SECTION 1- Identification of substance or of mixture and of the society/company 1.1. Product identification Product name Lactulose Solution USP / EP Grade CAS n 4618-18-2* REACH n : This substance has no registration number since the substance itself or its applications are exempted from registration according to Art. 2 of REACH(EC) n. 1907/2006, the annual amount does not require registration or registration is envisaged for a later date * referred to the active ingredient 1.2. Relevant identified use of the substance or mixture and not recommended uses Identified uses: Chemicals for laboratory, active pharmaceutical ingredient for substance production, food use, therapeutic category-laxative. 1.3. Information on supplier of the safety data sheet Fresenius Kabi ipsum-vicchio S.r.l., 50039 Vicchio/Italy Telefono +39-055-843901 Telefax +39-055-844730 1.4. Emergency telephone number Telephone +39-055-843901 SECTION 2: Hazards identification 2.1 Substance/mixture No. 1272/2008/EC classification This substance/mixture is not hazardous, according to Guidelines 1272/2008/EC This substance it is not classified as hazardous, according to Directive 67/548/EEC 2.2 Label elements This product must not be labeled in accordance with Community Directives or national laws 2.3 Other hazards No other data available SECTION 3: Composition/information on ingredients 3.1. Substances Synonyms Lactulose Syroup 4-O-ß-D-Galactopyranosyl-D-Fructose* Print date: 08.08.2017 Page: 1 of 6
4-O-β-D-Galactopyranosyl-D-fructofuranose* CAS 4618-18-2* EINECS 225-027-7* Molecular formula C 12 H 22 O 11 Molecular weight 342.30* Merck index 14,5346* *referred to the active ingredient SECTION 4- First Aid Measures 4.1. First Aid measures description Inhalation: if the product is inhaled, bring the person to the outside Cutaneous contact: if the product have contact with the skin, flush with copious amount of water and soap Eye contact: if the product have contact with eyes, assure adequate flushing of the eyes by separating the eyelids with fingers Ingestion: If the product is swallowed, wash out the mouth with plenty of water; check the status of consciousness, do not give anything by mouth to a unconscious person. Call a physician. 4.2. Main symptoms and effects, both acute and delayed Main symptoms are indicated in paragraph 2.2 and/or in the section 11 4.3 Indication of the need to consult immediately a physician or special treatments No information available SECTION 5 : Fire-Fighting Measures 5.1. Extinguishing media Water, alcohol-resistant foam, chemical powder or carbon dioxide 5.2 Special hazards derived from substance or from Mixture Under fire conditions material emits toxic fumes of carbon monoxide 5.3 Recommendations for firefighters For fire-fighting wear self-contained breathing apparatus if necessary and protective clothing to prevent contact with skin and eyes SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and procedures in case of emergency Avoid to breath vacuum, mists, gases or dust formation. For personal protective equipment Print date: 08.08.2017 Page: 2 of 6
see section 8 6.2 Environmental precautions Avoid product leakage 6.3. Methods and materials for containment and cleaning Remove and clean with absorbent material, placing the waste in suitable containers in accordance with applicable environmental laws. 6.4. Other section references For disposal operations refer to section 13. SECTION 7: Handling and storage 7.1. Precautions for Safe Handling Provide adequate expulsion ventilation in the places where dust is generated, with particular reference to the product pouring phases. Do not let staff eat, drink, or smoke near the product. Observe normal fire safety precautions. Avoid contact with skin, eyes, clothing. 7.2. Conditions for safe storage, including any incompatibilities Store in suitable tightly closed container. Store following the labeling in clean, well ventilated, fresh and dry places. 7.3 Particular end-use There are no other uses predicted except those reported in paragraph 2.2. SECTION 8: Exposure control/personal protection 8.1. Control parameters Existence of control parameters on workplace 8.2. Exposition control General methods of Industrial Hygiene. Personal protective equipment - D.P.I. Eyes protection: use goggles EN 166 Hand and skin protection: use gloves comply with Directive 89/686/EEC and EN374 nitrile rubber characterized Nitrile rubber characterized by suitable permeation time for the specific application scenario. Body protection: Lab coat or other safety clothes typical of the laboratories Respiratory protection: In presence of adequate ventilation it is not normally necessary to use a facial filter or other APVR. SECTION 9: Physical and chemical properties Print date: 08.08.2017 Page: 3 of 6
9.1. Physical Properties Boiling point Specific gravity 1.3 g / ml Vapour pressure Melting point Vapour density Solubility 100 % mixable with water Appearance and odour Clear light yellow liquid with slightly sweet odour Flash point Water content 35 % 9.2 Other informations No further information available SECTION 10: Stability and reactivity 10.1 Reactivity The product is stable under normal conditions. 10.2 Chemical stability The product is stable under normal conditions and under corrected storage conditions 10.3. Hazardous reactions possibility No information available 10.4 State to be avoided In presence of oxidants, could be possible slightly exothermic reactions 10.5. Incompatible materials Strong oxidizing agents 10.6 Hazardous decomposition products When the product is heated to decomposition, material emits acrid smoke and irritating fumes. In case of fire see section n 5 SECTION 11: Toxicological informations 11.1. Information on toxicological effects Acute effects May cause skin and/or eyes irritation Signs and symptoms of exposition May be harmful and/or irritating by inhalation, causing nausea, diarrhea, flatulence RTECS n LS6965000 Print date: 08.08.2017 Page: 4 of 6
Acute toxicity * referred to the active ingredient LD 50 31000 mg / kg (oral-mouse)* LD 50 18160 mg / kg (oral-rat)* SECTION 12: Ecological Information 12.1 Toxicity Toxic environmental effects are not known 12.2. Persistence and degradability 12.3. Bioaccumulative potential 12.4 Mobility in soil Absorb with inert material, place into appropriate container 12.5. Results of PBT and vpvb assessment since not required/non conducted 12.6. Other adverse effects SECTION 13: Disposal consideration 13.1. Waste disposal methods Biodegradation through an active sludge waste waters plant. Dissolve or mix the material with a combustible solvent and burn in a suitable incinerator equipped with an afterburner and scrubber. Observe all applicable federal regulations Contaminated containers Treat as product containers to dispose SECTION 14: Transport information 14.1. ONU number 14.2. Proper ONU shipping name ADR/RID: Non-hazardous for road transport IMDG: Non-hazardous for sea transport IATA: Non-hazardous for air transport Print date: 08.08.2017 Page: 5 of 6
14.3. Hazard classes transport-related 14.4. Packing group 14.5. Environmental hazards 14.6. Special precautions for users 14.7. Transport in bulk according to Annex II of Marpol 73/78 and the IBC Code SECTION 15: Regulatory information 15.1. Safety, health and environmental regulations / legislation specific for the substance or mixture This Safety Data Sheet is in compliance with Regulation No. 1907/2006. The product is not classified according to European standards 15.2 Chemical safety assessment SECTION 16: Additional Information The information in this material safety data sheet meets international requirements. This document is intended only as a guide to the appropriate precautionary handling of the material by a person trained in chemical handling. The user is responsible for determining the precautions and dangers of this chemical for particular application depending on usage. Protective clothing including eye and face guard and respirators must be used to avoid contact with material or breathing chemical vapours / fumes. Fresenius Kabi ipsum-vicchio disclaims any other warranties, expressed or implied, with regard to the product supplied hereunder. As new documented general safety information becomes available, Fresenius Kabi ipsum- Vicchio will periodically revise this material safety data sheet. It is user s responsibility to contact our customer service department for the updated version of this document. Print date: 08.08.2017 Page: 6 of 6