. Methanol: Reproductive toxicity - As: no data available sessment Alkyl-polyethylen-glycolpolypropylen-glycolether: Reproductive toxicity - As: no data available sessment 2-(2-hexyloxy-ethoxy)ethanol: Reproductive toxicity - As: Animal testing did not show any effects on fertility. sessment Teratogenicity Components: Succindialdehyde: Teratogenicity - Assessment : no data available Dimethoxytetrahydrofurane: Teratogenicity - Assessment : no data available Ethanol: rat, Oral, NOAEL: 2.000 mg/kg Teratogenicity - Assessment : Animal experiments showed mutagenic and teratogenic effects. Methanol: Teratogenicity - Assessment : no data available Alkyl-polyethylen-glycolpolypropylen-glycolether: Teratogenicity - Assessment : no data available 2-(2-hexyloxy-ethoxy)ethanol: Teratogenicity - Assessment : Did not show teratogenic effects in animal experiments. STOT - single exposure no data available STOT - repeated exposure no data available Z11255 ZSDB_P_SG EN Page 9/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Print Date 08.07.2015 Repeated dose toxicity Components: Ethanol: rat: NOAEL: 2.400 mg/kg , Oral Aspiration toxicity no data available SECTION 12: Ecological information 12.1 Toxicity Components: Succindialdehyde : Toxicity to fish : no data available Toxicity to daphnia and other : no data available aquatic invertebrates Toxicity to algae : no data available Dimethoxytetrahydrofurane : Toxicity to fish Toxicity to daphnia and other aquatic invertebrates Toxicity to algae Ethanol : : LC50 (Leuciscus idus): 2.500 mg/l, 96 h, DIN 38412 : no data available Toxicity to fish Toxicity to daphnia and other aquatic invertebrates Toxicity to algae : LC50 (Leuciscus idus (Golden orfe)): 8.140 mg/l, 48 h : EC50 (Daphnia magna (Water flea)): > 5.000 mg/l, 48 h : no data available : IC50 (Scenedesmus quadricauda (Green algae)): > 100 mg/l, 72 h Methanol : Toxicity to fish Toxicity to daphnia and other aquatic invertebrates Toxicity to algae : LC50 (Lepomis machrocirus): 15.400 mg/l, 96 h : NOEC (Daphnia magna): 10.000 mg/l, 48 h Toxicity to fish : LC50 (Danio rerio (zebra fish)): 1 - 10 mg/l, 96 h, OECD Test Guideline 203 : not determined : NOEC (Scenedesmus quadricauda (Green algae)): 8.000 mg/l, 192 h Alkyl-polyethylen-glycolpolypropylen-glycolether : Toxicity to daphnia and other aquatic invertebrates Toxicity to algae : not determined 2-(2-hexyloxy-ethoxy)ethanol : Toxicity to fish Toxicity to daphnia and other aquatic invertebrates Toxicity to algae : LC50 (Pimephales promelas (fathead minnow)): 200 - 230 mg/l, 96 h : EC50 (Daphnia magna): 370 mg/l, 48 h : no data available 12.2 Persistence and degradability Product Biodegradability Z11255 ZSDB_P_SG EN : Readily biodegradable., OECD 301D / EEC 84/449 C6 Page 10/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Chemical Oxygen Demand (COD) Revision Date 04.12.2013 Print Date 08.07.2015 : ca. 7.929 mg/l , 1% solution 12.3 Bioaccumulative potential Components: Succindialdehyde : Bioaccumulation : no data available Dimethoxytetrahydrofurane : Bioaccumulation : No bioaccumulation is to be expected (log Pow <= 4). Ethanol : Bioaccumulation : Bioaccumulation is unlikely. Partition coefficient: n: log Pow: -0,14Method: calculated octanol/water Methanol : Bioaccumulation : Does not bioaccumulate. Partition coefficient: n: log Pow: -0,77 octanol/water Alkyl-polyethylen-glycolpolypropylen-glycolether : Bioaccumulation : not determined 2-(2-hexyloxy-ethoxy)ethanol : Bioaccumulation : No bioaccumulation is to be expected (log Pow <= 4). 12.4 Mobility in soil Components: Succindialdehyde : Mobility : no data available Dimethoxytetrahydrofurane : Mobility : no data available Ethanol : Mobility : no data available Methanol : Mobility : no data available Alkyl-polyethylen-glycolpolypropylen-glycolether : Mobility : not determined 2-(2-hexyloxy-ethoxy)ethanol : Mobility : Mobile in soils 12.5 Results of PBT and vPvB assessment Product This mixture contains no substance considered to be persistent, bioaccumulating nor toxic (PBT). 12.6 Other adverse effects Product Additional ecological information : none SECTION 13: Disposal considerations 13.1 Waste treatment methods Product Z11255 ZSDB_P_SG EN : Dispose of the product according to the defined EWC (European Waste Code) No. Page 11/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Print Date 08.07.2015 Contaminated packaging : Take empty packaging to the recycling plant. Waste key for the unused product Waste key for the unused product(Group) : European waste catalog (EWC) 070601 : Waste material of HZVA from fats, lubricants, soaps, detergents, disinfectants and personal protection products. SECTION 14: Transport information 14.1 UN number ADR Not dangerous goods IMDG Not dangerous goods IATAIATA_C Not dangerous goods 14.2 Proper shipping name ADR Not dangerous goods IMDG Not dangerous goods IATAIATA_C Not dangerous goods 14.3 Transport hazard class ADR Not dangerous goods IMDG Not dangerous goods IATAIATA_C Not dangerous goods 14.4 Packing group ADR Not dangerous goods IMDG Not dangerous goods IATAIATA_C Not dangerous goods 14.5 Environmental hazards ADR Not dangerous goods IMDG Not dangerous goods IATAIATA_C Not dangerous goods 14.6 Special precautions for user For personal protection see section 8. Further information Z11255 ZSDB_P_SG EN : Not classified as supporting combustion according to the transport regulations. Page 12/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Revision Date 04.12.2013 Print Date 08.07.2015 14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Exempt SECTION 15: Regulatory information 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture Legislation on the control of major-accident hazards involving dangerous substances : Directive 96/82/EC does not apply Volatile organic compounds : 18 %, Directive 1999/13/EC on the limitation of emissions of volatile organic compounds Other regulations : Take note of Dir 94/33/EC on the protection of young people at work. Take note of Dir 92/85/EEC on the safety and health at work of pregnant workers. 15.2 Chemical Safety Assessment Exempt SECTION 16: Other information Full text of R-Phrases R10 R11 R20 R21 R23/24/25 R25 R36 R36/37 R39/23/24/25 R41 Flammable. Highly flammable. Harmful by inhalation. Harmful in contact with skin. Toxic by inhalation, in contact with skin and if swallowed. Toxic if swallowed. Irritating to eyes. Irritating to eyes and respiratory system. Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed. Risk of serious damage to eyes. Full text of H-Statements H225 H226 H301 H311 H312 H318 H319 H331 H335 H370 Highly flammable liquid and vapour. Flammable liquid and vapour. Toxic if swallowed. Toxic in contact with skin. Harmful in contact with skin. Causes serious eye damage. Causes serious eye irritation. Toxic if inhaled. May cause respiratory irritation. Causes damage to organs. Full text of other abbreviations Z11255 ZSDB_P_SG EN Page 13/14 0082271652 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 gigasept® FF (new) Version 01.04 Acute Tox. Eye Dam. Eye Irrit. Flam. Liq. STOT SE Revision Date 04.12.2013 Print Date 08.07.2015 Acute toxicity Serious eye damage Eye irritation Flammable liquids Specific target organ toxicity - single exposure Further information Changes compared with the previous edition!!! The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text. Z11255 ZSDB_P_SG EN Page 14/14 0082271652